Britain's AstraZeneca Plc said Friday it has formally filed a request for Japan's health ministry to approve its novel coronavirus vaccine, making it the second drugmaker to do so after U.S. pharmaceutical giant Pfizer Inc.
The firm is seeking fast-track approval on the basis of trials held overseas and in Japan. A clinical study of the AstraZeneca vaccine developed with the University of Oxford began in Japan last August and the results of the domestic clinical study with 256 participants are expected to be submitted in March.
"It is my understanding that a decision will be made after the efficacy and safety (of the vaccine) has been carefully verified based on the submitted data and latest scientific findings," Japan's top government spokesman, Chief Cabinet Secretary Katsunobu Kato, said at a press conference Friday.
AstraZeneca's announcement comes as Japan struggles to bring the coronavirus pandemic under control ahead of this summer's Tokyo Olympics and Paralympics. The nationwide tally of cases topped 400,000 on Friday, keeping up the pace of an increase of 100,000 in about three weeks.
Tokyo, which remains the hardest-hit area among 47 prefectures, reported 577 new infections the same day, bringing its cumulative total to 102,777. While figures for the capital have trended downward since Jan. 7, the day it saw a record 2,447 daily cases and a state of emergency was declared in Tokyo and three neighboring prefectures, the death number has been gradually rising since the beginning of January.
AstraZeneca is set to provide 120 million shots, enough for about 60 million people, to Japan. Unlike the Pfizer vaccine, AstraZeneca's does not need to be stored and transported at subzero temperatures, making it easier to handle. But, its efficacy stands at 70.4 percent, compared with 95 percent shown by clinical trial data of the Pfizer vaccine.
With the British drugmaker falling behind on its expected supply to the European Union, Kato said the Japanese government will also continue its efforts to support domestic production of the vaccine.
AstraZeneca plans to produce over 90 million COVID-19 vaccine doses in Japan, or about 75 percent of what the firm is set to provide to the country.
Pfizer, which applied for Japanese government approval for its vaccine in December, is expected to get the green light on Feb. 15, when the ministry holds a panel meeting, according to sources close to the matter.
Prime Minister Yoshihide Suga has pledged to secure vaccines for Japan's entire population of 126 million. Earlier this week, however, he admitted the country has fallen behind other countries in beginning to administer shots, citing an abundance of caution in ensuring their safety.
Health experts say vaccines are essential to reaching herd immunity, an indirect protection provided to those who are not immune to an infectious disease when at least 60 percent of a population carries the antibody.
But a government-run testing of 15,000 people for novel coronavirus antibodies in five prefectures found a 0.91 percent infection rate in Tokyo last December. The positivity rates for Osaka, Aichi, Fukuoka and Miyagi prefectures were at 0.58 percent, 0.54 percent, 0.19 percent and 0.14 percent, respectively.
The rates were drastically lower compared with those seen overseas, with England reporting a positivity rate of 4.4 percent last September, and New York City saying over 27 percent of its population had the antibody last summer.
