The Food and Drug Administration (FDA, English) of the United States, the entity that regulates drug marketing, authorized this Wednesday a third dose of the Pfizer vaccine for those over 65 and also for children of age at risk of health or specially exposed to the COVID-19.
This last group of people especially exposed consists of health workers, teachers, caregivers, supermarket employees, homeless and deprived of liberty, as detailed by the FDA.
"Today's decision shows that the science and data currently available continue to guide the decision-making of the FDA for Vaccines against the COVID-19 during this pandemic," the director of the organization Janet Woodcock said in a statement.
He also said that as more information is about "the safety and efficacy" of vaccines, including third doses, the FDA "will evaluate" that information.
This decision of the FDA arrives in full debate in the United States on 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 sufficient vaccines.
The authorization of the third dose for these groups of people is announced one week after a committee of FDA advisors recommended.
The recommendation was taken in a second vote after previously rejected, with wide support, the plan of a third dose for the majority of the population, when considering the evidence to administer a third dose to the whole world.
In this way, the request of Pfizer is restricted, which had requested approval for people over 16 years of this reinforcement, six months after the second dose.
This recommendation is a touch of attention for the Joe Biden government, who had given his explicit support to the Pfizer's proposal and begun to make plans to initiate the administration of this third dose over 16 years of age with an eye on. September 20.
In a statement, the CEO of Pfizer, Albert Bourla, said that "the reinforcements of the vaccine have an important role to play to address the continuous threat of this disease," and considered the FDA's decision as a "crucial milestone" In the fight against Covid-19.
Pfizer's is the only vaccine that has total approval for use by the FDA, since those of modern and Johnson & Johnson have only emergency authorization.Date Of Update: 23 September 2021, 05:26