US: Pfizer-BioNTech COVID-19 vaccine officially granted full approval by FDA
The Pfizer-BioNTech COVID-19 vaccine has finally received full approval from the US Food and Drug Administration (FDA) on Monday for use in people aged 16 and above in the country. Notably, the American drug regulator's move makes the Pfizer-BioNTech shot the world's first COVID-19 vaccine to move from the emergency use authorization (EUA) phase to the fully approved stage. Here are more details.
The American regulator's move is expected to trigger a fresh wave of vaccine mandates as the highly infectious Delta variant of COVID-19 wreaks havoc in the country. Health authorities believe the full approval would also help local authorities implement vaccine mandates easily. So, it is likely to increase the vaccine requirements by healthcare facilities, several state/local governments, government organizations, educational institutions, private businesses, etc.
The Pfizer-BioNTech vaccine's full approval comes as President Joe Biden's administration is intensifying efforts to inoculate more Americans. The FDA's final seal of approval is expected to persuade more people to take the shot as many were hesitant to receive EUA-approved vaccines. Kaiser Family Foundation's recent survey found 30% of unvaccinated people are more likely to take fully-approved vaccines than those cleared for EUA.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," said Janet Woodcock, the acting Commissioner of the FDA, in a statement. "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," she added.
To recall, the two-dose Pfizer-BioNTech COVID-19 vaccine was approved in the US on a EUA license in December. Later, Pfizer-BioNTech applied for full approval from the FDA on May 7. Now, the American regulator's full approval came after Pfizer submitted more data from its late-stage trials as well as ongoing vaccinations. Data from 44,000 clinical trial participants were presented to the FDA, said Pfizer.
According to Pfizer, the latest data from the 44,000 trial participants showed the Pfizer-BioNTech shot has a 91% efficacy rate in preventing the COVID-19 infection—this is slightly less than the 95% efficacy rate the data had shown in December when the FDA granted the EUA.
The Pfizer-BioTech vaccine—sold under the Comirnaty brand name—has been developed on a nucleoside-modified mRNA platform to deliver a mutated form of SARS-CoV-2's spike protein through lipid nanoparticles. It has been developed by American pharmaceutical company, Pfizer, and German biotechnology company, BioNTech. Initially, the gap between its two doses was 21 days, but it was later increased to up to 42 days in the US.
Previously, it was reported that after receiving full approval, Pfizer-BioNTech would request the FDA to clear the third dose of its vaccine as a booster shot. Pfizer would complete submitting the requisite data this week to show a third dose is safe and effective. The Biden administration earlier said fully-vaccinated adults should receive booster shots eight months after their second dose, starting September 20.