Pfizer Passes COVID-19 Vaccine Safety Milestone, Reveals 95% Efficacy Ahead of EUA - COVID-19 Clinical Trial
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Pfizer Passes COVID-19 Vaccine Safety Milestone, Reveals 95% Efficacy Ahead of EUA

Pfizer is preparing to file its COVID-19 vaccine for emergency use authorization (EUA) after passing a key safety milestone. CEO Albert Bourla, Ph.D., said Pfizer now has the median two-month follow-up data needed to secure EUA from the FDA, putting it a step closer to bringing its vaccine to market in the U.S.

Talking at virtual events hosted by The New York Times and Stat, Bourla said Pfizer is preparing to seek EUA for the vaccine, which it developed with BioNTech, using the safety data and the efficacy results it gave a glimpse of last week. Exactly when Pfizer will seek EUA from the FDA is unknown, with Bourla opting against making a statement that would create expectations. Pfizer also initially held off on providing a more detailed look at the efficacy data as it expected the effectiveness figure to change as more participants developed COVID-19. The detailed data arrived Wednesday when the Big Pharma revealed its vaccine was 95% effective in the phase 3 trial.

China’s Sinovac Sees Speedy Immune Response with COVID-19 Shot in Early Trials

A week after one of its tests in Brazil was stopped amid a safety scare, Chinese biotech Sinovac has published data showing its experimental COVID-19 vaccine can quickly boost an immune response.Published in the journal Lancet Infectious Diseases, the phase 1/2 trial for Sinovac’s CoronaVac inoculation across more than 700 patients was not set up to assess efficacy, but it did show it could provide sufficient protection against SARS-CoV-02.

This, the biotech said, is based on its experience with other vaccines and data from preclinical studies with macaques. “Our findings show that CoronaVac is capable of inducing a quick antibody response within four weeks of immunization by giving two doses of the vaccine at a 14-day interval,” the researchers said in the journal. This will not create the same excitement as Moderna and Pfizer/BioNTech’s phase 3 top-line peek this month, which showed their vaccines could offer 90%-plus efficacy, though these data still need to be published in full and peer reviewed and were later-stage efforts with different endpoints than the early tests from Sinovac published today.

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