People ages 65 and older and those who are immunocompromised will be allowed to receive an additional dose of Covid-19 vaccine this spring if they wish, the Food and Drug Administration announced Tuesday.
In authorizing another dose for people in these demographics, the agency is following in the footsteps of Canada and the United Kingdom, which earlier announced that older adults, adults who live in care facilities, and people who are immunocompromised would have access to an additional booster of vaccine this spring. In the U.K., adults 75 and older are eligible; in Canada, adults must be 80 or older to receive an extra dose.
The new booster guidance was part of a basket of changes the FDA announced to Covid vaccine policy, the aim of which is to simplify the extraordinarily complex existing Covid vaccine recommendations.
“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent Covid-19 vaccines and the agency believes that this approach will help encourage future vaccination,” Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said in a statement. “Evidence is now available that most of the U.S. population 5 years of age and older has antibodies to SARS-CoV-2, the virus that causes Covid-19, either from vaccination or infection that can serve as a foundation for the protection provided by the bivalent vaccines.”
People 65 and older should only get another shot if at least four months have elapsed since their most recent booster, according to the recommendation. For people who are immunocompromised, the suggested interval between shots is two months. The agency said immunocompromised people could get additional doses after that “at the discretion of, and at intervals determined by, their health care provider.”
Marks said the decision to defer the length of the interval between boosters for immunocompromised people to their health care providers is a reflection of the fact that there is a wide variety of conditions that trigger an immunocompromised state, making a one-size-fits-all approach impractical.
“Leaving this open to potentially a recommendation from [the Advisory Committee on Immunization Practices] or to societies that care for transplant patients, etc., we will hopefully allow individualization of the vaccination as appropriate for the degree of immunocompromise in different individuals,” he said during a press briefing.
The changes announced by the FDA made no reference to whether people who have recently had Covid should wait for a period before getting another booster. Current CDC guidance suggests that people who have recently had Covid “may” consider waiting three months before getting another booster.
The FDA issued what is known as a “permissive” recommendation, one that applies only to the bivalent vaccines made by Moderna and the Pfizer-BioNTech partnership. It is not trying to push everyone aged 65 and older and all people who are immunocompromised to get another jab this spring; rather the agency is saying people within those demographics who want another dose may get one. Rochelle Walensky, director of the Centers for Disease Control and Prevention, must sign off on the recommendation before it goes into effect; she is expected to do so.
The ACIP, which advises the CDC on vaccination policy, meets Wednesday to discuss the changes the FDA has announced. But the meeting’s agenda shows that no votes will be taken, indicating that while the agency wants to hear the committee’s views, the decision will be Walensky’s alone.
The Canadian recommendation is also a permissive one, worded as “may.” The U.K.’s Joint Committee on Vaccination and Immunization said adults in the designated demographics “should” get an additional jab. The Canadian recommendation also included people who are 65 and older who are not known to have experienced a Covid infection.
A study published last week in the New England Journal of Medicine suggested that people who got a bivalent booster last fall got additional protection against developing severe illness or death if they contracted Covid, but that the benefit waned over time. And extra protection against any infection was fleeting.
“Our results showed that the effectiveness of boosters declined to a low level after five months. In addition, older adults and people who are immunocompromised have much higher risks of hospitalization and death than young and healthy people. Thus, it would be sensible for those people to get a spring booster,” lead author Danyu Lin, a biostatistician at the University of North Carolina’s Gillings School of Global Public Health, told STAT. (Lin spells his given name Dan-yu when he publishes in the scientific literature.)
People looking for an additional booster should be able to get the vaccine at their local pharmacy — if the pharmacy still stocks Covid vaccine. The Biden administration announced Friday that even though the Covid public health emergency will expire on May 11, it is retaining an emergency power that allows pharmacists to vaccinate against Covid until at least the end of 2024.
A number of changes to the vaccination regimens for the messenger RNA vaccines made by Moderna and by the Pfizer and BioNTech partnership are going into effect, the FDA said.
Rather than using monovalent vaccine — which contains only the original strain of the SARS-CoV-2 virus — for the primary series and updated vaccine containing two strains, known as a bivalent, for booster doses, going forward anyone who gets a Covid shot in the U.S. will get the bivalent vaccine.
The sole exceptions will be people who opt not to get the Moderna or Pfizer/BioNTech vaccines, choosing instead one made by Novavax or Johnson & Johnson. Neither company has made a bivalent vaccine to date.
In fact, it seems likely the J&J vaccine, which has barely been used in the U.S., will soon disappear from this market. The vaccine was relegated to a sort of second-tier status — the FDA said last year that it should only be used if people refuse to get or cannot take the Pfizer or Moderna vaccines — because of a rare but sometimes fatal clotting side effect. The J&J vaccine will likely no longer be available in the U.S. after May, when existing government supplies expire. The company has slashed production of the vaccine, the Wall Street Journal reported earlier this year.
Another change in the new guidance relates to the number of doses people should get to be considered fully vaccinated going forward. A single dose of bivalent vaccine is recommended for the primary series; after that, booster doses may be obtained when they are recommended by the FDA and CDC.
The FDA statement suggested the move to a single-dose primary series for people who haven’t yet been vaccinated is viable because most people in the United States now have antibodies to the SARS-2 virus, even if they have never been vaccinated, because of previous infections.
“The immune response after one dose of vaccine among participants with evidence of prior infection was comparable to the immune response after two doses among participants without evidence of prior infection,” the statement said.
There is an exception involving young children. Children ages 6 months to 5 years who have never been vaccinated and who are receiving the Moderna vaccine should get two doses. For children who are 6 months to 4 years old who have never been vaccinated and are receiving the Pfizer/BioNTech vaccine, three doses are recommended.
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