By Vishwadha Chander and Carl O’Donnell
(Reuters) – German biotech company BioNTech and U.S. pharmaceutical company Pfizer Inc said Monday they would begin a critical global study to test their top candidate for the COVID-19 vaccine.
If the study is successful, 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.
Each patient receives two doses of the vaccine from drug manufacturers to help boost immunity, so the first 100 million doses would vaccinate about 50 million people.
The study is expected to include around 120 sites worldwide and could include up to 30,000 participants. It will include regions heavily affected by COVID-19.
“The start of the Phase 2/3 trial is a major step forward in our progress toward providing a potential vaccine to help combat the current COVID-19 pandemic,” said Kathrin Jansen, director of vaccine research and development at Pfizer.
The trial focuses on Pfizer’s most promising vaccine candidate, whom he calls BNT162b2. Previous studies leaked other possible vaccines.
Pfizer already has an agreement to sell 100 million doses of its vaccine to the US government and give it the option to buy an additional 500 million. It is in talks with other governments, including the European Union, about similar deals.
More than 150 vaccines against COVID-19 are being developed, which has claimed nearly 650,000 lives worldwide and has paralyzed economies.
The vaccine uses chemical messenger RNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it. Although the technology has been around for years, there has never been an approved messenger RNA (mRNA) vaccine.
Moderna Inc also launched an advanced stage test with 30,000 participants on Monday. Johnson & Johnson is beginning clinical trials this week.
(Report by Vishwadha Chander in Bangalore; Maju Samuel, Richard Chang and Aurora Ellis edition)
