EU gives green light to COVID-19 Omicron vaccines as it sets out action plan for winter
The European Commission authorized the Omicron bivalent vaccines on Thursday, with the two vaccines adapted to provide broader protection against COVID-19.
The decision follows the US FDA’s move to grant emergency use authorization to Omicron vaccines on August 31.
Member states to decide roll out
Comirnaty Original/Omicron BA.1 (Pfizer/BioNTech) and Spikevax bivalent Original/Omicron BA.1 (Moderna) have been authorized in Europe for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. The vaccines have been adapted to target the Omicron BA.1 subvariant in addition to the original strain of SARS-CoV-2.
“As the pandemic evolves, the EU’s strategy is to have a broad range of adapted vaccines that target different SARS-CoV-2 variants so Member States have a plurality of options to meet their needs when they design their vaccination strategies,” notes the Commission.
“This is a key element in the overall strategy to combat the pandemic as it is not possible to predict how the virus will evolve in the future and which variants will be circulating this winter.
“Other adapted vaccines incorporating different variants, such as the Omicron subvariants BA.4 and BA.5, are currently under review by EMA or will be submitted soon, and, if authorized, will further extend the arsenal of available vaccines. The clinical data generated with the original/BA.1 bivalent vaccines recommended today will support the evaluation and authorisation of further adapted vaccines.
“The original vaccines, Comirnaty and Spikevax, are still effective at preventing severe disease, hospitalization and death associated with COVID-19 and will continue to be used within vaccination campaigns in the EU, in particular for primary vaccinations.”
National authorities in EU Member States will determine who should receive which vaccines and when, taking into account factors such as infection and hospitalization rates, the risk to vulnerable populations, vaccination coverage and vaccine availability.
Commission: 'We need to be ready to face another challenging season'
The Commission has also proposed measures to avoid a surge of cases in autumn and winter, urging Member States to put the necessary strategies and structures in place, including vaccination and surveillance. The main focus of the actions is to increase the uptake of vaccines.
Stella Kyriakides, Commissioner for Health and Food Safety, said: “The pandemic is still very much with us. We must act now, together, in a coordinated and sustained manner to help avoid another surge of serious COVID-19 cases.
"To do so, it is crucial that all Member States have robust vaccination strategies in place to prepare for the autumn and winter, including for the roll-out of the newly authorized adapted booster vaccines. The vaccination gaps must be closed as a matter of top priority.
"It is also essential that resilient surveillance systems are set up to monitor the development of the virus, that strategies for the reintroduction of effective public health measures are in place if needed and that the capacity of health care systems is strengthened.
"To say it clearly, we need to be ready to face another challenging season.”
The Commission encourages the Member States to:
- Improve the vaccine uptake of the primary vaccination course and first booster dose among eligible individuals. (This is of particular importance for population groups at higher risk of severe outcomes and for countries with lower vaccination rates).
- Prioritize the administration of an additional booster dose for specific population groups, notably people aged 60 years and over and other eligible individuals of any age at risk of severe disease.
- Combine COVID-19 and influenza vaccination campaigns.
- Ensuring clear communication to citizens about the benefits of vaccination.