NOEL KING, HOST:
We don't just need a coronavirus vaccine, we need that vaccine to be safe to take. The Trump administration launched Operation Warp Speed in the spring to fast track a coronavirus vaccine. And the fast track part made some people nervous. Now a group of Black doctors say they will independently vet clinical trial data and decisions by the Food and Drug Administration, which, of course, approves vaccines. The FDA has been facing some criticism that politics, not science, are guiding its decisions. Dr. Leon McDougle is the president of the National Medical Association, one of the doctors who plans to do this vetting. Good morning, sir.
LEON MCDOUGLE: Good morning, Noel.
KING: Dr. McDougle, let me ask you how this works. Whose data are you vetting? Are you getting it from the drug companies that are trying to create vaccines? Are you getting it from the FDA?
MCDOUGLE: So there are a number of sources of information, one being information that's publicly available. However, you need to know what website link to refer to. And with our discussion yesterday morning with General Perna and Dr. Slaoui, we - myself made that a point of concern in regards to the data. For example, Moderna and Pfizer, on their website concerning the clinical trials, they're listing the number of people enrolled in the Phase 3 trials along with the demographic makeup of those persons enrolled.
We're advocating for having a centralized site on the Operation Warp Speed webpage so it's a one source. And it shouldn't just be the Black doctors being able to see what information is being revealed with the clinical studies. Transparency is the word of the day. So the public should be able to see this information. Also, we have members of our task force who are on the CDC - Centers for Disease Control and Prevention - Advisory Committee on Immunization Practices, the Infectious Disease Society of America, the Pediatric Infectious Disease Society and the CDC health equity work group. And they also have access to some of the outcomes and enrollment data as it pertains to the clinical trial.
So it will be a combination of sources, and combination with determinations that are being made. For example, just - most recently, the Food and Drug Administration stated that they would add a two-month requirement at the administration - after the administration of the second dose of the vaccine. That two-month period for observation will be required before the pharmaceutical company will be able to apply for emergency use authorization. So now we...
KING: Yeah. The FDA has said that they're going to make it - they have said this week, in fact, that they're going to make it - the timeline for approval longer. They will make it more difficult. And, you know, not deliberate difficult...
MCDOUGLE: Yes. Yes. Yes.
KING: ...But they're going to make stricter guidelines.
MCDOUGLE: But here's the issue. Not most recently, the administration - executive branch rebutted that. So there, again, that's where one needs a independent, nonpartisan group being able to make and provide input to inform the community.
KING: Dr. Leon McDougle, president of the National Medical Association. Thank you so much for your time this morning. We appreciate it.
MCDOUGLE: Oh, thank you. Transcript provided by NPR, Copyright NPR.
