A COVID vaccine developed by Pfizer — awaiting FDA approval — requires two separate shots, 21 days apart. If the vaccine is approved, Gen. Gus Perna and his team at Operation Warp Speed are planning to deliver it to 300 million Americans. https://t.co/XfCLlSAUfS pic.twitter.com/voLWfxs9yw— 60 Minutes (@60Minutes) November 9, 2020
Early data on Pfizer’s COVID-19 vaccine suggests the highly anticipated shots may be more than 90% effective, the company announced Monday.
If the late-stage clinical trial remains on track, the U.S.-based drugmaker said it would seek emergency-use authorization from the Food and Drug Administration later this month, an encouraging development as the relentless pandemic continues to rage across the country and the world.
But Pfizer, along with its German partner BioNTech, cautioned that the final efficacy percentage “may vary” and that it could still take some time before more data is collected to confirm the vaccine’s safety and effectiveness.
The company’s interim analysis, conducted by an independent data monitoring committee, looked at 94 infections out of nearly 44,000 study participants who got two doses of the vaccine or a placebo. The vast majority of those who tested positive were given a placebo, suggesting the vaccine may be far more effective than expected.
The early data also suggests the vaccine provided protection seven days after the second dose and 28 days after the first, according to a news release.
“Today is a great day for science and humanity,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement.
“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 said. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
Pfizer’s shots are among 10 vaccine candidates undergoing late-stage trials around the world. U.S.-based Moderna Inc. also expects to file an application for emergency use in late November.
Pfizer said the ongoing tests have found “no serious safety concerns.”
With News Wire Services
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