European Health Union: Statement by Commissioner Stella Kyriakides on the authorisation of the first COVID-19 variant-adapted booster vaccines

©European Union, 2021, Source: EC - Audiovisual Service©European Union, 2021, Source: EC - Audiovisual Service

Today, the European Medicines Agency (EMA) has given a positive opinion on the first two variant-adapted COVID-19 booster vaccines: Comirnaty and Spikevax, by BioNTech-Pfizer and Moderna respectively. Welcoming this important development in the fight against COVID-19, Commissioner for Health and Food Safety, Stella Kyriakides, said:

“Today’s positive opinions by the European Medicines Agency on the first two variant-adapted mRNA vaccines, from BioNTech-Pfizer and Moderna, are important to protect Europeans against the likely risk of autumn and winter waves of infections. We need to be ready to face another winter with COVID-19.

We will now proceed with an accelerated authorisation of these vaccines to ensure that they can be rolled out quickly across the EU. The adapted versions of these vaccines are to be used as booster doses that target the original virus and the Omicron BA.1 sub-variant. They are developed to offer increased, broader protection against current and future variants. Subject to the scientific assessment of the EMA, we also expect an opinion on Omicron BA.4 and BA.5 adapted vaccines in the coming weeks as part of our broad vaccines portfolio approach that has characterised our work since the outset.

With our Health Emergency Preparedness and Response Authority (HERA), we acted swiftly last spring already to make sure that contracts were amended so that all Member States have access to adapted vaccines in quantities needed in autumn and winter to protect citizens. This is European collaboration and solidarity in action, the key principle of the EU Vaccines Strategy.

I call again on Member States to plan and launch their vaccination campaigns, including adapted vaccines. It is essential to continue prioritising an uptake of the primary vaccination and first booster dose among all eligible individuals. To support Member States efforts, the Commission will soon present actions for COVID-19 vaccination strategies and set out measures to help avoid a surge of COVID-19 this autumn and winter. The European Medicines Agency and the European Centre for Disease Prevention and Control will also shortly publish considerations on the roll-out of adapted vaccines.

Everyone eligible for a vaccine or booster dose should get it as soon as possible. The pandemic is not over, but the swift development and adaptation of vaccines to respond to this virus is one of the greatest successes in the modern history of medicine: let’s now make sure that we protect as many as possible, for ourselves and our loved ones.”

For More Information

EU Vaccines Strategy