This content is relevant for:Coronavirus / Medical Biotechnology / Pharmaceuticals
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Mainz-based pharmaceutical company BioNTech announced interim phase III results necessary for approval of its Covid-19 vaccine. The mRNA-based vaccine candidate is more than 90 percent effective in preventing Covid-19 in study participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis conducted by an external independent data monitoring committee.
According to the interim findings, the case split between vaccinated individuals and those receiving a placebo is more than 90 percent seven days after the second dose. Protection is achieved one week after the second injection of a two-dose schedule – making the vaccine effective 28 days after vaccination initiation.
The vaccine BNT162b2 has been in development at BioNTech as part of the “Project Lightspeed” since mid-January. The phase III study phase, necessary for approval, began at the start of July in a number of countries.
More than 43,500 people have enrolled to date, with more than 38,000 already having received a second dose of the vaccine candidate as of November 8.
As well as investigating the degree of protection provided against Covid-19, it is also studying the degree to which the severity of Covid-19 symptoms and progression of the illness might be managed.
Although the study phase is still ongoing, BioNTech and Pfizer are the first companies worldwide to present successful coronavirus vaccine data at this critical phase. Pfizer and BioNTech are now working to prepare the necessary safety and manufacturing data to submit to the US Food and Drug Administration. The companies also plan to submit data from the full Phase 3 trial for scientific peer-review publication.