Friday, December 11, 2020. New York City – Today, Friday, December 11, 2020, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States of America. This is the first vaccine approved in the U.S.
The FDA said in a press release, “At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.“
“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.
“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.
According to The Guardian, the White House chief of staff, Mark Meadows, told Stephen M. Hahn, head of the US Food and Drug Administration to authorize Pfizer’s coronavirus vaccine on Friday or prepare to resign. “This is an untrue representation of the phone call with the chief of staff,” Hahn said in a statement.
“Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA 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 FDA said.
Alex Azar, the U.S. secretary of health and human services, said on Friday, “We could see people getting vaccinated Monday, Tuesday of next week.”
New York state governor, Andrew Cuomo, said on Friday, December 11, “346,000 doses of the Moderna vaccine are expected to be delivered to New York State the week of December 21, in addition to the 170,000 Pfizer doses coming this weekend.”
At the press conference on Friday, December 11, Mexican President Andrés Manuel López Obrador said that the vaccine will be free for everyone in Mexico.
Mexico was the fifth country in the world to issue the first emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine after the United Kingdom, Bahrain, Canada and Saudi Arabia, and is the first in Latin America. The United States of America was the sixth country to issue the first emergency use authorization for the same Pfizer-BioNTech COVID-19 vaccine.
Common Side Effects
According to the FDA, “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.”
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