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Expected to apply for emergency FDA approval in November
The company plans to apply for emergency use of its vaccine to the US Food and Drug Administration (FDA) in November, as the effectiveness of the Corona 19 vaccine jointly developed by Pfizer and Bioentech was announced as an interim result. from Germany. see.
Pfizer said on the 9th (local time) that an analysis of 94 of the participants in the phase 3 clinical trial of the COVID-19 vaccine showed that its vaccine was more than 90% effective in preventing COVID-19.
Although this is an intermediate result, the effectiveness of more than 90% is almost twice that of a regular flu vaccine. According to the Centers for Disease Control and Prevention (CDC), flu vaccines reduce the risk of infection by 40 to 60 percent. Pfizer’s COVID-19 vaccine is about the same level as the measles vaccine (93% effective).
Today’s announcement is an interim result of an independent external ‘Data Monitoring Committee’ regarding the phase 3 trial of Pfizer-Bioentech, and the final result may vary. It contains the analysis of 94 confirmed patients from the phase 3 trial conducted with a total of 43,538 people in the United States and five foreign countries.
Pfizer and Bioentech divided the clinical trial participants into two groups, administered Corona 19 vaccine to one group and a placebo (a fake drug) to the other group.
As a result, among participants who received the vaccine twice, the infection rate was less than 10%, the company said.
Pfizer Chief Executive Officer Albert Bulla made a statement: “When the world needs it most as new infection rates are set, hospital capacity approaches limitations and economic resumption is difficult, we are a major milestone in vaccine development. “It has arrived,” he said.
“We are one step closer to providing the world with a breakthrough that will help end this global health crisis,” said Bulla, saying that he will release additional data on the vaccine’s safety and efficacy in a few weeks.
He said in a CNBC interview that day: “I think we can finally see the light at the end of the tunnel.”
The US government and the scientific community expect the Corona 19 vaccine, including Pfizer, to be commercialized in the first half of next year.
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