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November 20, 2020

Pfizer requests emergency use authorization for its COVID-19 vaccine

The drugmaker is the first of several companies developing coronavirus shots to submit an application to the FDA

Prevention Vaccines
Pfizer Vaccine FDA Charles Guerin/Abaca/Sipa USA

Pfizer's COVID-19 vaccine showed it was 95% effective and had no serious safety issues during a late-stage clinical trial.

A long-awaited COVID-19 vaccine could be reaching millions of Americans next month.

Pfizer announced Friday that it is submitting an application for an emergency use authorization to the U.S. Food and Drug Administration for its experimental COVID-19 vaccine. It is the first of several companies developing vaccines to do so. 

Pfizer expects to distribute up to 50 million doses globally in 2020 and another 1.3 billion doses in 2021, It will be ready to deploy the vaccines within hours of authorization. In the U.S., initial supplies are set to go to high-risk populations, including health care workers. 

The vaccine, called BNT162b2, demonstrated an efficacy rate of 95% with no serious safety concerns during a phase 3 trial. Pfizer developed the vaccine with BioNTech, a German biotechnology company. 

The FDA process likely will take several weeks. An advisory committee is tentatively slated to meet Dec. 8-10 to discuss COVID-19 vaccines, according to CNBC. The committee will offer its opinions before the FDA makes a decision. 

The filing comes as coronavirus cases have surged to record levels across the country. Many cities and states are implementing stricter guidelines to mitigate the spread of the virus during the holiday season. The U.S. Centers for Disease Control and Prevention is advising people to limit Thanksgiving celebrations to their household. 

Moderna also is expected expected to file for an emergency use authorization for its COVID-19 vaccine by the end of the year. Early data from its phase 3 trial indicates its vaccine has a 94.5% efficacy rating. 

Johnson & Johnson and AstraZeneca also have vaccines in late-stage trials. 

"Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential," Pfizer CEO Dr. Albert Bourla said in a statement. "We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible."

The vaccine must be kept at -94 degrees Fahrenheit before use, a requirement that has prompted concerns about storage capabilities. Once a vaccine is thawed, it can be stored for up to five days in refrigerated conditions, approximately 35-46 degrees Fahrenheit. 

Pfizer said it created distribution hubs that can store doses for up to six months and temperature controlled shippers that can track the location and temperature of each vaccine shipment.

Pfizer said it will immediately submit applications to other regulatory agencies around the world, including those in Australia, Canada, Europe, Japan and the United Kingdom. 


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