This follows their application for emergency approval to the US Food and Drugs Administration on 20 November and to the UK’s Medicines and Healthcare Regulatory Agency on 23 November.
Pfizer/BioNTech announced on 18 November that their vaccine protected 95% of people over 65-years-old from COVID-19, and that the results indicated it was equally effective across all ethnicities.
The EMA said it plans to decide on authorisation of the Pfizer/BioNTech vaccine by 29 December. The European Commission also said that it is poised to issue final authorisation of the vaccine days after its EMA approval.
The US-German partners’ application for EU authorisation comes one day after US-based Moderna (MRNA) submitted its vaccine to the European and US drug regulators for emergency approval. Final data analysis from Moderna’s large-scale trial found its vaccine to be 94.1% effective at protecting people from the virus – and 100% when it came to preventing severe cases of COVID-19.
BioNtech and Pfizer were the first in the vaccine race to report success in large-scale Phase 3 trials in early November. Both BioNTech and Moderna have developed vaccines based on messenger RNA biotechnology, which work by transmitting a genetic code to cells telling them to produce a protein, which in turn activates the immune system.
The European Commission has already bought 300 million doses of the BioNTech vaccine and 160 million of doses of the Moderna one.
The UK government has secured 7 million doses of the Moderna vaccine, and 40 million doses of the Pfizer/ BioNTech vaccine.
According to a report in the Financial Times today, the UK could start vaccinating with the Pfizer vaccine as soon as 7 December, hours after it receives approval from the UK’s Medicines and Healthcare Regulatory Agency.
Watch: Moderna seeks US vaccine authorisation