FDA Advisory Panel to Review Moderna’s COVID-19 Vaccine This Week

Pfizer began moving vials of the first approved vaccine from its manufacturing facility near Kalamazoo, Michigan over the weekend, after a U.S. Food and Drug Administration advisory panel recommended the vaccine for emergency use last week.

The chair of the panel is University of Michigan epidemiologist Dr. Arnold Monto. He says the vaccine is being distributed in the U.S. despite reports of some allergic reactions among those who have already been immunized with it in Britain. 

Coming up this week, the panel will evaluate a vaccine manufactured by Moderna.

Click on the audio player above to hear Dr. Arnold Monto’s conversation with WDET’s Quinn Klinefelter about the Pfizer vaccine and what the FDA Advisory Panel will be looking for later this week when it weighs whether to recommend another vaccine manufactured by Moderna. Read the transcript of the conversation, edited for clarity, below:

University of Michigan Dr. Arnold Monto, chair of the independent U.S. Food and Drug Administration advisory panel on COVID-19 vaccines: I think it’s the best way to proceed because, in fact, (allergic reactions) happen with all vaccines at a very low frequency. That’s why it was a standard procedure for people to stay in an office or something like that for 20 minutes, half an hour after they receive a vaccine, where something could be done if they did have an allergic reaction. We’re so unused to having it happen that we now have practically drive-through vaccination sites. But it’s something which resolves. People got better after a short period of time. But they have to be watched immediately after the vaccination.

Quinn Klinefelter, WDET: Several members of the advisory panel were not sure of the effects on pregnant women or people that were 17-years-old or younger. Do you have any concerns about that?

The request (for approval) included 16 to 17-year-old children. There were not that many children of that age studied, (so some members) didn’t want to include children of that age. The FDA simply wanted to get the approval on record. It’s always a problem with pregnant women because companies typically do not monitor studies in pregnant women, because of potential liability issues. Usually, it’s only over time that you get information on pregnant women. For example, with the influenza vaccine, we currently recommend it for pregnant women, but at one time pregnant women were not taking it because of, again, potential issues. Now we know that pregnant women have a particular need for an influenza vaccine. We’re not sure about that for COVID, so it may take a little longer to get the vaccine approved in pregnancy.

Now you are looking at other companies along with the Pfizer vaccine — you have one coming up later this week that the panel is going to be examining.

That’s right. We expect things to go in a similar way. By that time, we may have had a fair amount of the vaccine used already in the United States. That may make a bit of a difference in the way people vote.

Are there significant differences between a different company and the type of vaccine that they make? Or is it all just the same basic stuff?

Actually, we have different platforms. However, the Moderna vaccine, which is coming up this week, is the same platform as the Pfizer vaccination. The good news about it, which is different, is the mRNA has been better stabilized so that you don’t need ultra-cold storage. You just put it in the regular freezer.

The White House has referred to this as Operation Warp Speed, but from what I understand this is an amazingly quick process to actually have tried to develop a vaccine and get it done this quickly, as opposed to the years and years that others would take. There are some people that will worry there may have been shortcuts taken or something to try to get this so quickly. Do you have any concerns that the very speed of getting all this together could let something kind of slip through the cracks that otherwise may not?

I’m not worried about it, for a number of reasons. First of all, one of the reasons it’s emergency use authorization and not for licensure is we still want to wait for several months to see whether anything unpredictable happens with the vaccine, but because of the need with the pandemic raging, we feel that it’s appropriate to have it available right now. The one thing that everybody agrees on is that the vaccine approach has not been politicized. Much of the work on developing these vaccines has been done at the National Institutes of Health under Tony Fauci. The Pfizer vaccine is the only one that was developed independently, but it is using methodology that is the same as the Moderna vaccine. So this part of the response has not been politicized. If anything it’s been speeded-up because it was the one part of the response in which there was interest from the White House.

When a sufficient amount of the population actually receives this vaccine, will that be the end of the pandemic?

What I would think is that we’re not going to totally get rid of the COVID virus. It will probably become something that we have to live with just like we live with the flu. What we probably will see is not too many very sick people. Now what’s going to help in making it behave itself the way flu does, going away at least for parts of the year, is immunity in the population, and that’s going to come from the vaccine. Paradoxically, it’s also gonna come from the infections that we’re seeing now. And we may need booster vaccinations. But that’s something we can manage. We’re not going to have that much of the vaccine (at first). We’ve looked at the first cousins of the COVID virus, they’re around only in the winter. So I think the wintertime, because we’re indoors and because these viruses prefer the winter to spread, is going to be a difficult time.