Pfizer & BioNTech Apply for FDA Authorization of COVID-19 Vaccine

A new important step was made this Friday toward approval for a coronavirus vaccine.

Pfizer and its German partner BioNtech said this Friday they are asking health authorities in the U.S. for an emergency approval for their COVID-19 vaccine.

It’s unclear how long the FDA (Food and Drug Administration) would take to decide if the two-shot vaccine is safe enough to be authorized for use, but it’s expected to take a few weeks.

The companies announced this week that their vaccine is 95% effective and effective in people over 65 years old, a group more susceptible to the coronavirus who suffer a higher mortality rate.

The vaccine’s Phase 3 clinical trial, the final step in the trial process, has included almost 44,000 participants.

If approved, the vaccine will probably be used first to immunize health care workers, older adults, and those who have underlying health conditions.

Pfizer and BioNTech are the first pharmaceutical companies to apply for regulatory approval of a coronavirus vaccine. 

Both shares were rising on Friday. By 2 pm ET, Pfizer was up 1.6% and BioNTech about 10%.

If approved, the two-shot vaccine will be the fastest developed in history, taking just ten months. The average is ten years in the U.S.

It will also be the first to use a new technology, called mRNA. Instead of using a weakened form of the virus, it uses a mechanism that triggers the immune system to produce protective antibodies.

According to the Financial Times, full submission to the European Medicines Agency, which was also expected this week, has been postponed because the EU regulator has asked for more trial data than the FDA.

Pfizer and BioNTech said they have the capacity to produce 1.35 billion doses of their vaccine by the end of 2021, including 50 million doses by the end of this year. The vast majority of those doses have been reserved by the U.S., European Union, United Kingdom, and Japan. 

They also said they would be able to distribute the vaccine just hours after getting approval from the FDA.

“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.

The American biotech company Moderna is also expected to soon file a request with the FDA for an emergency approval for its vaccine. Moderna’s vaccine also uses mRNA technology.