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FDA To Review, Possibly Authorize Pfizer Vaccine Next Week


NPR science correspondent Richard Harris has been monitoring vaccine progress. And now, of course, the rollout is nearly at hand. Richard, good morning.

RICHARD HARRIS, BYLINE: Good morning, Scott.

SIMON: We have heard and absorbed so much devastating news about the worsening of the pandemic this week. But - so let's try to look instead on potentially encouraging news.

HARRIS: Yeah. That works for me for sure.

SIMON: Is hope really just around the corner?

HARRIS: Well, I can't promise, but all indications are we are moving in the right direction and at a remarkable speed. I started the week talking to the president of Moderna, Dr. Stephen Hoge, about the prospects for his company's COVID vaccine. New data showed that it was 94% effective overall. And among the relatively few test subjects who took the vaccine and got sick anyway, he says not one of them had a severe case.

STEPHEN HOGE: So it looks like in the trial, we've been 100% effective at preventing severe COVID-19, which is really what's driving the burden of disease in hospitals and ultimately straining our public health systems.

HARRIS: The FDA is now reviewing what sounds like really encouraging data. And the Pfizer vaccine had similar results. In fact, health authorities in the United Kingdom approved Pfizer's vaccine last week. And the FDA will now review it at a public hearing this coming Thursday. If it looks good, an OK from the U.S. could come really almost immediately.

SIMON: And when would people begin to get it?

HARRIS: Well, people at the top of the list, like health care workers and older people who live in nursing homes and other group facilities like that, they could get the first dose of their first two shots this month. The list after that is long and will take many months to go through. It includes essential workers, people with underlying health conditions and those over the age of 65. And beyond that is everyone else. Though, you know, there are still big questions about pregnant women and children because, you know, they were not part of the original studies.

SIMON: What happens to them under this scenario?

HARRIS: Well, it's not entirely clear. When it comes to pregnant women, the FDA could simply leave that choice up to the women and their doctors. Vaccine researchers don't expect the shot will put the mother or newborn at risk. But, you know, they don't have a lot of data to draw on. Now, children are trickier question. One school of thought is they are unlikely to get seriously ill, so doctors should take their time to study this group carefully and not be in a rush to vaccinate them. But at a federal advisory committee meeting yesterday, Dr. Stanley Plotkin from the University of Pennsylvania said, kids do spread the disease. And they do face some risk, according to several studies he cited.

STANLEY PLOTKIN: About 2% of the children were admitted to pediatric intensive care. There was very low mortality, .08%. But nevertheless, a dead child is not a happy thing.

SIMON: Certainly not. Well, what do we know about the safety of the vaccine in adults?

HARRIS: Well, vaccine researchers say that most serious side effects from vaccines have tended to show up within the first two months. And the FDA already has data about that period for many of the study participants. To be safe, the government has also put together a very elaborate system to follow the health of people once they've been vaccinated. For example, the CDC has developed a smartphone app that vaccine recipients can use to track their health after getting a shot. Dr. Tom Shimabukuro at the CDC said it will send out frequent text messages asking for health updates.

TOM SHIMABUKURO: If they report that they missed work or were unable to do normal daily activities or receive medical care, we consider that a clinically important health impact. And at that point, we will reach out and call the individual.

HARRIS: Now, people will have to opt into this system, but the CDC hopes a lot of people will. At any rate, though, safety data will be collected with a whole bunch of other systems.

SIMON: NPR's Richard Harris, thanks so much.

HARRIS: Hey. Any time, Scott. Transcript provided by NPR, Copyright NPR.

Award-winning journalist Richard Harris has reported on a wide range of topics in science, medicine and the environment since he joined NPR in 1986. In early 2014, his focus shifted from an emphasis on climate change and the environment to biomedical research.
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