Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) has announced the commencement of combined Phase I & II clinical study of their mRNA COVID-19 vaccine candidate in Japan.
Pfizer to enroll 160 participants in a trial in Japan
According to a statement from the company, the trial will enroll 160 participants aged between 20 and 85 years. The companies had initially agreed to supply 120 million doses of the investigational COVID-19 vaccine to Japan in 1H 2021.
Pfizer is developing the mRNA vaccine in partnership with Germany-based BioNTech. The company has indicated that it will confirm the vaccine’s effectiveness as early as the end of this month. However, there is still a need for safety data from the global study of 44,000 participants, which is expected next month.
Japan has committed to ensuring its citizens get enough supply of a COVID-19 vaccine by mid-2021. Besides the deal with Pfizer and BioNTech, the county has a deal for the supply of a coronavirus vaccine with AstraZeneca Plc and other international vaccine makers. AstraZeneca and Oxford University’s investigational COVID-19 vaccine candidate resumed this month, having been put on hold because of a strange illness on a volunteer in the UK.
Pfizer to apply for EUA next month
Pfizer had indicated earlier that it is planning to file for US authorization of the vaccine in late November and could potentially make it available in the US by the end of this year. It is important to note that the vaccine candidate’s safety reviews will dictate the timeline for Pfizer’s filing. The US FDA requires data from at least 50% of the participants in a trial to be watched for up to two months for side effects. Pfizer could hit this milestone in late November, according to Pfizer CEO Albert Bourla.
Pfizer’s rival Moderna (NASDAQ:MRNA) is also studying its vaccine candidate in late stages. The company has indicated that it will apply for emergency use authorization by the end of this year. Moderna has said that it will have interim data from the 30,000 participant study as soon as next month.