Pfizer submits Emergency Use Authorization request to FDA for its COVID-19 vaccine

Pfizer submits Emergency Use Authorization request to FDA for its COVID-19 vaccine
Posted at 6:53 AM, Nov 20, 2020

Pfizer announced Friday that it would submit a request to the FDA Friday for its COVID-19 vaccine to be granted Emergency Use Authorization.

Earlier this week, Pfizer said that a final analysis of trial results showed the vaccine is 95% effective.

“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally. 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,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a press release.

Pfizer's two-shot vaccine has already been in mass production for months, and thousands of doses will be ready for delivery if and when the FDA grants authorization. Pfizer says that is on track to produce 50 million doses of the vaccine by the end of 2020 and plans to produce 1.3 billion doses of the vaccine in 2021.

According to "Operation Warp Speed," the federal government's plan for distributing the vaccine, upon authorization, the drug will initially be rationed for high-risk populations and health care workers. Dr. Anthony Fauci, the nation's top infectious disease expert, says he believes a vaccine won't be widely available until April.

On Wednesday, Pfizer announced that a final analysis of its vaccine candidate showed that of 40,000 participants who participated in the trial, 170 people had contracted the virus. Of those 170 people, 162 received only a placebo injection — meaning just eight out of the 20,000 people who actually received the vaccine contracted the virus.

The company added Wednesday that there have been no safety concerns with the vaccine. In a randomized survey of 8,000 participants, only 2% reported suffering severe fatigue, and only 4% reported suffering severe headaches. Those who say they suffered side effects only experienced them briefly after vaccination.

Pfizer's announcement comes as COVID-19 cases are spiking around the world. In the U.S. alone, about 2.5 million people have contracted the virus in the month of November alone. Hospitalizations linked to COVID-19 are at an all-time high, and deaths have begun to tick up in recent weeks.