COVID Concerns: FDA’s New Vaccine Guidelines Raise Questions

Millions of Americans have received a COVID-19 vaccine but demand is likely to drop after the Food and Drug Administration changed recommendations of who should get the vaccine each year – limiting its endorsement to high risk individuals.

Last week, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, outlined the agency’s new approach to COVID shots in an article published in the New England Journal of Medicine.

Under the FDA’s new framework, it will no longer recommend the COVID vaccine for healthy people between the ages of 6 months and 64 years old. But the vaccine remains recommended for those under age 65 with an underlying health condition that would put them at higher risk. Though the Cenders for Disease Control and Prevention wasn’t as clear about its recommendation (or lack thereof) for the vaccine. On May 29, the CDC updated its COVID vaccination guidelines for children, recommending healthy individuals make shared clinical decisions with their health care provider about taking the vaccine.

Makary and Prasad called for randomized, controlled trials to prove the benefits outweigh the risks for individuals between 6 months and 64 years with no risk factors to develop severe COVID-19 illness.

Critics of the move say it could possibly open the door for insurance carriers to no longer cover the cost of the vaccine for those who do not fit within the FDA’s recommendations for usage.

The FDA’s decision comes at a time when the number of cases of COVID variant NB.1.8.1 have been rising globally, which according to the World Health Organization, has been detected in 22 countries as of May 18.

To find out more about the potential implications, U.S. News spoke with Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Kathryn Edwards, retired pediatrician and global vaccine and vaccine safety expert who currently serves on the board of directors for the nonprofit, immunization advocacy organization Immunize.org.

These interviews were edited for length and clarity.

Do you have questions or concerns after the FDA limited its recommendation of the COVID-19 vaccine for just high-risk groups?

OFFIT: “Anybody who is not in a high-risk group who is less than 64 years of age is using a vaccine off label, and would that affect things? Would it affect availability, would it affect the insurance company coverage? Those are some of the questions that need to be answered.”

EDWARDS: “I think what they’re doing by saying it’s not recommended is they're going to tell the insurance companies that they don’t have to pay for it. By and large, if the FDA doesn’t license a vaccine for that group, then the insurance companies don’t have to pay for vaccines that are not recommended.”

How will the FDA’s approach to the COVID vaccine impact public trust?

OFFIT: “I think what’s happened is that both Makary and Prasad were sort of contrarians if you will during the COVID pandemic, and that’s how they ascended to their positions. The current administration is not just about less government but more anti-government, and so they pick people of those positions that have disdain for that agency.

“One person said to me that they thought RFK Jr., will lessen public trust in the public health system. No, I think he was picked because he doesn’t have trust in the public health system.”

EDWARDS: “I think that this is all a response to these people who had a different idea about what should go forward with COVID. I think [Dr. Jay] Bhattacharya, Makary and certainly Prasad were unhappy about a lot of things about the pandemic and clearly, we made mistakes, but it was really hard, and there were lots of people dying.

“I just feel there’s this attitude among them that they are going to come in and change everything, and that they’re going to get rid of people who they think don’t know anything. But the problem is that all those people who don’t know anything really know something, and they’ve been doing this a long time, and to just not do what they do because you want to spite them just cuts off your nose to spite your face.

“And that’s what part of the problem here is, that we just can’t get beyond this vindictiveness and say how we can work together and help each other and figure out what is the best thing to do, and there is none of that.”

What are the implications of requiring controlled trials for approval of an updated COVID vaccine?

OFFIT: “I think it’s more of an appearance of them doing more than has been done before than them actually doing more than has been done before. For example, they say they want to look at a prospective, placebo-controlled trial in 50- to 64-year-olds who are otherwise healthy. So what are they going to learn from that? I don’t think they’re going to learn much about efficacy – those papers are already published. I don’t think we’re going to learn much about serious disease because there’s not a lot of serious disease in that age group, so you would have to do a huge study to show that there’s an effect.

“I don’t think you could do that study ethically. I don’t think you could not give a vaccine to say, a healthy 50-year-old knowing that the virus stills circulates, and knowing that although that group is at low risk, they’re not at no risk. Suppose if there were more people who suffered serious disease in the placebo group? How can you ethically justify that?”

EDWARDS: “How many people, given the rate of COVID disease in 50- to 64-year-olds, are going to have to enroll in a trial? There should have been some projections of those numbers. How are you going to do these studies in the real world now? How much is it going to cost, and who is going to pay for it? If pharma is going to have to pay for this, these are going to be real costs. So, if you want drugs to be less expensive, then this is not going to help with that.

“I want vaccines to be safe and effective, but I think that we have to realize that these COVID vaccines have been given to millions of people and we have a lot of information about them already. So, I think it sort of suggests that there is a lack of understanding for the data that do exist.”

How could the FDA vaccine approval framework affect other types of vaccines, like for annual influenza?

EDWARDS: “I think the vaccine efficacy with each flu strain is complicated each year and I think you could ask the same questions and rationale to say why don’t we require studies for the flu vaccine every year. I think that’s not going to happen because we’ve been doing it for more than 50 years.

“Plus, these flu vaccines are practically free. If you have to do all these other studies, the cost of the flu vaccine is going to go up and nobody is going to pay for it. So, I don’t think they’re going to do that but the rationale for doing these studies of COVID vaccines are really no stronger than the rationale for doing them in the flu.”