JN.1 Subvariant SARS CoV-2 rS Vaccine(Novavax)

FDA’s CBER director Peter Marks was speaking virtually at the Jefferies London Healthcare Conference held from 19 to 21 November. Image credit: Robert Barrie / GlobalData. The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) director has said that a dialogue on vaccines, which is expected to intensify under the new administration, will be important to have “lies debunked”. “I don’t doubt that we are going to have a very vigorous dialogue about the benefits and risks of vaccines, [especially] around Covid-19 vaccines and paediatric vaccines. I hope that that dialogue allows us the opportunity to bring forth the data [to show] the facts,” Peter Marks said at the Jefferies London Healthcare Conference on 21 November. US President-elect Donald Trump’s decision to appoint Robert F Kennedy (RFK) Jr as head of the Department of Health and Human Services (HHS) in the new administration has caused uncertainty within the pharmaceutical sector. RFK Jr has previously stated views on vaccine safety unsupported by science and accused the FDA of waging a war on public health by cosying up to big pharma. One of RFK Jr’s most dangerous false claims is the positive link between the measles, mumps, and rubella (MMR) vaccine and autism. The relationship has been disproven in multiple studies since fraudulent data suggested the theory in 1998. “I don’t think there’s a lot to argue about. Measles kills people at a rate of about one in 1,000 if people aren’t vaccinated,” Marks said. Marks stated that a public debate around vaccines is not necessarily a bad thing because it provides an open setting for people to hear correct information about the drugs: “[Vaccine] misinformation has become a wastebasket term for lies…It would be nice to have some of the lies debunked in public…and false beliefs aired and corrected.” Regarding what policies Trump and RFK Jr will look to implement once in office, Marks said it is “too soon to know anything with certainty”. RFK Jr has insisted he is not “anti-vaccine”, but his comments suggest that routine childhood vaccination programmes and mandates could be altered. Executives from big pharma companies with vaccine products, including GSK and BMS have said at the Jefferies conference that the pharma industry will need to “adjust” and “adapt” to the new administration. RFK Jr has also vowed to shake up the FDA, suggesting some departments are no longer needed. Donald Trump will likely choose the Johns Hopkins surgeon and writer Martin Makary as the new FDA chief, as reported by Reuters today [21 November]. Amid the potential sweep of changes, Marks confirmed he is staying on in his position as CBER head as long as he is needed. “I will stay around as long as I’m considered to be welcome,” Marks said. “My intention is not to go anywhere. I think it’s very important that people see that there’s constant leadership [at the FDA], that we are here to work with either side of the aisle.” And while RFK Jr may look to overhaul the FDA, pushback will be inevitable. “I’ve been very heartened to know that there are some people I can’t name, who will be there for us as a backstop to help us make sure that we’re able to [pursue] the public health mission, for rare disease communities and vaccines,” Marks added. “I have to believe that at least some degree of moderation will prevail.”

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