Germany's BioNTech and US pharmaceutical company Pfizer have requested authorisation from the European Medicines Agency (EMA) to allow emergency use of their COVID-19 vaccine candidate.
The two companies have already requested authorisation with the US Food and Drug Administration and the UK's regulatory agency and have initiated rolling reviews in several other countries.
US biotechnology company Moderna announced yesterday that it too requested authorisation for its vaccine candidate.
The announcement means Pfizer's vaccine could become available in the European Union for vulnerable groups before the end of the year if the EMA "concludes that the benefits of the vaccine candidate outweigh its risks."
The European agency's rolling review of the Pfizer and BioNTech vaccine began on October 6, 2020 and the request for authorisation completes the rolling review process.
The BioNTech vaccine candidate is 95% effective, the company said, and in particular, it is 94% effective in adults over the age of 65, who are among those most at risk of developing severe COVID-19.
"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 [the vaccine],” said Ugur Sahin, CEO and Co-founder of BioNTech.
“We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”
The vaccine was "well-tolerated" among the 43,000 participants enrolled in the phase three trials, the company said earlier this month.
The EU recently signed a deal to secure up to 300 million doses of the BioNTech and Pfizer vaccine.
The vaccine, like the one developed by Moderna, is based on new technology that contains mRNA or genetic instructions that help the body to recognise the coronavirus' spike protein, which is used to enter the body's cells.
The Pfizer/BioNTech vaccine, however, needs to be stored at ultracold temperatures (-70 degrees Celsius), the infrastructure for which doesn't exist in many places.
This means that many countries are unlikely to have the capacity to distribute the vaccine.