U.S. regulators said Friday they were no longer considering allowing a second COVID-19 booster shot for all adults under 50 this summer, but instead focus on revamped vaccines for the fall that will target the latest. subvariants of the coronavirus.
Pfizer and Moderna expect to have updated versions of their shots available as early as September, the Food and Drug Administration said in a statement. That would form the basis for a fall booster campaign to strengthen protection against the latest versions of Omicron.
The announcement means the US will not pursue a summer round of boosters of current vaccines for adults under 50, as some Biden administration officials and outside experts previously suggested. They had argued that a new round of booster injections could now help prevent increasing cases and hospitalizations caused by the highly transmissible strains of Omicron.
Currently, all Americans age 5 and older are eligible for a booster shot five months after their first primary series. Fourth doses of the Pfizer or Moderna shots — a second booster — are recommended for Americans 50 and older and for younger people with serious health conditions that make them more vulnerable to COVID-19.
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The FDA urged adults who have not yet received a boost to get their additional injection now: “You can still take advantage of existing booster options and have time to receive an updated booster in the fall,” it said. office in a statement.
The White House has also stressed that getting a fourth dose now won’t affect a person’s ability to get Omicron-targeted shots once they’re available — though how long it’s been since their last dose will play a role in how quickly they are eligible.
Two Omicron sub-variants, BA.4 and BA.5, are even more contagious than their predecessors, pushing new daily cases above 125,000 and hospitalizations to 6,300. Those are the highest levels since February, although the number of deaths has remained low at about 360 a day, thanks to widespread immunity and improved treatments against the virus.
The subvariants are offshoots of the strain that has been responsible for nearly all virus spread in the US this year.
All of the COVID-19 vaccines given in the US so far are based on the original version of the virus that began spreading across the country in early 2020.
In June, the FDA told vaccine makers that any fall boosters should combine protection against Omicron BA.4 and BA.5 with the original coronavirus strain. Both manufacturers have accelerated production and data collection to have those so-called bivalent vaccines ready by the fall.
The FDA and the Centers for Disease Control and Prevention should sign for renewed shots before launch.
The US has a contract to buy 105 million doses of Pfizer’s combination injections once they are ready, along with 66 million of Moderna’s version. But it is not clear how quickly large amounts will become available.
As for timing, getting a booster too soon after the previous dose means missing out on the full benefit — something policymakers should keep in mind when rolling out refreshed shots.
The White House has been frustrated at times with the pace of decision-making at the FDA and CDC, particularly last summer when regulators took weeks to decide whether to approve the first booster dose for US adults. Privately, West Wing officials believe the delay has cost lives, prevents optimal protection amid the Delta and Omicron peaks, and fuels doubts about the effectiveness of vaccines and boosters that affected their uptake.
In recent weeks, some of those frustrations have bubbled up again as regulators considered whether to recommend a fourth shot for all adults, not just those most at risk for the virus. Some in the White House believe the extra dose would help somewhat with the rapidly spreading BA.5 subvariant and also boost the confidence of anyone who fears that protection has waned.
Still, government officials have recognized the risks of vaccine fatigue among Americans, including tens of millions who still haven’t received their first booster. Government figures show that less than half of those who qualify for a booster have received that third chance.
Associated Press writer Zeke Miller contributed to this story from Washington.