WASHINGTON — U.S. regulators said Friday they are no longer considering authorizing a second COVID-19 booster shot for all adults under 50 this summer, focusing instead on revamped vaccines for the fall that will target the newest viral subvariants. The Food and Drug Administration stated in a statement that
Pfizer and Moderna will have the latest versions of their vaccines available by September. That would set the stage for a fall booster campaign to strengthen protection against the latest versions of omicron.
The announcement means the U.S. won’t pursue a summer round of boosters using the current vaccines for adults under 50, as some Biden administration officials and outside experts previously suggested. They had argued that another round of shots now could help head off rising cases and hospitalizations caused by the highly transmissible omicron strains.
Currently, all Americans age 5 and over are eligible for a booster shot five months after their initial 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 issues that make them more vulnerable to COVID-19.
The FDA advised eligible adults to obtain their booster shot as soon as possible. “You can still get the existing booster options, and you have time to wait for the updated booster in fall,” it said.
The White House stressed that the availability of omicron targeted shots will not be affected by receiving a fourth dose. However, how long it has been since they were last administered may impact how quickly they are eligible.
Two omicron subvariants, BA. 4 and BA. 5, are even more contagious than their predecessors and have pushed new daily cases above 125,000 and hospitalizations to 6,300. Those are the highest levels since February, though deaths have remained low at about 360 per day, thanks to widespread immunity and improved treatments against the virus.
The subvariants of this strain are responsible for almost all the disease spread to the U.S. in 2018.
All the COVID-19 vaccines given in the U.S. until now have been based on the original version of the virus that began spreading across the country in early 2020.
In June, the FDA told the vaccine makers that any boosters for the fall would have to combine protection against omicron BA. 4 and BA. 5 and the original coronavirus strain. To have the so-called bivalent vaccines in time for fall, both manufacturers have increased production speed and data collection.
Before the shots are launched, both the FDA and Centers for Disease Control and Prevention will have to approve any changes.
The U.S. has a contract to buy 105 million doses of the Pfizer combination shots once they’re ready, and 66 million of Moderna’s version. It’s not clear when large quantities will be available. The government contracts include options to purchase 300 million doses each, but reaching that total will require more funding from Congress, the Biden administration said.
As for timing, getting a booster too soon after the previous dose means missing out on its full benefit — something policymakers will have to take into consideration when rolling out revamped shots.
The White House has at times been frustrated by the pace of decision-making at the FDA and CDC, most notably last summer, when the regulators took weeks to decide whether to authorize the first booster dose for U.S. adults. Privately, West Wing officials believe the delay cost lives, preventing optimum protection amid the delta and omicron surges, but also fed into doubts about vaccine and booster effectiveness that impacted 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 at highest risk from the virus. Some in the White House believe that the additional dose would have helped somewhat with the rapidly spreading BA. 5 subvariant, and also lift the confidence of anyone worried that their protection had waned. Officials from all levels of government acknowledge the dangers associated with vaccine fatigue in the United States, and the tens to millions of Americans who have not received their booster. Government figures show less than half of those eligible for a booster have gotten that third shot.
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Associated Press writer Zeke Miller contributed to this story from Washington.
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