SARS-CoV-2 Spike Protein Vaccine(Recombinant)(Novavax, Inc.)

Created with Canva Dreamlab †, iStock During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same. On Monday, I saw an outlandish story published in The Daily Beast . According to one source, the Trump administration could be planning to pull approved vaccines—ones that were fully vetted and subsequently approved by the FDA and have saved millions of lives—from the U.S. market. I hesitated before dropping it in our News Teams chat. Then, I did. On Tuesday morning, I reviewed our own story on this topic twice, going through every sentence, every paragraph, for nuance, for context—but that was all there, because we have an excellent news team here at BioSpace . What I was really searching for was; is this news we should be publishing? Is there a chance that what this source was saying could possibly come to fruition? A year ago, I would have said no. Yesterday, I hit publish. Because yes, I do truly believe that—given the context of the past eight months, with mRNA technology under attack at the highest levels of HHS, from Health Secretary Robert F. Kennedy Jr. and within the CDC’s Advisory Committee on Immunization Practices , in a culture where scientific facts are denied and distorted —the White House, and Kennedy, could actually be considering banning the COVID-19 vaccine in the U.S. “within months.” Ironically, the development of these vaccines was arguably the greatest accomplishment of Trump 1.0. It’s important to note that a spokesperson for the White House issued a relatively strong denial in a statement to The Daily Beast: “Unless announced by the administration . . . any discussion about HHS policy should be dismissed as baseless speculation.” In an email on Wednesday, an HHS spokesperson told me the division cannot comment on potential policy decisions. But if there is a grain of truth to the rumors reported this week, attributed to Make America Healthy Again (MAHA) advisor Aseem Malhotra, they appear to be in stark contrast to the spirit of MAHA’s new vaccine framework, laid out in a draft of the MAHA Commission’s latest report , which lists as a key bullet point, “Ensuring scientific and medical freedom.” Kennedy himself has said that he “won’t take away anybody’s vaccines.” But if Malhotra is to be believed, that appears to be exactly what the Trump administration is trying to do: take away from U.S. citizens the option to get vaccinated against COVID. The makers of all three of the vaccines approved in the U.S.—Pfizer/BioNTech, Moderna and Novavax, began trading lower following the report, according to Benzinga . On Wednesday, updated versions of all of these vaccines—Pfizer and BioNTech’s Comirnaty , Moderna’s Spikevax and mNEXSPIKE and Novavax’s Nuvaxovid —were approved for the fall season, but restricted to adults 65 years and older and younger people who are at elevated risk of severe outcomes. In a note to investors Wednesday evening, William Blair hailed the approvals as a signal that FDA is “maintaining autonomy” and continuing to uphold “data-driven science decisions on vaccine approvability.” Kennedy on X said the decision accomplished the goal of “[keeping] vaccines available to people who want them, especially the vulnerable.” “These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy continued. But will they be? The updated vaccines will now go on to the CDC’s Advisory Committee on Immunization Practices, which will convene September 18 and 19 to discuss recommendations for COVID-19 vaccination. Without an approval or recommendation for healthy adults and healthy children, will physicians prescribe the shots off-label? Will insurers pay for them? To me, the concept of medical freedom denotes choice. Kennedy—along with FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad— argued against vaccine mandates during the COVID pandemic, partly because they stifled choice . But now they’re doing the same thing. The pendulum is swinging the other way. “Any parent who wants their child vaccinated should have access to this vaccine; today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children,” Susan Kressly, president of the American Academy of Pediatrics, wrote in a statement Wednesday following the new approvals. “We urge the administration to allow these choices to remain with medical experts and families.” Kennedy and his MAHA compatriots are not alone in limiting access to COVID-19 vaccines. In Alberta—often referred to by Canadians outside of the province as Texas north—people who fall outside of a defined high-risk group will need to pay a $100 administration fee for the COVID-19 vaccine. This move is in response to the federal government’s transferring responsibility for procuring the shots to the provinces and territories earlier this year. The flu vaccine—never a political football on either side of the border—remains publicly covered. Unprecedented Times Back in the U.S., it’s clear that withdrawing approved vaccines from the market would not be normal. On Wednesday evening, CDC Director Susan Monarez was fired less than a month into her tenure after refusing to play ball in terms of “rescinding certain approvals for COVID-19 vaccines,” according to two individuals familiar with the matter who spoke to The Washington Post . “When CDC Director Susan Monarez refused to rubber-stamp unscientific, reckless directives and fire dedicated health experts, she chose protecting the public over serving a political agenda,” her lawyers, Mark Zaid and Abbe Lowell wrote in a statement, per the Post . “For that reason, she has been targeted.” Four other senior level CDC leaders left along with her. In a note sent to her staff, Chief Medical Officer Deb Houry wrote that science should “never be censored or subject to political interpretations,” STAT News reported. Houry is not the first high-pro leader to cite censorship on their way out the door. In May, prominent NIH scientist Kevin Hall announced that he was taking early retirement after HHS refused an interview regarding research he’d conducted into connections between ultra-processed foods and chronic disease. In a LinkedIn post, Hall wrote that he “experienced censorship in the reporting of our research” because of concerns that it did not fully support agency leadership’s “preconceived narratives” about ultra-processed food addiction. Prasad’s predecessor Peter Marks also alluded to censorship when he was given the choice in March to either resign or be fired after he refused to give Kennedy’s team full access to the agency’s Vaccines Adverse Event Reporting System (VAERS) system for fear that “they’d write over it or erase the whole database,” according to the Associated Press . Hand-in-hand with freedom of choice goes freedom of expression—and if your hypothesis or conclusion differs from that of Secretary Kennedy or the president, you just might find a target on your back. Just ask Susan Monarez. Or Erika McEntarfer . Or Lt. Gen. Jeffrey Kruse . These are unprecedented times, indeed.