Korea approves Pfizer oral drug

An oral drug for COVID-19 is likely to become available via prescription from late January, following the Food and Drug Ministry’s decision Monday to issue emergency authorization for Paxlovid, Pfizer’s oral pill for COVID-19.

The announcement came five days after the Korea Disease Control and Prevention Agency requested emergency authorization of the drug manufactured by the global drug giant.

“As the number of COVID-19 patients and those in serious condition has been increasing, we comprehensively considered the need to introduce pills that patients can take themselves, the examination review of safety and effectiveness of the drug and the results of an expert committee meeting,” Kim Kang-lip, head of the Ministry of Food and Drug Safety, said during a press briefing held Monday.

However, Merck Sharp & Dohme’s Molnupiravir, for which authorization was also requested, has not yet been approved. “We are currently reviewing more about its effectiveness, and the examination has not been finished,” Kim said.

According to authorities, Paxlovid is an antiviral pill for the treatment of mild to moderate COVID-19 in patients that can decrease risks of hospitalization or death. It is also known to be effective against variants. It became the first oral antiviral of its kind to be authorized for use here. The pills will be available free of charge.

Patients at residential treatment centers or those being treated at home can take the medication with a prescription. The pills are relatively easy to handle, as they can be kept at room temperature for up to 12 months and do not require an injection.

Minister of Health and Welfare Kwon Deok-cheol said at a COVID-19 response meeting on Monday that the oral pills for COVID-19 are likely to be put into use from late January.

“The clinical demonstrations show that Pfizer’s oral drug shows a 90 percent prevention rate in hospitalization and death of COVID-19 patients,” Kwon said.

Kwon also said the government has secured COVID-19 oral drugs -- Paxlovid by Pfizer and Molnupiravir by Merck Sharp & Dohme -- for 604,000 people. It is looking into securing more.

The US Food and Drug Administration granted emergency use authorization of Paxlovid and Molnupiravir on Thursday and Friday, respectively.

Meanwhile, Korea added 4,207 new COVID-19 cases Monday, marking the lowest figure in three weeks, partly due to fewer tests being given over the weekend. The country’s total caseload stands at 611,670.

The number of patients in critical condition was 1,078, staying above 1,000 for a week. The daily death toll stood at 55.

There were 69 additional omicron cases, pushing the total for the variant to 445. Of those cases, 49 were domestic transmissions and 20 came from abroad.

As of Monday, 107 people have been waiting for hospital beds in Greater Seoul for more than a day, while 42 are waiting to be admitted to a residential treatment center.

The government has been encouraging people to receive a third shot of the vaccine.

Authorities said 29.6 percent of Koreans, or more than 15 million, have received the third shot of the COVID-19 vaccine. Some 82.4 percent have received two shots, while 85.7 percent have received the first dose.

The government is also discussing the extension of social distancing rules, currently set to run through Sunday.

By Im Eun-byel (silverstar@heraldcorp.com)