The Food and Drug Administration (Fda) has given full and final approval to the Pfizer’s Covid vaccine, previously used thanks to an emergency authorization.
The vaccine, which can now be marketed under the brand Comirnaty, is the first to receive full approval, after the emergency one obtained on 11 December 2020.
Pfizer vaccine against Covid approved by the FDA
“The approval of this vaccine by the Fda it is a milestone as we continue to fight the pandemic, ”said Acting Commissioner of the Food and Drug Administration Janet Woodcock.
“While millions of people have already safely received vaccines against Covid-19, we recognize that for some FDA approval can now instill further confidence to get vaccinated, ”he continued.
The decision to give a definitive green light is based on updated data from clinical trials, including longer-lasting follow-ups, with safety and efficacy evaluated in over 40,000 people. The Pfizer vaccine remains available for emergency use for children ages 12 to 15.
Pfizer vaccine, Crisanti: “Definitive ok opens the door to obligation”
The final approval of the Pfizer vaccine by the FDA, which previously had instead guaranteed an emergency authorization, “opens the door to legal provisions that can lead to the obligation of vaccination”. He told SkyTg24 Andrea Crisanti, professor of microbiology at the University of Padua, who also initially stalled on anti Covid vaccines.
“They are extremely safe vaccines – explained Crisanti – there is no longer this formal alibi that was used. From a legal point of view it becomes an approved vaccine, which opens the door to legal provisions that can lead to the obligation of vaccination ”.
According to the expert, formal approval will also remove alibi ai no vax: no vax: “I think it is an approval that eliminates a whole series of ambiguities, which were born: I have heard many times people saying that they did not vaccinate because this vaccine was authorized in an emergency, and they did not take into account the fact that after four billion of doses administered in an emergency, ‘authorized’, in fact, was a term that would quickly be updated with approval – he stressed Chrysants -. Those who did not vaccinate, because it was an authorized emergency vaccine, no longer have this alibi: from the point of view of people’s fear, these are vaccines that have been administered in four billion doses, and have minimal side effects and reversible “.