German-US cooperation yields effective vaccine for COVID-19
The German life-sciences company BioNTech and US pharmaceuticals giant Pfizer have announced their vaccine against SARS-CoV-2 prevents COVID-19 in most cases. They report that the interim analysis of the Phase 3 clinical trial found the mRNA-based candidate BNT162b2 to be more than 90% effective in participants without evidence of prior infection with the novel coronavirus.
The independent Data Monitoring Committee (DMC) did the analysis. Reports say researchers evaluated results after 94 cases of COVID-19 had been confirmed. BioNTech and Pfizer said 43,538 people took part in the trial, with more than 40% of them coming from diverse backgrounds. So far, said the team, no serious safety concerns have been observed.
Two doses of the vaccine must be administered. The analysis found that, "The case split between vaccinated individuals and those who receive a placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose. This means that protection is achieved 28 days after the initiation of the vaccination." The results are the first from a Phase 3 COVID-19 vaccine trial to be released.
The team has said it will follow DMC recommendations to gather additional safety and efficacy data, adding that the trial will continue to a final analysis at 164 confirmed cases. The companies will apply to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) once the required safety targets have been achieved. BioNTech and Pfizer say they expect this to take place in the third week of November.
Mainz-based BioNTech describes itself as "a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases," saying it uses "a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals." In addition to BNT162b2 and similar vaccines, other product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.
The German Association of Research-based Pharmaceutical Companies, the vfa, has reported that there are at least six more vaccine development programs in Germany, with the country also cooperating in projects abroad. Among the companies involved are CureVac, PRiME Vector Technologies, LeukoCare, Univercells, and ARTES Biotechnology.
This latest news reflects the innovative strength of Germany’s medical biotechnology sector. Analysis and figures demonstrating this are presented in HEALTH MADE IN GERMANY’s Medical Biotechnology Industry Profile and the video MEDICAL BIOTECHNOLOGY MADE IN GERMANY.