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Tag: COVID-19 vaccine

  • FDA official, without providing data, claims link between COVID-19 vaccines and pediatric deaths

    Dr. Vinay Prasad, the director of the Food and Drug Administration’s vaccine division, sent a memo to staff that linked children’s deaths to the COVID-19 vaccine, but did not provide data to back the claim. 

    The memo said that a review “found that at least 10 children have died after and because of receiving COVID-19 vaccination,” according to multiple sources familiar with the email. The memo was first reported by the New York Times.  

    Prasad suggested that the deaths were related to myocarditis, or the inflammation of the heart muscle. Prasad did not share any data used in the review, including the children’s ages, whether they had existing health conditions, or how the FDA determined there was a link between their death and the vaccine. The findings were not published in a peer-reviewed medical journal.

    Myocarditis has been linked to the COVID-19 vaccine, but studies have largely confirmed that the risk of the condition is significantly higher after a coronavirus infection, pediatric cardiologists told CBS News in 2023. The prognosis following myocarditis due to the vaccine is also better than from infection, studies show. COVID-19 infection is also linked to other long-term complications.

    The risk of myocarditis appears to be higher when vaccine doses are given closer together, as was the case when the vaccines first hit the market. Now, most people receive each dose of the vaccine about a year apart. If someone receives the primary series before age 5, the risk virtually disappears. 

    Pfizer and Moderna COVID-19 vaccines carry warnings about the risk of myocarditis or pericarditis, a condition where the membrane surrounding the heart becomes inflamed. The warnings were expanded in April 2025 to apply to males aged 16 to 25. The rate of myocarditis and pericarditis was around 8 cases per million doses for children and adults under 65 years old after use of that season’s vaccines, the FDA said at the time.

    COVID-19 vaccines, developed during the first Trump administration, have become a target of the second. Top FDA officials selected by the administration under Health and Human Services Secretary Robert F. Kennedy Jr. overrode career staff to limit the approvals of COVID-19 shots from Novavax and Moderna, according to records released by the FDA. A Centers for Disease Control and Prevention official said in June that she was resigning from her role overseeing updates to the agency’s COVID-19 vaccine recommendations, following an order from Kennedy that forced an update to the agency’s guidance. 

    Changing COVID-19 vaccination guidance has caused confusion for many. The CDC’s vaccine advisory committee, known as the Advisory Committee on Immunization Practices, or ACIP, voted in September to change recommendations for the shot. All members of the committee have been picked by Kennedy, himself a vaccine skeptic. Several of the panel members have criticized the COVID-19 vaccine. 

    The updated CDC guidance recommends people make individual, informed decisions about COVID-19 vaccination, but did not specifically recommend the shots. The American Academy of Pediatrics said it was “strongly recommending” shots for children between 6 months and 2 years old, while the Infectious Diseases Society of America recommended the vaccine for everyone six months and older. State governments have also banded together, forming the West Coast Health Alliance and the Northeast Public Health Collaborative, to issue recommendations that differ from the CDC guidance. 

    Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told CBS News in August that 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, including the initial COVID vaccination series. 

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  • The significance of calls to split up the MMR vaccine into separate shots



    The significance of calls to split up the MMR vaccine into separate shots – CBS News










































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    Acting CDC Director Jim O’Neill is calling for the measles, mumps and rubella vaccine to be split into three separate shots. It comes as the CDC approves new guidelines for updated COVID vaccines. Dr. Celine Gounder explains.

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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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  • Why the COVID vaccine isn’t part of an injury compensation court



    Why the COVID vaccine isn’t part of an injury compensation court – CBS News










































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    A federal court compensates people who say they were injured by vaccines. Here is why the COVID vaccines are not currently part of it.

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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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  • DC residents can now get a COVID-19 shot without a prescription – WTOP News

    Emergency legislation signed by D.C. Mayor Muriel Bowser will authorize licensed pharmacies to administer COVID-19 vaccinations without a prescription.

    Emergency legislation signed this week by D.C. Mayor Muriel Bowser will authorize licensed pharmacies to administer COVID-19 vaccinations without a prescription.

    Changes in federal recommendations this year made it a requirement for those who wanted the COVID-19 vaccine to get a prescription first, unless a person was 65 or older or was considered at risk. The Centers for Disease Control’s immunization schedule lists the 2024-25 COVID-19 vaccine, but not the 2025-26 version — leaving the newer shots subject to a prescription requirement.

    That has resulted in several states resorting to implementing their own policies to negate the need for a prescription, which was not required in previous years since the pandemic.

    “D.C. will now match both Maryland and Virginia, so that residents don’t have to travel out of state to be able to get access to the vaccine,” said At-Large Council member Christina Henderson, who chairs the Committee on Health.

    It was her bill that was passed 12-0 by the council and signed by Mayor Bowser.

    Eligible Virginians also now have an easier time getting vaccines due to an order issued by the Virginia Department of Health two weeks ago. Neighboring Maryland will also protect access to vaccines for all of its residents with flu season approaching.

    “The D.C. Department of Insurance Securities and Banking has required that all insurance plans in the District continue to cover all vaccines that were approved as of last December through 2026,” Henderson added.

    Henderson is concerned that the current administration is not focused on proven, health-based practices.

    “I do wish that the federal government would get back on track in terms of truly following the science, as opposed to these associations not correlations that they are seeing in research,” she said.

    She pointed to President Donald Trump’s announcement this week that pregnant women should not take Tylenol because he said — without any supporting scientific evidence — that there is a link between acetaminophen and autism in children. The maker of Tylenol, Kenvue, as well as numerous scientific groups immediately and forcefully rebuked that claim.

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    Alan Etter

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  • Minnesota COVID-19 vaccine recommendations differ from federal direction

    In an unprecedented move, Minnesota is straying from federal COVID-19 vaccine guidance.

    The move comes after an executive order by Governor Walz to maintain vaccine access.    

    “The recommendations are that every adult should also be vaccinated,” said Dr. Ruth Lynfied, medical director and state epidemiologist with the Minnesota Department of Health.

    On Monday, MDH announced a standing order empowering pharmacists to give COVID-19 vaccinations to those who want them.

    The state agency recommends the vaccine for those six months and older, while strongly recommending it for people with underlying conditions. It comes amid drastic changes to vaccine guidance under Health and Human Services Secretary Robert F. Kennedy Jr., a known vaccine skeptic.

    Most recently, the CDC voted to drop the recommendation for most adults to get vaccinated. In August, the FDA limited COVID-19 vaccines for most age groups.

    “Vaccines can prevent severe disease, and we want people to use the tools that we have available,” said Lynfield.

    The state said it followed guidance from the American Academy of Pediatrics and American Academy of Family Physicians, among others. Those associations recommend the vaccine for kids under the age of 2, pregnant women and anyone at high risk for severe illness.

    Lynfield said allowing widespread access, despite the new federal restrictions, is key.

    “We wanted to ensure that anyone in Minnesota who wanted protection against severe disease from COVID-19 should be able to receive the vaccine,” said Lynfield.

    When asked if insurance will cover the COVID-19 vaccine, Lynfield said, “We are optimistic that there will be coverage.”

    Lynfeld said she hopes to learn more in the coming days, but Walz’s executive order started the conversations between MDH and insurance providers.

    “We just need to wait a little while for the insurance companies and the health plans to catch up with everything that’s been happening,” said Lynfield.

    Last season, Lynfield reported that 5,914 people in the state were hospitalized for COVID, with most being 65 or older.

    As for how bad COVID will be this year, Lynfield said that’s just too hard to predict.

    Jason Rantala

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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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  • CDC vaccine panel says COVID-19 shots are an individual choice

    The CDC’s Advisory Committee on Immunization Practices concluded its two-day meeting on Friday, with significant updates to vaccine recommendations. Dr. Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security, joins CBS News to discuss.

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  • New CDC advisory panel members include more COVID vaccine critics

    Some of the newest members of the Centers for Disease Control and Prevention’s vaccine recommendations committee have questioned established medical research on immunizations and the COVID-19 pandemic.

    In a press release shared Monday, the CDC and Department of Health and Human Services said five new members were appointed to the Advisory Committee on Immunization Practices, or ACIP — just days ahead of a scheduled meeting that is likely to discuss the fall season’s COVID vaccines and more.  

    “These appointments reflect the commitment of Secretary Robert F. Kennedy, Jr. to transparency, evidence-based science, and diverse expertise in guiding the nation’s immunization policies,” the release stated. But a look at the records of those selected shows some have voiced skepticism about vaccines and questioned evidence of their effectiveness.

    This isn’t the first time Kennedy, known for raising doubts about vaccines, has appointed people aligned with his views since taking over as HHS secretary. In June, he named eight new advisers after firing all 17 of the committee’s previous members. His appointments include several allies he has worked with closely over the years and some members with 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.

    Here’s a look at the newest committee members:

    Catherine M. Stein

    Catherine M. Stein is an epidemiologist and professor at Case Western Reserve University in Cleveland, Ohio. She received her doctorate in epidemiology and biostatistics from the same university in 2004 and has a focus on tuberculosis, according to her faculty page on the school’s website.

    Stein has been openly critical of the U.S. response to COVID-19 and has downplayed the severity of the pandemic. According to Ohio Capital Journal, Stein told Ohio lawmakers that health officials were inflating COVID-19 death and hospitalization numbers. The journal also tied her to Health Freedom Ohio, which is affiliated with Children’s Health Defense, an anti-vaccine nonprofit founded by Kennedy as well as Ohio Advocates for Medical Freedom, which the journal describes as an anti-vaccine advocacy group.

    Dr. Evelyn Griffin

    Dr. Evelyn Griffin is an obstetrician and gynecologist based in Louisiana, according to Baton Rouge General’s website. According to local reports, she has spoken against adding COVID-19 vaccines to the school immunization schedule as well as testified about adverse reactions of vaccines. 

    Hillary Blackburn

    Hillary Blackburn, a clinically trained pharmacist, is also the daughter-in-law of Sen. Marsha Blackburn, a Republican from Tennessee, according to Politico

    She is currently the director of medication access and affordability at online pharmacy company AscensionRx and hosts the podcast “Talk to Your Pharmacist,” the HHS release added. Her views on vaccines are unclear. 

    Dr. Kirk Milhoan

    Dr. Kirk Milhoan, a pediatric cardiologist based in Hawaii, is a senior fellow at Independent Medical Alliance, a group that showed support for Kennedy’s nomination, and the founder of For Hearts and Souls, a Christian medical missions organization.

    At a 2024 panel discussion on vaccine injuries convened by Rep. Marjorie Taylor Greene, a Georgia Republican and vocal COVID vaccine skeptic, Milhoan claimed COVID shots pose more harm than good. 

    According to local news reports, he was also investigated by the Hawaii Medical Board in 2022 for disseminating medical misinformation but charges were eventually dropped. 

    Dr. Raymond Pollak

    Dr. Raymond Pollak is a transplant surgeon and hospital whistleblower. In 1999 he reported the University of Illinois at Chicago’s hospital was diagnosing patients as sicker than they were to boost the number of transplants performed there, according to court documents.

    Pollak’s views on vaccines are unclear.

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  • Coloradans can get updated COVID vaccines, but insurance might not cover the shots

    Anyone 6 months and older who wants a COVID-19 shot in Colorado can now get one, but the vaccine will only be free for those with the right insurance — at least for now.

    Initially, pharmacies couldn’t administer the updated shots in Colorado unless a patient had a prescription. The state allows pharmacists to administer vaccines recommended by the Centers for Disease Control and Prevention’s advisory committee, but not other shots.

    Dr. Ned Calonge, chief medical officer for the state health department, responded by issuing a standing order — essentially, a prescription for every resident – allowing them to get vaccinated at retail pharmacies.

    But that order doesn’t guarantee insurance will cover the shots or that pharmacies will choose to stock them. Last year, fewer than half of people over 65 nationwide received an updated COVID-19 shot, with uptake dropping further in younger age groups, raising questions about whether health care providers will believe demand is high enough to justify buying the vaccine.

    “The standing order provides accessibility. It doesn’t necessarily provide availability,” Calonge said Tuesday.

    The Colorado Division of Insurance issued a draft rule last week that would require state-regulated plans to cover COVID-19 vaccines without out-of-pocket costs for people of any age, assuming the division passes it as written. Insurance cards from state-regulated plans typically have CO-DOI printed in the lower left corner.

    The state’s rule doesn’t apply to federally regulated plans, which account for about 30% of employer-sponsored insurance plans in Colorado, Calonge said. Typically, however, those plans try to offer competitive benefits, since they mostly serve large employers, he said.

    “My hope would be they would want to keep up with other insurers,” he said.

    This isn’t the first time that people on state-regulated plans have had benefits not guaranteed for people with federally regulated insurance.

    Colorado capped the cost of insulin and epinephrine shots to treat severe allergic reactions in state plans, but couldn’t require the same for plans the state doesn’t oversee. In those cases, it offered an “affordability program” requiring manufacturers to supply the medication at a lower cost for people who aren’t covered by the state caps, Medicare or Medicaid.

    At least two Colorado insurers surveyed by The Denver Post said all of their plans will cover COVID-19 vaccines, while others hedged.

    Select Health, which sells Medicare and individual marketplace plans in Colorado, said its plans currently cover COVID-19 vaccines without out-of-pocket costs for everyone. Kaiser Permanente Colorado said in a message to members that it will pay for the shot for anyone 6 months or older.

    Donna Lynne, CEO of Denver Health, said the health system’s insurance arm is waiting on clarification about when it should cover the vaccines. Denver Health Medical Plan offers multiple plan types, some state-regulated and some under federal rules, she said.

    “It’s less of a decision on our part than understanding what the health department and the insurance department are saying,” she said. “You can’t have one insurance company saying they are doing it and one saying they aren’t doing it.”

    Anthem said it considers immunizations “medically necessary” if the American Academy of Pediatrics, American Academy of Family Physicians or the CDC’s vaccine advisory committee has recommended them, but didn’t specify whether it would charge out-of-pocket costs for medically necessary vaccines.

    If those bodies stated that certain people could get a particular vaccine — but not that they should — Anthem would decide about coverage “on an individual basis,” its website said. The other groups have recommended the shots for people over 18 or under 2, with the option for healthy children in between to get a booster if their parents wish.

    The state’s Medicaid program is still waiting for guidance from federal authorities about whose vaccines it can cover, according to the Colorado Department of Health Care Policy and Financing, and Medicare isn’t yet paying for the shots.

    For most of the COVID-19 vaccines’ relatively brief existence, they were free and recommended for everyone 6 months and older. In 2024, the federal government stopped paying for them, which meant uninsured people no longer could be sure they could get the shot without paying.

    Almost all insurance plans still were required to pay for the shots, though, because the CDC’s Advisory Committee on Immunization Practices recommended them.

    In previous years, the committee recommended updated shots within days of the U.S. Food and Drug Administration approving them. In late August, the FDA approved the updated vaccines for people over 65 and those with one of about 30 conditions increasing their risk of severe disease, including asthma, obesity and diabetes.

    Doctors still could prescribe the vaccine “off-label” to healthy people, in the same way that they prescribe adult medications for children when an alternative specifically approved for kids isn’t available.

    This year, however, the committee won’t meet until Thursday, and may not recommend the shots when it does. Secretary of Health and Human Services Robert F. Kennedy Jr. dismissed all of the committee’s members earlier this year and replaced them with new appointees, most of whom oppose COVID-19 vaccines.

    Meg Wingerter

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  • Former CDC physicians speak out against new vaccine policies

    At the end of summer, Congress is often sleepy, and slowly gets back to work. But this past week was an exception. On Capitol Hill, Robert F. Kennedy Jr. arrived, and the controversial Health and Human Services Secretary sparked a reckoning over public health in America.

    At a hearing before the Senate Finance Committee on Thursday, Kennedy defended the Trump administration’s policies: “We at HHS are enacting a once-in-a-generation shift from a sick-care system, to a true health care system that tackles the root causes of chronic disease,” he said.

    Tempers ran hot at the hearing. Sen. Michael Bennet (D-Colo.) said, “This is not a podcast. It is the American people’s health that is on the line here.”

    Democrats rebuked Kennedy, perhaps the most high-profile member of President Donald Trump’s cabinet. Sen. Tina Smith (D-Minn.) asked Kennedy, “When were you lying, sir – when you told this committee that you were not anti-vax? Or when you told Americans that there’s no safe and effective vaccine?”

    To which Kennedy replied, “Both things are true.”

    There were Republicans who offered broad support for Kennedy. Sen. Mike Crapo (R-Ida.) said, “President Trump and Secretary Kennedy have made a steadfast commitment to make America healthy again.”

    Yet some Republicans notably did push Kennedy on how his long-standing opposition to vaccine mandates is affecting policy, and on Kennedy’s doubts about the safety of various vaccines. Sen. John Barasso (R-Wyo.) said, “There are real concerns that safe, proven vaccines like measles, like hepatitis B and others, could be in jeopardy.”

    The committee room standoff had been brewing for days. On August 27, the government announced new restrictions on eligibility for COVID vaccinations. That decision prompted some health organizations to warn the policy could cause confusion.

    That same day, the Trump White House said Susan Monarez, the director of the Centers for Disease Control and Prevention, who had just been confirmed by the Senate weeks earlier, was fired.

    The Trump White House stood by Secretary Kennedy’s sweeping changes, and by the firing. White House Press Secretary Karoline Leavitt said of Monarez, “She was not aligned with President Trump’s mission to make America healthy again.”

    In a statement to “Sunday Morning,” White House spokesman Kush Desai said, “The White House maintains full confidence in Secretary Kennedy’s leadership at HHS to advance President Trump’s MAHA agenda. With Operation Warp Speed’s unprecedented success delivering COVID-19 vaccines in record time, President Trump proved that it’s possible to shake up the status quo of our broken and bureaucratic public health system to deliver real results for the American people. Now the second Trump administration is building on this record and experience to restore Gold Standard Science as the guiding principle of health decision-making at HHS to Make America Healthy Again.”

    In a Wall Street Journal op-ed, Susan Monarez has written that she was pressured to “compromise science itself” – and to sign off on people who “have publicly expressed antivaccine rhetoric.”

    This turbulence has put Kennedy, who was a key Trump ally during last year’s campaign, in the spotlight.

    Asked whether there has been pressure within the Republican Party to stand by Kennedy, Kentucky Republican Senator Rand Paul said, “Nobody’s pressured me or ever called me on it. I sort of speak my mind. And these are long-standing beliefs for me.”

    Paul, an ophthalmologist, supports Kennedy, and lays blame on scientists – not skeptics – for worries about vaccine safety. “All the doubt over vaccines is – there might be some doubt coming from those who don’t want you to take a vaccine, but quite a bit of doubt is coming from the establishment that I believe is authoritarian in nature,” said Paul. “You don’t care whether they tell you what to do. You should just do what you’re told. We know better than you.”

    But some who have worked at the highest level are fighting back against criticism, and are sounding an alarm.

    “A significant distrust of vaccines”

    Four CDC officials – Doctors Jennifer Layden, Daniel Jernigan, Debra Houry, and Demetre Daskalakis – all have resigned in recent days, some citing Secretary Kennedy’s vaccine policies, others citing the upheaval at the CDC, which provides crucial health guidance nationwide.

    And all four expressed concerns about their resulting trust in CDC information about vaccines and vaccine safety data. “It’s why I left; I’m very concerned,” said Dr. Daskalakis. “We’ve already crossed the line. The COVID recommendations for children and pregnant women are completely not based in any evidence that world experts agree on.”

    I asked, “You know Secretary Kennedy would push back on that; what would you tell him?”

    “Ah, easy,” Daskalakis replied. “The recommendation is that there should be no healthy kids that get the vaccine; it should only be in kids with underlying conditions. Kids that are six-months-old, 56% of them that are admitted to the hospital have no underlying condition. So, by not offering the vaccine to parents who are willing to do it, those kids that could have been protected won’t be.”

    Asked how he would label Kennedy and his view of vaccines, Dr. Daniel Jernigan said, “I think he has a significant distrust of vaccines. I don’t know that he’s driving a get-rid-of-vaccines agenda. It’s more death by a thousand cuts, death by a thousand questions, calling into question data that has been accepted for many, many years, and simply that calling it into question brings into people’s minds that, ‘Maybe I shouldn’t get that vaccine.'”

    Dr. Debra Houry said that when Kennedy began at HHS, “I read his books. I wanted to better understand his research and his background on it. So, we were open, you know, to having those discussions.”

    In an additional statement to “Sunday Morning,” White House spokesman Kush Desai said:

    “Americans haven’t forgotten how ‘the science’ was politicized and weaponized during the COVID era by unaccountable ‘health officials’ to push intrusive mandates and stifle any semblance of the skepticism that actual scientific inquiry is based on. The Trump administration is committed to restoring evidence-based, Gold Standard Science and answering the questions that Americans haven’t been allowed to ask to restore trust, confidence, and accountability in our public health bodies.”

    Asked what the cost to Americans would be of doctors and other officials leaving the CDC, Dr. Jennifer Layden said, “We’re talking about the whole public health infrastructure of our nation. And I think when we start to see (and we will) outbreaks that normally don’t happen – more food-borne outbreaks, Legionella outbreaks, rising measles cases – people will start to care. That may take time for us to see some of those negative consequences, but that’s what the ripple effect of all this will do across our nation.”

    In fact, ripple effects are already apparent.

    “Diseases don’t obey borders”

    Just this past week, Florida’s Republican governor announced plans to eliminate all childhood vaccine requirements.

    Meanwhile, West Coast Democratic governors who oppose Secretary Kennedy’s policies are moving fast to protect vaccine programs in their states.

    I asked Dr. Atul Gawande, a surgeon who served in the Biden administration, “What is the consequence for the country when you have such a differentiation? It’s splintered.”

    “It’s severely splintered, and I’m very worried about it,” Gawandea replied, “because diseases don’t obey borders.

    For Gawande, Kennedy’s actions could upend not only federal agencies, but America’s standing in global health. “There isn’t always consensus, for sure, among our own medical community,” he said, “but we generally have been able to come together enough to be able to say, ‘Here is where we can assure getting – whether it’s COVID boosters, and making sure we don’t leave out the people who are most in need of vaccination – to making sure we’re not abandoning our childhood immunization. Other countries around the world are baffled by our now falling into a civil war over whether the discoveries that have saved the world mattered.”

    Later this month, the CDC’s vaccine advisory board – now featuring Kennedy appointees – will meet to decide future guidelines.

    At the end of the day, Gawande says, “Trust helps assuage doubt.”

    But, I asked, “Is trust still possible in this environment?”

    “Trust is still possible,” said Gawande, “but it is not possible while we have leaders who actively drive chaos, who actively are trying to create uncertainty and break down trust. But ultimately, people have to choose the leaders who have the track record of demonstrating better outcomes. And those leaders are scientists, health professionals, and others who have demonstrated over years that they actually get you better results.”

          
    For more info:

         
    Story produced by Ed Forgotson and Jack Weingart. Editor: Carol Ross. 

          
    See also: 



    Key takeaways from tense RFK Jr. Senate hearing

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  • Hochul expands COVID vaccine access at NY pharmacies | Long Island Business News

    In Port Washington on Friday, New York State Gov. Kathy Hochul signed an executive order to allow people to get the COVID-19 vaccine at pharmacies without a prescription across the state.

    New Yorkers can “go into a pharmacy, as they’re accustomed to doing, and the pharmacist will now, as a result of this signing, be authorized to administer COVID shots to those who choose to have them,” Hochul told reporters during a visit to Manorhaven Elementary School in Port Washington.

    The executive order was developed to get around newly imposed federal restrictions on vaccine access introduced last week that limited eligibility to those 65 and older, or younger with underlying health conditions.

    On Friday, Hochul said that “we’re going to make sure that everyone who has health insurance has coverage” to get the COVID vaccine, and added that Medicaid covers it.

    “Many of the large insurers have said they’ll cover it anyhow, because if you can prevent an illness, isn’t that a lot less expensive to treat in the long run?” Hochul said. “The insurance companies understand how important these are, but we’re going to work through some of the details.”

    Many of those details “can be settled when we come back with more comprehensive legislation in January,” Hochul said. But, she added, “I can’t wait that long. We are in peak COVID season. It’s starting up now. The cases are going up. People need to be aware of this, and this is the time when people should be thinking about getting their shots for themselves and their families if they choose.”

    She said that people have been “conditioned to be able to walk into a pharmacy, and I want to keep the status quo,” and added that she did not think people would take the time to get to a doctor’s office to get a prescription. “I don’t want there to be barriers to their or their family’s health because of an artificial roadblock.”

    Hochul said she and her team are “working around the clock to ensure that whatever Washington does, that we’re prepared to respond, so there’s no gap in coverage for New Yorkers.”


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  • CDC’s new acting director Jim O’Neill faces looming decisions on vaccines

    The Centers for Disease Control and Prevention is at a crossroads. Last week, CDC Director Susan Monarez was ousted less than a month into her tenure after resisting Secretary Robert F. Kennedy Jr.’s push to align with his vaccine policy agenda. Within hours, three senior leaders — including the chief medical officer and the heads of vaccine safety and respiratory infections — resigned in protest. Their exits capped weeks of mounting tension: biased scientific reviews, the withdrawal of key documents, and a shooting at CDC headquarters tied to COVID misinformation. Hundreds of staff publicly applauded the departing scientists in a rare “clap-out.” 

    Into that vacuum stepped Jim O’Neill, deputy secretary of Health and Human Services, now installed as acting CDC director.

    O’Neill’s résumé breaks sharply with CDC tradition. A Bush-era HHS official turned Silicon Valley investor, he is neither a physician nor a scientist — an unusual profile for the agency’s top post. He is expected to retain his deputy role at HHS while leading the CDC. After his early government service, O’Neill spent nearly two decades in close partnership with billionaire Peter Thiel, managing his funds, directing the Thiel Foundation, and co-founding the Thiel Fellowship. He also led the SENS Research Foundation, a nonprofit focused on anti-aging science. In June, he returned to Washington as deputy secretary; he now holds that position alongside his role as CDC director.

    Health and Human Services Secretary Robert F. Kennedy, Jr., right, conducts the swearing-in ceremony of Jim O’Neill as deputy secretary on June 9, 2025, in Washington, D.C. 

    Department of Health and Human Services via AP


    Former colleagues on both sides of the aisle describe him as smart and diligent, with a deep knowledge of HHS mechanics. They also note his libertarian streak, which could align him well with Secretary Kennedy but set him at odds with school vaccination requirements. His most controversial stance, voiced in 2014, was that the FDA should approve drugs once proven safe, leaving effectiveness to be determined in the marketplace — a proposal widely criticized by public health experts as dangerous.

    O’Neill insists he is “very strongly pro-vaccine,” but his recent post on social media — asking if “omicron is the best vaccine” and suggesting CDC could “redefine the word vaccine at will” — sparked new concerns about his grasp of vaccine science. Experts counter that infection is not the same as vaccination, which confers protection without the risks of acute illness or long COVID.

    He could wear both hats for some time. The White House and Kennedy appear eager to avoid a bruising Senate confirmation fight. Until COVID, the CDC director was not a Senate-confirmed position; Republicans changed that in the pandemic’s aftermath. Leaving O’Neill in an “acting” role could paralyze major decision-making at the agency for the foreseeable future.

    Meanwhile, the CDC’s vaccine advisory committee — made up of all new Kennedy appointees — is preparing for a pivotal September meeting. On the agenda: the newborn hepatitis B dose, infant RSV protection, COVID vaccination for healthy children and young adults, and the combined measles-mumps-rubella-varicella shot. Revisiting so many long-standing childhood immunizations at once would be unprecedented. If recommendations are weakened, Medicaid, the Children’s Health Insurance Program and the Vaccines for Children program could restrict coverage, creating new barriers for families.

    The stakes for CDC are profound. O’Neill has promised to “refocus CDC on infectious disease” and “restore trust,” yet staff and state partners say politicized decisions and budget cuts are already eroding core work. 

    The September vaccine advisory meeting will be the first real test for O’Neill. If he restores scientific processes, including transparent reviews, expert briefings, and evidence being vetted and posted before votes, CDC insiders say he could stabilize morale at the agency and preserve the credibility of its scientifically-based recommendations. If not, the resignations of senior scientists may prove the start of a broader exodus, leaving states and families without clear guidance just as flu, RSV and COVID converge this fall.

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  • Can you get a COVID vaccine at your pharmacy? It depends on what state you’re in



    Can you get a COVID vaccine at your pharmacy? It depends on what state you’re in – CBS News










































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    The nation’s largest pharmacy chains are offering appointments to get the new COVID-19 vaccine, but not in all states and not for all Americans. Shanelle Kaul reports.

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  • CVS and Walgreens limit access to COVID vaccines as required by some state guidelines

    CVS and Walgreens are now requiring a prescription or are not offering COVID-19 vaccines in some states as the companies attempt to follow state guidelines that require approvals from the Centers for Disease Control and Prevention.

    The Food and Drug Administration has approved vaccines from Pfizer, Moderna and Novavax for all seniors, but only for younger adults and children with health conditions.

    In a statement, CVS said the pharmacy chain cannot vaccinate those even with a prescription in Massachusetts, Nevada and New Mexico due to state laws and regulations.

    “Based on the current regulatory environment,” CVS said it’s offering COVID-19 vaccinations in the following states: Alaska, Alabama, Arkansas, California, Connecticut, Delaware, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, North Dakota, New Hampshire, New Jersey, Ohio, Oklahoma, Oregon, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming. 

    CVS said the list of states offering COVID-19 vaccines without a prescription may change at any time.

    In the other 16 states, CVS said it can administer a COVID-19 vaccination, depending on the patient’s age, with an authorized prescriber’s prescription. 

    In a statement, Walgreens said, “With the recent FDA approval of the 2025–2026 COVID-19 vaccine, Walgreens is prepared to offer the vaccine in states where we are able to do so.” 

    The FDA’s decision to end emergency authorization for the Pfizer vaccine for children under 5 will limit vaccine choices for younger children, leaving the Moderna vaccine as the only vaccine available for those 6 months to 4 years old with at least one health condition. Last week, the American Academy of Pediatrics released vaccine recommendations that, for the first time in 30 years, differ from U.S. government advice. 

    In the guidance published Aug. 19, the AAP said it’s “strongly recommending” COVID-19 shots for children ages 6 months to 2 years old. However, the CDC doesn’t recommend COVID-19 shots for healthy children of any age, but instead says kids may get the shots in consultation with a physician.

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  • Can you get a COVID-19 vaccine in 2025? Here’s what to know.

    Winter is approaching. U.S. COVID-19 cases are rising. Questions about accessing protective vaccines are swirling.

    Nearly five years since the first U.S. patient got vaccinated to help stem what was then a raging coronavirus pandemic, doctors, patients and pharmacists are navigating a radically different public health landscape.

    Data point No. 1: The U.S. Food and Drug Administration on Aug. 27 announced it had approved some COVID-19 vaccines — but for far fewer people than in years past.

    Data point No. 2: If you tried to schedule a COVID-19 vaccine this week, your pharmacy’s online scheduler might have told you it isn’t available yet.

    Data point No. 3: Leading medical organizations disagree with the government’s latest COVID-19 vaccine guidance.

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    If all that leaves you wondering about your ability to get a COVID-19 shot, you’re not alone. It’s confusing.

    We sought answers.

    Q: Who can get a COVID-19 vaccine?

    First, what we do know: The FDA approved the 2025-26 vaccines for anyone age 65 and older and any person 6 months and older who has at least one underlying health condition that increases their risk of severe COVID-19 infection.

    So, people in those groups should be able to schedule vaccinations as soon as health care providers who are authorized to administer the vaccine receive it — likely in the next few weeks.

    Q: I don’t fit into those categories. Am I banned from getting a COVID-19 vaccine?

    Not “banned,” per se. But it may require more legwork on your end. You’ll need to consult your doctor, who can legally prescribe a COVID-19 vaccine for you even if you don’t fall within the categories the FDA specified. 

    “Physicians can prescribe medications and vaccines that are beyond the label, beyond the license,” said Dr. William Schaffner, Vanderbilt University Medical Center professor of infectious diseases.

    That’s true for adults and children — and the practice of prescribing medications and vaccines for “off-label” use is fairly common in pediatrics, he said.

    Q: OK, so will insurance still cover COVID-19 vaccinations under these new rules?

    If you’re in one of the two FDA-approved categories the outlook is probably better than if you’re not.

    Federal law requires that most health insurance plans fully cover vaccines recommended by the U.S. Centers for Disease Control and Prevention and its vaccine advisory committee.

    Here’s the rub: Because the CDC hasn’t yet adopted 2025-26 COVID-19 vaccine recommendations, whether the shots will be covered by insurance is a gray area.

    The CDC’s panel of experts, the Advisory Committee on Immunization Practices, had planned to vote on updated COVID-19 vaccine recommendations at its June meeting but did not. And it’s unclear when or if the ACIP will vote on the recommendations.

    But there could be another avenue for people to get insurance-covered COVID-19 vaccines. The CDC’s vaccine recommendations typically include a provision for what’s known as “shared clinical decision making,” Schaffner said. 

    That means, for example, “If you were 52 years old and otherwise healthy, but you nonetheless wanted to get the vaccine, you could discuss that with your doctor — shared clinical decision making — and you could receive the vaccine, and insurance companies would honor that,” he said. 

    That provision could be important for healthy people who want to avoid COVID-19 infection because they are close contacts with or care for people with high risk conditions.

    But again, without CDC recommendations, “We don’t know if that provision is still there,” Schaffner said. 

    To confirm whether your insurance will cover your COVID-19 shot, Schaffner recommends talking to your doctor and, potentially, your insurance provider. But first, give it a little more time: Healthcare providers themselves are still working out the details.

    Pfizer, left, and Moderna bivalent COVID-19 vaccines are readied for use at a clinic, Nov. 17, 2022, in Richmond, Va. (AP)

    Q: If my insurance doesn’t cover vaccination, how much might it cost?

    Vaccine manufacturers report that COVID-19 vaccines cost about $142, according to the CDC’s price lists. It’s unclear whether that would be the out-of-pocket cost for patients receiving a COVID-19 vaccine not covered by insurance. 

    Q: Are COVID-19 vaccines still recommended during pregnancy? And if I’m pregnant and want one, what can I do? 

    Health and Human Services Secretary Robert F. Kennedy Jr. in May announced he’d unilaterally removed COVID-19 vaccines from the recommended immunization schedule for healthy children and pregnant women. The health-focused news outlet STAT reported that no one from the CDC or ACIP was consulted before Kennedy announced this change. Vaccine experts called the move concerning and unprecedented

    Removing the vaccines from the immunization schedule could limit vaccine access by reducing insurance companies’ coverage of the shot. But again, by consulting with your doctor, you might still be able to access it. Some pharmacies also might be able to provide it, because the CDC lists pregnancy as a factor that increases risk of severe COVID-19 infection.

    Q: Is there anyone who should not get the COVID-19 shot?

    Broad health guidance always comes with exceptions. For example, people who have had “a very severe adverse reaction to a previous COVID-19 vaccine” should not get this season’s version, Schaffner said. You should discuss your health situation with your physician for personalized guidance.

    Q: Why is the outlook for COVID-19 vaccines so different this year?

    In short, Kennedy has long been broadly critical of vaccinations and, now that he’s in charge of the nation’s health care policy, has taken actions to overhaul their regulation and distribution.

    Typically, the CDC recommends vaccines based on guidance from the ACIP. ACIP’s recommendations become CDC policy if they’re adopted by the CDC director. This year, Kennedy fired all 17 members of ACIP and replaced them with new members, many of whom have expressed antivaccine views. CDC Director Susan Monarez was fired Aug. 27 amid a dispute with Kennedy over vaccine policy. 

    In previous years, the CDC recommended annual COVID-19 vaccines for everyone ages 6 months and older. The committee still hasn’t issued COVID-19 vaccine recommendations for this year.  

    HHS Secretary Robert F. Kennedy Jr. speaks alongside FDA administrator Dr. Martin Makary, left, and Dr. Jay Bhattacharya, director of the National Institutes of Health, as they announce that the government would no longer endorse the COVID-19 vaccine for healthy children or pregnant women. (HHS via AP)

    Q: Aren’t there some medical organizations that recommend COVID-19 vaccinations for most people, though? 

    Yes. In recent months, professional organizations have issued their own recommendations that contradict new messaging from the federal government. 

    The American Academy of Practices recommends routine COVID-19 vaccines for all children ages 6 months through 23 months and for kids ages 2 to 18 in some situations including if they’re at high risk of COVID-19, have never been vaccinated against it or live in a household with people who are high risk. 

    And the American College of Obstetricians and Gynecologists recommends that anyone pregnant or lactating receive updated or “booster” COVID-19 vaccines.

    Dr. Tina Tan, president of the Infectious Disease Society of America, said the FDA’s decision to limit the COVID-19 vaccine’s approval “contradicts the evidence base, severely undermines trust in science-driven policy and dangerously limits vaccine access.” 

    Q: What qualifies as an underlying health condition that puts someone at higher risk? 

    The FDA and HHS did not point us to a list of health conditions that meet the high risk requirements. 

    The CDC’s website catalogs a number of underlying conditions that it said demonstrate “a conclusive increase in risk for at least one severe COVID-19 outcome.” They included: chronic lung diseases, cancer, certain chronic kidney and liver diseases, diabetes, some disabilities, heart conditions, HIV, physical inactivity, primary immunodeficiencies and some mental health conditions.

    Q: But I clicked on those lists and both say “pregnancy and recent pregnancy” are risk factors. How do I square that with the latest changes?

    You’re right. These lists are inconsistent with the messaging coming from top HHS officials. Again, the American College of Obstetricians and Gynecologists continues to recommend COVID-19 vaccines for people who are pregnant and lactating. Talk to your doctor.

    Q: Is this season’s COVID-19 vaccine formula different from last season’s?

    Yes. After the FDA passed its recommendations to vaccine manufacturers in May, the COVID-19 vaccines were updated to target the viral strain expected to circulate this year. The changes align with the World Health Organization’s recommendations.

    Q: When will the updated COVID-19 shots be available? 

    Since FDA’s approval, updated vaccines are set to start shipping immediately and might even be available now in some pharmacies. Pfizer said it was shipping immediately and would be available across the U.S. “in the coming days.” Sanofi, the company distributing the Novavax non-mRNA vaccines, said its vaccine should be available “in the early fall.”

    But what that means for how quickly you can access it could depend on where you live, your age and your health. (See next question!)

    A sign for flu and COVID-19 vaccinations is displayed Sept. 13, 2023, at a pharmacy store in Palatine, Ill. (AP)

    Q: Where can I get the updated COVID-19 shots? 

    We knew you were going to ask. And we wish we had a straightforward answer.

    If you typically get your COVID-19 shots at a local pharmacy, it might not be that easy this year. 

    As of Aug. 29, the scheduling apps for Walgreens and CVS notified patients in some locations that they could not schedule a COVID-19 vaccine appointment because of state restrictions, inventory or the need for a prescription. 

    In 18 states and Washington, D.C., pharmacists’ authority to administer vaccines is linked to the CDC’s recommendations, said Brigid Groves, American Pharmacists Association’s vice president of professional affairs. The states are: Colorado, Connecticut, Georgia, Iowa, Kentucky, Maine, Maryland, Massachusetts, Montana, Nevada, New Jersey, New Mexico, North Carolina, Oregon, Pennsylvania, South Carolina, Virginia and West Virginia. 

    That means even though the FDA has issued its approval, in those 19 places, pharmacists cannot administer it because it isn’t on the CDC immunization schedule yet, Groves said.

    The American Pharmacists Association has asked those states’ governors to issue executive orders granting pharmacists broader authority to administer vaccines.

    In the other 32 states, with some exceptions, it’s possible that a pharmacy can administer the updated COVID-19 shots for patients who fall within the FDA-approved categories of recipients.

    If you are getting it “off label,” however, because you don’t have one of those underlying conditions, you might need to get it straight from your prescribing doctor.

    One caveat: If the ACIP votes on recommendations for COVID-19 vaccines that includes giving them to healthy people through the “shared clinical decision making” process, Groves said pharmacists would be able to vaccinate almost anyone. That’s because pharmacists are considered clinicians who can conduct that shared decision making.

    Q: When might the ACIP vote on COVID-19 vaccine recommendations? 

    The committee has a Sept 18-19 meeting scheduled, according to the CDC’s website. A meeting agenda hasn’t been published yet.

    Q: How will a pharmacy know if I have an underlying condition?

    Typically, pharmacies ask patients to self-attest whether they have an underlying condition, Groves said. For example, a person who is under age 65 but has severe asthma would self-attest to that  when making a vaccine appointment. So far, all signs point to that self-attestation still being the case. 

    Q: When is the best time to get vaccinated? 

    During fall and winter months, when COVID-19 infections are typically expected to spike alongside other respiratory infections.

    Q: What do the administration’s vaccine changes mean for future COVID-19 vaccines?

    Kennedy recently canceled $500 million in funding for mRNA vaccine development. Two of the most effective COVID-19 vaccines are mRNA. Some companies had been researching combined mRNA flu and COVID-19 shots, and those projects’ status is unclear.

    The FDA also recently announced that vaccine makers seeking approval for future COVID-19 vaccines, or boosters, would need to conduct new randomized clinical trials of healthy populations. That move, combined with the decision to narrow the FDA’s vaccine approval for certain segments of the population, is expected to limit COVID-19 vaccine access

    RELATED: It’s almost flu season. Should you still get a shot, and will insurance cover it?

    RELATED: ​​Can RFK Jr. ban COVID-19 vaccines? What to know about federal rules around the process

    RELATED: RFK Jr. fired everyone on a key vaccine panel. Here’s who he replaced them with. 

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  • CVS, Walgreens now require prescriptions for COVID vaccines in Colorado

    People who want to get an updated COVID-19 vaccine at CVS or Walgreens pharmacies in Colorado this fall will need to present a prescription.

    State law allows pharmacists to administer vaccines recommended by the Advisory Committee on Immunization Practices, a group that counsels the director of the Centers for Disease Control and Prevention about who will benefit from which shots.

    In previous years, the committee recommended updated COVID-19 vaccines within days of the U.S. Food and Drug Administration approving them. This year, the committee doesn’t have any meetings scheduled until late September, and may not recommend the shot when it does meet, since Secretary of Health and Human Services Robert F. Kennedy Jr. appointed multiple members with anti-vaccine views after removing all prior appointees in June.

    The lack of a recommendation also means that insurance companies aren’t legally required to pay for the COVID-19 vaccine without out-of-pocket costs. Most private insurers will cover the updated shots this year, though that could change in 2026, according to Reuters.

    Initially, CVS said it couldn’t give the COVID-19 vaccine to anyone in Colorado or 15 other states, because of their ACIP-approval requirement. As of Friday morning, its pharmacies can offer the shots to eligible people who have a prescription, spokeswoman Amy Thibault said.

    As of about 10 a.m. Friday, CVS’s website wouldn’t allow visitors to schedule COVID-19 shots in Colorado.

    Walgreens didn’t respond to questions about its COVID-19 vaccine policy, but its website said patients need a prescription in Colorado. A New York Times reporter found the same in 15 other states.

    The FDA this week recommended the updated shots only for people who are over 65 or have a health condition that puts them at risk for severe disease.

    The listed conditions include:

    • Asthma and other lung diseases
    • Cancer
    • History of stroke or disease in the brain’s blood vessels
    • Chronic kidney disease
    • Liver disease
    • Cystic fibrosis
    • Diabetes (all types)
    • Developmental disabilities, such as Down syndrome
    • Heart problems
    • Mental health conditions, including depression and schizophrenia
    • Dementia
    • Parkinson’s disease
    • Obesity
    • Physical inactivity
    • Current or recent pregnancy
    • Diseases or medications that impair the immune system
    • Smoking

    Meg Wingerter

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  • The most widespread misinformation about COVID-19 vaccines this year

    In a new KFF poll, 3 in 5 adults say they will “probably not” or “definitely not” get the COVID-19 vaccine this fall. While there are many reasons why some decide against vaccination, doctors say misinformation is one factor that could be playing a role. CBS News Confirmed executive editor Rhona Tarrant reports on some of the persistent, false claims.

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  • Pediatrics group’s COVID-19 vaccine recommendations differ from CDC advice

    The American Academy of Pediatrics is sharing new vaccine recommendations that, for the first time in 30 years, differ from U.S. government advice. 

    In the guidance published Tuesday, 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 up to parents’ discretion, the AAP said.

    The Centers for Disease Control and Prevention’s advice is different. Under Health Secretary Robert F. Kennedy Jr., the CDC doesn’t recommend COVID-19 shots for healthy children of any age, but instead, the administration says kids may get the shots in consultation with physicians.

    In a news release Tuesday, AAP President Dr. Susan J. Kressly, said the organization’s immunization recommendations will continue to be “rooted in science” and in the “best interest of the health of infants, children and adolescents.”

    “Pediatricians know how important routine childhood immunizations are in keeping children, families and their communities healthy and thriving,” Kressly said. 

    In a statement to CBS News, HHS communications director Andrew Nixon said the American people “deserve confidence that medical recommendations are based solely on science and public health.”

    “We call on the AAP to strengthen conflict-of-interest safeguards and keep its publications free from financial influence, ensuring every recommendation reflects only the best interests of America’s children,” the statement continued, in part, adding Kennedy has “stood firm in his commitment to science, transparency, and restoring public trust.”

    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. 

    “Parents should really stick the course and make sure that their children get all of the routine childhood vaccinations,” she said on “CBS Mornings Plus,” adding that more announcements are expected from other professional societies in the coming weeks.

    Gounder added AAP’s recommendations are really just reaffirming what they’ve previously advised. 

    “The first encounter with COVID should be with the shot, not with the virus,” she said. “There is still a very high risk in younger children, particularly 6 months to 2 years, for hospitalization and severe complications if they get COVID.”

    The AAP’s recommendations also included guidance for RSV, or respiratory syncytial virus, and flu vaccines.

    For RSV, the APP recommends immunizations for infants younger than 8 months old who aren’t protected via a vaccine from the pregnant parent, and for children 8 to 19 months old at high risk of severe infection. 

    For the flu, the AAP recommends annual vaccines for all children starting at 6 months old, unless they have a medical reason that would prevent them from getting the vaccine. 

    contributed to this report.

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