Watch the AMA's daily COVID-19 update, with insights from AMA leaders and experts about the pandemic.
Featured topic and speakers
In today’s COVID-19 Update, AMA President Susan R. Bailey, MD, recaps her third discussion with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA, including efficacy data and updates on the distribution process.
Watch the full conversation in episode 5 of the AMA's vaccine webinar series.
Learn more at the AMA COVID-19 resource center.
Speakers
- Susan R. Bailey, MD, president, AMA
Transcript
Unger: Hello, this is the American Medical Association's COVID-19 update. Today, I am joined by the AMA's president, Dr. Susan Bailey, an allergist and immunologist in Fort Worth, Texas, who will be talking about what she learned in her recent conversation with Dr. Peter Marks of the FDA about COVID-19 vaccines. You can view the entire conversation with Dr. Marks on AMA's YouTube channel. I'm Todd Unger, AMA's chief experience officer in Chicago. Well, hi, Dr. Bailey. This is the third time you've talked with Dr. Marks in the past three months, and I would say we've come a really long way since that initial conversation. We now have two authorized vaccines with hopefully more on the way. What did you hear from Dr. Marks in terms of assurances that we can provide physicians so they feel comfortable recommending vaccines to patients and even, of course, getting it themselves?
Dr. Bailey: Well, as most everybody knows, Dr. Marks is the head of the FDA's Center for Biologics Evaluation and Research, so his responsibility is to make sure that any vaccine is safe and effective. He overviews the review and the regulatory, as well as the approval process. And these webinars have been designed to make sure that physicians get all of the information that they need to feel comfortable that COVID vaccines are safe and effective so that they can then convince their patients that these vaccines are safe and effective. And so Dr. Marks talked more about the Emergency Use Authorization [EUA] process as it has been used in vaccines. Originally, the EUA process was established after 9/11 for new therapeutics and so these are really the first times that EUAs have been used for vaccines.
But he described very nicely how this process has, what he called, "cutout the white space" in the approval process so that we were able to get these things authorized so quickly without compromising safety and streamlining the process. And so he talked about how the EUA standard is really the floor for safety and efficacy, but really, with these authorizations, they're really functioning more closer to the ceiling. And so the EUA process really is not that different from the standard biologics license application that vaccines have had to apply for in the past still having done very well designed and executed phase three trials.
Unger: Yeah, well, given the urgency of the situation, it makes so much sense how they've really looked at their process to really maximize efficiencies and not cut corners, but really speed it to market and to people's arms. Given your specialty, you often treat people who have severe allergies. Did Dr. Marks provide any guidance that will help you and other physicians to determine who should and shouldn't get the vaccines among their patient population?
Dr. Bailey: Yes, we had a great discussion about that. And as an allergist, immunologist, drug allergy is definitely one of the things that I do in my practice and have for more than 30 years. And even though we haven't seen many allergic reactions to COVID vaccines, there definitely have been some, and, of course, they've been very well-publicized, but he estimates that about one in 100,000 or one in 200,000. So when you think back to the size of the trials, we really didn't see it much in the trials because it's so infrequent. These cases are occurring more often in women, which is interesting. But one of the, I think, incredible things about this whole process, and we've discussed with Dr. Marks in previous webinars about looking at international data, and he said that the international data on reactions, the FDA has been able to pool its data with other countries, which has been incredibly valuable.
There's a really great international collaboration going on, including the CDC. And so they've got really good surveillance coming in to follow these reactions. So what they're recommending now is that individuals that have a known history of severe reactions to any component of the vaccine, not get one of the mRNA vaccines. So we don't really yet know what the actual allergen is, but we suspect it's either polyethylene glycol, or PEG, P-E-G, which is an ingredient that is found in some laxatives, in bowel preps. It's an inert substance, but evidently is definitely allergenic. I've seen one case of PEG anaphylaxis in my 30 plus years of practice. And polysorbate-80 is another possibility. Now, that one is found in a number of injectable medications. And so there's lots of work going on right now to figure out exactly what it is in these vaccines that's causing reactions. But overall, they appear to be incredibly safe.
Unger: That's great news. In terms of side effects, there's been a lot of talk about this. What do we know about them and what should physicians be telling their patients in setting those expectations?
Dr. Bailey: Well, the good news, the side effects, for the most part, are very mild, maybe moderate. But it's very important for physicians to discuss this with their patients because many patients are having more trouble after the second vaccine than after the first, so patients need to be prepared for this. And it's the kind of a thing that we have seen after flu vaccines, feeling achy, maybe a fever, very tired, maybe some joint aches, chills, headache and this tends to come on maybe 12 or so hours after, especially the second vaccination. But typically, after a day, it's gone. But patients really need to be prepared for this. Maybe plan to have their schedule not be quite so busy the day after vaccine just in case they might need to rest for a day. But then recovery is complete, and we're just not seeing unusual side effects happening after that initial reaction period.
Unger: Yeah, that's great perspective. There's been a lot of talk about variants lately and whether or not the vaccines are going to be effective against them. Was Dr. Marks able to reassure us on that?
Dr. Bailey: Yes. We talked about the new variants that have been popping up, and he said that he believes that the mRNA vaccines that are currently in use should be effective against the variants that are coming up. We need to stay tuned. And so I asked, I said, "Well, if we do need to revise the vaccines, how long is that going to take? Because I thought, well, are we going to have to go through a whole other eight to 10 month clinical trial process in case they need to update the vaccines for new variants?" And the good news is that he said, "No," that, that type of update can be done much more quickly, maybe with clinical trials with only a few hundred people maybe, as opposed to thousands, because they'd still be using the same vaccine platform, the same ingredients. Everything would be the same. So all that still remains to be seen, but that made me feel good that if we do have to update the vaccine, that it won't take as long as the initial one did.
Unger: Yeah, that is very encouraging. Did he talk about new vaccines that are in the pipeline? We've heard about Novavax coming up. Are we expecting any other authorizations soon?
Dr. Bailey: Yes. There are two vaccines that are pretty close, although he wouldn't give us a date. I asked him when the next advisory panel meeting was going to be, and he goes, "Oh, stay tuned." But we've got two vaccines that are not mRNA vaccines. These are actually viral vector vaccines that are different types of viruses that have the spike protein incorporated so they can sneak them in that way. But these viruses don't cause infections so they're very safe. So that's the AstraZeneca-Oxford vaccine that we've heard about, is a viral vector vaccine as is the Johnson & Johnson Janssen vaccine. And we're hoping that we'll get information on those very soon. And actually, while we were in the webinar Friday afternoon, Johnson & Johnson announced that its single dose vaccine, which is very cool, was very effective, 72% efficacy, and that we would be getting data on that soon.
And so I said, "Well, okay, we know we've seen some of that evidence and the media is already saying, 'Okay, well these vaccines are a failure because they don't work as well as the incredibly effective mRNA vaccines,'" and he said, "Let's all take a deep breath." Really, we were going to be happy at 50% effectiveness. Seventy percent efficacy is still really good. And this is not data that has been submitted to the FDA yet. This is press release status. So we need to take a look at the actual data. We don't want anybody to think that they're getting an inferior vaccine, but we need every tool in our tool chest to help get us to herd immunity and get past this.
Unger: Yeah, that is an excellent point. And I'll ask the same question that I do after your talk at each of these webinars, if there's one thing that you're going to take away from your discussion with Dr. Marks, what is that key message for physicians?
Dr. Bailey: I think the key message for physicians is that the mRNA vaccines appear to be incredibly safe and well tolerated. That was very concerning to me, and I know many of my colleagues very early on when we heard about this new vaccine technology that had not been in widespread use, many of us were afraid that we would have weird reactions to it, and that's not happening. It seems to be a very typical type of a vaccine reaction, maybe flu-like feeling, more often after the second dose than the first one. Older people are less likely to have reactions than younger people, which I thought was interesting. But the fact that we have come so far in such a short period of time and are seeing such success to me is just absolutely amazing.
Unger: It is amazing. And thank you so much for these continuing series of webinars. I think they're really valuable and what a great chance for our viewers out there to hear directly from Dr. Marks. That concludes today's COVID-19 update. There was a lot covered in the important webinar that we didn't have a chance to discuss today, including what messages are most effective in talking to your patients about COVID vaccines. To view the whole webinar, visit AMA's YouTube channel, and check out the AMA site and our resources on COVID-19 at ama-assn.org/covid-19. Thanks for joining us. Stay safe. Be well.
Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.
