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Pfizer approaches USFDA to secure emergency use authorisation for COVID vaccine

Pfizer that its EUA submission is supported by solicited safety data from a randomised subset of approximately 8,000 participants aged 18 years or above and unsolicited safety data from approximately 38,000 trial participants

twitter-logoBusinessToday.In | November 21, 2020 | Updated 01:34 IST
Pfizer approaches USFDA to secure emergency use authorisation for COVID vaccine

Pharmaceutical major Pfizer has approached the US health regulator to secure emergency use authorisation for its experimental coronavirus vaccine. The company stated on Friday that the authorisation would enable the use of its vaccine in high-risk populations of the United States by the middle or end of December this year.

Pfizer has been working with German biotech company BioNTech on an mRNA vaccine candidate, BNT162b2, for novel coronavirus. The companies have submitted a request for emergency use authorisation (EUA) to the US Food and Drug Administration (USFDA) for the same. On Wednesday, they had released final efficacy data for their jab that showed 95 per cent effectiveness against the virus at the end of Phase 3 clinical trials.

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"The submission is based on a vaccine efficacy rate of 95 per cent demonstrated in the companies' Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose," Pfizer said.

The pharma major further added that its EUA submission is supported by solicited safety data from a randomised subset of approximately 8,000 participants aged 18 years or above and unsolicited safety data from approximately 38,000 trial participants. At the end of its human trials earlier this week, Pfizer had claimed that its COVID-19 vaccine candidate meets the efficacy and safety prerequisites mandated by the USFDA.

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"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," said Pfizer Chairman and CEO Albert Bourla.

Bourla further added that his company would continue to work with regulatory authorities worldwide to secure authorisation for its COVID-19 vaccine candidate as quickly as possible. Pfizer and BioNTech have already initiated filing submissions with several regulatory agencies around the world to begin distribution and use of its COVID-19 jab.

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If authorised, Pfizer-BioNTech's BNT162b2 would be the second vaccine against coronavirus to be rolled out after Russia's Sputnik-V. With 95 per cent vaccine efficacy, it would also be the most effective out of the three most advanced vaccines. While Moderna's m-1273 has claimed 94.5 per cent effectiveness, Russian Sputnik-V has shown 92 per cent efficacy, as per claims by their respective developers.

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