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Pfizer and BioNTech have announced that they have submitted a revised plan to the FDA to increase the number of candidates for the critical Phase 3 clinical trial of the new crown vaccine BNT162b2 from 30,000 to up to 44,000, and that the amendment will allow for the recruitment of new participants.
BNT162 research and development project with Pfizer and BioNTech initially included four different mRNA vaccines.
BNT162b2, which entered Phase 2/3 clinical studies, is an mRNA candidate that encodes the new coronavirus full-length prickly protein and has been granted fast-track qualification by the FDA.
Phase 3 clinical trial of BNT162b2 was launched on July 28 and is expected to reach its initial target of registering 30,000 subjects next week.
this amendment will allow for a further increase in the diversity of the participating population, including adolescents over 16 years of age, as well as chronic and stable people living with HIV, hepatitis C or HBV.
it will also provide more security and validity data.
this critical trial evaluates vaccines based on the number of events that occur, and many variables may affect the final data reporting time.
, based on current infection rates, the two companies continue to expect to have concluding data on efficacy by the end of October, according to a press release.
original title: Recruiting diverse populations, Pfizer/BioNTech plans to expand key clinical trials of the new crown vaccine