The U.S. Food and Drug Administration on Friday gave emergency approval to the nation’s first COVID-19 vaccination, giving hope that an end to the pandemic is near.
The first doses will be going to health-care workers and nursing home residents in coming days, the Associated Press reports.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn in a statement. “The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
The FDA has determined that Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria for emergency use, the agency said Friday night.
“The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals,” the FDA said.
“In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.”
The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA, a genetic material, along with a small piece of the SARS-CoV-2 virus’s messenger RNA that instructs cells in the body to make the virus’s distinctive “spike” protein, the FDA said.
When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against COVID-19.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Pfizer BioNTech COVID-19 vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the emergency-use authorization include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants.
These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever.
Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.
