Pfizer-BioNTech's Covid-19 vaccine may get full approval in US next week
Pfizer-BioNTech's two-dose vaccine against the coronavirus disease (Covid-19) is poised for full approval by the United States Food and Drug Administration (FDA) early next week, which will expedite an earlier timeline for licensing the shot, Bloomberg reported on Saturday. The development comes amid the Joe Biden administration's efforts to woo more Americans to get the Covid-19 vaccine, the agency added.
The Pfizer-BioNTech Covid-19 vaccine, sold under the brand name Comirnaty, is expected to get full approval from the US FDA by Monday or Tuesday, reported Bloomberg, citing an official familiar with the agency's planning but speaking on the condition of anonymity. The vaccine is currently being administered in the US on an emergency use approval (EUA) license.
The Pfizer-BioNTech vaccine, developed by the German biotechnology company BioNTech in collaboration with the American pharma giant Pfizer, is a nucleoside-modified mRNA (modRNA)-based shot encoding a mutated form of the full-length spike protein of the SARS-CoV-2 virus encapsulated in lipid nanoparticles. The interval between two doses of the intramuscular injection was initially 21 days but was later extended up to 42 days in the US and up to four months in Canada.
According to the New York Times, drug regulators in the US were aimed to finish the approval process for the Pfizer-BioNTech vaccine by Friday but were bogged down with paperwork and negotiation with the company. The news organisation reported that the approval is now expected to come on Monday, but may slide well beyond that date in case a few components of the review need more time.
If the Pfizer-BioNTech vaccine is approved in the US, it is likely to generate interest to take the shot among Americans who were earlier hesitant to take a vaccine that was authorised only for emergency use. Moreover, health authorities also expect that the vaccine's full approval will also make local officials more comfortable in implementing vaccine mandates.