Washington, November 9: Pharmaceutical giant Pfizer, which is developing a COVID-19 vaccine in coordination with German drugmaker BioNtech, announced on Monday that it achieved 90 percent efficacy in the third phase of trials. With this success rate, the company is expected to clear the remaining decks by November-end before filing for emergency use approval. COVID-19 Vaccine Race to Intensify in January 2021, Says Skoltech Expert.

Efficacy in the majority of participants, safety data and consistent manufacturing are the three requirements that are needed before we are able to file for Emergency Use Authorisation, as the per the guidelines set by the US Food and Drug Administration (FDA).

"We are proud to announce, along with BioNTech Group, that our mRNA-based vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection," Pfizer said in a statement.

Pfizer Announces Success in Phase 3 Trials

In phase 3 of the trials, analysis evaluated 94 confirmed cases of COVID-19 in trial participants. Study enrolled 43,538 participants, with 42 percent having diverse backgrounds, and no serious safety concerns have been observed. The safety and additional efficacy data would continue to be collected.

"Submission for Emergency Use Authorization (EUA) to the US FDA is planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November," added the statement issued by Pfizer.

Clinical trial, the company said, will continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints.

(The above story first appeared on LatestLY on Nov 09, 2020 05:48 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).