Written by 6:34 PM News

Pfizer, BioNTech plan emergency move to use Covid-19 vaccine in December

Earlier this week, Pfizer Inc. and BioNTech SE had confirmed that its vaccine candidate is 95 per cent effective at preventing COVID.

The filing with the Food and Drug Administration could permit the vaccine to be administered to high-risk populations in the US either by the middle or the end of December, the companies said in a statemen

In a respite to a pandemic-hit world, the US drugmaker and its German partner had confirmed earlier this week that a final analysis of clinical trial data showed the shot was 95% effective at preventing the disease.

The filing with the Food and Drug Administration could permit the vaccine to be administered to high-risk populations in the US by the middle to the end of December, the companies said in a statement.

In their application, Pfizer Inc. and BioNTech SE have also included safety data on about 100 children 12-15 years of age. The company said 45 per cent of US trial participants are 56-85 years old.

Pfizer Chief Executive Officer Albert Bourla has said that this move by the drugmakers marks a critical milestone.

The submission is based on a vaccine efficacy rate of 95% (p<0.0001) 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. The first primary objective analysis was based on 170 confirmed cases of COVID-19. This submission also is supported by solicited safety data from a randomized subset of approximately 8,000 participants ≥18 years of age and unsolicited safety data from approximately 38,000 trial participants who have been followed for a median of two months following the second dose of the vaccine candidate. The submission also includes solicited safety data on approximately 100 children 12-15 years of age. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age. To date, the Data Monitoring Committee (DMC) for the study has not reported any serious safety concerns related to the vaccine.

“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 Dr. Albert Bourla, Pfizer Chairman and CEO. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”

“Filing for Emergency Use Authorization in the U.S. is a critical step in making our vaccine candidate available to the global population as quickly as possible,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We intend to continue to work with regulatory agencies worldwide to enable the rapid distribution of our vaccine globally. As a company located in Germany in the heart of Europe, our interactions with the European Medicines Agency (EMA) are of particular importance to us and we have continuously provided data to them as part of our rolling review process.”

The companieshave already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, and intend to submit applications to other regulatory agencies worldwide in the coming days. In some cases, governments may have regulatory pathways similar to an EUA. The companies will be ready to distribute the vaccine candidate within hours after authorization.

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic.

The BNT162b2 vaccine candidate is not currently approved for distribution anywhere in the world. Both collaborators are committed to developing this novel vaccine with preclinical and clinical data at the forefront of all their decision making.

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