Pfizer says vaccine is 95 percent effective in updated data

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Pfizer said Wednesday that its coronavirus vaccine is 95 percent effective and safe, according to final results from its late-stage trial in nearly 44,000 people. The effect was consistent across age, race, gender and ethnicity.

The company and its German partner, BioNTech, will seek emergency authorization from the FDA “within days,” according to a joint statement.

Pfizer is the first coronavirus vaccine developer to announce results from a completed Phase III trial. The company had released a preliminary analysis on Nov. 9 that found its shot was more than 90 percent effective.

Diving into data: The final analysis shows that the vaccine can prevent mild and severe disease. It is based on 170 trial participants who contracted Covid-19: 162 who received a placebo, and 8 who received the vaccine. Ten of those cases were severe, with the majority — nine — occurring in the placebo group.

The vaccine was more than 94 percent effective at preventing infection in adults over 65. The question of how well the coronavirus vaccines in development will work for older adults has been an open question, because the immune system generally weakens with age.

No serious safety concerns were observed among trial participants, Pfizer and BioNTech said. Some of the most common side effects were fatigue and headache.

What’s next: After Pfizer and BioNTech submit their application to FDA for an emergency-use authorization, agency regulators will begin reviewing it — as will an independent advisory committee set to meet in early December. The FDA is not bound by the recommendations of such advisory committees, but it usually follows them.

Federal officials have said that vaccination of high-priority groups will start within 24 hours of any vaccine authorization. The Trump administration has purchased 100 million vaccine doses from Pfizer, with an option to buy another 500 million more.

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