FDA commissioner discusses pandemic, vaccines

 Words from Woodcock

Dr. Janet Woodcock, Acting Commissioner of the FDA, described her experience of being at the helm of the FDA during the COVID-19 pandemic as “exciting, inspirational, intense and hectic” when she joined SiriusXM Doctor Radio’s “Doctor Radio Reports” with host Dr. Marc Siegel. Woodcock described the process followed in reviewing vaccines for FDA certification and explained the process for submitting COVID vaccine boosters for EUA approval. She also talked about how and why the FDA and CDC decided to pause distribution of the J&J vaccine, the data used in the decision to lift the pause, the shifts in the virus and how the variants will impact the efficacy of the current vaccines and therapeutics.

Siegel: Will the current EUA COVID-19  vaccines  become Certified vaccines? 

Woodcock: Companies have to submit a biologics license application, and that goes through somewhat more review than an EUA would. There are more manufacturing controls that are standard. I would expect that the firms would be submitting an application. Having these on a standard footing would be good.

Siegel: Will boosters for the vaccines require the same approval process as the original vaccines?

Woodcock: Companies would simply have to submit what's called an efficacy supplement to the agency that would have the clinical data about that. Rationale number one is the safety data of giving another dose. When is it appropriate to boost people, at what interval, and so forth. If we were boosting people, say a variant arises that is not well covered by the current vaccines, then FDA's issued guidance to industry on how to work that up and develop it, but they would also have to submit different manufacturing information, and so forth because that would be a different construct. But it wouldn't be a whole new process. It would be a modification to the existing EUA vaccine.

Siegel: Why did the FDA and CDC pause the Johnson & Johnson vaccine?

Woodcock: The FDA and CDC did a very deep dive and did all the analysis of the reported cases. It's always a question, is it more prudent to pause and take a look or, simply encourage people to keep getting vaccinated while you're reviewing adverse events? We paused because this is a very unusual adverse event. We didn't know if clinicians had been sensitized to diagnose it properly and then report it. And we were concerned people didn't know how to treat it properly and they would treat it with standard anticoagulation. It seems like a lot of people like the one-and-done aspect of this vaccine. And some people also are suspicious of the new platform in the mRNA vaccine, and they would prefer getting this vaccine, a more traditional vaccine.

Siegel: What are the challenges the COVID variants present:

Woodcock: Any immunologically based therapy or preventive may be vulnerable to big antigenic shifts in the virus. If the immune response targets certain epitopes and they change, then it may diminish the effectiveness of vaccination or say a monoclonal antibody. FDA has already issued guidance to industry which vaccines, monoclonal antibodies and diagnostics could be affected by variants and how to monitor for that and then how to adapt these products if in fact it turns out that a variant renders them less effective or safe.

Siegel: How does it feel to be in your position during this crucial and tumultuous time? 

Woodcock: I’m happy to be able to do what I can for my country and the world. We all are in this together. Everybody’s pulling together, everybody on the front lines, the people who are working on response to developing products to people in industry. It’s very inspiring. All international regulators are working together. For the FDA, our other work doesn’t go away. The last few days we had an advisory committee on accelerated approvals for cancer drugs. They’re very controversial discussions. Many other very serious diseases need to continue to be addressed. It’s as if there are two tracks of work. All the usual work that needs to get done, and then everything to do with this pandemic, so it is very intense.