“The first interim analysis of our global Phase III study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science and a global collaborative effort,” commented Prof. Ugur Sahin, BioNTech Co-founder and CEO. “While we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality".
BioNTech reports high efficacy of COVID-19 vaccine
BioNTech/Pfizer are the first COVID-19 vaccine developers who provided the definitive proof-of-concept that it is possible to protect people from an infection with the pandemic new coronavirus. Results of an interim analysis of BioNTech’s/Pfizer’s Phase III vaccine candidate BNT162b2 by an independent Data Monitoring Committee (DMC) demonstrate that the mRNA-based jab was more than 90% effective in preventing COVID-19 in healthy volunteers.The result is based on unblinded data determining the
case ratio between volunteers who received the placebo and vaccinated individuals. No data were published on antibody titres or T-cell dependent immunity. However, experts previously suggested the experimental mRNA jab may give protection for about one year. Data from other vaccines will show the role of antibody titers and T-cell titres to establish protection from infection with SARS-CoV-2.
In contrast to previous plans, the DMC conducted the first interim analysis after 94 confirmed cases of COVID-19 had occured in the study population 7 days after two vaccinations with BNT162b2. That is more than half of the 164 cases required for completion of the study. The original study protocol, which was adapted by the FDA and the developers foresaw a first interim analyses after 32 cases. Following a safety analysis scheduled for the third week in November the company will apply for an FDA Emergency Use Authorisation (EUA) while long-term safety and efficacy will be invesitgated for a total of two years.
The companies, who did not receive any state funding for the development of BNT162b2 said they didn't observe any serious adverse events after having enrolled 43,538 participants. As the study continues, the final vaccine efficacy percentage may vary.However, for the moment, the efficacy is significantly above the minimum efficacy of 60% set by the FDA. The EMA has decided to do without such a minimum efficacy.
As BNT-162b2 must be stored at –80°C distribution will become a challenge. According to Cowen Inc, BNT162b2 is among the higher-price vaccines ($19.50 per dose) if one looks at the prices the US government has paid for 100 millions of doses (with AstraZeneca at the lower end with $4/dose).