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Pfizer to approach USFDA 'within days' for quick approval of COVID-19 vaccine

Pfizer and BioNTech informed that primary efficacy analysis of their coronavirus vaccine candidate showed that it was 95 per cent effective beginning 28 days after the first dose

twitter-logoBusinessToday.In | November 18, 2020 | Updated 21:58 IST
Pfizer to approach USFDA 'within days' for quick approval of COVID-19 vaccine

After claiming that its experimental vaccine is 95 per cent effective in preventing novel coronavirus, US pharmaceutical major Pfizer and German biotechnology company BioNTech are now planning to file for emergency use authorisation (EUA) with US Food and Drug Administration (USFDA). Pfizer claimed that it has also met the safety standards of USFDA and will soon approach the regulator for authorisation. The companies have closed phase 3 trials and will also approach regulators across the world for authorising their COVID-19 vaccine candidate. With the highest efficacy data out the three most advanced vaccine candidates so far, Pfizer is likely to have an edge.

"The companies announced that the safety milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved. Pfizer and BioNTech plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine. These data also will be submitted to other regulatory agencies around the world," the company said.

The Pfizer-BioNTech vaccine candidate, BNT162b2, had shown 90 per cent efficacy in interim tests. On Wednesday, the companies informed that primary efficacy analysis of the coronavirus vaccine showed that it was 95 per cent effective beginning 28 days after the first dose. This analysis encompassed 170 confirmed cases of COVID-19, with 162 observed in the placebo group and 8 in the vaccine group.

ALSO READ: Game of one-upmanship! Pfizer now says vaccine efficacy 95% - not 90%

Pfizer has claimed that vaccine efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94 per cent, it further added. The company further assured that the vaccine was safe and did not generate any adverse effects shortly after vaccination.

"The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8 per cent and headache at 2 per cent following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination," Pfizer said.

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, as revealed by Pfizer. Out of them, 41,135 volunteers have received a second dose of the vaccine candidate as of November 13, 2020.

Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021. Four of Pfizer's facilities are part of the manufacturing and supply chain; St. Louis, Missouri; Andover, Massachusetts; and Kalamazoo, Michigan in the US; and Puurs in Belgium. BioNTech's German sites will also be leveraged for global supply.

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

COVID-19 vaccine candidates show promise

The efficacy results for Pfizer-BioNTech vaccine candidate came out a day after another US-based Moderna announced that interim analysis data showing 94.5 per cent efficacy for its COVID-19 vaccine. Notably, Pfizer and BioNTech, and Moderna and Russia's Sputnik V are the only vaccines that have claimed over 90 per cent efficacy of their respective candidates so far. While Russia had already rolled out the Sputnik V for the masses in August, the recently announced data results on the efficacy of Moderna, and Pfizer and BioNTech's vaccine raise high hopes.

Moderna says its COVID-19 vaccine candidate remains stable for 30 days at 2-degree Celsius to 8-degree Celsius, the temperature of a standard home or medical refrigerator. The company is also planning to apply for EUA; it has said that it will submit final efficacy data in days to come.

However, these broad and early efficacy figures may not tell the whole story. The data results are based on a relatively smaller group of participants (170 in case of Pfizer). Moderna's vaccine was analysed based on results of 95 patients, while Sputnik V's efficacy was observed by analysing just 20 participants. Nonetheless, those numbers raised hopes around the world that vaccines could help put an end to the pandemic soon. The efficacy numbers will, however, change as the vaccine trials advance.

ALSO READ: Pfizer CEO 'thrilled' about Moderna's COVID-19 vaccine candidate results

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