FDA and CDC clear second booster of COVID vaccine for ages 50 and over
More than 34 million Americans aged 50 and older are now eligible to receive another booster shot, after the Food and Drug Administration said Tuesday that it had authorized a new round of the Moderna or Pfizer and BioNTech COVID-19 vaccines for those who want them.
The Centers for Disease Control and Prevention echoed the FDA's authorization on Tuesday afternoon, signing off on guidance making a second booster dose of Pfizer-BioNTech or Moderna's COVID-19 vaccine available for eligible people "who wish to increase their individual protection."
The CDC also went a step further, clearing a second booster dose for all adults "who received a primary vaccine and booster dose of Johnson & Johnson's Janssen COVID-19 vaccine at least 4 months ago."
"We're hoping that by taking this action, we will help allow people to take steps to protect themselves should we have another wave that comes through this country," the FDA's top vaccines official, Dr. Peter Marks, told reporters Tuesday.
Americans who are old enough to be eligible will be able to get the second booster as early as four months after their first booster. Immunocompromised Americans ages 12 and older who were boosted will also be able to get another shot.
Until now, only Americans with compromised immune systems have been eligible to receive a fourth shot if they were first vaccinated with the Pfizer-BioNTech or Moderna vaccines, or a third shot if they had initially gotten Johnson & Johnson.
The FDA said Tuesday's decision was based on data from health authorities in Israel that showed "no new safety concerns" with a fourth dose of Pfizer and BioNTech's vaccine that was rolled out for residents there age 60 and older. The regulator also said data from "an independently conducted study" showed the Moderna fourth dose found no safety concerns "up to three weeks of follow up after the second booster dose."
Marks said the regulator had decided to expand eligibility beyond Israel's cutoff down to age 50 to address challenges during previous efforts to "operationalize" federal recommendations. Around a third of people from 50 to 65 years old "have significant medical comorbidities," Marks said, and other vaccine policies rely on 50 years old to define those at "higher risk."
Both Moderna as well as Pfizer and BioNTech are also pursuing new versions of their vaccines that could be rolled out later this year. The companies hope the revised shots will outperform current formulations that were designed to target the initial "prototype virus."
But for now, the new round of boosters will draw on the same supply currently deployed for initial vaccinations and boosters. Marks said getting a second booster now would "not preclude people" from getting another round of shots in the fall, if a new version of the vaccine is rolled out.
"There may be a need for people to get an additional booster in the fall along with a more general booster campaign if that takes place because we may need to shift over to a different variant coverage," said Marks.
Federal officials have sought for weeks to separate their deliberations over the "immediate situation" to boost the most vulnerable Americans against a new potential wave of COVID-19 cases and discussions over longer-term decisions on fall boosters for the broader population.
Tuesday's move was announced without publicly airing the data before either the CDC or FDA's outside vaccine advisers. Marks said the move had been "a relatively straightforward decision" that did not need to be run by the panel.
The FDA does plan to convene a meeting of the Vaccines and Related Biological Products Advisory Committee next week on the topic.
"On April 6, the FDA will have an important meeting — and CDC will participate — on what does a fall booster look like? How will we make decisions about that fall booster? Do we, will we, need that fall booster?" CDC Director Dr. Rochelle Walensky told an event hosted by Columbia University on Monday.
Though the CDC has touted data suggesting the mRNA vaccines "continued to be highly effective" at averting severe outcomes from COVID-19 during the Omicron wave, the agency also acknowledged the significant uptick — and disparities — in severe Omicron infections.
CDC data also suggests Johnson & Johnson recipients died at higher rates during the Omicron wave compared to other vaccinated Americans, even among those who had received a booster, and face a higher risk of hospitalization.
"I think we're in a relatively weak position on the sort of policy front around exactly what the data are that are compelling decisions about fourth doses," Dr. Kate O'Brien, a top vaccines official at the World Health Organization, said at the Columbia event.
"The gap between the evidence required for regulatory authorization of uses of vaccine and really sound policy decisions about optimization of vaccine programs has always been a gap. It continues to be a gap," said O'Brien.
Supply of second boosters
The move to expand eligibility for a second booster comes as the campaign to roll out first boosters has slowed for months, down to less than 75,000 additional doses per day.
Overall, the White House estimates that some two-thirds of eligible adults have received a booster shot. More than 34 million Americans aged 50 and older were boosted four months ago, according to CDC data.
The Biden administration claims it has enough supply to support fourth doses "for our most vulnerable, including seniors" this spring.
However, White House officials have also warned publicly for weeks that it had run out of money to buy enough additional boosters for all Americans later this year, or to replace current batches if vaccine makers roll out updated formulations tweaked for new variants.
Moderna's executives told investors last week that the firm was "actively preparing" for the possibility it would need to sell its vaccine on the private market in the U.S.
"We just want to be ready because we don't want to be in a world, obviously, where Americans don't have access to vaccines in the fall," said Moderna's CEO Stéphane Bancel.
Marks suggested it was possible new COVID-19 vaccines may be rolled out timed to the annual flu shot campaign in the coming years, citing the possibility of "operational efficiency" in pairing the two rollouts.
"At some point we're going to have to realize that this is a virus that's going to be with us, and that we have to come to grips with dealing with it on a regular basis," said Marks.