August 24, 2021
The COVID-19 vaccine from Pfizer and partner BioNTech received full approval from U.S. regulators on Monday, August 23, which many public health officials and vaccine experts hope will encourage hesitant populations to get the shot, reports The Wall Street Journal.
The Food and Drug Administration’s clearance of the shot for people 16 years and older is the agency’s first full approval of a COVID-19 vaccine. The decision was expected this week, the Journal and other news outlets reported.
The vaccine was first cleared in December by the FDA on an emergency-use basis for people 16 years and older after the drugmakers showed it to be highly effective at preventing symptomatic COVID-19. The two-dose shot, resulting from the fastest vaccine development ever in the West, has since become the most-received COVID-19 vaccine in the United States.
The vaccine was authorized for children as young as 12 years in May. Pfizer plans to request full approval for that group once it has collected and analyzed six months of safety data from clinical-trial subjects, according to the company.
Pfizer—which will market the vaccine under the name Comirnaty—is now permitted to market the vaccine to doctors, providers, and the general public, as it does with other approved products. The FDA is permitted to restrict such communications with emergency authorization.
The vaccine is also eligible for off-label prescriptions, which could include booster doses, according to the FDA.
The FDA, under pressure to give COVID-19 vaccines full approval swiftly, made its decision less than four months after Pfizer began its approval submission. The process of reviewing applications normally takes up to approximately ten months.
The FDA said its review found the vaccine to be safe and effective in preventing COVID-19 as well as severe disease, hospitalization, and death. The most common side effects by clinical trial participants who received the vaccine included fatigue, headache, joint pain, chills and fever.
“We have not lost sight that the COVID-19 public health crisis continues in the U.S.A. and that the public is counting on safe and effective vaccines,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the United States.”
The approval comes as U.S. hospitals are seeing a surge in cases tied to the contagious Delta variant, and as the government weighs when vaccinated adults should receive additional doses (the consensus: eight months after the second shot).
Pfizer already has submitted data to the FDA showing that a third dose of its vaccine boosts the immune system against the original virus and against the Beta and Delta variants to higher levels than the standard two-dose regimen. Pfizer plans to submit a request for booster authorization as an amendment to the full approval.
Of the three authorized vaccines in the United States, only Pfizer had submitted all the required information to the FDA, according to the companies, and analysts expected it to be the first to receive clearance.
Moderna, whose authorized two-dose shot uses similar mRNA technology as the Pfizer-BioNTech vaccine, has said it is still completing rolling data submissions. Johnson & Johnsonwhose shot was authorized in February, has said it plans to file for full approval later this year.
Research contact: @WSJ