The Food and Drug Administration has authorized a fourth dose of Pfizer and Moderna Covid vaccine for everyone over the age of 50, despite uncertainty over whether an even more contagious version of omicron will cause another wave of infections in the U.S.
The FDA approved a second Pfizer booster shot and a second Moderna booster for adults with compromised immune systems. The new boosters are given at least four months after the last shot.
The FDA made the decision without a meeting of its vaccine advisory committee, a rare move the agency has made more frequently over the course of the Pandemic. Pfizer and Moderna asked the FDA to allow a second booster shot, based on data from Israel, just two weeks ago. The Centers for Disease Control and Prevention is expected to sign off on the decision.
The vaccine experts are expected to hold a broad discussion about boosters and will not vote on a specific recommendation.
Dr. Paul Offit criticized the FDA for moving forward without holding an open meeting where the American public can hear experts weigh the data and make a recommendation to the FDA about the best path forward. The vaccine advisory committee's recommendations are not binding, but they help provide transparency.
Offit said that the FDA authorization was just a formality. We talk about how we follow the science, but it doesn't seem to work out that way.
The FDA has not called on the committee members to make a recommendation on booster shots since last fall when they voted in favor of a third Pfizer or Moderna dose for people age 65 and older and younger people at risk of severe Covid.
The debate on whether a fourth vaccine dose is needed is nuanced. The elderly or immune compromised may benefit from additional protection. Young, healthy adults are less susceptible to severe illness from Covid, which is why another booster shot is more controversial.
Dr. Peter Hotez said that some scientists think the shots are only used to keep people out of the hospital. Hotez said that vaccine policy should try to prevent infections and long Covid. Over time, the effectiveness of the third dose against hospitalization from omicron has declined.
The effectiveness of the third dose against emergency room visits and hospitalization declined after the vaccine was given, according to a study published in February by the CDC.
Hotez supports a fourth dose based on Israeli data showing another booster increases protection for people older.
The death rate from omicron was lower in senior citizens who received a fourth Pfizer dose compared with those who received just three shots, according to a study by Israeli scientists. Clalit Health Services, Israel's largest health-care provider, examined the medical records of more than 500,000 people from January through February.
The FDA decision to authorize fourth doses for those 50 and older was broader than Pfizer's request. Pfizer and Moderna both asked the FDA to allow them for all adults over the age of 18. Stephane Bancel, CEO of Moderna, told CNBC last week that the company filed a request with the FDA to give them more flexibility in deciding which age group needs a fourth dose.
Moderna's request for a fourth dose for all adults is an aggressive, blanket application that doesn't distinguish between the different needs of older and younger people.
Moore said that the old and frail person has more need of an additional vaccine dose than a young healthy athlete.
The authorization of fourth shots comes as major European nations and China are battling their worst outbreak of the year. BA.2 is gaining ground in the U.S. and is expected to become the dominant variant in the coming weeks. White House chief medical advisor Dr. Anthony Fauci said that infections might increase in the U.S.
The vaccines have the same level of effectiveness against both types of the variant, according to studies from South Africa. Peer review has not been done for either study.
It is unclear if the FDA will approve fourth doses for younger adults at some point, as there is less data to support such a decision right now. An Israeli study found that a fourth dose does not boost immunity, but restores it to the peak strength of the third dose. Many people in the study who received a fourth dose still got infections, though they were either mild or asymptomatic.
A fourth vaccination of healthy young health-care workers may have only marginal benefits, according to Dr. Gili Regev-Yochay and a team of scientists from Sheba Medical Center and Israel's Ministry of Health.
In September last year, the FDA advisory committee voted against a third dose for everyone over the age of 16 because there wasn't enough data to support such a decision. After two months, the FDA authorized Moderna and Pfizer boosters for all adults without holding an advisory committee meeting, and then lowered eligibility to include everyone 12 and older in December and January.
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