FDA authorizes Moderna and Johnson & Johnson booster shots
By Noah Weiland and Sharon LaFraniere
The Food and Drug Administration authorized booster shots earlier this week for tens of millions of recipients of Moderna’s two-dose coronavirus vaccine and Johnson & Johnson’s single-dose shot, significantly expanding efforts to bolster protection for vulnerable Americans.
The agency also authorized medical providers to give people a booster shot of a different COVID-19 vaccine, a strategy known as “mix and match.”
That decision may dampen interest in the United States in Johnson & Johnson’s vaccine, which studies have found provides less protection than the other two. Recipients of that vaccine will have the option of seeking a Moderna or Pfizer-BioNTech booster, which could prompt a more substantial jump in protective antibodies. Recipients of the other two vaccines will have the same leeway to choose a different vaccine for a booster shot.
The regulators, who authorized boosters for high-risk recipients of the Pfizer-BioNTech vaccine last month, did not recommend any one vaccine over another as a booster.
“We do not have preferential recommendations,” Dr. Janet Woodcock, the FDA’s acting commissioner, said at an evening news briefing. “We feel that if patients have questions, they should consult with perhaps their physician or another provider.”
The latest authorizations arrived amid what is shaping up to be a busy stretch of major regulatory decisions on vaccines. The FDA is expected to decide in the coming weeks whether Pfizer-BioNTech’s vaccine should be authorized for 5- to 11-year-olds. The agency’s independent vaccine advisory committee is set to consider the matter Tuesday and make a recommendation.
Regulators may also decide as early as November whether to allow even more people to obtain booster shots, including younger adult recipients of the Pfizer or Moderna vaccines who are not yet eligible. While many vaccine experts have questioned whether younger, healthy people need booster shots at this time, some members of the advisory committee urged the agency last week to expand eligibility.
Dr. Peter Marks, the FDA’s top vaccine regulator, said the agency could be “nimble” in including more younger adults. “It is something that can happen as soon as we see and feel that we need to take that action,” he said.
A key question before regulators was whether to authorize a full or a half-dose of Moderna’s vaccine as a booster shot. Data from a federally funded study suggested a full-strength dose of Moderna could hugely boost the antibody levels of Johnson & Johnson recipients and increase the antibody levels of Pfizer recipients better than an additional shot of the same vaccine.
But Moderna only sought permission for a half-dose as a booster shot, submitting data in support of that. In the end, the FDA decided to authorize a half-dose as a Moderna booster for recipients of all three vaccines, at least in part, Marks suggested, in order to limit confusion among providers.
The move Wednesday to make a much larger swath of Americans eligible for boosters followed unanimous votes last week from the FDA’s advisory committee to recommend the authorizations. A separate committee advising the Centers for Disease Control and Prevention is scheduled to vote on Thursday on its own recommendations for Moderna and Johnson & Johnson boosters.
The panel will also consider whether people need more guidance about when and whether to switch vaccines for a booster shot. CDC officials are expected to argue for flexibility.
Given the existing data, “we have to be noncommittal about what is the best,” Marks said. “We have to simply say that any one of these combinations is reasonable.”
The CDC’s director typically endorses the panel’s recommendations as a final step before vaccines are put into use. If the agency agrees with the FDA, the booster shots could be available to the public as soon as this weekend.
Eligibility requirements for a booster differ depending on vaccine. Pfizer and Moderna recipients will be able to get an extra shot six months after their second injection if they are at least 65 years old or at high risk of severe COVID-19 complications because of medical conditions or where they work. Johnson & Johnson recipients — all of whom are 18 and older — will be eligible for a second shot at least two months after the first.
The decision to allow recipients to switch to a different vaccine as a booster adds yet another layer of complexity. “Although it is not simple,” Marks said, “it’s not utterly hopelessly complex.”
Since the Pfizer-BioNTech vaccine was authorized as a booster shot last month, some state health officials have clamored for mix-and-match flexibility, saying it would help them reach older and at-risk residents in cases where they did not have a supply of the same vaccine that people initially received.
Top CDC officials suggested last week that the mix-and-match rules would also leave room for those concerned about side effects — for example, younger women worried about the Johnson & Johnson vaccine’s ties to a rare blood clotting condition — to switch brands. Some may be interested in switching to Johnson & Johnson, on the other hand, if they have concerns about rare heart-related side effects linked to the Moderna and Pfizer-BioNTech vaccines.
“We would expect many people will continue to get the same series that they had already received,” Woodcock said, but she added, “We wanted to provide a lot of flexibility.”