The German company BioNTech has just become the second pharmaceutical company to apply for vaccine approval in the EU, making the possibility of a coronavirus vaccine rollout before the end of the year seem more and more likely. 

BioNTech and Pfizer submit EMA application

Hot on the heels of the US pharmaceutical company Moderna, the Mainz-based company BioNTech has now submitted a formal application for conditional marketing authorisation to the European Medicines Agency (EMA) for their mRNA vaccine against COVID-19. 

The announcement comes just a week after BioNTech and its US partner company Pfizer applied for emergency approval from the US Food and Drug Administration (FDA). In the US, the responsible FDA committee will meet on December 10, when a decision will be made on approval. 

In Europe, there are stricter rules on rapid approval. A so-called rolling review process is already running at EMA for BioNTech and Pfizer’s mRNA vaccine. This is intended to accelerate the approval process without sacrificing scientific integrity or safety. The Paul Ehrlich Institute (PEI), which is responsible for vaccine approval in Germany, said that approval will only be granted if, after an interim analysis, there is “sufficiently convincing data” on safety and efficacy. 

According to a BioNTech press release, if the EMA “concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will most likely recommend granting a CMA that could potentially enable the use of the vaccine in Europe before the end of 2020.” Germany is already planning how the vaccine, which must be kept at minus 70 degrees celsius, could be stored and transported across the country. 

Coronavirus vaccine 95 percent effective in clinical trials

In the final phase III trials, the BioNTech and Pfizer vaccine candidate was found to be 95 percent effective at protecting study participants from COVID-19. In order to deliver that level of protection, two immunisations are needed; the second seven days after the first. The effectiveness of the vaccine has so far been consistent across all age, gender and ethnic groups. 

“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” said Ugur Sahin, MD, CEO and co-founder of BioNTech. 

In addition to submission to the EMA, the FDA and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), Pfizer and BioNTech have initiated rolling submissions in other countries, including Australia, Canada and Japan.