UMich professor talks role on FDA COVID-19 vaccine advisory committee, vaccine research
The Michigan Daily sat down with Arnold Monto, professor of epidemiology at the University of Michigan’s School of Public Health and recently appointed chair of the Food and Drug Administration’s committee evaluating COVID-19 vaccines, over the phone on Tuesday, Nov. 24. He discussed his role on the committee, background working with vaccines and how the COVID-19 vaccine process has worked as a result of the pandemic. This interview has been edited and condensed for clarity.
The Michigan Daily: What is your background working with vaccines?
Arnold Monto: Well, I’ve been working here at the University of Michigan for more than 50 years, working with influenza vaccines since the start. Matter of fact, during the 1968 pandemic, I was involved in the study, trying to see if you vaccinate school-aged children in the community, if you can reduce transmission in the entire community. This is a demonstration of herd immunity. So I’ve been at this for a long time. Currently, our Center (the University “Flu Lab”), which I head along with Emily Martin, who is very much involved in the local response, has been evaluating influenza vaccines in terms of prevention of mild and severe influenza.
TMD: How did you get onto the committee to evaluate the COVID-19 vaccine?
AM: The Vaccines and Related Biological Products Advisory Committee is a standing committee of the FDA with four-year terms. I was selected to be on that committee in 2016 and I was chairman for four years starting in February 2016. I rotated off at the start of this year in January, but I was asked to come back to chair the committee for COVID-19. So it was the choice of FDA for me to be brought back.
TMD: Recently, there has been encouraging news about possible COVID-19 vaccines: early data from Pfizer’s and Moderna’s vaccines show more than 90 percent efficacy, with AstraZeneca also producing somewhat promising results. Can you give me some of your general thoughts about the vaccine timeline, specifically what creating a vaccine has looked like for the different pharmaceutical companies?
AM: Coronavirus vaccines have been produced more rapidly than traditionally, because the production schedule has been telescoped. In other words, because funding is available and the process for the manufacturers has been de-risked, they have been able to do things which they would generally do in sequence, in parallel. Manufacturers would typically not produce vaccines until it’s approved, because what if it’s not approved? So what has happened is that a great deal of vaccines have already been produced because the government has underwritten the payment for the doses. The other parallel consequence of the funding mechanism is that these trials are much larger than typically conducted, which is why we got the results so quickly. The number of people who are participating relates directly in terms of how many failures are going to occur. And that’s how they figure out when to do a preliminary analysis, because they have to see a certain number of cases. The more people who are in the trial, the quicker you see the number of cases. So everything has been done to speed the process and nothing has been done that would affect assessment of safety.
TMD: Can you tell me a little bit about what the timeline for rolling out the vaccine will likely look like?
AM: Well, the timeline for rolling out the vaccine is really less of what I am involved with. The committee will have a vote on whether we think that the vaccine should be approved on the basis of safety and efficacy. The FDA can either listen to us or not listen, but most of the time they do listen. For the Pfizer vaccine, we will have our meetings about that on December 10th. On December 17th, it will be Moderna that will be discussed. The dates of these meetings are basically driven by the manufacturers. This is a public-private partnership — things are driven by the company submitting its data to FDA and that’s how the schedule of meetings has been determined. We make our recommendations, then the FDA has to officially approve. And this is an emergency use authorization, not regular licensure, which will follow at a later time. After this, the Advisory Committee on Immunization Practices will meet virtually and approve a policy for what groups should be first in line. And this is where Operation Warp Speed comes in, but that’s where things get to be a little more vague in terms of how things will be handled.
TMD: What was different about this vaccine process? What has stayed the same about this process?
AM: What is different is the telescoping of the various events. We’ve gone through usual production and laboratory testing of vaccines. At the same time, it very quickly went into humans. Usually, you wait for a period of time to do phase one and two studies and then to get into big trials. But all this happened very quickly.
A key thing to bear in mind is that first is the emergency use authorization and the full licensure will require six months of follow up. However, the efficacy still has to be demonstrated for folks. There’s no difference in efficacy requirements in the emergency use authorization, it just is quicker. And people should realize that there has been no compromise in efficacy. Efficacy is effectiveness for observational studies, where you see how the vaccines work in the real world. Now, what will happen afterward, is that everyone will be looking at effectiveness. The University is going to be involved here — we’ve expanded what we usually do with the flu to include the COVID-19 vaccine. So we will be part of a network looking to see how the various vaccines work in terms of prevention of disease, and also in terms of safety.
TMD: Why is a vaccine so important to ending the pandemic?
AM: Well, given the fact that we don’t have any immunity to this novel virus, it can infect everybody, potentially. And therefore, we need to have the antibodies in the population so that we can reduce infection, illness and spread.
TMD: What would you say to anyone who might be hesitant about any vaccine that does get approved?
AM: This vaccine will have been approved by the standard mechanism. By the time the vaccine becomes available to the general population it will have standard, non-emergency approval. And the people who would be first in line to get it, with emergency-use authorization, are at higher risk of either developing infection or getting more sick ... if they do get infected. So they will probably talk about the risk-benefit ratio. The risk is we haven’t followed the vaccine for as long as we typically do. The benefit is they don’t get COVID. As with anything that you put in your body, there’s always some degree of risk. We want it to be as low as possible, but you always have to balance the benefits with a small risk.
TMD: Any final comments?
AM: The proceedings of our deliberations are open and they will be livestreamed on YouTube.
Daily Staff Reporter Paige Hodder can be reached at firstname.lastname@example.org
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