FDA makes controversial changes to COVID-19 vaccine framework

frederickkingcumque2005ant

Transcript

00:00The Food and Drug Administration has outlined new regulations for COVID-19 booster shots,

00:05setting stricter approval standards for younger and healthier Americans.

00:09FDA Commissioner Dr. Martin McCary and top vaccines official Dr. Vinay Prasad outlined

00:15the new guidelines in an article published Tuesday. They write that for new COVID boosters

00:19for healthy people between the ages of six months and 64 years old, more testing is required before

00:24updated vaccines can be approved. Prasad spoke about the changes at an FDA town hall Tuesday.

00:30I do think this is a step forward and a lot of these questions will be answered by next calendar

00:35year when we start to get the interim results of some of these studies back.

00:40CBS News medical contributor Dr. Celine Gowner joins us now. She's also a senior fellow and editor at

00:44large for public health at KFF Health News. So walk us through the change here and why the FDA says

00:49it's making it. So essentially they're dividing people up into two groups. So you're over 65 or

00:55you have a chronic medical condition that puts you at increased risk for severe disease from COVID.

01:01They are including pregnant women and recently pregnant women in that higher risk group. Now,

01:05how recently pregnant is you and I were discussing earlier? We don't know exactly what that cutoff is.

01:11But for that higher risk group, the bar that these COVID boosters would need to hit is based on

01:18antibody levels. So as long as they elicit, trigger a certain level of antibodies in the person

01:26vaccinated, they would move forward with approval. But for everybody else, so everybody under 65 who

01:32does not have one of these chronic medical conditions, who's healthy, not pregnant or recently

01:36pregnant, for those people, the bar would be much higher where the randomized clinical trials would

01:42need to prove as a primary endpoint that these vaccines are reducing symptomatic. So in other

01:49words, COVID infections that cause symptoms. In addition, they would be looking at other outcomes,

01:55which are even more important, frankly, which is, are you hospitalized from COVID and do you die from

02:00COVID? So some are finding this controversial. Why is that? Well, think about how long it would take to do

02:06those trials. So if you update the vaccine and then you need to do these huge clinical trials in people

02:12to show these levels of protection, by the time you would actually have the data, you would be past

02:18COVID season. And so how useful is that information? With the antibody levels, you know, that's something,

02:24yes, you could, you could get the information pretty quickly in advance of the fall, but you're not

02:29going to be able to do that for other people with the kinds of clinical trials that they're saying

02:33they're going to require moving forward. What does this mean for people who still want a COVID booster

02:37shot? Well, that is a very good question and it's really unclear. So some of this will depend also

02:43on whether the old booster from the previous season is still available or only an updated booster from

02:50the new season. So if the old booster is available, you might still be able to get that, but to get the

02:55new booster, it's going to require going through these clinical trials now. And frankly, from the

03:01perspective of the pharmaceutical company to have two separate manufacturing lines, one for the old

03:06one, one for the new one, is really not realistic. So I think what in essence this could mean is for

03:11people under 65 who are healthy, not pregnant, that you lose the option of getting a booster.

03:17And that's really contrary to what Senator Kennedy said, which was, I am not going to take away people's

03:22vaccines. And in fact, that is what this could result in. Before we let you go, we've been reporting

03:27on the former president's health and a Biden spokesperson says that the former president's

03:31last prostate specific antigen test for prostate cancer was 2014, that he has never been diagnosed

03:38with prostate cancer prior to Friday. Some people might hear 2014 and they might think that's a really

03:43long time to not be tested. What would be the reasoning of that? Is that normal? Well, the recommendations

03:49are to routinely test men until they are 70. He was 71 at the time of that 2014 PSA test. So in fact,

03:58if he has not had a PSA since then, that's following the screening recommendations that

04:03what we recommend against is over testing because that can result in too many biopsies, too much

04:10treatment for something that's really not going to impact your health. And most older men who get

04:14prostate cancer at that age, it's very slow growing and really doesn't create issues for them. They

04:20end up dying from somebody else, from something else. Okay. Dr. Celine Gounder, thank you.

Category

Transcript

Recommended