FDA expands emergency authorization for Covid-19 booster shots to all adults

The Food and Drug Administration expanded the emergency use authorization for the Pfizer and Moderna Covid-19 vaccine boosters on Friday, signaling that the shots can be given to anyone aged 18 or older at least six months after completion of the primary vaccine series.

The new policy still requires signoff from the Centers for Disease Control and Prevention to go into effect. The CDC’s vaccine advisory panel will meet Friday on the issue. But if the CDC agrees with the FDA, this will be in effect the completion of a Biden administration promise, announced in mid-August, to provide all American adults Covid booster doses this fall.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech Covid-19 vaccine for individuals 18 years of age and older helps to provide continued protection against Covid-19, including the serious consequences that can occur, such as hospitalization and death,” acting FDA Commissioner Janet Woodcock said in a statement announcing the agency’s ruling.

Pfizer applied to the FDA earlier this month for an expansion of the emergency authorization for its booster shot to make it available to anyone 18 or older. Moderna announced Wednesday that it too had asked the FDA for a broadening of the emergency use authorizations for its booster, which has already been authorized for people 18 and older in Canada and elsewhere.

The FDA and the CDC agreed in October that all people who received the one-dose Johnson & Johnson vaccine should receive a booster shot two months or later after their initial jab.

Though the Biden administration announced its intention to offer boosters to all vaccinated Americans in August, two groups of outside experts who advise the FDA and the CDC were initially unconvinced of the need — and irked by a White House decision that circumvented normal processes for this type of a decision.

At a September meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, the expert panel indicated it felt Pfizer boosters should be offered to a narrower band of people. The FDA defined that as those 65 and older, people 18 to 64 with health conditions that raise their risk of severe Covid infection, and people 18 to 64 whose jobs or living conditions put them at increased risk of contracting Covid.

Initially that latter group was described as people such as health care workers, teachers, prison guards and prisoners, as well as people who work and stay in homeless shelters. More recently, though, more than a dozen states, including Massachusetts, California, and Colorado, have declared that because of high local transmission rates, everyone 18 and older meets the threshold for a booster.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will … help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

It remains to be seen whether the CDC’s vaccine expert panel, the Advisory Committee on Immunization Practices, will recommend expanding the booster eligibility. In September, this group voted against recommending the Pfizer booster for people 18 to 64 whose occupations or living conditions put them at high risk of Covid, but was overruled by CDC Director Rochelle Walensky. It was only the second time a CDC director has opted not to follow a recommendation from the ACIP.

In subsequent meetings about booster shots, several members of the committee have openly admitted they thought they were voting to recommend booster shots for people who did not yet need them. But they have not balked again and may have concluded that the writing is on the wall when it comes to the U.S. Covid booster shot policy.

The group will almost certainly spend time, though, studying any available data to determine what can be said about the risk of a rare side effect that has been seen after receipt of messenger RNA vaccines; both the Moderna and Pfizer vaccines are mRNA vaccines.

Some people who receive these vaccines go on to develop myocarditis or pericarditis — inflammation of heart muscle or tissue around the heart, respectively. This side effect has been seen most commonly in males in their late teens and 20s. Although these conditions can be serious, most of the myocarditis and pericarditis cases associated with Covid vaccination have been at the mild end of the severity spectrum.

The FDA statement Friday noted that side effects reported after booster doses of these vaccines were similar to those seen after earlier doses: pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills. It noted, though, that there were more reports of swollen lymph nodes in the underarm after receipt of a booster than after the first two doses.

Data from the CDC suggest that people who are eligible for booster shots are getting them, with 37.3% of fully vaccinated people 65 and older having already received a booster. Vaccine uptake in that age group is reasonably high; 86.2% of Americans 65 and older are fully vaccinated.