FDA issues emergency use authorization for first U.S. coronavirus vaccine
The first Emergency Use Authorization (EUA) was issued to the coronavirus vaccine of American drugmaker Pfizer in partnership with German company BioNTech, allowing the vaccine to be distributed in the United States.
The FDA has determined that Pfizer-BioNTech coronavirus vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech coronavirus vaccine may be effective in preventing coronavirus, said the FDA in a statement.
The data also show 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, said the FDA.
"The FDA's authorization for emergency use of the first coronavirus 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 Hahn.
"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," he said in a statement.
The Pfizer-BioNTech 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.
The vaccine is administered as a series of two doses, three weeks apart.
Global coronavirus cases surpassed 70 million on Friday, according to the Center for Systems Science and Engineering at Johns Hopkins University. The United States reported the most cases and deaths around the world as of 4:28 p.m. local time (2128 GMT), numbering 15,758,661 and 293,785, respectively. ■