BioNTech and Pfizer are keeping their word: The aim was to begin the final clinical test phase for a vaccine candidate against the Sars-CoV-2 virus in July – the causative agent of the global COVID-19 pandemic, which has been rampant for months. Now the time has come. Based on the data from the phase 1/2 clinical studies in Europe and the USA, the duo selected a Led candidate for the upcoming extensive study.
As part of the study, the up to 30,000 test subjects between the ages of 18 and 85 will be administered twice to the vaccine candidate BNT162b2 with a dose of 30 µg each. “This decision reflects our primary goal of bringing a well-tolerated and highly effective vaccine to the market as soon as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio,” said BioNTech CEO Ugur Sahin to the upcoming work- The study has already started in the USA and is to be rolled out worldwide, 120 test centers are to participate. Regions with a high SARS-CoV-2 transmission risk should be included in the study. The Mainz-based biotech company has announced that it wants to investigate whether the vaccine candidate BNT162b2 successfully prevents COVID-19 infection. “The phase 2/3 study protocol meets all of the FDA’s clinical trial design requirements for COVID-19 vaccine studies,” said Kathrin U. Jansen, senior vice president and head of vaccine research & development at BioNTech’s development partner Pfizer.
Now things should go quickly: “If the study is successful, Pfizer and BioNTech continue to plan to apply for the approval process as early as October 2020 and, if approved or approved, up to 100 million vaccine doses worldwide by the end of 2020 and potentially over 1.3 billion vaccine doses by the end of 2021, ”BioNTech announced on Tuesday night.