A controversial requirement for specific trials in Japan has delayed the deployment of Covid-19 vaccines in Asia’s largest advanced economy and threatened the Tokyo Olympics.
Small clinical trials which demonstrate that vaccines generate a similar level of antibodies when used in Japan are the primary outstanding condition for the approval of the jabs from BioNTech / Pfizer and several other companies.
From Japan request for proof that the safety and efficacy do not differ from country to country means that it will not start vaccinations until the end of February – three months after the first deployments and less than five months before the delayed the Tokyo Olympics must begin.
Olympic organizers said they were working on the assumption that athletes participating in the Games will not have been vaccinated by the summer.
Ken Ishii, professor of vaccine science at the University of Tokyo, said Japanese regulators were “cautious rather than late” because they wanted to avoid an anti-vaccine reaction.
But he admitted the requirement was difficult to justify scientifically. “Asking for an additional clinical trial with just 200 people doesn’t make a lot of sense,” he says. “It doesn’t give you enough power to tell if the Japanese are different.”
the Pfizer clinical trial involving more than 40,000 people in the United States, including 800 of Asian origin, Professor Ishii said, and provided a better source of evidence for any genetic effects on safety or efficacy.
Japanese officials said that, as a common practice, vaccines developed abroad must show that they generate a similar level of antibodies when tested on local patients. They don’t require further placebo-controlled trials to see how many patients get Covid-19.
South Korea, which is also finalizing its vaccine distribution plans, performs similar precautionary tests before starting the massive inoculations in February.
“We will go through a review process to verify the safety and effectiveness of Covid-19 vaccines on South Koreans, taking into account racial and ethnic differences,” Kim Hee-sung, team leader of evaluation of vaccines at the Department of Food and Drug Safety told the Financial Times.
Last year, Japan agreed to buy 120 million doses of the coronavirus vaccine from Pfizer, 120 million from AstraZeneca and 40 million from Moderna. Two doses are needed for each vaccination.
Pfizer has started an ongoing submission for approval of its vaccine. He started a local trial in October and full results are expected shortly. AstraZeneca began local trials last summer, and Japanese officials said they were unsure why the company had yet to submit its vaccine for approval.
Meanwhile, Moderna is just beginning its Japanese trial through local partner Takeda Pharmaceutical, so it is unlikely to submit its vaccine for several months.
This means that Japan will rely heavily on BioNTech / Pfizer to roll out its vaccination campaign. The American company was engaged to supply every 120m at the end of June, but global demand is intense and the pace of deliveries to Japan is unclear.
Last week, Japan signed a replacement contract with Pfizer, which will now supply 144 million doses of its vaccine by the end of 2021.
Japan intends to vaccinate medical personnel first, followed by the elderly. An official said the country’s annual flu campaign – where it injects around 50 million people over two months – would represent the upper limit on the pace of vaccinations, but the deployment of Covid-19 would likely be slower.
Local governments will send vouchers for Covid-19 injections to the elderly. Recipients will then be responsible for making their own appointments at vaccination clinics.
Above the Covid-19 inoculation campaign in Japan is the national rejection vaccinations against human papillomavirus to protect against cancer of the cervix.
After a group of young women called for the vaccine caused extreme neurological symptoms, the government has stopped recommending it. Immunization rates have fallen to less than 1%, compared to near universal coverage in some European countries.
Polls show that only around 65% of the Japanese population want the Covid-19 vaccine. Professor Ishii said his task was to persuade the remaining 35%.
“Everyone in Japan needs to change their mindset. It is not a government problem, it is the people’s problem. We need to help the government make it a success.
Additional reporting by Song Jung-a and Edward White in Seoul