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German biotech company BioNTEch (BNTX), and US pharma giant Pfizer (PFE) announced on Monday (27 July) that they have started late-stage human trials on a potential messenger RNA (mRNA) vaccine against coronavirus this week.
The companies said that up to 30,000 people aged between 18 and 85 will participate in the global trial, across 120 sites, including in 39 states in the US.
BioNTech chief executive Ugur Sahin said in a statement that the decision to start the broad trial reflects “our primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio.”
The partners said that if the trials are a success, they will be on track to request regulatory review as early as October this year. They added that if regulatory authorisation or approval is obtained, they “plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.”
Mainz-based BioNTech and Pfizer received approval from Germany’s regulatory authority to start their first round of human clinical trials in April.
If the vaccine in development is a success, Pfizer and BioNTech will receive $1.95bn from the US government for an initial order of 100 million doses, as part of the government’s Operation Warp Speed program to speed up development of coronavirus treatments.
There are some 150 vaccines in development around the world, according to the WHO. BioNtech is one of the two leading German companies in the global race, the other being CureVac.The German government as well as pharma company GlaxoSmithKline have both invested in CureVac.
Earlier this month, researchers at Oxford university announced that the vaccine they are developing was showing promise – it appeared safe and triggered an immune response in trials for over 1,000 people.
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