New COVID vaccine policy limits choice, could raise risk for younger groups
On May 20, the Food and Drug Administration (FDA) announced a new regulatory framework for COVID-19 vaccination for the fall that will permit use of the vaccines only for people over age 65 and those with certain medical conditions. Writing in the New England Journal of Medicine, FDA officials Vinay Prasad and Martin Makary, MPH ’98, also said that new clinical trials will be required in healthy people ages 50 to 64 to track COVID vaccine outcomes. Bill Hanage, professor of epidemiology at Harvard T.H. Chan School of Public Health, discusses the potential impact of the policy change.
Q: What’s your reaction to this new COVID vaccine policy?
A: COVID boosters are certainly far more important for older folks. It’s for this reason that many other countries have restricted them to certain age groups and it is far from crazy to seriously question their cost benefit in healthy adults under the age of 65. But if the administration is really pursuing a “vaccine choice” policy, it seems odd to deprive millions of Americans of the choice to receive a booster.
Q: Trump administration officials are saying that, for people under age 65 and not at high risk, we need “gold-standard data” on whether or not to recommend that they take vaccines. Is this a reasonable approach?
A: It goes further than recommendations. According to the new policy for people under age 65 and not at high risk, “the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.” It is hard to see how any such study could be achieved in time to be available for the fall when it would be most needed. Randomized controlled trials for an updated vaccine would need to enroll large numbers of participants to accurately determine vaccine efficacy and would take months to complete. Even the breakneck speed of the original trials in 2020 only yielded results once the winter surge was already underway.
Such trials are far from the only source of data on the benefits of vaccination. By requiring them the FDA is ignoring a huge body of existing evidence that can be used to guide decisions on COVID vaccination policy. For instance, we can compare the vaccination status of people with respiratory illness who test COVID-positive with those who test negative. Such studies can provide a better measure of how effective a vaccine is in the real world than a trial. And millions of people have now received mRNA vaccines, so we have a good body of evidence on their safety.
Q: We know that the COVID virus changes over time and that new variants can be unpredictable. What are the implications of the virus’ variability under the new policy?
A: We’ve just come out of a pretty mild winter with COVID, with flu being a more serious concern. But the year before it was the other way around, and COVID was considerably worse, even compared with historically bad flu seasons. This was partially because the virus around at the time had evolved to evade our immunity, allowing it to infect more of us. The next time the virus makes one of those leaps, withholding vaccination from younger age groups will lead to more of them getting seriously ill and dying.
Q: Could limiting access to COVID vaccines increase risk for certain groups disproportionately?
A: Booster rates are lower than they should be already because many people, even older people, think they don’t need them. This new policy is not likely to help that because it just adds to the message that people don’t need vaccination, and anything that gets in the way decreases vaccination rates. The risk will certainly be highest for the “healthy” 50-64 age group who won’t be eligible for the vaccine, which is why Trump administration officials have suggested trials be conducted in this group. And it’s worth noting that the rate of COVID hospitalization for children under 5 this last winter was similar to that for flu, even though it was a pretty mild COVID season and a really bad flu one.
Q: Do you think that the new policy has to do with the vaccine skepticism that we’ve seen expressed by some in the Trump administration?
A: The policy speaks of evaluating the “benefit-risk balance of each regulatory submission.” That suggests vaccination carries a risk, comparable to that of the disease itself. This certainly harmonizes with the song being sung by avowed vaccine skeptics in the administration.
Q: Does the science support this change in policy?
A: It’s important to think about the goals of the policy and whether the science suggests the administration will achieve them. COVID hospitalizations and deaths were way down this past winter. But if the virus changes again, science tells us that vaccines can help protect all of us, even if some of us will benefit more than others.
The article announcing the policy justifies it with the observation that many other countries restrict access to boosters based on age and other risk factors. This is correct, but these countries have very different health care systems. For instance, the U.K. has universal health care and so needs to balance the benefits of vaccines with their expense to the taxpayer. The U.S. health care system has left those decisions to insurance companies. Up until now this has allowed people to choose for themselves, in consultation with their doctor, whether they would like to receive a COVID booster. The goal of the new COVID vaccine policy is not clear, but it is certainly not to preserve or enhance that freedom for millions of Americans.
