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Emergency Use Authorization Granted for Pfizer's COVID-19 Pill

#Hot Issues of the Week l 2022-01-02

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ⓒYONHAP News

The government on Monday granted emergency use authorization for Pfizer's COVID-19 pill, the first domestic approval for an oral treatment.

The Ministry of Food and Drug Safety's decision regarding Paxlovid followed a request for the review from the Korea Disease Control and Prevention Agency(KDCA).

The ministry considered it necessary to authorize the pill amid a resurgence in infections following an evaluation of its safety and efficacy and a meeting with an advisory panel of experts.

The advisory committee reportedly agreed on the need to green light the pill, citing the country's virus situation and clinical study data.

Pfizer said Paxlovid was found to reduce the risk of hospitalization and death by 88 percent when given to an unvaccinated person at high risk of severe infection within five days of symptoms starting.

Additionally, it said lab experiments showed the drug will attack a key protein in the omicron variant.

The KDCA later outlined plans to introduce the antiviral pills as early as mid-January.

So far, deals for pills enough to treat 604-thousand people have been made, with an amount covering 242-thousand people to come from Merck & Co. and pills to treat 362-thousand people to come from Pfizer. 

The government is seeking to secure oral medication for an additional 400-thousand people with contracts to be signed early this month.

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