The Food and Drug Administration (FDA) of the United States, the body that regulates the marketing of drugs, has authorized this Wednesday a third dose of the Pfizer vaccine for those over 65 years of age and also for adults in health risk or especially exposed to covid-19. This last group of especially exposed people consists of health workers, teachers, carers, supermarket employees, the homeless and those deprived of liberty.
“Today’s decision demonstrates that currently available science and data continue to guide FDA decision-making for covid-19 vaccines during this pandemic,” agency director Janet Woodcock said in a statement. He also noted that as more information becomes available on “the safety and efficacy” of vaccines, including the third doses, the FDA will “evaluate” that information.
This FDA decision comes in the middle of a debate in the United States about the need to administer a third dose to its entire population and worldwide on the suitability of doing so while other countries still do not have enough vaccines.
Authorization of the third dose for these groups of people is announced a week after it was recommended by an FDA advisory committee. The recommendation was made in a second vote after having previously rejected, with broad support, the plan of a third dose for the majority of the population, considering insufficient evidence to administer a third dose to everyone.
This restricts the request of Pfizer, which had requested approval for people over 16 years of this booster, six months after the second dose.
This recommendation is a wake-up call for the Government of Joe Biden, which had given its explicit support to Pfizer’s proposal and began to make plans to start the administration of this third dose to those over 16 years of age with an eye on the future. September 20.
In a statement, Pfizer CEO Albert Bourla said that “vaccine boosters have an important role to play in addressing the continuing threat of this disease,” calling the FDA’s decision a “crucial milestone.” in the fight against covid-19.
Pfizer’s is the only vaccine fully approved for use by the FDA, as Moderna and Johnson & Johnson’s have only emergency clearance.