US-based Pfizer and German biotech firm BioNTech have announced the start of a late stage clinical trial of a Covid-19 vaccine jointly developed by the two companies. The Phase 2/3 study will involve up to 30,000 participants between 18 and 85 years of age. If the study is successful, the companies could submit the vaccine for regulatory approval as early as October, putting them on track to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021, Reuters reported.
The vaccine candidate, BNT162b2, recently received US Food and Drug Administration (FDA) Fast Track designation, encodes an optimised SARS-CoV-2 full length spike glycoprotein (S), which is the target of virus neutralising antibodies.
Patients are each given two doses of the drugmakers' vaccine to help boost immunity, so the first 100 million doses would vaccinate around 50 million people. The study is expected to include about 120 sites globally and could include up to 30,000 participants. It will include regions heavily impacted by COVID-19.
"The initiation of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help fight the ongoing COVID-19 pandemic," Reuters reported Kathrin Jansen, head of vaccine research and development at Pfizer as saying.
During preclinical and clinical studies of four BNT162 RNA vaccine candidates, BNT162b1 and BNT162b2 emerged as strong candidates based on assessments of safety and immune response.
Pfizer and BioNTech selected BNT162b2 as the candidate to progress to a Phase 2/3 study based on the totality of available data from its preclinical and clinical studies, including select immune response and tolerability parameters.
Over 150 vaccines are being developed against COVID-19, which has claimed nearly 650,000 lives globally and crippled economies.
Moderna Inc also launched an advanced stage trial with 30,000 participants on Monday. Johnson & Johnson is starting clinical trials this week.
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