US to distribute Pfizer COVID vaccines early December after candidate shows 90% efficacy

On November 10, Pfizer Inc announced that its mRNA-based COVID-19 vaccine candidate which was found 90 percent effective in the first interim analysis from Phase III study, will be distributed in December across the US, Pfizer confirmed in a press release. Developed with the German partner BioNTech SE, Pfizer’s COVID-19 vaccine was declared effective against SARS-CoV-2 by the independent Data Monitoring Committee (DMC) in an analysis conducted on November 8, 2020. US’ top infectious diseases expert, Dr. Anthony Fauci, meanwhile, said at a presser that the first doses of a safe and effective vaccine will be available for high-risk Americans in late December. 

“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen,” he added.

Bourla said that Pfizer was now closer to the much-needed breakthrough to help end the devastating global health crisis. The company would share the safety data generated in weeks ahead. “After discussion with the FDA, the companies elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases,” Pfizer informed in the release. It added that with the administration of its COVID-19 experimental vaccine, the evaluable case count reached 94 and the DMC performed its first analysis.

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“The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose,” Pfizer revealed.

Final stages of accumulating safety data

Meanwhile, BioNTech co-founder and CEO Prof. Ugur Sahin said in the release that the vaccine’s interim analysis in its Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. “This is a victory for innovation, science and a global collaborative effort,” he said. Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci said in a live-streamed chat with Dr. Francis Collins, director of the National Institutes of Health that the vaccine front runners, such as Pfizer and Moderna are expected to file for Emergency Use Authorization (EUA) for the COVID-19 vaccines based on safety data in late November. Pfizer and BioNTech are in the final stages of accumulating safety data, and as per estimate, a median of two months of safety data following the second and final dose of the vaccine candidate – the amount of safety data specified by the FDA will be submitted by the end of this month.

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