The Michigan Daily sat down with Dr. A. Oveta Fuller, associate professor of microbiology and immunology and member of the FDA vaccine and biological products advisory committee. She discussed the committee’s recent recommendation to give the Pfizer COVID-19 vaccine emergency use authorization for use in children ages 5-11, previous votes concerning COVID-19 vaccinations and vaccine hesitancy.
This interview has been edited and condensed for clarity.
The Michigan Daily: Why did you vote to recommend the Pfizer COVID-19 vaccine for pediatric use?
A. Oveta Fuller: Obviously, we’re in a pandemic of coronavirus, and we need to use every tool available that is safe and effective. Based on the data that was presented for the clinical trials with 5- to 11-year-olds, as well as the rollout effects of the Pfizer vaccine over the last 10 months in millions of people, the benefits seem to far outweigh the risk. So I voted yes, to make that available as something that parents who choose to have their children vaccinated can do. My opinion was not so much to make it mandatory but to make it accessible.
TMD: What does the FDA advisory panel on COVID-19 vaccinations take into consideration when deciding whether or not to authorize a new vaccine for use in a given population?
A. O. Fuller: We consider what the FDA presents to us after going through the data and doing their own analysis. We consider the original information from the company, in this case, it was Pfizer, looking at their clinical trials. We consider the overall status of the pandemic, and what’s the risk to the people that we are hoping to protect? Without the product, is there something else that will give the same results with less risk? And what are the benefits of the particular product versus the known risk or the potential risk?
We realized children 5 to 11 have been under incredible conditions where they can’t go to school, or they do go to school now, but that runs the risk of shutdowns, with the added stress of wearing masks all the time and still wondering if you’re safe. Infected children can bring home a virus that may not make them sick, but can make someone who is less immuno-competent sick. So those are stresses I know many parents have been going through, and we’re waiting for something that would help them.
We saw the lower dose of the vaccine in children works to be protective, as well as not cause greater side effects. That’s what we’re looking for — something that is reasonably safe as we can study it, and something that is effective at blocking hospitalizations in this age group. We know from the data presented for national demographics that COVID is one of the top 10 causes of death for children between 5 and 11. We were initially made to think that it was a disease that was most detrimental for older people, but that’s not necessarily true.
TMD: Do the COVID-19 virus and vaccines affect young children differently than adults or the 12 to 18 age group? If so, how?
A. O. Fuller: With COVID, we know all ages can get sick. There’s something called multisystem inflammatory syndrome, or MIS-C, that is associated with COVID in children ages 5 to 11, causing long-term fatigue and potentially really serious body issues. When we look at vaccines, the fact that there were no cases of COVID in vaccinated children, essentially meant protection from serious disease was high. And so it seems to be something that’s very much needed in helping to protect our population. The studies over six months that were needed to help ensure safety for children have been done.
TMD: Last December when the FDA advisory panel voted to grant emergency use authorization for the Pfizer vaccine, you were one of four no votes, while you did vote yes on giving the Moderna and Johnson & Johnson vaccines EUA. Why did you vote no for Pfizer?
A. O. Fuller: I voted no for Pfizer, not because I don’t believe in vaccines, but because the way the data were presented that day did not answer some key questions I had regarding the effects of the vaccine in the population. The way the sessions were formatted in a virtual platform, which is not typical, meant that you couldn’t really see your other colleagues, and there was only so much time for questions. So there were questions I had that I thought were germane to the issue of benefit versus risk that had not been answered. I wasn’t willing to push the “yes” button to release this to millions of people without having some sense of these answers. I didn’t think we had the opportunity to get the information to assure us of the things that weren’t known.
TMD: Have you seen any changes in the vetting process on the advisory panel since this initial “no” vote? If so, what are they?
A. O. Fuller: Yes, even the next week with Moderna, the FDA VRBPAC committee review process changed to open up lots more time in the afternoon for discussions and questions. That really made a huge difference because we could ask the sponsors, the people or company asking for approval, questions until we were satisfied that all of the questions have been asked. Then we had time to discuss among ourselves any concerns or questions or thoughts. That’s been true for every subsequent meeting on COVID vaccines.
TMD: What has your experience been like sitting on this panel and having the responsibility of making safe, informed recommendations regarding COVID-19 vaccines for the general public during the pandemic?
A. O. Fuller: It’s been an amazing experience. I don’t think I had a sense of how intense it could be and how much we’d like to think science is absolute. But in this pandemic, there’s a lot we don’t know about COVID-19 itself. And certainly, in that backdrop, we can’t know everything about the vaccine that we’d like to know, like the long-term effects. But, we don’t have the luxury of waiting five or six years to look at what happens. We have no evidence of any vaccine having an effect except protection from COVID, and adverse effects usually show up very soon after an individual receives their dose. I think I’ve been surprised at some of the subtleties of having to think about what is best in the big picture for individuals, as well as for society.
TMD: Was there more pressure when making the recommendation for the Pfizer vaccine in younger children than there was for more adult populations, why or why not?
A. O. Fuller: I think it’s a heavy responsibility any way you look at it, whether it’s for adults, adolescents, or pediatrics. For me, I was thinking of parents having to make the decision to vaccinate their 5- to 11-year-old children. I knew there were lots of parents who had been very careful with their children and very stressed about what happens with their children, particularly in online and in-person school.
Being a parent myself, I knew the angst of wanting what’s best for your child. Choosing between not having them progress socially as they should if they were in school, or possibly exposing them to an environment with coronavirus is a tough choice. It didn’t seem fair to withhold the protection of a COVID vaccine for children from parents who want to do the best they can to balance their children’s safety and learning. There are some parents that may not want to do this, and that’s okay if that’s what they feel is best for their child.
TMD: How do you think systemic barriers to health care and general education about science and health care affect vaccine hesitancy?
A. O. Fuller: There has been a legacy of distrust, rightly so, with the health care systems and research systems. People of color and women have not always had the best health care or trustworthy medical service. That legacy of mistrust or lack of engagement, or lack of the best care, certainly spills over into COVID-19. The hesitancy may be in part, especially for people of color, that they are asking, ‘How do I know this is okay?’ Because there have been things that have come for my community that are not okay, nobody told us, and so I think that’s part of it.
I think another part is it became politicized very early. Some think brave people don’t get vaccines, or COVID is not going to hurt you, and that is wrong. Unfortunately, I think a lot of people may have lost their lives because of that.
TMD: What would you say to a person who is hesitant to get the vaccine themselves, or to vaccinate their child, to help them make an informed decision about it?
A. O. Fuller: 90% of the people in hospitals with COVID are people who are unvaccinated, which means that not having a vaccine is a risk factor for getting COVID, and that should be convincing. Side effects of the vaccine, from what we know from clinical trials as well as the rollout over millions of people, are relatively benign. There is no direct connection between getting the vaccine and death.
TMD: What is next for the FDA’s COVID-19 advisory panel on vaccines?
A. O. Fuller: We don’t know. I don’t know what we will be reviewing next, or even if we will be reviewing anything next. Each committee is composed of people who are available, who don’t have conflicts of interest and whose subjects of expertise are relevant to what’s being discussed. I imagine there might be some sort of approval of Moderna’s pediatric vaccine, but I don’t know.
This story has been updated to correct a quote from A. O. Fuller.
Daily Senior News Editor Hannah Mackay can be reached at mackayh@umich.edu.