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The U.S. Food and Drug Administration (FDA), the agency that regulates the marketing of drugs, authorized on Wednesday the third dose of Pfizer’s vaccine for people over 65 years of age and also for elderly people at health risk or especially exposed to COVID-19.
Healthcare workers, teachers, caregivers, supermarket employees, homeless and prison inmates are considered “especially exposed” to COVID, said the FDA.
“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic,” agency director Janet Woodcock said in a statement.
She said that as more information becomes available on the “safety and efficacy” of the vaccines, including the third dose, the FDA will “evaluate” that information.
This FDA decision comes in the midst of the debate in the United States on the need to administer the third dose to its entire population and worldwide on the appropriateness of doing so while other countries still do not have enough vaccines.
The third dose approval process
The authorization of the third dose for these groups of people comes a week after it was recommended by an FDA advisory committee.
The recommendation was made in a second vote after previously rejecting, with broad support, the plan for a third dose for the majority of the population, deeming insufficient evidence to administer a third dose to everyone.
This restricts Pfizer’s request, which had sought approval for people over 16 years of age for this booster six months after the second dose.
This recommendation is a wake-up call for Joe Biden’s government, which had given its explicit support to Pfizer’s proposal and started making plans to initiate the administration of this third dose to those over 16 years of age with a view to September 20.
In a statement, Pfizer CEO Albert Bourla said that “We believe boosters have an important role to play in addressing the continued threat of this disease” and called the FDA’s decision a “crucial milestone” in the fight against COVID-19.
Pfizer’s vaccine is the only vaccine with full FDA approval for use, as those from Moderna and Johnson & Johnson have only emergency clearance.