COVID-19 vaccine: Pfizer 'very close' to emergency use authorisation

Pfizer is "very close" to applying for an emergency use authorisation for its COVID-19 vaccine, having collected the safety data necessary to submit an application to the US Food and Drug Administration, CEO Albert Bourla said on November 17.

Bourla, during a virtual summit conducted by medical news site STAT, said: "We are very close to submitting for an emergency use authorisation." However, he didn't disclose whether the filing would be made this week. "Let us not create expectations," he said in conversation with STAT's Matthew Herper. "We will announce it as soon as we are doing it."

The FDA requires manufacturers to follow at least half of the people who received vaccines in their Phase 3 clinical trials for two months, to ensure there is at least that amount of safety data before a vaccine is considered for use.

Pfizer announced last week along with its partner BioNTech SE that its vaccine has an efficacy rate of more than 90 per cent in preventing symptomatic cases of COVID-19. Pfizer, which is producing a messenger RNA, or mRNA, vaccine, was the first to announce preliminary results from its Phase 3 trial.  

Pfizer's announcement was followed this week by word from Moderna that its vaccine, also an mRNA vaccine, had been shown to be highly protective with an efficacy rate of 94.5 percent. Bourla said he was relieved to see that another vaccine was also successful and hoped there were many more, because the global need for Covid vaccines exceeds the production capacity of any single company.

Pfizer's vaccine is expected to be the first COVID-19 vaccine cleared for use in the US. If all goes according to plan, vaccinations could begin sometime in December. It's expected the company will be able to supply the US with enough vaccines in 2020 to vaccinate 20 million people.

Also read: What makes a good COVID-19 vaccine? Serum Institute's Adar Poonawalla explains