(BIVN) – The first COVID-19 vaccine has been given emergency use authorization in the United States.
On Friday, the U.S. Food and Drug Administration decided to allow the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
“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, M.D. in a news release. “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 timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
From the FDA:
The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. 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. 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 (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. 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 SARS-CoV-2.
“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 Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
President Donald Trump announced that “today our Nation has achieved a medical miracle,” calling the FDA authorization “one of the greatest scientific accomplishments in history.”
“Today is a day of great hope and promise,” said U.S. Senator Brian Schatz (D-Hawai‘i). “The emergency use authorization of the first vaccine to prevent COVID-19 means that our frontline health care workers and vulnerable populations in Hawai‘i and across the country will start receiving the vaccine within days. There is light at the end of the tunnel. We can get through this as a community, if we stay safe, keep our distance, and keep our masks on.”
“Today’s announcement is a long-awaited milestone in our nation’s fight against COVID-19, and I commend the many people in government and the private sector whose dedication, professionalism, and ingenuity made this achievement possible,” said U.S. Senator Mazie K. Hirono (D-Hawaii). “While we celebrate the authorization of the first coronavirus vaccine, we cannot ignore the immense, ongoing human toll of this pandemic – which has already claimed nearly 300,000 lives and is currently surging across the country. The authorization of this vaccine alone will not end the pandemic, and all of us must continue doing our part – by wearing a mask, washing our hands, and practicing social distancing.”
“We expect the first doses of this vaccine to be distributed in the coming days, beginning with frontline health care workers and our kupuna living in elder care facilities,” Sen. Hirono added. “I plan to get vaccinated on a timeline determined by the State of Hawaii and based on the recommendations from the Centers for Disease Control and Prevention to ensure equitable distribution. I encourage every Hawaii resident and American to do the same.”