The European Medicines Agency (EMA) issued a positive opinion for Comirnaty, the Pfizer/BioNTech vaccine, making it the first COVID-19 vaccine that could be authorised for marketing in the European Union. This opinion still has to be confirmed by the European Commission. Belgium purchased the vaccine and will use it immediately in its vaccination campaign.
After a thorough risk-benefit analysis, the EMA gave a positive opinion for the Pfizer/BioNTech COVID-19 vaccine. The European Commission will soon decide whether to grant a conditional marketing authorisation.
Requirements were not lowered
In order to carry out its assessment as efficiently as possible, the EMA launched a rolling review on 6 October 2020. In the case of a rolling review, EMA’s scientific committee (CHMP, Committee for Medicinal Product for Human Use) evaluates data as they become available from ongoing studies. Pfizer/BioNTech submitted a formal application for marketing authorisation on 1 December 2020.
The positive assessment by the EMA means that there is sufficient evidence that the vaccine is safe, efficacious and of good quality. The assessment was carried out according to the same requirements that apply to all medicinal products. The package leaflet, the summary of product characteristics (SmPC) and the EPAR (European Public Assessment Report) will be available shortly.
Already purchased by Belgium
Subject to its marketing authorisation, the Pfizer/BioNTech vaccine had already been purchased on 18 November 2020 by the Belgian authorities. Five million doses are planned for 2021. The vaccine is to be administered twice at least 21 days apart.
Post-authorisation surveillance
As for all other medicinal products, the safety and efficacy of COVID-19 vaccines are monitored after being placed on the market. Thus, there is a follow-up of all adverse reactions at national and European level. Pfizer/BioNTech's vaccine has obtained a conditional marketing authorisation, meaning that once its vaccine is on the market, the manufacturer shall provide additional information to the EMA at set times. Besides, for COVID-19 vaccines, existing safety monitoring systems have been reinforced both at national and European level.
How does the Pfizer/BioNTech vaccine work?
The Pfizer/BioNTech vaccine is a messenger RNA (mRNA) vaccine. These vaccines contain the genetic code (mRNA) of viral particles against which our immune system will react. The mRNA is encapsulated within lipid bubbles so that it reaches the body's cells more easily. Lipid bubbles are not toxic or harmful. Our body uses the messenger RNA to make some of the virus' proteins itself. Our immune system will react against these proteins. In the event of a subsequent infection, the body will remember these proteins. It will produce the right antibodies and activate the right cells to destroy the virus in order to protect us from the disease.
More information
The EMA press release on the Pfizer/BioNTech COVID-19 vaccine
COVID-19 vaccines
Questions and answers on COVID-19 vaccines