As the Delta variant strikes the country, the US Food and Drug Administration (FDA) completely authorized Pfizer Covid-19 vaccine on Monday, triggering a fresh wave of vaccine obligations.
In a statement, acting FDA Commissioner Janet Woodcock said, “The FDA’s approval of this vaccination is a milestone as we continue to tackle the Covid-19 pandemic.”
“While millions of people have already received Covid-19 vaccinations successfully, we understand that the FDA approval of a vaccine may give some people more confidence to get vaccinated.”
The first vaccine to obtain full approval is the Covid vaccine, which can now be marketed under the brand name Comirnaty.
Comirnaty is apparently supposed to be a portmanteau of several words — community, immunity, COVID-19, and mRNA — Fierce Pharma writes.
After FDA approves Pfizer vaccine, several steps remain before kids under 12 can be vaccinated
Under an emergency use authorization (EUA) obtained on December 11, 2020, tens of millions of vaccinations have already been administered.
The decision to give it approval was based on new data from the drug’s clinical study, which included a longer period of follow-up and tested the drug’s safety and effectiveness in almost 40,000 people.
The vaccination will be mandated by the US military as soon as it achieves complete certification, and a plethora of private businesses and universities are anticipated to follow suit.
The vaccine is still available to children aged 12 to 15, but now that it has been completely licenced, doctors may prescribe it to youngsters under the age of 12 if they consider it will be beneficial.