The EU medicines agency on Thursday approved Pfizer/BioNTech and Moderna Covid-19 vaccines adapted for the Omicron variant, paving the way for a booster campaign this winter.
The so-called “bivalent” vaccines target both the original virus, which emerged in the Chinese city of Wuhan in 2019, and the BA.1 subvariant of Omicron, the European Medicines Agency (EMA) said.
Vaccines will not be updated for the newer and more contagious BA.4 and BA.5 types that have become dominant worldwide, with a decision on vaccination to counter these variants expected within weeks.
The Amsterdam-based EMA said the two vaccinations, which were supported on Thursday for people aged 12 and over, were the “first adapted Covid-19 booster vaccines recommended for approval in the EU”.
“These vaccines are adapted versions of the original vaccines Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) to target the subvariant Omicron BA.1 in addition to the original strain of SARS-CoV-2,” it said.
European nations have been keen to speed up the new generation of vaccinations so they can launch booster campaigns ahead of a feared Covid surge in the second half of this year.
EU Health Commissioner Stella Kyriakides welcomed the decision as “important to protect Europeans from the likely risk of autumn and winter waves of infection”.
“We must be ready to face another winter with Covid-19,” she said in a statement.
The EMA said studies showed the new vaccines could induce “strong immune responses” against Covid.
“In particular, they were more effective at eliciting immune responses against the BA.1 subvariant than the original vaccines.”
– New varieties –
The EU’s Kyriakides said she expected the EMA to decide on vaccines adapted for the currently dominant strains BA.4 and 5 “in the coming weeks”.
Pfizer recently applied for approval of a vaccine matched against the two newer types.
The United States on Wednesday approved its first anti-omicron vaccines and approved Pfizer and Moderna vaccinations for the BA.4 and BA.5 strains.
The UK approved the Moderna vaccine for type BA.1 in mid-August.
The 27-nation EU is currently still using the same coronavirus vaccines that were approved for use against the original strain almost two years ago.
While they offer some protection against newer variants, the race is on to produce Jabs that also target the milder but more contagious Omicron strains.
While previous “variants of concern” like Alpha and Delta eventually dried up, Omicron and its sublines have dominated throughout 2022.
Types BA.4 and BA.5 in particular have helped fuel a wave of new cases in Europe and the United States in recent months.
Health authorities have therefore been keen to receive updated vaccines as soon as possible ahead of a feared new wave of the disease later this year.
All Omicron variants tend to have a milder course of the disease, as they settle less in the lungs and more in the upper nasal passages, causing symptoms such as fever, fatigue, and loss of smell.
