Major U.S. drugmaker Pfizer Inc. on Friday filed for a fast-track approval in Japan of its COVID-19 vaccine, marking the first such application made in the nation, with industry sources saying the formal approval could come within months amid the ongoing novel coronavirus pandemic.
The U.K. and the U.S. have already started this month administering the firm's mRNA vaccine, developed jointly with Germany’s BioNTech SE, and this week Singapore became the first Asian country to grant approval for its use.
Friday’s application came about two months after Pfizer started the first two phases of the drug's three-phase clinical trial in Japan, conducted on 160 Japanese age 20 to 85.
In a statement, the Japanese subsidiary of the New York-based firm said it expected to compile data by February and submit its findings to Japanese regulators soon after.
Pfizer says it has already submitted data to the health ministry showing that its vaccine was 95% effective in preventing COVID-19 in broader late-stage trials, which enrolled more than 43,000 participants in the U.S., Germany, Turkey, South Africa, Brazil and Argentina, of which 5% were Asian.
The health ministry in July signed a basic agreement with Pfizer to obtain vaccines for 60 million people, roughly half of all residents, by the end of June next year. The Diet passed a revised Immunization Act earlier this month to make the vaccinations free of charge and allow the government to compensate pharmaceutical companies for any adverse health consequences.
“We would approve it after screening the effectiveness and safety (of the vaccine) based on data and the latest findings,” Chief Cabinet Secretary Katsunobu Kato told a news conference. Later the same day, he said that when Pfizer submits its additional findings the government "will make it a top priority in the screening process."
One of the challenges of the program will be the particular care needed in handling the Pfizer vaccines, which industry sources say may limit the locations where vaccinations can be offered to facilities such as large hospitals. The health ministry says they have to be stored in extremely cold temperatures, within 15 degrees Celsius of minus 75 C.
The government said last week it would secure 3,000 special freezers to store the vaccines. Once they are thawed, they can be stored in a normal refrigerator for up to five days, Pfizer says.
Kato said the government was working with local municipalities to streamline a system for an effective rollout of the vaccines and to make vaccine transportation at deep-freeze temperatures possible.
Medical experts said Japanese approval for the Pfizer vaccine could come in a few months — much more quickly than usual. When Japan fast-tracked approval of the antiviral drug remdesivir to treat severe COVID-19 cases in May, it took just three days for the government to reach the decision, a week after authorization of the drug for emergency use by the U.S.
“I think the approval could come as early as in two to three months' time in a fast-track screening,” Dr. Tetsuo Nakayama, a project professor at Kitasato Institute for Life Sciences and director of the Japanese Society of Clinical Virology. “Vaccine approval usually takes a year or two in general.
“Because Pfizer confirmed the effectiveness of its vaccine in Phase 3 clinical trials conducted overseas, they are arguing that they can expect the same level of effectiveness and create the same antibodies in Japanese people as confirmed overseas.”
The European Union and the U.S. have a “mutual recognition agreement,” which allows the drugs to be used within each other’s borders to avoid the duplication of clinical trials.
But Japan is one of very few countries that require additional clinical trials within the nation to ensure safety, which means that it usually takes more time for drugs to be approved for use here.
Experts have said that vaccine manufacturers could have difficulty conducting successful clinical trials in Japan because it has seen fewer cases than some other countries, although the number of new infections recorded daily has risen over the past week to more than 3,000.
Staff writer Satoshi Sugiyama contributed to this report.
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