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Debate over COVID vaccine approval standards

The FDA's vaccine chief says the agency plans to tighten approval standards for COVID-19 vaccines, citing concerns about potential risks for children. In a leaked memo, Dr. Vinay Prasad says a review of records links 10 children's deaths to the COVID vaccine. He did not provide data to support the claim. CBS News medical contributor Dr. Celine Gounder explains what to know.
Dec 1, 2025 (03:24)

TRANSCRIPT FOR: “DEBATE OVER FDA PLANS TO TIGHTEN COVID-19 VACCINE APPROVAL STANDARDS”

GAYLE KING:
00:00:00

The FDA's vaccine chief says the agency plans to tighten approval standards for COVID vaccines, citing concerns about potential risks for children. So in a leaked memo-- this was first reported by the NewYork Times,then confirmed by CBS News-- Dr. Vinay Prasad says a review of records linked 10 children's deaths to the COVID vaccine, but he did not provide data to support that claim. CBS News Medical Contributor Dr. Céline Gounder is editor-at-large for public health at KFF Health News, is here to help us sort this all out. Céline, it's good to have you here, especially because this is so confusing to me. No data is given, but you scare the bejesus out of people when you do a headline like this. How seriously should this be taken? Well, until we have data-- for example, autopsy data, medical record data. What he is quoting are numbers from the Vaccine Adverse Event Reporting System, what we call VAERS for short. And I could go in today and say, I got a flu shot. My hair turned purple. You'd have to go in and actually prove. And so the idea here is to capture as many potential side effects and adverse events as possible, but you still have to drill down and do the work of proving that the vaccine caused the death, and there is no data that has been released to show that. But I want to point out, over 2,000 kids died from COVID infection over the last several years, and so we know that for sure. But you don't know of any child that's died from the COVID vaccine? We've never seen any evidence, definitive evidence that a child has died from the COVID vaccine. So I didn't know kids were still getting COVID vaccines. I thought-- I just got my booster a couple of weeks ago, but I thought it was for people over 65 or people who had some kind of medical issue that were immunocompromised. Are kids/should kids still be getting the COVID vaccine? Well, it depends on who you ask. So if you turn to the professional medical societies, whether it's the American Academy of Pediatrics, the Infectious Diseases Society of America, and others, they are recommending that children over the age of six months be getting their primary series of the COVID vaccine. Scientifically, in terms of what you want for protection, you want to be getting your immunity from the vaccine first before you encounter the virus to prevent those worst side effects of having a COVID infection. So things like myocarditis, you're much more likely to have that inflammation of the heart muscle with an actual infection. So why does Dr. Prasad say that the benefits of vaccinating children are unclear? There's no science to back up that claim. I think, unfortunately, COVID has been politicized since, really, the beginning of the pandemic, since 2020, and that's what we're seeing coming out of the CDC and FDA now. All right, so what should parents take away from all of this? Because it can be quite confusing. Look, there is no definitive evidence that COVID vaccines cause death in children, no definitive evidence that COVID vaccines are dangerous for children. What we do know is COVID infection is dangerous as, again, over 2,000 have died from COVID since the start of the pandemic, and that is what you want to guard against. Yeah, as a doctor, to see it politicized, though, it must be very difficult when you're saying, yeah, because the research is the research. Science is the science on this. Yeah, and I should be able to talk about science and not worried about being accused of being political. I mean, I'm just trying to be straight up here. But it's tough when people are told not to trust experts and the research. All right, Dr. Céline Gounder, thank you so much.

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