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The Food and Drug Administration on Friday authorized the first emergency use authorization for a COVID-19 vaccine. The hurdle allows the Pfizer-BioNTech COVID-19 vaccine to be distributed in the United States, the federal agency said in a statement.
The authorization allows the vaccine to be given to anyone age 16 and older. The Bay Area, including Alameda and Contra Costa counties, could start receiving doses of the vaccine as soon as Monday or Tuesday.
FDA Commissioner Dr. Stephen M. Hahn hailed the vaccine’s authorization as the beginning to control the deadly virus.
“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. Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide,” he said in the statement.
The totality of the available data provides clear evidence that the Pfizer-BioNTech COVID-19 vaccine may be effective in preventing COVID-19, the agency said in its statement.
“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. 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.”
How it works
The vaccine contains a small piece of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus’ messenger RNA (mRNA), which is a piece of genetic material that instructs cells in the body to make the virus’ distinctive “spike” protein. The body of a person who receives the vaccine produces copies of the spike protein, which triggers the immune system to react defensively and produce an immune response against SARS-CoV-2, the virus that causes COVID-19 disease. Pfizer’s vaccine showed a 95% efficacy against the virus. Pfizer BioNTech COVID-19 vaccine is administered as a series of two doses, three weeks apart.
The FDA noted there isn’t data to determine how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of the virus from person to person.
The emergency authorization is not a final approval of the vaccine, but it allows its distribution in the U.S. because of the dire emergency health crisis caused by the coronavirus. Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the statement that “the vaccine’s known and potential benefits clearly outweigh its known and potential risks. … Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process.”
Drug trials enrolled 37,586 participants in a randomized, placebo-controlled international study, the majority of whom are U.S. participants. A total of 18,801 participants received the vaccine and 18,785 received a saline placebo. Researchers followed them 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.
“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,” the FDA noted.
The researchers analyzed 36,523 participants in the international study who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Among these participants, 18,198 received the vaccine and the rest received a placebo. The vaccine was 95% effective in preventing COVID-19. Only eight participants developed COVID-19 in the vaccine group compared to 162 in the placebo group. Of these 170 cases, one in the vaccine group and three in the placebo group were classified as severe.
Find comprehensive coverage on the Midpeninsula’s response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.
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