Oct. 21, 2021 — Millions of American adults are now eligible for a COVID-19 vaccine booster following Thursday’s approval from the CDC, which also gave the go ahead for mixing of vaccines for the first time.
A panel of experts that advises the CDC weighed in earlier Thursday on who should get boosters after their Moderna or Johnson & Johnson vaccines. Both recommendations were unanimous, 15–0.
The Advisory Committee on Immunization Practices (ACIP) says everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, a recommendation that affects an estimated 13 million Americans. That booster can be any of the available COVID-19 vaccines.
CDC Director Rochelle Walneksy, MD, later gave final approval to the panel’s recommendations making boosters available immediately.
Those eligible for a booster at least 6 months after their last the Moderna shot are the same groups who can get a Pfizer booster. They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
There are an estimated 47 million people who have gotten Pfizer vaccines and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people under age 50. They worried that being so permissive with boosters could send the wrong message to Americans and undermine confidence in the vaccines.
In the end, however, they felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“I can’t say that I am comfortable that anybody under 50 needs—an otherwise healthy individual–needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, a professor of pediatrics at Drexel University in Philadelphia.
During the deliberations, she said she hoped the Committee could try to mitigate the potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines because we have the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death. But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Thursday, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomized to get a booster of their Cominarty vaccine, the other half were given a placebo. Over the next 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo. The data was posted in a press release and has not yet been peer reviewed, but it is the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses of the COVID-19 comes from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies. The studies demonstrated that boosters indeed restore high levels of antibodies, but they were not able to show that these antibodies prevented COVID-19. These studies also weren’t powered to pick up on any less common safety problems that might arise. After another dose of the shots.
In the end, however, the ACIP felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflect real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta who was not involved in the ACIP’s deliberations.
Varkey said he would recommend that anyone who is under the age of 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.