The European Medicines Agency (EMA) has approved another COVID-19 booster vaccine adapted by BioNTech-Pfizer (Comirnaty) that targets BA.4 and BA.5 subvariants of the Omicron variant.
“It is another key step in supporting Member States’ autumn/winter vaccination efforts,” EU Health Commissioner Stella Kyriakides tweeted, adding that authorisation by the European Commission followed.
On 1 September, EMA gave a positive opinion for approving two vaccines by BioNTech-Pfizer and Moderna (Spikevax), adapted for the subvariant BA of the Omicron variant.
The European Centre for Disease Prevention and Control (ECDC) and EMA have issued joint recommendations for the adapted vaccines in the vaccination campaigns expected by member states before the coming autumn and winter.
ECDC and EMA recommend that the Member States prioritise the vaccination with these boosters of people aged 60 and above, the immunocompromised, vulnerable people with underlying conditions and pregnant women.
It is for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19.
“The bivalent vaccines encode the spike protein of the SARS-CoV-2 wild-type as well as a spike protein of an Omicron subvariant.
“They aim to provide broader immunisation against COVID-19 caused by the current dominant Omicron sublineages and previous variants of concern,” said Ugur Sahin, CEO and co-founder of BioNTech, in a press release.
The EMA’s Head of Health Threats and Vaccines Strategy, Marco Cavaleri, said that BA.4 and BA.5 adaptive vaccines “are nearly identical to the BA.1 adaptive vaccines in terms of their composition.”
Based on assessed data, the EMA concluded that Comirnaty Original/Omicron BA.4-5 is expected to be more effective than Comirnaty at triggering an immune response against the BA.4 and BA.5 subvariants.
“This booster vaccine will further extend the arsenal of available options that can be used by member states in their re-vaccination campaigns,” Cavaleri said.