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  • Can RFK Jr. ban COVID-19 vaccines?

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    A single-source news report that said Trump administration officials plan to take COVID-19 vaccines off the market prompted fresh questions about Health and Human Services Secretary Robert F. Kennedy Jr.’s power over vaccines. 

    The Daily Beast reported Aug. 25 that “a decision to remove the (COVID-19) vaccine from the U.S. market pending further research will come ‘within months,’” citing British cardiologist Dr. Aseem Malhotra. Malhotra is chief medical adviser at Make America Healthy Again Action — an advocacy group run by longtime Kennedy allies. In July, the group launched an advertising campaign supporting Kennedy and President Donald Trump’s MAHA goals.

    Malhotra is not listed among Trump administration officials. But some of his anti-COVID-19 vaccine statements align with past statements by administration officials, including Kennedy.

    Kennedy has long opposed vaccines and once called the COVID-19 vaccine “the deadliest vaccine ever made,” contradicting scientific evidence. Kennedy said in November 2024 that he didn’t plan to ban vaccines: “If vaccines are working for somebody, I’m not going to take them away.” 

    But if he changed his mind, could Kennedy ban COVID-19 vaccines?

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    Not unilaterally, vaccine law experts say. Although there are ways the administration can make COVID-19 vaccines harder for Americans to get, there’s a process for taking approved vaccines off the market, and attempts to take vaccines off the market could face legal challenges. 

    “The Administration is relying on gold standard science and is committed to radical transparency to make decisions that affect all Americans,” White House spokesman Kush Desai told PolitiFact when asked about The Daily Beast’s report that the administration was considering a COVID-19 vaccine ban. “Unless announced by the Administration, however, any discussion about HHS policy should be dismissed as baseless speculation.”

    An HHS spokesperson said the agency doesn’t comment on potential policy decisions. 

    Can HHS remove approved vaccines from the market? 

    To take an approved vaccine off the market, the U.S. Food and Drug Administration would have to revoke the manufacturers’ license for that vaccine.

    The FDA has licensed and approved three COVID-19 vaccines for at least some segments of the population. Those include two mRNA vaccines — one made by Moderna and another made by Pfizer-BioNTech — and Novavax’s protein-based vaccine. 

    The FDA’s approval of the COVID-19 vaccines — in some cases, during Trump’s current term — could make it more difficult to completely remove them from the market. 

    The FDA could try to remove a vaccine if the agency had significant safety concerns or “concerns about manufacturing practices,” reported KFF, a nonprofit health policy research, polling and news organization. 

    For years, Kennedy has said that vaccines are inadequately tested and unsafe.

    But federal regulations specify how the FDA would revoke a license, said Dorit Reiss, a vaccine law and policy expert at University of California Law San Francisco.

    “You need to meet procedural requirements and show that the removal was not arbitrary and capricious,” Reiss told PolitiFact in November.

    It can be done, though: The FDA recently announced it suspended a French drugmaker’s license for a live-attenuated vaccine that protects against chikungunya, a virus spread by mosquitoes. 

    Kenendy has also already made moves that reduce Americans’ access to the COVID-19 vaccines. 

    In May, Kennedy announced he’d removed COVID-19 vaccines from the recommended immunization schedule for healthy children and pregnant women — a move that could limit vaccine access by reducing insurance companies’ coverage of the shot. The FDA also announced that vaccine makers seeking approval for future COVID-19 vaccines, or boosters, would need to conduct new randomized clinical trials of healthy populations. Such moves are expected to limit COVID-19 vaccine access. 

    Steps toward revoking an approved vaccine 

    Under federal rules, the FDA commissioner — not the HHS secretary — can try to revoke a vaccine license. FDA Commissioner Marty Makary is a pancreatic surgeon and a proponent of the “Make America Healthy Again” movement; he said he has a good relationship with Kennedy.

    Makary could seek to revoke a vaccine’s license if, as the law outlines, he found it “fails to conform to the applicable standards” that ensure the product’s “continued safety, purity, and potency” or if he determined “the licensed product is not safe and effective” for its intended uses.

    The FDA commissioner typically must notify the vaccine manufacturer of the agency’s plans to revoke the license, provide the agency’s grounds for the revocation and give the manufacturer an opportunity for a hearing. An FDA official known as an administrative adjudicator — an executive branch official — would preside over the hearing, Reiss said. 

    “It should be a chance to provide safety data and lay out their case,” she said. After the hearing, the FDA would decide whether to revoke the license and the company could then challenge a revocation, Reiss said. 

    Initiating the procedure to remove an approved vaccine “without new information and sufficient evidence of harms or other concerns” would likely trigger legal challenges, KFF said. 

    “Most vaccines that were removed from the market were removed voluntarily, so there’s not really a lot of experience,” Reiss said. “Companies do not always sue FDA; it might not be cost-effective to do so. But they can, and I would be surprised if none of them do.”

    Wendy Parmet, director of Northeastern University law school’s Center for Health Policy and Law, said that if the vaccine manufacturers contested a license revocation, she expected they would have a strong case, given the reams of vaccine safety data and post-market studies of COVID-19 vaccine use around the world. 

    But some companies have been unwilling to fight the Trump administration, she said. 

    “They’ve already lost contracts from mRNA research,” Parmet said, referring to Kennedy’s decision to cut mRNA vaccine development funding. And the companies have broad portfolios with numerous business interests that could be affected by the Trump administration’s policies more widely.

    “Are they going to be afraid that they’ll be hit with retaliatory tariffs?” Parmet said. “We’ve seen companies being afraid of asserting their rights because they’re being pressured in other ways.” 

    If vaccine manufacturers don’t challenge the government, physicians groups or patients groups could file legal challenges, Parmet said. 

    “I think there’ll be litigation. I would expect a court to try to give temporary relief,” she said. “But we’ve seen the Trump administration have greater success the higher up the judicial ladder we go. So I don’t know what’s going to happen.”

    RELATED: Ask PolitiFact: If Robert F. Kennedy Jr. is confirmed as HHS secretary, could he ban vaccines?

    RELATED: RFK Jr. ended COVID vaccine recommendation for kids, pregnant women. What do facts show about risk?

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

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  • Hotez Says RFK’s Slashed Funding on mRNA Vaccines Could Have Deadly Results

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    Global immunization expert Dr. Peter Hotez says the federal government’s recent decision to slash $500 million in research funding for mRNA vaccines is dangerous, and potentially deadly, for Americans.

    U.S. Health and Human Services Secretary Robert F. Kennedy announced the cuts earlier this month, claiming that mRNA technology is unsafe and ineffective. The decision comes on the heels of a $700 million cut for Moderna flu vaccines.

    “He’s pulling out all government funding for mRNA technology when it represents one of our best hopes for pandemic preparedness,” Hotez said. “When you have a brand new emerging viral pathogen, the mRNA technology has the advantage of being the first out of the starting gate in terms of immunizing a population that hasn’t seen that pathogen before.”

    And it’s absolutely proven to be highly effective, the doctor added, noting that mRNA vaccines potentially saved 3.2 million lives during the height of the COVID-19 pandemic.

    RFK’s decision to cut funding “has deadly impacts,” Hotez said. “It takes off the table our most promising technology for new pandemic threats.”

    Hotez, who serves as co-director of the Texas Children’s Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, developed a patent-free COVID-19 vaccine with Dr. Maria Elena Bottazzi, and the two were nominated for a Nobel Peace Prize in 2022 as a result.

    The vaccine they developed, a recombinant protein-based product that does not use mRNA technology, is only available in India and Indonesia because that’s where it was licensed, he said. “There was never a path offered to us to get it licensed in the U.S. through the [Food and Drug Administration],” he said. “They were very much affixed to the pharma companies.”

    Hotez is now researching mRNA technology for a cancer vaccine but there’s limited access to funding, so he’s hoping some private-sector and biotech companies will step up.

    “There are certain things that you need the government for,” he said. “The government had an important role for mRNA technology and now, by pulling out, it means that the U.S. won’t be in the lead on this. We’ll have to pick up the pieces through private sector funding, which will never be quite as good.”

    It’s also a step backward for the federal government to withdraw its support and confidence in medical professionals, he added.

    “The Department of HHS under Kennedy seems sort of impervious to criticism from the scientific community,” Hotez said. “The American Academy of Pediatrics recently criticized him for his position on childhood immunizations and COVID, but it doesn’t seem to matter. He seems to be moving forward without any White House or congressional oversight and just does whatever he wishes.”

    Kennedy said data showed mRNA vaccines, developed during the first Trump administration, “fail to protect effectively against upper respiratory infections like COVID and flu”, and that the funding would be shifted what he maintains are “safer, broader vaccine platforms that remain effective even as viruses mutate.”

    The HHS secretary is instead shifting the funding to older technology developed in China that “has a lot of problems” and did not work well during the COVID pandemic, Hotez said. “This is not the technology you want to use for virus respiratory pathogens unless there’s no other alternative,” he said.

    “They did not stand up to the variants well, and if you remember, back in 1976 with swine flu they used that technology and it caused a high rate of [autoimmune disease] Guillain-Barré Syndrome,” he said.

    Hotez claims that RFK is pulling the funding, not for scientific reasons but for ideological reasons. “He’s very much tied to the wellness and influencer industry which pushes a false narrative that says the mRNA vaccine technology is not safe, it doesn’t work and it doesn’t protect against respiratory infections, and none of those things are true,” Hotez said. “IIt increases the vulnerability of the U.S. population and it weakens our pandemic preparedness.”

    The doctor said it’s been a battle to combat misinformation in RFK’s “Make America Healthy Again” campaign. The HHS secretary has focused on publicizing the dangers of processed foods and eliminating junk food from welfare benefits while pushing a destructive anti-vax narrative, Hotez said.

    The federal government’s apathetic stance on childhood vaccines probably contributed to a deadly measles outbreak that began in a West Texas Mennonite community in January, Hotez said. State health officials announced recently that the measles epidemic appears to have come to an end following 762 reported cases, more than 100 hospitalizations, and two deaths.

    Hotez said the Department of State Health Services reported that the measles epidemic is over because it’s gone through two complete 21-day incubation periods with no reported cases.

    “If there were going to be new cases from this current epidemic, we would have seen it by now,” he said. “That’s a reasonable assumption. But take stock of what’s happened. This was an eight-month epidemic, a pretty devastating epidemic. The worry is that this won’t be the last one.” Measles is highly transmissible, and in the pre-vaccine era, it peaked in late winter/early spring, Hotez said.

    “So we’re going to have to hold our breath again as kids are going back to school in the fall,” he said. “Don’t be surprised if we see another major measles epidemic. It’s not just measles. Others are likely to follow. Nationally, we’ve seen big increases in whooping cough and pertussis. I’m looking out for that, and I’m worried about polio.”

    “We’ve entered a new era where the return of childhood catastrophic infections becomes more common,” he added.

    The Texas Legislature passed a law earlier this year that makes it easier for parents to opt out of immunizations for their school-age children. About 100,000 Texas children already aren’t vaccinated, and there are many more who are homeschooled and not counted by county health departments.

    People tend to gather data by looking at state immunization rates when it’s more useful to look at counties, said Hotez, who predicted in 2016 that there would be a West Texas measles epidemic. So how did Americans get to a point where people believe that vaccines are bad? The doctor said that’s a long story.

    “What started out as false claims about autism became more of a political enterprise about a decade ago under this Libertarian concept of health freedom and medical freedom,” he said. “That’s when you started to see a rise in vaccine exemptions.”

    “In the last few years, the most recent add-on is the wellness and influencer industry, which peddles supplements and low-cost generic anti-parasitic drugs that they can buy in bulk and jack up the price, and unfortunately they also use that as an opportunity to denigrate modern science. They’re particularly active in Texas.”

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  • Bivalent Boosters Are Better Against Recent COVID Strains: Pfizer

    Bivalent Boosters Are Better Against Recent COVID Strains: Pfizer

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    Nov. 7, 2022 – If you’re among the 92% or so of Americans yet to get a bivalent COVID-19 booster, here’s some news to consider. The Pfizer/BioNTech updated vaccine triggers a stronger immune response than a fourth dose of their original vaccine, the company says. 

    This evidence supports getting this Omicron-specific booster before a potential COVID-19 surge this winter.

    The bivalent vaccine offers the strongest protection in people older than 55. One month after receiving a booster, those in this age group had four times more neutralizing antibodies against Omicron BA.4 and BA.5 subvariants than others who received the original vaccine as a booster.

    The researchers compared neutralizing antibody levels before and after the booster in different age groups. They found that levels increased 13 times in the 36 people in the study older than 55 and almost 10 times in the 38 people ages 18 to 55. By contrast, levels increased three times in the group of 40 people who received the original vaccine as a booster.

    The bivalent product contains two strains of vaccine – one to protect against the original COVID-19 virus and another to protect against these Omicron subvariants. 

    The newly released data is “very encouraging and consistent now with three studies all showing a substantial three- to fourfold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” says Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, CA, and editor-in-chief of Medscape, WebMD’s sister site.  

    Pfizer/BioNTech announced the updated findings in a Nov. 4 news release.

    The bivalent vaccine is authorized for emergency use in people ages 5 and older. CDC data this week show that 8.4% of eligible Americans have received the bivalent vaccine. The agency also estimates about 2,500 Americans are dying from COVID every week. 

    The safety profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company says. 

    Until recently, the BA.5 Omicron variant was the dominant strain in the United States but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus. 

    Some Skepticism

    “It is important to note that these data are press-release level, which does not allow a view of the data totality,” says Hana El Sahly, MD, professor of molecular virology and microbiology at Baylor College of Medicine in Houston, TX. 

    “For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination, which often affects the response to subsequent boosting,” she says. The findings are not surprising, El Sahly says. 

    “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”

    More research results are warranted. 

    “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” El Sahly says.

    An Uncertain Winter Ahead

    “As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5,” Albert Bourla, Pfizer chairman and chief executive officer, says in the news release. 

    The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Topol says. 

    It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern — at least not yet, El Sahly says. 

    “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”

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