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Why the COVID vaccine isn’t part of an injury compensation court
From inoculations against polio and smallpox to protections from measles and tetanus, vaccines are critical health care tools that have saved more than 150 million lives in the past 50 years.
Rarely, they can also have side effects.
This week on 60 Minutes, correspondent Jon Wertheim reports on vaccine court, a little-known legal forum that has, for almost four decades, been compensating Americans who say they were injured by vaccines. Whether a person developed chronic arthritis after receiving an MMR vaccine or a shoulder injury resulting from a misplaced tetanus shot, the vaccine court is intended to provide an efficient way to compensate claimants without overwhelming vaccine makers with legal fees.
But for the more than 14,000 people who say they were injured after receiving a COVID vaccine, finding compensation is currently a little more complicated.
History of the VICP
In the 1980s, there was a public health scare over the DTP vaccine, an older version of today’s DTaP. At that time, families who said their children had been injured by the vaccine successfully sued the drug manufacturers in civil court. This caused all but one of those drug companies to stop production of the DTP vaccine.
Members of Congress and public health officials were concerned that if vaccine manufacturers weren’t given some form of legal protection, they might stop other vaccine production, putting the public health at risk. In response, Congress passed a bipartisan bill establishing the Vaccine Injury Compensation Program (VICP). The program acknowledged both that vaccines could cause injury while also partially shielding drug manufacturers from liability so they would continue to produce vaccines.
Vaccine court is part of that program. It allows people who claim vaccine-related injuries to seek compensation through a simplified legal process. There’s no jury in vaccine court. Instead, cases are decided by one of eight judges called special masters. The court is no-fault, which means that petitioners who bring claims don’t have to prove negligence. They just prove that more likely than not, their injury was caused by the vaccine.
The money for this program comes from a 75-cent tax added to every dose of recommended childhood vaccinations. Since the Vaccine Injury Compensation Program began, some 12,000 Americans have received almost $5 billion in payouts.
This program is structured around the Vaccine Injury Table, listing vaccines and eligible injuries. When the VICP began, it included six vaccinations. Today, that table has expanded to 16 immunizations, including the seasonal flu vaccine and those that inoculate against HPV.
Vaccine injuries remain very rare, but when they do occur, they can range from a physical injury in the shoulder because the needle is misplaced, to rare, severe cases in which a vaccine triggers a neurological condition.
Where COVID sits today
The vaccines that protect against COVID-19 are not among those included on the Vaccine Injury Table. That is because, to date, they are still included in a separate program for emergency measures.
In 2005, Congress established the Public Readiness and Emergency Preparedness Act (PREP Act) to ensure public health during emergencies. The legislation partially shields manufacturers and health care workers from most lawsuits related to the use of certain medical treatments during public health emergencies, including vaccines.
People who do experience serious harm or death due to these medical measures may be eligible for compensation through the Countermeasures Injury Compensation Program (CICP). This program only covers severe injuries or fatalities caused by approved emergency treatments.
Unlike VICP, the CICP is an administrative program. It has a one-year statute of limitations and is more restrictive than the vaccine court program, which is a judicial program with a three-year statute of limitations for vaccine injuries. In vaccine court, claimants can also be compensated for pain and suffering.
Around 14,000 claims have been brought to the countermeasures program regarding the COVID vaccinations. About 5,000 of those claims have been denied, and fewer than 100 have been compensated. The most common injuries compensated have been cases of myocarditis.
The COVID vaccines are considered safe and effective by public health organizations, including the CDC, which notes the rigorous clinical trials they underwent. As of May, more than 676 million doses of the COVID vaccines had been administered in the U.S.
Adding COVID vaccines to the VICP
Today, many legal experts say the COVID vaccines should be added to the VICP.
“Those people went out and did exactly what was asked of them to protect themselves, their communities, and their families. And they’re basically being hung out to dry in the countermeasures program without any real compensation,” said Renée Gentry, a top vaccine injury litigator and head of the Vaccine Injury Litigation Clinic at the George Washington University Law School.
For the COVID vaccines to be rolled into the VICP, three things would need to happen. First, the vaccine would again need to become a recommended childhood vaccine. Earlier this year, the Centers for Disease Control and Prevention’s vaccine advisory committee voted to change recommendations for the COVID-19 vaccine. The CDC now says parents of children over 6 months should speak with a health care provider about the COVID vaccination.
Next, Congress would need to pass an excise tax on the COVID vaccination so that the vaccine court would have the money to cover claims.
Finally, Secretary of Health and Human Services Robert F. Kennedy, Jr. would have to put the COVID vaccine on the Vaccine Injury Table.
In an email to 60 Minutes, Kennedy said the CDC makes the underlying decision, and he “will accept their recommendations, including as to COVID vaccines.”
If the PREP Act Declaration for COVID is terminated before the vaccines protecting against it are added to the vaccine court, COVID vaccine manufacturers would lose their shield from legal liability. The Department of Health and Human Services late last year extended certain elements of the PREP Act for COVID, keeping liability protections for certain countermeasures — including vaccine manufacturers and distributors — through 2029.
“Crushing” to add the COVID vaccine
The concern with adding COVID to the vaccine court is a matter of backlog, given the thousands of Americans who believe that they were injured by the COVID vaccine who have already brought claims to the countermeasures program. The number of special masters who adjudicate such claims has stayed at eight since the late 1980s, even though the number of cases in the court has multiplied.
“Without any improved infrastructure, without any additional special masters, it’s going to be crushing,” Gentry told 60 Minutes. “Because we know there are 10,000 unresolved cases in COVID in the countermeasures program still that haven’t been addressed. If just those cases came over, it would be a massive impact on the court. But we know that there are tens of thousands of other potential cases that are out there.”
The vaccine court’s chief special master agrees. He addressed the possibility of adding COVID vaccines to the court in a letter to Congress last year, writing, “The court’s ability to resolve vaccine injury claims efficiently will be crippled in the event we are not permitted to add more judicial officers…”
Still, those with knowledge about the subject say the COVID vaccine should be added.
“It is a medical intervention that we administered to otherwise healthy people that can cause side effects, and the fact that by having them vaccinated means that people who can’t be vaccinated are protected. That herd immunity, if you will,” said retired special master Denise Vowell.
Vowell and another former special master, George Hastings, addressed the possibility that, were the COVID vaccines added to the vaccine court, it might dissuade people from receiving the vaccine, an outcome that would be at odds with the court’s founding purpose.
“That’s always been a concern going back for the whole life of the Vaccine Injury Compensation Program, that the fact that you even had this system might worry people that vaccines can cause injuries,” Hastings said. “But the overall benefit is to have a program that, if there are rare instances where there are some adverse reactions, you compensate them without forcing people into a litigation system that would take forever. And then you’ll keep the vaccines flowing into people’s arms.”
Vowell was more pointed, noting that, while many public health interventions have side effects, the benefits outweigh them — especially when it comes to children’s health.
“Overall, the vaccine process has saved lives,” Vowell said. “If you go to an old cemetery and you look at headstones and you see the number of children who died at six months or three years of age, and then you go to a more modern cemetery today, you don’t see that number of children. Why? Because vaccine preventable illnesses have not been conquered, but they have been put in check.”
The video above was produced by Denise Schrier Cetta, Brit McCandless Farmer, Elizabeth Germino, and Jane Greeley. It was edited by Scott Rosann.
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Families grappling with rare vaccine injuries turn to government program for compensation
At his six-month check up, Jacob Thompson received a combination shot that included the recommended childhood vaccinations against diphtheria, tetanus and pertussis, or DTaP, all deemed safe and effective in clinical trials. Later that day, Jacob began to seize.
Doctors hoped the seizure was a one-time reaction. It wasn’t. In the following months as the seizures continued, doctors diagnosed Jacob with a rare and severe form of epilepsy. His parents, John and Huali, became increasingly convinced that their son’s condition could be traced back to his six-month shot.
“Vaccines are great. They’ve done a lot to help people. I think that parents need to know what can happen,” John Thompson said.
Serious vaccine injuries are so rare that, while hard to quantify precisely, their have been likened to lottery odds and lightning strikes. When an injury happens, families like the Thompsons can go to vaccine court, part of the National Vaccine Injury Compensation Program. The court is not a place to prove or disprove the safety of vaccines, but rather to compensate the injured.
The Thompsons’ experience with vaccine court
Jacob’s life now is drastically different than it was before his first seizure. He was born in St. Louis on New Year’s Eve 2011, rounding out a family of four, with sister Meili and parents John and Huali.
“He would be able to jump up and down on my wife’s lap, and very alert, recognized who mom and dad was,” Jacob’s father said.
That all changed after he got his six-month vaccinations, Jacob’s parents said. By age two, Jacob could suffer up to 700 seizures in one day.
60 Minutes
The Thompsons, seeking accountability, took their case to Renée Gentry, who is a leading vaccine injury litigator and director of the Vaccine Injury Litigation Clinic at George Washington University Law School.
“All of my clients are vaccinated. Most of them will start the conversation by saying, ‘I’m not anti-vax,'” Gentry said.
The Thompsons are not anti-vaxxers and are not invested in the heavily charged vaccine debate. They’re invested in their son, Jacob — an anguishing exception, harmed by what they say is otherwise a public health force of good.
In July, the Thompsons received a judgment of $2.1 million in vaccine court based on the special master’s ruling that it was more likely than not that Jacob’s six-month vaccinations aggravated an underlying genetic mutation. Jacob, now 13, also received a lifetime annuity to cover his future care.
The development of the National Vaccine Injury Compensation Program
Jacob is one of around 12,000 Americans who’ve received payments through vaccine court since it was started in the late 1980s. Almost $5 billion has been made in payouts since the program began.
The National Vaccine Injury Compensation Program was established in response to a public health scare in the 1980s. When families of injured children went to civil court and successfully sued the manufacturers of the DTP vaccine — an older version of the DTaP vaccine — it caused all but one of those drug companies to pull out of the market, resulting in vaccine shortages.
Congress crafted a bill that partially shielded drug manufacturers from liability so they would continue to develop life-saving vaccines.
“It’s bipartisan. It takes everyone’s views into account. And everybody compromises, which is a dirty word now. But that’s the goal of it,” Gentry said. “And it’s helped these people. Jacob will be taken care of for the rest of his life because of this program.”
60 Minutes
While global immunizations have saved an estimated 154 million lives worldwide, Congress acknowledged that vaccines can cause injury. As bill sponsor Sen. Ted Kennedy described, when “children are the victims of an appropriate and rational national policy, a compassionate Government will assist them in their hour of need.”
There’s no jury in vaccine court. Cases are decided by one of eight judges called special masters. The court pays lawyers by the hour. Where does money come from? There is a 75-cent tax imposed on recommended childhood vaccines which goes into a trust fund earmarked for vaccine injury compensation.
People who believe they’ve been injured by a vaccine can still sue a manufacturer, but they have to file in vaccine court first. And the burden of proof for claimants is lower in the National Vaccine Injury Compensation Program, so it’s easier for people to get compensation, Gentry said.
Drug companies are left out of the proceedings in the National Vaccine Injury Compensation Program. It’s a “no fault” court, meaning negligence does not need to be proven, just that the vaccine more likely than not caused the injury.
“There’s very clear indication that said it would be better to compensate somebody that wasn’t injured than to miss somebody who was,” Gentry said.
The program is structured around a Vaccine Injury Table listing eligible vaccines and injuries. If your child, for instance, got a rubella vaccine and developed chronic arthritis within seven to 42 days, you may be eligible for damages.
The most common compensation is for shoulder injuries suffered from a misplaced injection. You can file for an injury not on the table. Overall, about half of all claims are dismissed.
The table now has 16 vaccines listed, up from six when it was created. It includes the annual flu shot, though not the COVID vaccine. Autism is not listed among the eligible injuries.
Vaccine court and autism
The decision to leave autism off the injuries list did not come easily, retired Special Masters Denise Vowell and George Hastings said. The issue was litigated and decided in their court 15 years ago.
In the early 2000s, cases alleging vaccinations caused autism flooded the court, more than 5,000 in all. Vowell, Hastings and a third special master oversaw what was a class action of sorts that spanned almost a decade.
60 Minutes
Vowell said the special masters ultimately concluded the evidence wasn’t there. Vowell had hoped it would be. “Because the parents of children with autism go through so much,” she said.
But, she told 60 Minutes, she could not base her decision on sentiment.
“I had to apply the law. And the law was that if there is a preponderance of evidence of vaccine causation, I rule for them. If there isn’t, I rule against them,” Vowell said.
All three special masters concluded there was no link between vaccines and autism. On appeal, eight additional federal judges unanimously upheld the vaccine court decisions.
This has not been persuasive to Health and Human Services Secretary Robert F. Kennedy Jr.
Secretary of Health and Human Services Kennedy, whose uncle was a champion of the court, is imbued with the authority to add or redefine injuries on the vaccine table.
He declined a 60 Minutes request for an on-camera interview but said via email that he would like to “expand the table,” which he hopes will create an easier path to compensation. In particular, he wants to broaden definitions for “seizures and encephalopathy,” two neurological conditions that can be associated with autism.
Criticism of vaccine court
Kennedy told 60 Minutes that though the court’s original intent was “idealistic, compassionate, and sensible,it has become “a disaster for the families of injured children. Its effective function is delay, denial, and systematic cruelty.”
Ryan Farrell, who received a tetanus shot in 2017 after cutting his hand on some rusty metal, is very familiar with the delays in vaccine court.
He started suffering pain a few days after getting the tetanus shot.
“I felt like my back was just, like, being stabbed, like I was being like crushed,” Farrell said.
60 Minutes
At one point, he could see out of only one eye. His bladder shut down. He was hospitalized multiple times over the next few years. Doctors diagnosed him with a rare autoimmune disease.
“I didn’t wanna live for a long time,” Farrell said. “That’s how I felt.”
His wife, Angela, made the link between Farrell’s condition and his tetanus shot. She hadn’t heard of the National Vaccine Injury Compensation Program at the time, but stumbled upon it online and found a lawyer.
They filed a case in 2019, and only in July of this year did the special master rule that the tetanus shot more likely than not, likely led to Farrell’s illness.
Vaccine court was intended to compensate people for vaccine injuries “quickly, easily, and with certainty and generosity,” according to Congress.
“That couldn’t be further from the truth,” Farrell said.
He remains unable to work. And six years in, the court has yet to determine his damages.
The court acknowledges the delays. Citing a backlog of more than 3,000 cases, its chief special master has — in documents obtained by 60 Minutes — asked Congress for help four years running, saying, “it becomes more difficult each year to resolve the huge number of case filings in the expedient fashion they deserve.”
Yet, Congress has not acted.
Vaccination has become such a loaded, heavily politicized issue that some legislators appear to be reluctant to wade in.
“If what you care about are vaccine-injured people, and them being compensated, then you want this court to work. And you want this court to be here,” Gentry said.
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Vaccine court: Where Americans who suffer rare injury after vaccination can take their claims
If you’ve never before heard of the national vaccine court, you’re hardly alone. It sits inconspicuously, a few hundred yards from the White House; and stands as a model of effective public policy, balancing the societal good of widespread vaccination with rare individual harm. Founded in the 1980s, the court has, with little fanfare, paid out billions of dollars to Americans who have claimed injury after getting a vaccine. Today, with vaccine skepticism rising and given voice in the highest ranks of government, we wondered: can this singular court block out the noise, withstand the political winds, and stay true to its mission?
Jacob Thompson is 13 years old. He loves airplanes, swimming and Chick-fil-A. But Jacob can speak only a handful of words and needs help walking more than a few yards.
Jacob was born in St. Louis on New Year’s Eve, 2011, rounding out a family of four, with sister Meili and parents John and Huali — he, a pilot for FedEx; she, a recent immigrant from China.
John Thompson: We had this perfectly normal, happy little baby. He would be able to jump up and down on my wife’s lap, and very alert, recognized who mom and dad was.
At his six-month checkup, Jacob received a combination shot that included the recommended childhood vaccinations against diphtheria, tetanus and pertussis, or DTaP, all deemed safe and effective in clinical trials.
60 Minutes
Hours later, Jacob began to seize. Doctors hoped it was a one-time reaction. It wasn’t.
John Thompson: Within I’d say six months or less, he didn’t know that we were mom and dad anymore, and he was slithering on the floor like a snake.
Jon Wertheim: Unrecognizable–
John Thompson: Un– yeah.
Jon Wertheim: –from the child you knew?
John Thompson: Yeah.
By age two, Jacob could suffer up to 700 seizures in one day. He was diagnosed with a rare and severe form of epilepsy.
The Thompsons became increasingly convinced that his condition could be traced back to his six-month vaccinations. And, they began to seek accountability. They took their case to attorney Renée Gentry.
She’s a leading vaccine injury litigator and director of the Vaccine Injury Litigation Clinic at George Washington University Law School in Washington, D.C.
Renée Gentry: I represent both vaccine-injured children and adults. All of my clients are vaccinated. Most of them will start the conversation by saying, “I’m not anti-vax.”
Jon Wertheim: Why do you think they need to tell you right off the bat they’re not anti-vax, but?
Renée Gentry: There’s a lot of public pressure when you say that you have a vaccine injury, that people think you’re some kind of a crazy person or you’re out there. And also, because most people have never heard of a vaccine injury. They’re rare.
So rare that, while hard to quantify precisely, the chances of serious vaccine injury have been likened to lottery odds, lightning strikes. Bear in mind, in total, global immunization has saved an estimated 154 million lives, six lives each minute.
But when an injury does occur, families can come to vaccine court, seen in this informational video.
Part of the National Vaccine Injury Compensation Program, the court was established in response to a public health scare in the 1980s.
When families of injured children went to civil court and successfully sued the manufacturers of the DTP vaccine, an older version of DTaP, it caused all but one of those drug companies to pull out of the market, resulting in vaccine shortages.
Congress acted, crafting a bipartisan bill that partially shielded drug manufacturers from liability so they would continue to develop life-saving vaccines.
And, at the same time, Congress acknowledged that vaccines can cause injury. As bill sponsor Sen. Ted Kennedy described, when children are, “…the victims of an appropriate and rational national policy, a compassionate Government will assist them in their hour of need.”
60 Minutes
Renée Gentry: It was hailed as such a unique accomplishment back in the day because you had these disparate groups, you had the parents of vaccine-injured children together in the room with, with the manufacturers and everybody agreed that this was the best-case scenario.
Jon Wertheim: Is that fair to the public? They think they have an injury caused by a vaccine, but they can’t sue the vaccine manufacturer directly?
Renée Gentry: You can still opt out of this program and sue a manufacturer. You have to just start in this program. But it’s a lower burden of proof in our program. So it’s an easier thing for vaccine-injured people to get compensation.
Drug companies are not only not being sued; they’re not part of the proceedings. Vaccine court is a “no fault” court, meaning in cases like Jacob Thompson’s, negligence does not need to be proven, just that the vaccine, more likely than not, caused the injury.
Vaccine court is not your typical court. There’s no jury. Cases are decided in front of one of eight judges called special masters. Since the program began in the late ’80s, 12,000 Americans have received almost $5 billion in payouts. There are no financial windfalls for lawyers — the court pays them by the hour. Where does all this money come from? A 75-cent tax, imposed on recommended childhood vaccines, goes into a trust fund earmarked for vaccine injury compensation.
In July the Thompsons received a judgment of $2.1 million based on the special master’s ruling that it was more probable than not that Jacob’s six-month vaccinations aggravated an underlying genetic mutation. Jacob also received a lifetime annuity to cover his future care.
Jon Wertheim: Is there any doubt that the vaccine caused Jacob’s injury?
Renée Gentry: We can’t ever prove scientific certainty on it.
Jon Wertheim: Does that not mean though that some cases are being compensated when in fact the science might not support it?
Renée Gentry: Sure. Sure. And that’s what Congress intended. There’s very clear indication that said it would be better to compensate somebody that wasn’t injured than to miss somebody who was.
Jon Wertheim: How do you feel about that?
Renée Gentry: I think that’s fine. While vaccines are critically important public health tools, they’re not magic. You know, you can have an allergic reaction to aspirin. So it’s a lot of different factors come into play to have a person be injured by a vaccine. Their genetics, their immune system. That’s why the no-fault part is critical. The vaccine caused it. But there’s no bad actor in this case.
The program is structured around a Vaccine Injury Table, basically, a conversion chart of vaccines and eligible injuries — if your child, for instance, got a rubella vaccine and developed chronic arthritis within seven and 42 days, you may be eligible for damages.
The most common compensation is for shoulder injuries suffered from a misplaced injection. You can file for an injury not on the table. Overall, half of all claims have been dismissed.
Today, vaccines on the table have jumped from the original six to 16, including the annual flu shot, though, notably not COVID. As for the eligible injuries, autism is not one of them.
That decision did not come easily, as retired special masters Denise Vowell and George Hastings explained.
60 Minutes
Jon Wertheim: There’s been a lot of talk lately about a possible link between vaccines and autism. This has been litigated and decided in your court 15 years ago.
George Hastings: You know, I spent many, many years of my life, almost full-time looking at that issue.
In the early 2000s, cases alleging vaccinations caused autism flooded the court. Vowell, Hastings and a third special master oversaw what was a class action of sorts, a vaccine court proceeding that spanned almost a decade, incorporating testimony from dozens of medical experts and hundreds of scientific articles.
Jon Wertheim: What did you ultimately conclude?
Denise Vowell: Ultimately concluded there simply was not the evidence. I hoped there would be.
Jon Wertheim: Why?
Denise Vowell: Because the parents of children with autism go through so much.
But Vowell said she could not decide cases based on sentiment.
Denise Vowell: I had to apply the law. And the law was that if there is a preponderance of evidence of vaccine causation, I rule for them. If there isn’t, I rule against them.
All three special masters concluded there was no link between vaccines and autism. On appeal, eight additional federal judges unanimously upheld the vaccine court decisions.
This has not been persuasive to Robert F. Kennedy, Jr.
We wanted to know RFK, Jr.’s views about vaccine court, a court his uncle championed, because today, as secretary of Health and Human Services,, he is imbued with the authority to add or redefine injuries on the vaccine table.
He declined our request for an on-camera interview but said via email that, yes, he would like to “expand the table,” which he hopes will create an easier path to compensation. In particular, he wants to broaden definitions for “seizures and encephalopathy,” two neurological conditions that can be associated with autism.
Although the original intent was “idealistic, compassionate, and sensible,” the court, RFK, Jr. told us, has become “a disaster for the families of injured children. Its effective function is delay, denial, and systematic cruelty.”
Vaccine court delays are something Ryan Farrell knows only too well.
60 Minutes
Husband to Angela and father of three, Ryan worked as a lineman for a Boston-area power company, hanging electrical wires 100 feet high.
On the job in 2017, Ryan cut his hand on rusty metal and got a tetanus shot. A few days later, the pain started.
Ryan Farrell: I felt like my– my back was just, like, being stabbed.
Angela Farrell: He would take a shower, he was like, “I feel like there’s razor blades hitting my skin.”
Over the next few years, Ryan was hospitalized multiple times. Doctors diagnosed him with a rare autoimmune disease.
Ryan Farrell: I didn’t wanna live for a long time, you know. That’s how I felt.
Jon Wertheim: When did you make the link that “I had this vaccine. Maybe there’s some correlation here?”
Angela Farrell: I made the correlation.
Like most Americans, Angela Farrell had never heard of vaccine court, but she stumbled upon it online and found a lawyer. They filed a case in 2019. And only in July, did the special master rule: the tetanus shot more likely than not led to Ryan’s illness.
Jon Wertheim: Do you feel like you were treated with compassion?
Ryan Farrell: I mean the special master was kind to me and my family when we were in the courtroom.
Jon Wertheim: [The] court was intended to compensate people for vaccine injuries. I want to quote this, “quickly, easily, and with certainty and generosity.”
Ryan Farrell: That couldn’t be further from the truth. You know–
Jon Wertheim: What do you mean?
Ryan Farrell: I feel like they made it way too– way too long.
Ryan remains unable to work. Six years in, the court has yet to determine his damages.
The court acknowledges the delays. Citing a backlog of more than 3,000 cases, its chief special master has, in documents obtained by 60 Minutes, asked Congress for more resources four years running, saying, “… it becomes more difficult each year to resolve the huge number of case filings in the expedient fashion they deserve.” Congress has yet to act.
Our reporting suggests that this inaction is, in part, because vaccination has become such a loaded, heavily politicized issue that legislators are reluctant to wade in.
The Thompsons are not invested in the heavily-charged vaccine debate — they’re invested in their son, Jacob — an anguishing exception, harmed by what’s otherwise a public health force of good.
Jon Wertheim: I do wonder if people aren’t going to hear your story and be terrified of giving their kids vaccinations.
John Thompson: We’re definitely not anti-vaxxers. We think– and– I mean, vaccines are great. They’ve done a lot to help people. But I think that parents need to know what can happen.
Renée Gentry: If what you care about are vaccine-injured people, and them being compensated, then you want this court to work. And you want this court to be here.
Jon Wertheim: We have this program that incentivizes the manufacturing of vaccines, but also acknowledges that in some rare cases, there are injuries and damages.
Renée Gentry: Right. It’s bipartisan. It takes everyone’s views into account. And everybody compromises, which is a dirty word now. But that’s the goal of it. And it’s helped these people. Jacob will be taken care of for the rest of his life because of this program.
Produced by Denise Schrier Cetta. Associate producers, Elizabeth Germino and Arman Badrei. Broadcast associate, Mimi Lamarre. Edited by Warren Lustig.
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RFK Jr. fires NIH vaccine whistleblower Dr. Jeanne Marrazzo
Health Secretary Robert F. Kennedy Jr. has fired a top official with the National Institutes of Health who blew the whistle on internal clashes over vaccine research in the early months of the Trump administration.
On Wednesday, Dr. Jeanne Marrazzo received a letter from Kennedy — which CBS News reviewed — informing her that her role leading NIH’s National Institute of Allergy and Infectious Diseases, or NIAID, had been terminated. He did not cite a cause beyond his constitutional authority to do so. Last month, in an exclusive interview with CBS News, Marrazzo said she had been silenced when she and her colleagues pushed back against NIH officials appointed by President Trump who questioned the importance of childhood flu vaccines and canceled long-running clinical trials.
“My termination, unfortunately, shows that the leaders of HHS and the National Institutes of Health do not share my commitment to scientific integrity and public health,” Marrazzo wrote in a statement following her firing. “Congress must act to protect scientific research from those who would serve political interests first.”
Marrazzo had been in her role since August 2023, succeeding Dr. Anthony Fauci, who had served as NIAID director for nearly four decades. She was put on indefinite leave in March and filed a whistleblower complaint with the U.S. Office of Special Counsel in September, alleging illegal retaliation. In a statement, Marrazzo’s attorney alleged her firing is further “retaliation for her protected whistleblower activity.”
Despite following a well-established whistleblower process by filing a complaint with OSC, recourse for Marrazzo is far from certain. Mr. Trump fired the head of the independent agency in February and has since installed his top trade official Jamieson Greer to lead the agency on an acting basis.
In August, the office launched an ethics probe into Jack Smith, the former special counsel who indicted Mr. Trump before he returned to office for his actions around the January 6, 2021, attack on the U.S. Capitol, and for allegedly mishandling classified documents from his first term.
The allegations in Marrazzo’s whistleblower complaint focus on Dr. Matthew Memoli, who served as acting NIH director earlier this year before moving to the health agency’s No. 2 post.
Marrazzo claimed Memoli made statements downplaying the importance of vaccines that closely mirrored the views of Kennedy, a longtime vaccine skeptic. In a series of meetings, Memoli argued that “vaccines are unnecessary if populations are healthy,” and that the NIH “should not focus on vaccines,” Marrazzo alleged in her complaint.
Marrazzo told CBS News it was like “hearing the echo of” the vaccine skepticism often promoted by Kennedy. “It was extremely alarming,” Marrazzo said.
An HHS spokesperson defended Memoli to CBS News, writing in a statement: “He remains fully aligned with this administration’s vaccine priorities and consistently champions gold-standard evidence-based science.”
In June, Kennedy removed all 17 members of the Advisory Committee on Vaccine Practices, which makes vaccine recommendations to the Centers for Disease Control. He then handpicked their replacements, and the newly reconstituted panel recently voted to endorse splitting the measles, mumps, rubella and varicella vaccine into separate shots.
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3 new Minnesota measles cases reported last week in Dakota County, MDH says
Three more measles cases have been reported in Minnesota in the past week.
The Minnesota Department of Health said the new cases all involved unvaccinated children, ages 5 to 17, who are all from the same family.
Health officials are working with local health departments to contact people believed to have been exposed.
These new cases bring the state’s number of identified cases this year to eight.
“Unfortunately, we still see kids die of measles and it is a vaccine-preventable disease,” said Stacene Maroushek, pediatric infectious disease specialist with Hennepin Healthcare. “Three is considered an outbreak and it is concerning because we know our vaccine rates have really dropped off since COVID.”
Measles is one of the most contagious infectious diseases, and in some cases can cause severe infections in the lungs and brain that can lead to cognitive issues, deafness or death.
The best way to prevent measles, according to health experts, is through immunization.
Officials recommend children receive two doses of the measles, mumps and rubella vaccine — the first at 12 to 15 months old and the second between 4 and 6 years old.
Maroushek blames the current outbreaks of the disease, once thought to be eliminated more than two decades ago, on misinformation spread online — namely, that vaccines can cause autism.
“I think we as physicians need to do a better job of promoting all of the stuff that we actually know from a scientific standpoint, and good data, to a level that people can readily access and understand,” Maroushek said.
Earlier this summer, state health officials announced an unvaccinated child, also from Dakota County, exposed hundreds of people to measles during a visit to Mall of America’s Nickelodeon Universe.
As of Friday, the Wisconsin Department of Health Services has identified 36 measles cases this year, with the most recent cases connected to an out-of-state visitor who exposed customers at separate rest stops in Roberts and Beloit.
So far this year, the U.S. has reported more than 1,500 cases of measles, with more than 760 in Texas alone.
Taylor Johnston and
contributed to this report.
Stephen Swanson
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Court sides with voodoo worshiper over religious exemption
BOSTON — A state appeals court has sided with a medical worker and voodoo worshipper who was fired by University of Massachusetts Medical Health Care after her request for a religious exemption to the COVID-19 vaccine was rejected.
The ruling, issued Monday by the state Court of Appeals, overturns a Superior Court ruling that rejected a lawsuit filed by Rachelle Jeune against UMass Medical over its denial of a religious exemption in October 2021 as part of her employment as a surgical technician.
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By Christian M. Wade | Statehouse Reporter
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Court sides with voodoo worshiper over religious exemption
BOSTON — A state appeals court has sided with a medical worker and voodoo worshipper who was fired by University of Massachusetts Medical Health Care after her request for a religious exemption to the COVID-19 vaccine was rejected.
The ruling, issued Monday by the state Court of Appeals, overturns a Superior Court ruling that rejected a lawsuit filed by Rachelle Jeune against UMass Medical over its denial of a religious exemption in October 2021 as part of her employment as a surgical technician.
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By Christian M. Wade | Statehouse Reporter
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Should kids get flu and COVID shots this fall? Here’s what to know as some vaccine guidance shifts.
As the fall respiratory season approaches and differing recommendations for children’s COVID-19 and flu shots cause confusion, who should be getting vaccinated to protect against illness?
Earlier this month, the Centers for Disease Control and Prevention’s vaccine advisory committee, known as the Advisory Committee on Immunization Practices, or ACIP, voted to change recommendations for the COVID-19 vaccine.
The ACIP’s recommendations are not the final say — they must be reviewed and approved by the CDC director to become official guidance. But CDC directors have almost always accepted the recommendations.
Here’s where recommendations currently stand.
Flu shots
Guidance on the flu shot for kids is consistent across top medical groups: Children 6 months and older are generally advised to get the shot.
The CDC recommends that everyone 6 months and older get a flu vaccine every season, with rare exceptions.
The American Academy of Pediatrics (AAP) also recommends that everyone 6 months and older without medical contradictions get vaccinated.
For pregnant women, flu shots — specifically the injection, not the nasal spray — are also recommended by both the CDC and AAP.
Protecting kids from the flu is important because infections can lead to hospitalizations and sometimes be deadly, the CDC says. During the 2023-24 flu season, for example, the CDC reported nearly 200 flu-related deaths among children in the U.S. Most of them were eligible for a vaccine but were not fully vaccinated, the CDC said.
Flu season typically starts in December and peaks in February, so the optimal time to get vaccinated is heading into the season,
doctors say. It takes about 2 weeks for protection to develop after vaccination.COVID vaccine
For the COVID-19 vaccine, advice currently varies.
The CDC says parents of healthy children ages 6 months to 17 years old should discuss the benefits with a health care provider and “may receive” it, but the agency stops short of recommending the shot. The agency broadly recommends COVID-19 vaccines for moderately or severely immunocompromised children.
The American Academy of Pediatrics, however, recently shared vaccine recommendations that, for the first time in three decades, differ from U.S. government advice. In the guidance, the AAP is “strongly recommending” COVID-19 shots for children ages 6 months to 2 years old. For older children, shots are also advised but it’s up to parents’ discretion, the AAP said.
Other top medical groups have also shared recommendations differing from the CDC’s advice.
For example, the Infectious Diseases Society of America, a medical association representing physicians and scientists who specialize in infectious diseases, recommends the COVID-19 vaccine for everyone ages 6 months and older.
And a group of four West Coast states has joined together to issue recommendations on COVID-19 shots and other vaccines that differ from CDC guidance. The West Coast Health Alliance recommends the COVID vaccine for all children 6 months to 23 months old and those 2 to 18 years old with risk factors or who have never been vaccinated.
The announcement was made last week in a joint statement from Oregon Gov. Tina Kotek, Washington Gov. Bob Ferguson, California Gov. Gavin Newsom and Hawaii Gov. Josh Green, all Democrats, saying they were putting safety before politics.
In the Northeast, New York and its neighbors created the Northeast Public Health Collaborative, with Gov. Kathy Hochul calling it a rebuke to Washington’s retreat from science. The voluntary coalition includes New York state, New York City, Connecticut, Maine, Massachusetts, New Jersey, Pennsylvania and Rhode Island.
“Every resident will have access to the COVID vaccine, no exceptions,” Hochul said in a statement, which advises vaccinations for children 6 months to 18 years old.
CDC advisory panel’s proposed COVID changes
The CDC’s advisory committee, the ACIP, has undergone changes in recent months, with all new members picked by Health and Human Services Secretary Robert F. Kennedy Jr., who is known for raising doubts about vaccines.
In their latest meeting, the ACIP voted for people to make individual, informed decisions about COVID vaccination, and it declined to specifically recommend COVID vaccination. This is a change from current guidance, since it drops recommendations for even children at high risk.
The updated recommendations, which are not yet considered official but are expected to be soon, would include the following for children:
- Individuals 6 months to 64 years: Vaccination based on individual-based decision-making — with an emphasis that the risk-benefit of vaccination is most favorable for individuals who are at an increased risk for severe COVID-19 disease and lowest for individuals who are not at an increased risk, according to the CDC list of COVID-19 risk factors.
Dr. Paul Offit — a vaccine researcher at Children’s Hospital of Philadelphia and a former government adviser who has sparred with Kennedy for years — said that with this proposed change, “the good news is anyone can get the vaccine.” But “the bad news is that no one is encouraged to get it even if you’re in a high-risk group,” he recently told The Associated Press.
Varying advice has already caused confusion for parents.
Dr. Amesh Adalja, a senior scholar at Johns Hopkins Center for Health Security, said he expects confusion around the COVID vaccine due to the panel’s recent vote.
“What I think it means is that people are going to be uncertain whether or not the COVID-19 vaccine is a benefit to them,” he told CBS News on Friday.
Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, says there’s “a lot of noise out there” when it comes to vaccines, but advises parents to “stick the course” and talk to your doctor about making sure children get all their necessary vaccinations.
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Parents trying to navigate mixed messages on vaccines
Parents are hearing mixed messages from federal and state officials when it comes to vaccines, and that’s having a real impact inside doctors offices. Cristian Benavides has more.
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Vaccine Advisers Change COVID Shot Guidance – KXL
In this March 2, 2021, file photo, Hollie Maloney, a pharmacy technician, loads a syringe with Pfizer’s COVID-19 vaccine at the Portland Expo in Portland, Maine. (AP Photo/Robert F. Bukaty, File)ATLANTA (AP) — Health Secretary Robert F. Kennedy Jr.’s new vaccine advisers added confusion Friday to this fall’s COVID-19 vaccinations.
For the first time since the shots were developed, the group has declined to recommend their use — instead leaving the choice up to those who want them.
The Food and Drug Administration recently put new restrictions on this year’s shots from Pfizer, Moderna, and Novavax, reserving them for people over 65 or younger ones at higher risk.
The Centers for Disease Control and Prevention advisers declined to recommend that those people seek a shot but narrowly avoided urging states to require a prescription for those who want one.
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Grant McHill
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Watch Live: CDC advisory panel discusses COVID-19 vaccine risks, spars with outside experts over process
After the tabled hep B vote, some liaison members from top medical organizations shared their agreement for holding off on making changes to the current recommendations. Some also urged more transparency in how decisions will be made on future potential recommendation changes.
“I would urge the committee to use the methodical scientific method to weigh the risks and benefits appropriately,” said Dr. Amy Middleman, a liaison for the Society for Adolescent Health and Medicine. She added, “This is important for all vaccine decisions, and this is what I think some of us are really concerned about in terms of the absence of it.”
ACIP member Retsef Levi said he appreciated the desire to keep scientific methods but took issue with the liaison member’s comments.
“I have to say that one thing that puzzles me is that many of the speakers that push for the scientific approach are speaking very confidently in the absence of the gold standard evidence of robust long-term clinical trials against placebo,” Levi added, who has been pushing for more research beyond what the CDC has presented during the meetings.
When ACIP chair Kulldorff began to move on from the hep B discussion, Dr. Jason Goldman, president of the American College of Physicians, chimed in asking for more explanation and to call out the committee for muting him.
“That is disrespectful. You want debate and discussion, but you’re muting people and silencing them,” Goldman said. “Please provide to the public so they can have trust, faith and confidence in vaccination as to what process we are going to be using to properly vet and discuss all future vaccines. … Tell the public how you are going to be analyzing all of these vaccine decisions so we can have confidence in this committee.”
Kulldorff responded that he previously responded to that comment already before moving on to the next agenda matter.
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RKF Jr.’s hand-picked committee changed its recommendations for key childhood shots
A key committee of the U.S. Centers for Disease Control and Prevention voted Thursday to alter its recommendation on an early childhood vaccine, after a discussion that at times pitted vaccine skeptics against the CDC’s own data.
After an 8 to 3 vote with one abstention, the CDC’s Advisory Committee on Immunization Practices will no longer recommend that children under the age of 4 receive a single-shot vaccine for mumps, measles, rubella and varicella (better known as chicken pox).
Instead, the CDC will recommend that children between the ages of 12 to 15 months receive two separate shots at the same time: one for mumps, measles and rubella (MMR) and one for varicella.
The first vote of the committee’s two-day meeting represents a relatively small change to current immunization practices. The committee will vote Friday on proposed changes to childhood Hepatitis B and COVID vaccines.
But doctors said the lack of expertise and vaccine skepticism on display during much of the discussion would only further dilute public trust in science and public health guidance.
“I think the primary goal of this meeting has already happened, and that was to sow distrust and instill fear among parents and families,” said Dr. Sean O’Leary, chair of American Academy of Pediatrics’ Committee on Infectious Diseases, during a Zoom press conference Thursday.
“What we saw today at the meeting was really not a good faith effort to craft immunization policy in the best interest of Americans. It was, frankly, an alarming attempt to undermine one of the most successful public health systems in the world,” O’Leary said. “This idea that our current vaccine policies are broken or need a radical overhaul is simply false.”
Giving the MMR and chickenpox vaccines in the same shot has been associated with a higher relative risk of brief seizures from high fevers in the days after vaccination for children under 4 — eight children in 10,000 typically have febrile seizures after receiving the combination shot, compared with four out of 10,000 who receive separate MMR and chickenpox shots at the same time.
Distressing as they are for family members to witness, seizures are a relatively common side effect for high fevers in young children and have not been associated with any long-term consequences, said Dr. Cody Meissner, a former pediatric infectious diseases chief at Tufts-New England Medical Center who is serving on ACIP for the second time (he previously served under Presidents George W. Bush and Barack Obama).
The problem with splitting vaccines into multiple shots is that it typically leads to lower vaccine compliance, Meissner said. And the risks of not vaccinating are real.
“We are looking at a risk-benefit of febrile seizures … as compared to falling below a 95% coverage rate for herd immunity, and the consequences of that are devastating, with pregnant women losing their babies, newborns dying and having congenital rubella syndromes,” said Dr. Joseph Hibbeln, a psychiatrist and neuroscientist and another current ACIP member.
Meissner, Hibbeln and Hilary Blackburn were the only three members to vote against the change.
The meeting ended with a vote regarding continued coverage of the MMRV shot under the CDC’s Vaccines for Children Program, a publicly-funded service that provides immunizations to nearly half of the nation’s children. VFC currently only covers shots that ACIP recommends.
As chair Martin Kulldorff called the vote, several committee members complained that they did not understand the proposal as it was written. Three abstained from the vote entirely.
As the meeting broke up, members could be heard trying to clarify with one another what they had just voted for.
The committee also spent several hours debating whether to delay the first dose of the Hepatitis B vaccine, a shot typically given at birth, until the child is one month old. They will vote on the proposal Friday.
The medical reason for altering the Hepatitis B schedule was less clear.
“What is the problem we’re addressing with the Hepatitis B discussion? As far as I know, there hasn’t been a spate of adverse outcomes,” said pediatrician Dr. Amy Middleman, one of several people to raise the point during the discussion and public comment period.
Committee member Dr. Robert Malone replied that changing the recommendation for when children should get vaccinated for hepatitis B would improve Americans’ trust in public health messaging.
“A significant population of the United States has significant concerns about vaccine policy and about vaccine mandates, [particularly] the immediate provision of this vaccine at the time of birth,” Malone said. “The signal that is prompting this is not one of safety, but one of trust.”
Hepatitis B is often asymptomatic, and half of infected people don’t know they have it, according to the CDC. Up to 85% of babies born to infected mothers become infected themselves, and the risk of long-term hazards from the disease is higher the earlier the infection is acquired.
Infants infected with the hepatitis B virus in the first year of life have a 90% chance of developing chronic disease, and 25% of those who do will die from it, according to the the American Academy of Pediatrics.
Since the vaccine was introduced in 1991, infant hepatitis B infections have dropped by 95% in the U.S. Nearly 14,000 children acquired hepatitis B infections between 1990 and 2002, according to the CDC; today, new annual infections in children are close to zero.
This week’s two-day meeting is the second time the committee has met since Kennedy fired all 17 previous ACIP members in June, in what he described as a “clean sweep [that] is necessary to reestablish public confidence in vaccine science.”
The next day, he named seven new members to the committee, and added the last five earlier this week. The new members include doctors with relevant experience in pediatrics, immunology and public health, as well as several people who have been outspoken vaccine skeptics or been criticized for spreading medical misinformation.
They include Vicky Pebsworth, a nurse who serves as research director for the National Vaccine Information Center, an organization with a long history of sharing inaccurate and misleading information about vaccines, and Malone, a vaccinologist who contributed to early mRNA research but has since made a number of false and discredited assertions about flu and COVID-19 shots.
In some cases, the new ACIP members also lack medical or public health experience of any kind. Retsef Levi, for example, is a professor of operations management at MIT with no biomedical or clinical degree who has nonetheless been an outspoken critic of vaccines.
“Appointing members of anti-vaccine groups to policy-setting committees at the CDC and FDA elevates them from the fringe to the mainstream. They are not just at the table, which would be bad enough; they are in charge,” said Seth Kalichman, a University of Connecticut psychologist who has studied NVIC’s role in spreading vaccine misinformation. “It’s a worst-case scenario.”
Though ACIP holds three public meetings per year, it typically works year-round, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a former ACIP member in the early 2000s.
New recommendations to the vaccine schedule are typically written before ACIP meetings in consultation with expert working groups that advise committee members year-round, Offit said. But in August, medical groups including the American Medical Association, the American Academy of Pediatrics and Infectious Diseases Society of America were told they were no longer invited to review scientific evidence and advise the committee in advance of the meeting.
That same month, Kennedy fired CDC director Dr. Susan Monarez — who had been appointed to the position by President Trump and confirmed by the Senate. This past Wednesday, Monarez told a Senate committee that Kennedy fired her in part because she refused to sign off on changes he planned to make to the vaccine schedule this month without seeing scientific evidence for them.
She did not specify during the hearing what those changes would be.
ACIP’s recommendations only become official after the CDC director approves them. With Monarez out, that responsibility now goes to Health and Human Services deputy secretary Jim O’Neill, who is serving as the CDC’s acting director.
Asked by reporters on Wednesday whether the U.S. public should trust any changes ACIP recommends to the childhood immunization schedule, Sen. Bill Cassidy (Rep. – LA) was blunt: “No.”
Cassidy chairs the Senate committee that oversees HHS, and cast the deciding vote for Kennedy’s nomination. Before running for office, Cassidy, a liver specialist, created a public-private partnership providing no-cost Hepatitis B vaccinations for 36,000 Louisiana children.
He cast his vote after Kennedy privately pledged to Cassidy that he would maintain the CDC immunization schedule.
As public trust in the integrity of CDC guidelines wobbles, alternative sources for information have stepped up. Earlier this year, the American Academy of Pediatrics announced that it would publish its own evidence-based vaccination schedule that differs from the CDC’s on flu and COVID shots. And on Wednesday, Gov. Gavin Newsom signed a law giving California the power to establish its own immunization schedule, the same day the state partnered with Oregon and Washington to issue joint recommendations for COVID-19, flu and RSV vaccines.
On Tuesday, an association representing many U.S. health insurers announced that its members would continue to cover all vaccines recommended by the previous ACIP — regardless of what happened at Thursday’s meeting — through the end of 2026.
“While health plans continue to operate in an environment shaped by federal and state laws, as well as program and customer requirements, the evidence-based approach to coverage of immunizations will remain consistent,” America’s Health Insurance Plans said in a statement. The group includes major insurers like Aetna, Humana, Kaiser Permanente, Cigna and several Blue groups. UnitedHealthcare, the nation’s largest insurer, is not a member.
It’s unclear what will be covered after 2026.
Corinne Purtill, Jenny Gold
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As bird flu makes its return in Minnesota, turkey farmers hinge hopes on vaccine
Earlier this week, a turkey flock in Redwood County, Minnesota, tested positive for bird flu. It’s the first positive test among commercial birds since April, and it has turkey farmers on alert.
There are nearly 10,000 turkeys inside the grower barn at Fahlun Farms in Kandiyohi County.
Jake Vlaminck is the owner. Just a few years ago his entire farm sat empty after avian influenza forced him to eliminate his entire flock.
“Talk about seeing grown men cry. All the guys that work out here they raise these turkeys, they know they’re going for meat. We want them to be useful animals and to see them go to waste is just heartbreaking,” said Vlaminck.
To keep that from happening again, he installed lasers that keeps ducks and geese away from his barns during fall migration. Migratory birds are the main spreaders of bird flu.
“I was so happy with how that was working that I doubled down and got that one on the windmill tower,” said Vlaminck. “We’ve installed about 200 of these lasers throughout Minnesota now at different sites. And it really has had an impact in keeping the virus away. It’s been positive.”
He said it’s cut avian influenza cases by nearly 50% in recent years. But lasers alone may not be enough.
A year ago Vlaminck says a majority of Minnesota turkey farmers weren’t interested in an avian influenza vaccine for their birds. Now, he says, that mindset has changed.
As president of Minnesota Turkey Growers Association, he and 15 other farmers recently traveled to Washington to meet with lawmakers and to push for a vaccine.
“It’s going to be a while. The first step is we have to figure out what that strategy would be, what would it look like. That’s something that will have to come from the USDA,” said Vlaminck.
He believes a vaccine could be available in the next year or two. Until then, he’ll rely on lasers and biosecurity to protect his birds.
“Turkey is a big economic engine for Minnesota. So, it’s not just the farmer on the farm it’s also the people who process it. It’s the people who make the feed, grow the crops, all the people in-between who fix the trucks and make sure everything stays running,” said Vlaminck.
Minnesota is the nation’s top turkey producer, and the USDA said it is safe to eat. In recent years there have also been cases of avian influenza in dairy cows, but those cases have not been fatal, and milk is safe to consume.
John Lauritsen
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Watch Live: CDC’s vaccine advisory panel, with new members picked by RFK Jr., to vote on measles, hepatitis B shots
Some ACIP members clash in discussion on hep B risk evidence
After all presentations on the potential risks of hepatitis B vaccination, some members of the ACIP clashed on what the data meant for the vote they would be taking later today.
Member Vicky Pebsworth, a regional director of the National Association of Catholic Nurses, said “there are gaps in what we know and understand about the effects of hepatitis B, particularly on very young infants, and I think that the conclusion that it is safe is perhaps premature.”
Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel, however, called the vaccine “safe” with “no evidence of harm.”
If the recommendation changes, he added, it would “increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series.”
Changing hep B recommendation could put more infants at risk of infection, presenter says
In the first presentation for the hepatitis B vaccine, presenter Dr. Adam Langer with the CDC outlined how changing the current recommendation for a first dose within 24 hours of birth could put more children at risk, even those born to mothers who test negative for the disease.
Langer gave examples of situations where unvaccinated infants are at risk of HBV infection, including:
- They live with a person who has chronic hepatitis B, not necessarily their mother
- People who have an HBV infection come to visit their homes
- They go to daycare or other places where even “minuscule amounts of infectious blood or fluids might be present.”
“About half of people with HBV infection are unaware of their infection so they could unknowingly expose infants that are in their care,” he said.
Additionally, he said there is “no evidence that the risk of already rare adverse events is any greater among newborns than among older infants.”
The only potential benefit to rescinding the current recommendation is a potential reduction in rare cases of adverse effects from the birth dose vaccine, according to the presentation.
“When they do occur, these adverse events tend to be mild. The worst adverse event you could imagine, anaphylaxis has been very rarely reported at only 1.1 cases per 1 million vaccine doses administered,” Langer said.
Hepatitis B presentations, discussions begin after break
After the lunch break, presentations and discussions shifted to the hepatitis B vaccine.
ACIP chair Martin Kulldorff reminded the group that the proposed recommendation changes concern only the hep B birth dose — the dose given to babies within 24 hours of birth — to mothers who test negative for the disease.
“So if the women test positive for hepatitis B, or if it’s unknown, we are not considering any changes for that population,” he said.
Recommendation change would take away parents’ choice, ACIP member says
Just before the group paused for lunch, ACIP member Dr. Joseph Hibbeln brought up the impact the proposed recommendation change for MMRV vaccines would have on parents who want the single, combined measles, mumps, rubella and varicella shot for their children, since they would no longer be covered by the Vaccines for Children program which helps pay for immunizations.
“So that implies that the parents’ choice, unless they want to pay for it themselves, the parents’ choice is taken away,” he said, adding even if parents wanted the single shot, understood the benefits and risk, or even had a hard time accessing clinical care, “that option is basically taken away from them.”
Andrew Johnson, a representative with the Centers for Medicare & Medicaid Services, added that the change would also have coverage implications in the Medicaid and Children’s Health Insurance Program as well as individual and group markets.
American College of Physicians president says “this was not a thoroughly vetted discussion”
Dr. Jason Goldman, president of the American College of Physicians, shared his concerns about the MMRV presentation at the meeting following a recent change in the ACIP process that removed top medical organizations from the committee’s working groups.
“You do not have those subject matter experts with the real-world experience to understand the implementation of these vaccines and the concerns of the patients,” Goldman said. “You don’t have the voice of the patients we take care for. You’re not looking at all of the aspects of how we evaluate vaccine implementation. You’re looking at very small data points and misrepresenting how it works in the real world and how we take care of our patients. So no, this was not a thoroughly vetted discussion”
Other medical organization leaders chimed in to echo his concern and message.
Committee shares proposed MMRV vaccine recommendation ahead of vote
The proposed recommendation language, which will later go to a vote, was presented as follows:
“The pediatric vaccine schedule should be updated to reflect the following change:
- For measles, mumps, rubella and varicella vaccines given before age 4 years, the combined MMRV vaccine is not recommended.
- Children in this age group should receive separate measles, mumps, and rubella vaccine and varicella vaccine (MMR+V).”
Currently, the CDC says the MMRV vaccine may be used in that age range if preferred by parents or caregivers to reduce the number of shots.
Measles vaccine presentations wrap with questions about febrile seizure risk
After presentations on the background and potential risks of febrile seizures with an MMRV vaccine — which combines the MMR and varicella shots — versus separate MMR and varicella shots, members discussed whether guidance should be changed.
Some members were satisfied with the current recommendations, which make clear the slightly higher risks of febrile seizures with the combined shot.
“I think the current wording is appropriate,” Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel, said.
Others were not assured, saying there were too many assumptions being made. Some also pointed out that even if there are no worries about the physical impact of febrile seizures, the mental impact the event can have on children and families could affect vaccine compliance.
Dr. Richard Haupt, the head of global medical and scientific affairs, vaccines and infectious diseases at Merck, the vaccine’s manufacturer, noted the recent decline in vaccination rates among kindergarten children and highlighted the need to make guidance clear for the public.
“Considering these trends, any policy decision that compromises the clarity or consistency of vaccination guidance has the potential to further diminish public confidence,” he said.
ACIP chair says he was never contacted by ousted CDC director about vaccine concerns
During Thursday’s meeting, ACIP chair and biostatistician Martin Kulldorff noted the removal of CDC Director Dr. Susan Monarez and other members of CDC leadership, including former chief medical officer Dr. Debra Houry — both of whom testified a day prior about their removal.
“On vaccines, this committee is the key adviser to the CDC director, but during her short tenure, she never contacted me as the ACIP chair about any of her questions or concerns, which would have been natural if she had such concerns, neither was I contacted by any of the three CDC leaders, who subsequently resigned,” he said.
Kulldorff said the CDC leadership left citing divergent opinions about vaccines, but Monarez said she was also pressured by Kennedy to fire career experts without cause and approve vaccine recommendations without scientific evidence.
Kulldorff also said the American Academy of Pediatrics ended its participation with the committee and ignored invitations for open discussion about vaccines.
Last month, for the first time in 30 years, the AAP shared guidance that differed from the U.S. government. The organization said it is “strongly recommending” COVID-19 shots for children ages 6 months to 2 years old. Under Kennedy, the CDC doesn’t recommend COVID-19 shots for healthy children of any age. Instead, it says parents may get their kids vaccinated in consultation with physicians.
ACIP members highlight vaccine views during meeting roll call: “I’m not anti-vax”
As the meeting kicked off Thursday with a roll call, ACIP members presented some of their career backgrounds — and some took the time to highlight their views on vaccines.
Dr. Evelyn Griffin, an obstetrician and gynecologist based in Louisiana who was added to the panel earlier this week, said she would call herself “pro-informed consent.”
“Because of medical ethics, for discussing risk benefits and alternatives with the patient,” she said. “During the pandemic, I myself was COVID vaccinated.”
An earlier Kennedy pick, Dr. Joseph Hibbeln, who is retired from the National Institutes of Health, said he has a “neutral mind towards vaccines” and is “approaching this with a scientific equity.”
Dr. James Pagano, described by Kennedy as a “strong advocate for evidence-based medicine,” disclosed that he’s been vaccinated numerous times against various diseases.
“So I’m not anti-vax,” he said. “I am pro-intelligent and informed utilization of these potentially life-saving medications in a manner that reflects the current state of the art regarding their benefits, the target populations, optimal dosing and timing and, yes, of their potential adverse effects in some people.”
Science, politics and the future of vaccination in spotlight
The ACIP is convening under an unaccustomed spotlight. The committee usually attracts little attention as it deliberates vaccine schedules and eligibility, but suddenly finds itself navigating political scrutiny, public skepticism and internal upheaval.
The stakes extend well beyond the technical details of dosing intervals or eligibility cutoffs. The panel’s decisions could reshape public trust in childhood vaccines, restrict access to vaccines through Medicaid and Medicare, and signal whether scientific consensus or political pressure will steer the nation’s vaccination strategy.
Current recommendations for hepatitis B and MMRV vaccines
For hepatitis B, the CDC currently recommends the first dose within 24 hours after birth. Universal infant vaccination became the norm in 1991 after data showed too many cases of hepatitis B among pregnant women were missed during prenatal care.
A universal birth dose acts as a safety net, protecting infants whose parent’s infection might have been missed. Before birth-dose policies, the U.S. saw an estimated 1,000 preventable infections in newborns each year.
To protect against measles, mumps, rubella and varicella (or chickenpox), there are two options: a combo MMRV vaccine or separate MMR and varicella vaccines.
The CDC currently recommends a two-dose series beginning at age 12 to 15 months. However, the combination vaccine contains certain risks for younger age groups; specifically, the combo shot carries a slightly higher risk of fever-related “febrile” seizures when used as the first dose in young toddlers aged 12-23 months.
“For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately,” the CDC says, but adds MMRV may be used if preferred.
Former CDC director said she is “very nervous” about the upcoming childhood vaccine panel recommendations
While testifying at a Senate hearing Wednesday about why she was ousted as CDC director, Dr. Susan Monarez said she’s “very nervous” about the newly appointed ACIP members and what their recommendations might be.
“I know that the medical community has raised concerns about whether or not, again, they have the commensurate backgrounds to be able to understand the data, the evidence, and to evaluate it appropriately, but I certainly will be watching,” she said.
In another part of the hearing, Monarez said she refused to rubber-stamp vaccine recommendations without seeing the evidence behind them because she “built a career on scientific integrity.”
“My worst fear was that I would then be in a position of approving something that would reduce access to lifesaving vaccines to children and others who need them,” she said.
Monarez added she is not aware of any scientific evidence to support changing the childhood vaccination schedule for measles, chicken pox and hepatitis B.
Kennedy’s newly appointed ACIP members include allies and vaccine critics
After firing all 17 of the committee’s previous members in June, Kennedy named eight new advisers to the ACIP, one of whom later withdrew. They include several allies he has worked with closely over the years and some have a history as vaccine critics.
Kennedy appointed the new members directly, breaking with the past practice of agency officials vetting potential experts before sending them to the secretary for approval.
Just this week, the group gained five new members, the HHS announced. The latest additions include some who have questioned established medical research on immunizations and the COVID-19 pandemic.
Panel to consider COVID vaccine recommendations Friday as West Coast states move ahead
A day before the ACIP meetings kicked off, a group of four West Coast states recommended that all adults and children in those states who want them can receive the COVID-19 vaccine and other common shots.
The announcement was made in a joint statement from Oregon Gov. Tina Kotek, Washington Gov. Bob Ferguson, California Gov. Gavin Newsom and Hawaii Gov. Josh Green, all Democrats, saying they were putting safety before politics.
The guidance, which aligns with mainstream medical groups like the American Academy of Family Physicians and American Academy of Pediatrics, comes amid confusion over the CDC’s messaging on vaccinations.
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California moves to distance itself from CDC on vaccines, considers creating its own agency
UPDATES AS THEY COME IN. OTHER NEWS, RIGHT NOW, HEALTH OFFICIALS ARE FOCUSING ON VACCINE DEADLINES. THIS WEEK, A CDC COMMITTEE WILL CONSIDER POSSIBLE CHANGES TO RECOMMENDATIONS TOMORROW. AND NOW THE STATE OF CALIFORNIA IS CONSIDERING DISTANCING ITSELF FROM THE FEDERAL GOVERNMENT’S GUIDELINES. THE POTENTIAL CHANGE IN GUIDANCE COMES AS THE RECENTLY FIRED CDC DIRECTOR WARNS THOSE CHANGES MAY NOT BE BASED ON SCIENCE. WE HAVE TEAM COVERAGE FOR YOU OF WHAT YOU NEED TO KNOW. ASHLEY ZAVALA HAS THE CHANGE IN STATE VACCINATION GUIDELINES, BUT WE START WITH JACKIE DEFUSCO LIVE ON CAPITOL HILL FOR US WITH A MESSAGE FROM THE FORMER CDC DIRECTOR. YEAH. HEY THERE, ANDREA CURTIS ON CAPITOL HILL TODAY, THE FORMER CDC DIRECTOR, SUSAN MONAREZ, CLAIMED THAT SHE WAS FIRED IN PART FOR ESSENTIALLY REFUSING TO PRE-APPROVE VACCINE RECOMMENDATIONS WITHOUT SEEING THE SCIENTIFIC EVIDENCE FIRST. SHE TOLD SENATORS THAT SHE IS NERVOUS ABOUT WHAT’S TO COME. TAKE A LISTEN. BASED ON WHAT I OBSERVED DURING MY TENURE, THERE IS A REAL RISK THAT RECOMMENDATIONS COULD BE MADE RESTRICTING ACCESS TO VACCINES FOR CHILDREN AND OTHERS IN NEED WITHOUT RIGOROUS SCIENTIFIC REVIEW, WITH NO PERMANENT CDC DIRECTOR IN PLACE, THOSE RECOMMENDATIONS COULD BE ADOPTED. HEALTH SECRETARY ROBERT F KENNEDY JR HAS DENIED THAT HE ORDERED MONAREZ TO RUBBER STAMP VACCINE RECOMMENDATIONS. BUT THE DISPUTE COMES AS THE CDC’S INFLUENTIAL ADVISORY PANEL, WHOSE MEMBERS WERE RECENTLY REPLACED BY KENNEDY, IS SET TO CONVENE TOMORROW TO CONSIDER POSSIBLE CHANGES TO GUIDANCE ON COVID 19, CHICKENPOX AND HEPATITIS B SHOTS. TELLING LAWMAKERS THAT SHE HAS NOT SEEN ANY DATA AT THIS POINT TO SUPPORT CHANGING ELIGIBILITY CRITERIA. FORMER CDC CHIEF MEDICAL OFFICER DEBORAH OURY, WHO RECENTLY RESIGNED, ALSO TESTIFIED TODAY. AND SHE SAID THAT ONE OF KENNEDY’S POLITICAL ADVISERS TOLD HER NOT TO INCLUDE INFORMATION THAT COULD SUPPORT MAINTAINING HEPATITIS B SHOTS FOR NEWBORNS TO PREVENT THE DEADLY DISEASE FROM SPREADING FROM THE MOTHER. YOU’RE SUGGESTING THAT THEY WANTED TO MOVE AWAY FROM THE BIRTH DOSE, BUT THEY WERE AFRAID THAT YOUR DATA WOULD SAY THAT THEY SHOULD RETAIN IT. IT. WHAT DO WE DO NOW? IT’S STILL UNCLEAR AT THIS POINT HOW EXACTLY THE ADVISORY PANEL WILL VOTE LATER THIS WEEK, BUT SOME MEMBERS IN THE PAST HAVE QUESTIONED THE NECESSITY OF THE HEPATITIS B SHOT FOR NEWBORNS, AND HAVE ALSO SUGGESTED THAT THERE SHOULD BE A MORE CONSERVATIVE SET OF VACCINE RECOMMENDATIONS FOR THE COVID 19 SHOT, REGARDLESS OF WHAT THAT PANEL RECOMMENDS. ULTIMATELY, THE ACTING CDC DIRECTOR, JIM O’NEILL, WILL NEED TO SIGN OFF BEFORE THEY BECOME OFFICIAL LIVE ON CAPITOL HILL. I’M JACKIE DEFUSCO, KCRA THREE NEWS. JACKIE, THANK YOU. AND CLOSER TO HOME, CALIFORNIA LEADERS TODAY CONTINUE TO DISTANCE THE STATE FROM THE CDC WITH A SERIES OF ANNOUNCEMENTS. KCRA THREE POLITICAL DIRECTOR ASHLEY ZAVALA EXPLAINS THE ACTION GOVERNOR GAVIN NEWSOM TOOK TODAY. WELL, THIS COMES AS THE STATE CONTINUES TO CLASH WITH THE FEDERAL GOVERNMENT OVER VACCINES AND SCIENCE. OVERALL. TODAY, NEWSOM, ALONGSIDE THE GOVERNORS OF OREGON, WASHINGTON AND HAWAII, ROLLED OUT THEIR OWN VACCINE RECOMMENDATIONS FOR THE WINTER. THE GROUP IS ALSO NOW KNOWN AS THE WEST COAST HEALTH ALLIANCE. AS OF A COUPLE OF WEEKS AGO, THE RECOMMENDED SHOTS INCLUDE THE COVID 19 SHOT, FLU AND RSV SHOTS. THE GOVERNOR TODAY ALSO SIGNED A NEW STATE LAW THAT ALLOWS CALIFORNIA TO TAKE VACCINE RECOMMENDATIONS FROM MEDICAL GROUPS OUTSIDE OF THE CDC. THIS COMES AFTER ROBERT F KENNEDY JR FIRED ALL 17 MEMBERS OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES AND REPLACE THEM WITH VACCINE SKEPTICS. THE TRUMP ADMINISTRATION LOOSENED RECOMMENDATIONS AROUND THE COVID 19 VACCINE. ALSO IN A STATEMENT, THE WEST COAST GOVERNOR SAID, OUR STATES ARE UNITED IN PUTTING SCIENCE, SAFETY AND TRANSPARENCY FIRST AND IN PROTECTING FAMILIES WITH CLEAR, CREDIBLE VACCINE GUIDANCE. THE WEST COAST HEALTH ALLIANCE STANDS UNITED IN PROTECTING PUBLIC HEALTH AND ALWAYS PUTTING SAFETY BEFORE POLITICS. MEANWHILE, A SPOKESPERSON FOR THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES SAID DEMOCRAT RUN STATES THAT PUSHED UNSCIENTIFIC SCHOOL LOCKDOWNS, TODDLER MASK MANDATES AND DRACONIAN VACCINE PASSPORTS DURING THE COVID ERA COMPLETELY ERODED THE AMERICAN PEOPLE’S TRUST IN PUBLIC HEALTH AGENCIES. ACIP REMAINS THE SCIENTIFIC BODY GUIDING IMMUNIZATION RECOMMENDATIONS IN THIS COUNTRY. AND HHS WILL ENSURE POLICY IS BASED ON RIGOROUS EVIDENCE AND GOLD STANDARD SCIENCE, NOT THE FAILED POLITICS OF THE PANDEMIC. END QUOTE. NOW, SEPARATELY FROM THE GOVERNOR’S ANNOUNCEMENT TODAY, SOME DEMOCRATIC STATE LAWMAKERS AND LABOR GROUPS LAUNCHED AN EFFORT THAT WOULD ESSENTIALLY CREATE CALIFORNIA’S OWN CDC AND FOUNDATION FOUNDATION TO FUND MEDICAL RESEARCH. THIS WOULD FIRST NEED TO PASS AT THE STATE CAPITOL, THOUGH, BEFORE GOING TO VOTERS IN A BALLOT MEASURE IN NOVEMBER OF 2026. SO HOW MUCH MONEY ARE THEY EXPECTING TO SPEND ON THIS PROPOSAL? YEAH, ESSENTIALLY THEY’RE GOING TO ASK CALIFORNIA VOTERS TO APPROVE A MEASURE THAT WOULD INVOLVE BORROWING $23 BILLION IN BONDS. WE WILL HAVE A LOT MORE ON THIS AT FIVE. A LOT OF QUESTIONS AROUND THA
California’s Democratic leaders on Wednesday announced a series of efforts to distance the state from President Donald Trump’s Centers for Disease Control and Prevention as the state and federal government continue to clash over vaccines and science. Gov. Gavin Newsom on Wednesday signed legislation that allows the state to set future immunization guidance on credible, independent medical organizations instead of the CDC. Those organizations could include but are not limited to the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians. Also on Wednesday, the governor and the California Department of Public Health, along with other West Coast governors, rolled out vaccine recommendations for the upcoming winter, countering advice from the CDC. The recommendations include the COVID-19 shot, flu shot, and RSV vaccine. It comes two weeks after the leaders of California, Oregon, Washington and Hawaii established the West Coast Health Alliance to rebuke the Trump administration’s policies. States typically follow guidance from the CDC, but the Democratic leaders established the alliance after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. fired all 17 members of the federal panel that advises on immunization practices and replaced them with vaccine skeptics. “Our states are united in putting science, safety, and transparency first — and in protecting families with clear, credible vaccine guidance. The West Coast Health Alliance stands united in protecting public health and always putting safety before politics,” the governors said in a joint statement. Separately from Newsom’s announcement Wednesday, labor groups and some California lawmakers announced an effort to try to establish their own CDC and foundation to fund medical research. The proposal specifically would involve borrowing $23 billion in bonds. The legislation, known as Senate Bill 607, would first need to pass the state Legislature before giving voters the final say on the November ballot in 2026. “In communities across California, families are counting on science to deliver cures, protect our health, and prepare us for the challenges of the future,” said Assemblymember José Luis Solache, D-Lynwood. “Donald Trump’s cuts threaten not just research, but the lives of our loved ones. This measure makes clear that Californians will take control of our future and invest in life-saving research – because our families, our health, and our economy are too important to leave in the hands of Washington politicians playing games with people’s lives.””Democrat-run states that pushed unscientific school lockdowns, toddler mask mandates, and draconian vaccine passports during the COVID era completely eroded the American people’s trust in public health agencies,” a statement from the U.S. Department of Health and Human Services read. “ACIP remains the scientific body guiding immunization recommendations in this country, and HHS will ensure policy is based on rigorous evidence and Gold Standard Science, not the failed politics of the pandemic.” See more coverage of top California stories here | Download our app | Subscribe to our morning newsletter | Find us on YouTube here and subscribe to our channel
SACRAMENTO, Calif. —California’s Democratic leaders on Wednesday announced a series of efforts to distance the state from President Donald Trump’s Centers for Disease Control and Prevention as the state and federal government continue to clash over vaccines and science.
Gov. Gavin Newsom on Wednesday signed legislation that allows the state to set future immunization guidance on credible, independent medical organizations instead of the CDC. Those organizations could include but are not limited to the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the American Academy of Family Physicians.
Also on Wednesday, the governor and the California Department of Public Health, along with other West Coast governors, rolled out vaccine recommendations for the upcoming winter, countering advice from the CDC. The recommendations include the COVID-19 shot, flu shot, and RSV vaccine.
It comes two weeks after the leaders of California, Oregon, Washington and Hawaii established the West Coast Health Alliance to rebuke the Trump administration’s policies. States typically follow guidance from the CDC, but the Democratic leaders established the alliance after U.S. Health and Human Services Secretary Robert F. Kennedy Jr. fired all 17 members of the federal panel that advises on immunization practices and replaced them with vaccine skeptics.
“Our states are united in putting science, safety, and transparency first — and in protecting families with clear, credible vaccine guidance. The West Coast Health Alliance stands united in protecting public health and always putting safety before politics,” the governors said in a joint statement.
Separately from Newsom’s announcement Wednesday, labor groups and some California lawmakers announced an effort to try to establish their own CDC and foundation to fund medical research. The proposal specifically would involve borrowing $23 billion in bonds.
The legislation, known as Senate Bill 607, would first need to pass the state Legislature before giving voters the final say on the November ballot in 2026.
“In communities across California, families are counting on science to deliver cures, protect our health, and prepare us for the challenges of the future,” said Assemblymember José Luis Solache, D-Lynwood. “Donald Trump’s cuts threaten not just research, but the lives of our loved ones. This measure makes clear that Californians will take control of our future and invest in life-saving research – because our families, our health, and our economy are too important to leave in the hands of Washington politicians playing games with people’s lives.”
“Democrat-run states that pushed unscientific school lockdowns, toddler mask mandates, and draconian vaccine passports during the COVID era completely eroded the American people’s trust in public health agencies,” a statement from the U.S. Department of Health and Human Services read. “ACIP remains the scientific body guiding immunization recommendations in this country, and HHS will ensure policy is based on rigorous evidence and Gold Standard Science, not the failed politics of the pandemic.”
See more coverage of top California stories here | Download our app | Subscribe to our morning newsletter | Find us on YouTube here and subscribe to our channel
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Hepatitis B vaccine Q&A: Why do babies need the shot?
The people at highest risk for contracting hepatitis B include health care workers, IV drug users and people having sex.
So why do babies get vaccinated for hepatitis B as soon as they are born? It’s a fair question, and health care providers have compelling answers.
Hepatitis B is a virus that can do serious, sometimes fatal, liver damage. Although groups that are more exposed to swapping bodily fluids are at greater risk, anyone can get infected.
Getting infected with hepatitis B as a baby is extra dangerous. Infected infants have a 90% chance of developing the disease’s more dangerous chronic form. And a quarter of those babies will go on to die prematurely from the disease when they become adults, according to the American Academy of Pediatrics.
When the vaccine was invented in the 1980s, doctors initially vaccinated only the highest risk individuals. Cases didn’t meaningfully decline.
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In 1991, the Centers for Disease Control and Prevention began recommending vaccinations for everyone at birth.
The protocol produced results: New infections dropped significantly, especially among children and adolescents.
“Now it’s a very uncommon disease in young children because of that vaccine,” Dr. Paul Offit, Children’s Hospital of Philadelphia pediatrician and infectious disease expert, said. “It was a remarkable, remarkable achievement.”
Today, infants get their first dose within 24 hours of birth and receive two to three more doses by the time they are 6 months old.
But the CDC’s independent vaccine panel is scheduled to reevaluate the vaccine schedule at its Sept. 18 meeting. KFF Health News reported that the panel is expected to vote on whether to delay the vaccine until children are 4.
Here’s what you should know about hepatitis B and what is behind the CDC’s longstanding “at birth” hepatitis B vaccine recommendation.
What is hepatitis B?
The hepatitis B virus attacks the liver. Some people become very sick upon initial infection. Others have only mild symptoms or none at all. Acute cases can resolve on their own, but sometimes they develop into chronic infections.
Long-lasting infections can be asymptomatic, and dangerous. They develop more slowly and symptoms may not show up until much later in life, sometimes decades after the first exposure.
“It’s a stealth infection,” said Dr. William Schaffner, Vanderbilt University School of Medicine professor and infectious disease expert. “After you get over the acute infection, you can have this smoldering infection and be contagious to others and feel perfectly normal.”
Untreated, chronic hepatitis B infections can cause cirrhosis and death. It is also one of the leading causes of liver cancer. Patients can seek treatments to reduce the virus’ worst effects. But there is no cure.
The CDC estimates about 640,000 adults have chronic hepatitis B, but because of its asymptomatic nature, about half of people with the virus do not know they are infected and contagious.
Who gets hepatitis B and how?
Anyone can get it.
Hepatitis B is transmitted through bodily fluids like blood, semen and vaginal fluids. It is usually transmitted through sexual activity, direct contact with blood, or from mother to child during delivery due to contact with bodily fluids.
Because hepatitis B is an especially tough virus, it can live outside the body on surfaces for up to seven days. Even a small amount can be infectious.
That means that although you can get it through sexual contact or health care work, mundane contact can also result in transmission. Small amounts of dried blood on innocuous household items like nail clippers, razors or toothbrushes could be enough.
Many hepatitis B patients are never sure how they contracted it.
“Those environmental routes of transmission of hepatitis B undoubtedly play a small but notable role,” Schaffner said.
Because so many people are unaware they are infected, preventing transmission was much more difficult — until the vaccine.
How do babies get hepatitis B?
The fact that so many infected people have no idea they have it makes it nearly impossible to guarantee a child will never come into contact with a hepatitis B-positive individual.
Babies can get infected from their mothers during childbirth. Testing for hepatitis B during pregnancy is recommended, and patients who receive regular prenatal care are highly likely to be tested at some point. But not all expecting mothers receive regular medical care. In some cases, those at highest risk for contracting hepatitis B are also less likely to access prenatal care, Schaffner said.
The vaccine works well to prevent infection in babies born to mothers with hepatitis B.
But even if a mom tests negative, the child’s risk of contracting hepatitis is not zero. The reasons are varied: The test produces some false negatives. Pregnant patients can contract hepatitis B after being tested. Children may become infected simply by being in contact with the world at large.
Offit said that prior to the vaccine being recommended for all infants, around half of children under 10 were infected from their mother during birth. The other half contracted it somewhere else.
How does the vaccine work and has it been effective at reducing cases?
The hepatitis B vaccine was first introduced in 1981; the version in use today was put in place in 1986.
It uses proteins from the surface of the hepatitis B virus to provoke an immune response that gives the body a defense against future infection. It is not a live virus, and the vaccine can’t infect someone with hepatitis B.
Doctors expect the vaccine may provide lifelong protection, but they are still monitoring results of the 39-year-old vaccine.
Prior to the vaccine, around 200,000 to 300,000 people were infected with hepatitis B each year, including approximately 20,000 children, older CDC reports show.
Since hepatitis B vaccines began being universally administered to babies, overall cases are down to around 14,000 annually. The change is especially dramatic among young people. In 2022, the CDC reported 252 new chronic hepatitis B infections among people up to age 19, or 0.4 out of every 100,000 kids.
Dr. James Campbell, a University of Maryland pediatric infectious disease doctor, said the low rate is directly related to the recommended hepatitis B vaccine schedule: “Because we’ve been vaccinating nearly the entire population since 1991 those people are now 30 something years old.” New infections are largely among older Americans.
All the doctors we spoke with, the CDC and the American Academy of Pediatrics describe the vaccine as safe and effective.
But why not delay the vaccine until a child is a little older?
When it comes to hepatitis B, that first year of life is critical.
Whereas the Department of Health and Human Services reports that 90% of infants who become infected go on to develop a chronic hepatitis B infection, that rate is 2% to 6% for adults. And with research showing that 25% of infected infants die prematurely from the disease, public health officials have long held that early delivery is crucial.
“Think about it,” Campbell said. “We used to have 18,000 or 20,000 kids a year being born with this, a quarter of them going on to have liver cancer. We now have almost none.”
Delaying administration by even a few months increases a baby’s risk should they come into contact with the virus, Offit said. And Schaffner said delaying a vaccine can easily lead to never getting it: An unvaccinated child can become an unprotected adolescent or young adult with sexual partners, “and boom, then they get infected,” he said.
What are the hepatitis B vaccine’s safety risks?
The most common side effects are mild and short term including pain or soreness where the shot is given, headache, fatigue or fever, according to the CDC. Very rarely, some people have a severe allergic reaction to the shot called anaphylaxis, which can be treated.
The vaccine contains small amounts of aluminium, an additive used to enhance the body’s immune response. Although large amounts of aluminum can be harmful, the vaccine contains less aluminum than infants get from their natural surroundings.
According to the Children’s Hospital of Philadelphia, babies get about 4.4mg of aluminum from vaccines in their first six months; they get around 7mg from breastmilk and around 38 mg from formula in the same time.
I heard that the risk of a baby dying from hepatitis B is 1 in 7 million. Is that wrong?
Health and Human Services Secretary Robert F. Kennedy used that statistic during recent Senate testimony. “That means you need to give 7 million hepatitis B vaccines to prevent one death,” he said.
The vaccine is not administered to prevent babies from dying as babies. It aims to prevent them from developing the more harmful chronic hepatitis B, which can be fatal when they get older. It also prevents severe illness.
Kennedy’s statistic for babies who will eventually die from hepatitis B is still missing a lot of context.
It’s based on a 2020 research paper that tried to quantify how many people would have died of hepatitis B in 2014 had there never been mass vaccination.
The study estimated that 1,740 children ages 10 or younger would have contracted a deadly case of hepatitis B in a single year, 2014.
But to make his “1 in 7 million” calculation, Kennedy left out 99% of those deadly cases — any considered to be due to “elevated risk” of exposure, including among children born to infected mothers, children living with infected individuals, or those in communities with large numbers of infected people.
Since many people do not know they are infected, it can be hard to know if you are at elevated risk or reside in a community with infected individuals.
Vaccines given at birth “protect not only infants and children in their infancy and childhood, but throughout their lives,” Schaffner said. “It’s a larger series of issues that we’re trying to address. We’re trying to protect not only babies, but the transmission of the virus to the next generation.”