Federal regulators granted public access to a third dose of the Pfizer-BioNTech vaccine to boost waning immunity for seniors over 65 and other vulnerable adults, setting the Biden administration up to deliver on its promise to get extra shots to the adult population.
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Seniors, people with comorbidities that could make illness more severe, front-line health workers, and others with jobs at greater risk of exposure to COVID-19 will be eligible for the booster.
The Food and Drug Administration’s decision to approve the petition to green-light the boosters comes after a federal panel of scientists with the agency met last week and overwhelmingly recommended against giving the shots to everyone. However, it unanimously endorsed them for seniors and high-risk people.
The company submitted the findings to the FDA in mid-August to show the extent that booster shots can shore up a weakened immune response roughly six months after receiving the second of two doses.
Although the FDA is not obligated to follow the panel’s recommendations, it usually does.
The Centers for Disease Control and Prevention, the agency at which Director Rochelle Walensky will get the final say on booster approval, began a high-stakes two-day conference to decide who should get the boosters first. The decision could come as late as Thursday afternoon with Walensky’s final word following soon after.
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The FDA fully approved the two-dose vaccine for people 16 and older on Aug. 23, about eight months after the agency first granted emergency use authorization. The EUA is a pathway reserved for times in which treatments or vaccines are so badly needed — like during a pandemic — that a slimmer body of evidence showing they work will suffice in the meantime.
The approval comes a little bit later than the Biden administration had hoped. This is the week when President Joe Biden predicted boosters would be rolled out to people who have completed the Pfizer vaccine regimen, roughly 99.5 million people 12 and older.
