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Pfizer-BioNTech start late-stage study trial of their lead COVID-19 vaccine candidate

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Reuters    29 July 2020

On Monday, German biotech BioNTech and U.S. drugmaker Pfizer Inc said that they would initiate a pivotal global study to assess their lead COVID-19 vaccine candidate. And if the study is effective, the companies would submit the vaccine for regulatory approval as early as October. If the trial is successful then they can supply up to 100 million doses by the end of 2020 and 1.3 billion by the year 2021 end.

Patients would be given two doses of the drugmakers vaccine to boost immunity, hence the first 100 million doses would vaccinate approximately 50 million people. The study is projected to include about 120 sites worldwide and will include up to 30,000 participants. It will mostly include regions that are heavily impacted by COVID-19.

Kathrin Jansen, head of vaccine research and development at Pfizer said that the beginning of the Phase 2/3 trial is a major step in the progress toward producing a potential vaccine to fight the ongoing COVID-19 pandemic. The trial will enhance Pfizers most promising vaccine candidate, known as BNT162b2. Previous studies had filtered the other potential vaccines.

Pfizer has already made an agreement to sell 100 million doses of its vaccine to the U.S. government and has also given the option to buy 500 million more doses. It is also in talks with other governments that includes the European Union, regarding similar deals.

More than 150 vaccines are being developed against COVID-19 that has claimed nearly 650,000 lives worldwide and had crippled economies.

The vaccine uses chemical messenger RNA to mimic the surface of the coronavirus and instill the immune system to recognize and neutralize it. Even though the technology has been existing for years, but never had an approved messenger RNA (mRNA) vaccine.

ModernaIn chad also launched an advanced stage trial with 30,000 participants on Monday. Johnson & Johnson has also started clinical trials this week.

Source: ET Healthworld

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