Pfizer's vaccine meets emergency approval standards, FDA panel says

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The FDA's vaccine advisory committee confirmed that Pfizer's vaccine is highly effective, has no significant safety risks and meets the agency's standards for emergency approval, according to documents published by the agency Dec. 8. 

"Safety data from approximately 38,000 participants ... suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the committee wrote.

After reviewing data submitted by Pfizer, the committee confirmed the vaccine is 95 percent effective at preventing COVID-19 a week after the second dose is given. The committee said some protection against the virus appears after the first dose, but it couldn't make a conclusion about how effective a single dose is. The vaccine is intended to be given in two doses three weeks apart. 

It's unclear how long protection against COVID-19 lasts since researchers haven't had enough time to monitor clinical trial participants. Most side effects reported were mild fevers, muscle aches, fatigue and injection site pain. 

The vaccine appears to be effective across different populations, though researchers said they couldn't make conclusions about its efficacy in people younger than 16, pregnant women or those with compromised immune systems. 

 

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