FDA issues import permit for Pfizer COVID-19 drug

• By Lee I-chia / Staff reporter

The Food and Drug Administration (FDA) yesterday issued a special import permit for Paxlovid, an oral antiviral drug developed by Pfizer Inc to treat COVID-19, and the first shipment is expected to arrive before March, the Central Epidemic Command Center (CECC) said.

Pfizer’s import permit application was approved after a specialists’ meeting at the agency yesterday morning, FDA Director Wu Shou-mei (吳秀梅) said.

Having assessed Paxlovid’s therapeutic effect, safety, risks and benefits, and considering the domestic COVID-19 situation and public health demand, the specialists agreed to grant special approval to the drug, according to Article 48-2 of the Pharmaceutical Affairs Act (藥事法), she said.

Photo: Reuters

Pfizer is required to implement a risk management plan during the special permit period to ensure the drug’s safety, she added.

Paxlovid should be administered after a diagnosis of COVID-19 and within five days of the onset of symptoms, for adults who are at high of risk developing severe illness from the virus and children aged 12 or older weighing at least 40kg with mild to moderate symptoms, she said.

The drug is administered as three tablets — two tablets of PF-07321332 (150mg) and one tablet of ritonavir (100mg) — which are packaged together to take orally twice daily for a five-day course, Wu said, adding that not following the course could affect the treatment.

PF-07321332 works by blocking the activity of an enzyme that SARS-CoV-2 needs to multiply, and ritonavir helps slow the metabolism of PF-07321332, allowing it to remain active at higher concentrations in the blood for extended periods, she said.

Minister of Health and Welfare Chen Shih-chung (陳時中), who heads the CECC, said that the ministry has signed a procurement contract with Pfizer to purchase 20,000 courses of Paxlovid, and that the first batch is expected to arrive before March.

Paxlovid is the second oral antiviral COVID-19 medication to obtain a special import permit from the FDA, after the CECC on Wednesday said that a permit was issued to US drugmaker Merck’s Taiwan branch for its molnupiravir antiviral drug.