The Food and Drug Administration (FDA) authorized both Pfizer-BioNTech and Moderna Covid-19 booster shots for all United States adults 18 and older on Friday, expanding eligibility to more than 180 million individuals. A Centers for Disease Control and Prevention (CDC) panel also signed off on the decision, making every American vaccinated at least six months ago eligible for a booster shot of their choosing—pending approval from CDC Director Rochelle Walensky, which is expected later today, report Spencer Kimball and Robert Towey for CNBC.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” Peter Marks, who leads the FDA division that regulates vaccines, said in a statement.
Covid-19 cases have risen than 20 percent in the U.S. in the past two weeks, according to Politico’s Adam Cancryn, and Biden Administration officials are eager to offer boosters ahead of anticipated Thanksgiving gatherings. Another motivating factor is growing evidence that vaccine protection is waning over time.
“Enough is enough. Let’s get moving on here,” said White House chief medical advisor Anthony Fauci Wednesday night. “We know what the data are.”
A CDC panel unanimously endorsed the FDA’s authorization Friday afternoon and issued recommendations on how the boosters should be used. When Walensky signs off on broader use, the extra shots could be available for all adults as soon as this weekend, according to Sharon LaFraniere and Noah Weiland for the New York Times.
At a White House briefing on Wednesday, Walensky said the agency would “quickly review the safety and effectiveness data and make recommendations as soon as we hear from FDA.”
The move helps President Joe Biden fulfill the pledge he made earlier this summer to offer booster shots to every eligible adult. Before the recent authorization, boosters were limited to those 65 or older, or those deemed at high risk because of their medical conditions, job, or living situation. The roughly 15 million Americans who received a Johnson & Johnson jab are also eligible to get a booster two months after their first dose.
Before authorizing the mRNA-based boosters, the agency debated the benefit of an extra dose for young, healthy individuals. One concern is the rare risk of myocarditis, an inflammation of the heart muscle, that has been linked to the vaccine. Still, some say the benefits of vaccination outweigh the very small risk of myocarditis, which has appeared mostly as mild, treatable cases in young men.
The FDA authorization allows eligible Americans to pick from any of the country’s three authorized vaccine brands as a booster. Experts aren’t recommending one jab over the other, instead advising that the decision be made based on personal factors, like the practicality of getting a certain brand at a local pharmacy, or the associated side effects. Fauci noted that widespread access to boosters should reduce the risk of hospitalization and death, and decrease the chance of having a symptomatic Covid-19 infection and condition called “long Covid.”
“I don’t know of any other vaccine that we only worry about keeping people out of the hospitals,” Fauci said in the press briefing Wednesday. “I think an important thing is to prevent people from getting symptomatic disease.”
More than 30 million Americans, or about 16 percent of those fully vaccinated, have already gotten additional shots, according to the Times. In recent weeks, a number of states have made booster shots available for all adults, including Massachusetts, Rhode Island, Kansas, Kentucky, Maine, Vermont, Arkansas, California, Colorado, and New Mexico.
Those critical of the recent decision say that despite some degree of waning protection, the initial course of Covid-19 vaccines is still highly effective at preventing severe disease and hospitalization. Booster shots are rolling out at a time when the country is struggling to convince more than 60 million Americans to get their first dose, reports CNBC’s Spencer Kimball. Public health officials emphasize the importance of getting an initial vaccination if you haven’t yet done so.
“It is not too late. Get vaccinated now,” Fauci said. “And importantly, if you are already vaccinated six months or more ago and eligible for a boost, get a boost.”