Science

Pfizer to seek USFDA nod for ‘emergency use’

Our Bureau Mumbai | Updated on November 19, 2020 Published on November 18, 2020

Efficacy consistent across age, gender, race and ethnicity

Reporting an efficacy rate of 95 per cent, pharma giant Pfizer and its German collaborator, BioNTech, expect to submit data on their mRNA Covid-19 vaccine candidate to the US regulator for an Emergency Use Authorisation (EUA), the companies said.

Giving an update, they said that a final efficacy analysis from ongoing advanced trials on the vaccine candidate had met all the study’s primary endpoints and indicated an efficacy rate of 95 per cent.

 

“The safety milestone required by the US Food and Drug Administration (FDA) for 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,” they said, adding that the data would also be submitted to other international regulatory agencies.

“Analysis of the data indicates a vaccine efficacy rate of 95 per cent 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,” the note said.

Another positive feature was that the 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,” they said. And till date, the Data Monitoring Committee for the study had not reported any serious safety concerns related to the vaccine, the companies said.

“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Albert Bourla, Pfizer Chairman and Chief Executive. The companies expect to have up to 50 million doses by 2020 and 1.3 billion doses by end 2021. Four of Pfizer’s facilities are part of the manufacturing and supply chain. BioNTech’s German sites would also be leveraged for global supplies.

Storage confidence

A downside for the vaccine was its storage requirement of – (minus) 70 degrees C. But Pfizer was confident of its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world. “The companies have developed specially designed, temperature-controlled thermal shippers utilizing dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network,” it said

Trial details

The trials were done at 150 clinical trials sites in the US, Germany, Turkey, South Africa, Brazil and Argentina.

The Phase-3 clinical trial began on July 27, enrolling 43,661 participants till date. Approximately 42 per cent of global participants and 30 per cent of US participants have racially and ethnically diverse backgrounds, and 41 per cent of global and 45 per cent of US participants are 56-85 years of age, the note said.

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Published on November 18, 2020
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