The Food and Drug Administration determined in an extensive analysis of the first-ever COVID-19 vaccine candidate for U.S. distribution has officially "met the prescribed success criteria" in a clinical study, according to an initial report from The Wall Street Journal — which means the agency is closer now than ever to green-lighting the world-historic product.
FDA said Pfizer/BioNTech Vaccine 'met success criteria'
The agency released two different analyses on Tuesday — one from its staff scientists and another from the manufacturers of the vaccine, Pfizer Inc. and its German partner BioNTech SE.
The new FDA analysis emphasized several "known benefits" from the vaccine — including "reduction in risk of confirmed COVID-19 occurring at least seven days after Dose 2." Notably, Pfizer's vaccine needs two doses for full immunization to COVID-19 in humans.
UPDATE Dec. 8, 9:50 AM EST: COVID-19 vaccine could gain FDA Emergency Use Authorization this weekend
The FDA also noted another benefit of the Pfizer/BioNTech vaccine — namely, the reduction in the risk of confirmed COVID-19 cases after the first dose and before the second dose. An additional clear yet significant benefit, added the agency, was "reduction in the risk of confirmed severe COVID-19 any time after dose 1."
On Thursday, a group of independent experts will review both analyses and advise the agency whether Emergency Use Authorization (EUA) is warranted, reports the National Review. If the panel sides with approval, the FDA may reportedly authorize the vaccine as early as this weekend.
This comes on the heels of the Pfizer/BioNTech achieving a 95% effectiveness rating for preventing symptoms of COVID-19. The U.K. has already begun administering the vaccine at 50 hospital hubs and nursing homes, as of Tuesday. The pandemic has taken 284,000 lives in the U.S., according to The New York Times — with 1.54 million dead worldwide. Suffice to say the COVID-19 vaccine can't come soon enough.
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