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Final data on COVID-19 pill released to FDA

Published: Dec. 15, 2021 at 11:53 AM EST
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(CNN) - Final data on Pfizer’s experimental treatment for COVID-19 has been shared with the Food and Drug Administration as part of the company’s application to authorize the pill for emergency use.

If authorized, the pill could be another tool in the fight against the virus.

Pfizer says updated results show the treatment cuts the risk of hospitalization or death by 89% if given to adults within a few days of first symptoms.

”The pill is potentially a lifesaver for everyone,” Dr. Anthony Fauci said.

Pfizer hopes to offer the pills under the name Paxlovid for people to take at home before they are sick enough to go to the hospital.

”When you have peaks of this disease, when you have the waves that are coming, the hospitals are really overcrowded, and that creates significant issues to the health care system,” Chairman and CEO of Pfizer Albert Bourla said. “With this pill, we are expecting out of ten people going to hospital, one will go and no one is dying.”

The company says it expects the drug to retain activity against variants like omicron, and it appears to do so in lab tests because the drug blocks an enzyme involved in viral replication.

Pfizer’s CEO wants to make it clear that the pill treats COVID-19 but does not prevent it.

”Vaccines are needed. Vaccines is the primary frontier that you should be using to stop the disease,” Bourla said.

If the FDA grants emergency-use authorization, Pfizer says the pill could be in the U.S. this month.

No date has been set yet by the FDA advisory committee that is expected to weigh in on the treatment.

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