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South Korea approves special import of Pfizer vaccine

By Lim Jeong-yeo
Published : Feb 3, 2021 - 18:01
Updated : Feb 3, 2021 - 18:01

Korea`s Drug Minister Kim Gang-lip on Wednesday announces decision to specially import Pfizer`s COVID-19 vaccine through COVAX facility (Yonhap)

South Korea on Wednesday gave special approval to Pfizer’s COVID-19 mRNA vaccine Comirnaty, specifically for the batch to be imported through the global COVAX facility.

As per this decision, a total of 117,000 doses of Comirnaty will arrive in Korea after mid-February, the country’s Ministry of Food and Drug Safety said. As the vaccine needs to be administered twice, the COVAX batch can cover around 60,000 people.

Authorities have made clear that the initial batch of vaccines are for medical professionals fighting the pandemic at medical forefronts. Korea estimates the number of doctors, nurses and other personnel working at COVID-19 combat centers to be around 48,900.

The Drug Ministry pointed out that the vaccine batch acquired through COVAX differs from the ones to be directly imported through Pfizer Korea. Pfizer has applied for an emergency use authorization of its vaccine in Korea on Jan. 25. The 40-day review is still ongoing.

Special imports of pharmaceuticals are allowed during public health care crises such as the current pandemic. With a formal request from the head of relevant state institutes, pharmaceuticals so far unauthorized by the Drug Minister can be given exception for import.

Since 2015, there have been 40 special import cases of 15 pharmaceuticals, which include treatment for radiation exposure in March 2020 and Gilead Sciences’ COVID-19 therapy remdesivir in June 2020, according to the Drug Ministry.

Such special imports take place per case count and is an authorization for customs. It differs from a proper pharmaceuticals authorization, which means that the application made by Pfizer Korea will proceed according to schedule, the Drug Ministry said.

In deciding to allow COVAX’s offer of Comirnaty, Korean authorities have consulted 11 experts in infectious diseases, vaccine and virology, as well as active medical professionals.

The team of experts studied the clinical data of the Pfizer vaccine and took into consideration that 28 other regulatory bodies have granted the emergency use of the vaccine.

Pfizer’s Comirnaty is being inoculated in the US, the UK, in some European Union countries, Canada, Singapore, Israel and more.

Comirnaty’s clinical data, collected from global multicenter clinical trial, have shown a 95 percent protection rate against COVID-19 among those over 16 years of age.

The vaccine had shown mild and expected side effects such as pain and swelling in the injection spot, tiredness, headache, muscle and joint paint, chill and fever. These side effects went away after a few days of inoculation.

The team of local experts agreed that Comirnaty should be given to those 16 and older, with a minimum of 21 days‘ interval between the required two doses.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)

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