Pfizer files request for Japan COVID-19 vaccine approval

Dec 18, 2020 – 21:05 KYODO NEWS

Photo shows Pfizer headquarters in New York in November 2015. (Kyodo) 

TOKYO – U.S. pharmaceutical giant Pfizer Inc. on Friday requested Japan’s health ministry to approve its novel coronavirus vaccine, making it the first drugmaker to file such a request in the country.

If approved, vaccinations could begin in Japan as early as March, government officials said. Japan has already agreed with Pfizer to receive a supply of 120 million doses in the first half of next year, enough for 60 million people, or roughly half of the population.

“We will strictly screen the effectiveness and safety (of the vaccine) before making a judgment,” health minister Norihisa Tamura told a news conference. “We will conduct the screening with the utmost priority.”

Akihisa Harada, president of the Japan unit of Pfizer, said the company wants to help get life back to normal.

“In the event that we win approval, we would like to ensure a fast delivery of our vaccine to people in Japan and play a part in normalizing their social life,” he said.

Boxes containing the Pfizer-BioNTech COVID-19 vaccine are prepared to be shipped at the Pfizer Global Supply Kalamazoo manufacturing plant on Dec. 13, 2020, in Portage, Michigan. (Pool/Getty/Kyodo)

Pfizer is seeking fast-track approval without having to conduct large-scale trials on the basis that the vaccine has been approved in other countries.

Pfizer and its German partner BioNTech SE, which have conducted clinical trials on over 40,000 people outside of Japan, have said data from late-stage trials showed a 95 percent efficacy rate against COVID-19, the respiratory disease caused by the novel coronavirus.

In Japan, Pfizer has already conducted clinical trials involving 160 people, aiming to report the results to the health ministry by February together with the data from overseas.

The government plans to ask municipalities to prepare venues and medical institutions to conduct vaccinations, and make systems available for accepting reservations.

The United States and Britain have already begun administering the coronavirus vaccine jointly developed by Pfizer and BioNTech, while Singapore and some other countries are expected to follow suit.

But concerns remain over its safety as U.S. authorities said Wednesday a health care worker in Alaska suffered a serious allergic reaction to the vaccine. Similar allergic reactions in two health care workers have also been reported in Britain.

Earlier in the month, Japan’s parliament enacted a law to cover the costs for residents to be vaccinated, with a recent resurgence of infections demonstrating the importance of inoculation.

More than 2,800 additional cases of the virus were reported in Japan on Friday, a day after the nationwide tally hit a single-day record of over 3,200 cases, amid growing concerns about the strain on the country’s medical system.

The Pfizer-BioNTech vaccine is projected to be delivered in batches of 1,000 doses, which need to be stored at minus 75 C or lower and administered within approximately 10 days.

Japan has also agreed with Moderna and Britain’s AstraZeneca Plc to receive sufficient numbers of vaccine doses to cover the entire population and more.

As the soon to be available COVID-19 vaccines must be stored at low temperatures, the Ministry of Health, Labor and Welfare will secure about 3,000 freezers with the capacity to store items at minus 75 C and about 7,500 freezers with a minus 20 C capability, which will be used at vaccination centers across the country.

Cr. KYODO NEWS