More than 34 million Americans age 50 and older could soon be eligible for another booster shot after the Food and Drug Administration said Tuesday it had approved a new round of COVID-19 vaccines from Moderna or Pfizer and BioNTech for those that you wish.
The Centers for Disease Control and Prevention must also approve updated recommendations before providers can begin administering the additional boosters.
“Current evidence suggests that protection against serious consequences of COVID-19 diminishes over time in elderly and immunocompromised individuals,” said Dr. Peter Marks of the FDA in a statement.
Previously, only immune-compromised Americans were eligible for a fourth shot if they were first vaccinated with either Pfizer-BioNTech or Moderna vaccines, or a third shot if they originally received Johnson & Johnson.
Americans old enough to be eligible can receive the second refresher as early as four months after their first refresher. Immunocompromised Americans 12 and older who have been boosted may also receive another injection.
The FDA said its decision was based on data from health officials in Israel that showed “no new safety concerns” with a fourth dose of Pfizer and BioNTech’s vaccine. The regulator also said data from “an independently conducted study” showed that the fourth dose of Moderna “up to three weeks of follow-up after the second booster dose” did not raise any safety concerns.
Pfizer and BioNTech hadon March 15 to introduce second boosters for seniors aged 65 and over. The companies said they submitted “two real-world datasets from Israel,” introducing fourth shots for adults 60 and older. Moderna later said so too but for all adults, hoping to “offer flexibility” to federal health officials.
Both Moderna, Pfizer, and BioNTech are also pursuing new versions of their vaccines that could launch later this year. The companies hope the revised shots will outperform current formulations, which target the original “ancestral strain” of the virus.
But for now, the current booster round will use the same stock of vaccines currently used for primary and booster vaccinations.
Federal officials have spent weeks trying to separate their deliberations on the “immediate situation” to strengthen the most vulnerable Americans against a new potential wave of COVID-19 cases and discussions about longer-term decisions about snap boosters for the general population.
Tuesday’s move was announced without releasing the data publicly to the CDC’s or FDA’s outside vaccine advisors. The FDA plans to call a meeting of the Vaccines and Related Biological Products Advisory Committee on the issue next week.
“On April 6th, the FDA will have a key meeting — and CDC will attend — about what a fall booster looks like? How will we make decisions about this Fall Booster? Do we need, will we, this fall booster?” CDC Director Dr. Rochelle Walensky said Monday at a Columbia University event.
Although the CDC has touted data suggesting that mRNA vaccines “remained highly effective” in averting severe outcomes from COVID-19 during the Omicron wave, the agency also recognized the significant rise — and disparity — in severe ones omicron infections.
CDC data also suggests thiswere more likely to die during the Omicron wave compared to other vaccinated Americans, even among those who received a booster shot.
“I think we’re in a relatively weak position in terms of the nature of the political front, which is exactly the data that’s compelling decisions about fourth doses,” said Dr. Kate O’Brien, a senior World Health Organization vaccine official at the Columbia event.
“The gap between the evidence required for regulatory approval of vaccine use and really sound policy decisions about optimizing vaccine programs has always been a gap. It remains a void,” O’Brien said.
Delivery of second boosters
The move to expand eligibility for a second booster comes as the campaign to launch the first booster has slowed for months, falling to fewer than 75,000 additional doses per day.
Overall, the White House estimates that about two-thirds of eligible adults have received a booster shot. Four months ago, more than 34 million Americans age 50 and older were boosted, according to CDC data.
The Biden administration claims it has enough supplies to support fourth doses “for our most vulnerable, including seniors” this spring.
However, White House officials have also publicly warned for weeks that he has run out of money to buy enough extra boosters for all Americans later this year, or to replace current batches when vaccine makers introduce updated formulations optimized for new variants .
Moderna executives told investors last week that the company was “actively preparing for the possibility” of selling its vaccine in the private market in the United States
“We just want to be ready because obviously we don’t want to live in a world where Americans don’t have access to vaccines in the fall,” said Stéphane Bancel, CEO of Moderna.