00:00Well, we're keeping an eye on shares of Moderna and Pfizer's after the FDA is said to be investigating whether COVID-19 vaccines potentially cause deaths in adults as part of a safety review.
00:10The investigation comes at a time when HHS Secretary Arv K. Jr. has repeatedly questioned the safety of the shots, despite numerous studies proving their efficacy.
00:20Let's discuss with Dr. Marty McCary. He is the Commissioner of the Food and Drug Administration. Doctor, great to see you on set.
00:26Good to be here, Katie. Romaine?
00:28So let's start there. A spokesperson sent a statement to Bloomberg last Tuesday that the FDA is doing a thorough investigation across multiple age groups here of deaths potentially related to COVID vaccines.
00:42What is the end goal for this inquiry?
00:45So, first of all, it's been known that there have been rare cases of death following the COVID shot.
00:50That's been published in the New England Journal of Medicine.
00:52It came out in a Senate subcommittee report, and we have patient testimonials from families out there.
00:59So this is nothing new.
01:00But the moral dilemma when we came into office is that under the Biden administration, there were cases reported to the FDA.
01:08And the question is, should they be public information or not?
01:11So we believe they should, but we wanted to make sure, in fact, there was truly a link between the COVID shot and the death before we make it public.
01:20And so CNN also reported in the past week or so that the FDA is considering a black box warning on COVID vaccines.
01:29And just for the audience, a black box warning is one of the strongest pieces of caution out there.
01:34So this is a bit of a two-part question.
01:37First of all, whether or not the FDA is looking at that.
01:40And when you think about the risks of the disease itself, whether putting such a warning on sort of matches that risk-reward balance.
01:49Well, first of all, it's up to doctors whether or not to recommend it.
01:51And we are generally in the United States moving towards the same model they use in Europe.
01:57That is a risk-stratified approach as opposed to an absolute recommendation for every single person, including young, healthy children.
02:05Does a six-year-old girl need another 70 COVID shots, one each year for the rest of her life?
02:10That's a theory.
02:11It's a scientific unknown.
02:12In France, you have to be 80 years old to have the shot recommended or high risk.
02:16In the UK, I think it's 75.
02:18So we're just moving more towards that risk-stratified approach internationally.
02:22Now, when it comes to the black box warning, we have no plans to put that on the COVID vaccine.
02:28The Safety and Epidemiology Center within the FDA did recommend that.
02:33It was a recommendation formally put out.
02:36But some of our scientists and leadership, like Dr. Vinay Prasad, have said it may be different today than it was in the first year of COVID when the shot came out.
02:46Because when you have those two doses three months apart, that's when you see the side effects go way up, like myocarditis in young people.
02:54Now that it's annual, you may not see that same prevalence.
02:56So we don't want to extrapolate findings to today if it's not transferable.
03:00I am curious, and this broadens it out beyond just COVID, but overall, the reviews that the FDA takes on existing drugs and applications out there relative to new ones coming in.
03:12How do you balance out the need to sort of speed up the initial application process with this idea that, of course, drug makers don't necessarily like you coming back to them after something's been approved and saying,
03:21OK, we need that now to vet this all over again?
03:23Well, I mean, we have a simple process.
03:27Companies present data to us, and we decide whether or not the claims that companies want to make about their products match the data they've submitted.
03:34So it's a pretty simple process.
03:36If a drug works and it's safe, it's going to get approved by the FDA.
03:40We took a big step this year in the spirit of transparency to make all FDA rejection letters public information, because if we don't accept a drug, the public deserves to know why.
03:49It also reduces corporate spin to investors of a company when they're told that, hey, the FDA wanted one little tweak.
03:57Well, that may not be the case.
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