Covid-19 vaccine: Pfizer, BioNTech start combined clinical trials in Japan
1 min read 20 Oct 2020, 02:15 PM ISTThe study will recruit 160 people aged from 20 to 85, the firms said in a statementJapan has pledged to secure enough vaccine supply for its entire population by the middle of 2021
PremiumPfizer Inc and BioNTech SE announced on Tuesday the start of its combined Phase I and Phase II clinical trials of their mRNA vaccine candidate against the coronavirus in Japan.
The study will recruit 160 people aged from 20 to 85, the firms said in a statement. Earlier, they had agreed to supply Japan with 120 million doses of their experimental coronavirus vaccine in the first half of 2021, reported Reuters.
Pfizer, which is developing the vaccine with German partner BioNTech, has said it may confirm if the vaccine is effective as soon as this month, but also needs safety data from a global trial of 44,000 people that will not be available until next month.
Moreover, Pfizer had earlier said that it could file in late November for U.S. authorization of the COVID-19 vaccine it is developing, suggesting that a vaccine could potentially be available in the United States by the end of the year.
Safety reviews will dictate the time line, with the U.S. Food and Drug Administration requiring that at least half the people in the study be watched for side effects for two months. That milestone should be achieved in the third week of November, Pfizer Chief Executive Officer Albert Bourla said in an open letter published Friday on the company’s website.
Rival vaccine-maker Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.
Apart from that, Japan has pledged to secure enough vaccine supply for its entire population by the middle of 2021. In addition to Pfizer, it has struck deals on supplies with AstraZeneca Plc and other overseas makers of vaccine candidates.
Meanwhile, clinical trials of AstraZeneca and Oxford University's experimental COVID-19 vaccine resumed in Japan this month after being put on hold over the illness of a British volunteer.
People around the world are counting on a vaccine to control the spread of the coronavirus, which has killed more than a million people and ravaged the global economy.
With agency inputs
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