Pfizer and BioNTech have begun combined Phase I and Phase II clinical trials of their mRNA vaccine candidate against Covid-19 in Japan.
The trials will enrol approximately 160 participants aged between 20 and 85.
In July this year, Pfizer and BioNTech entered an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate in the first half of next year.
Pfizer, which is co-developing the vaccine with Germany-based firm BioNTech, has stated that it is likely to give confirmation this month if the vaccine is effective. However, it also added that it requires safety data from a global trial of 44,000 people and this data will be available next month.
The BNT162 programme is based on BioNTech’s mRNA technology and is supported by Pfizer’s global vaccine development and manufacturing capabilities.
Japan has committed to get a sufficient supply of vaccine for its population by the middle of next year.
The country has also made vaccine supply deals with AstraZeneca and other international developers of vaccine candidates.
Clinical studies of AstraZeneca and Oxford University’s experimental Covid-19 vaccine recommenced in Japan this month after this trial was put on hold following a British volunteer falling ill.
Earlier this month, Pfizer and BioNTech started participant enrolment in a Phase III clinical trial of their Covid-19 vaccine candidate in South Africa.