The European medicines regulator on Thursday approved Covid-19 vaccines adapted to the Omicron variant from Pfizer/BioNTech and Moderna. The vaccines “target the Omicron BA.1 subvariant in addition to the original strain” of the coronavirus, the Amsterdam-based European Medicines Agency (EMA) said in a statement.
They are intended for people aged 12 and over who have received at least one primary vaccination against Covid-19. These vaccines are adapted versions of the original vaccines Comirnaty from Pfizer/BioNTech and Spikevax from Moderna. However, they do not target the contagious BA.4 and BA.5 lineages of the Omicron variant, which have emerged in recent months as the dominant strains in the world.
Other vaccines under review
The EMA recently said it was aiming for approval “as early as the fall” of Covid vaccines targeting these two subvariants. “Other suitable vaccines incorporating different variants, such as the Omicron BA.4 and BA.5 subvariants, are either under review by the EMA or will be submitted soon and, if approved, will further expand the arsenal of available vaccines,” the EMA said on Thursday.
Vaccines targeting the Omicron variant are eagerly awaited by European countries so they can launch booster campaigns ahead of a feared resurgence in Covid-19 cases this winter. “Today’s positive opinions from the European Medicines Agency on the first two variant-matched mRNA vaccines, from BioNTech-Pfizer and Moderna, are important to protect Europeans against the likely risk of waves of autumn and winter infections. “, European Commissioner for Health Stella Kyriakides said in a statement.
“We have to be ready for another winter with Covid-19,” she added. The American health authorities have already authorized on Wednesday the new version of the vaccines against Covid-19 from Pfizer and Moderna specifically targeting the BA.4 and BA.5 lineages of the Omicron variant.
Omicron, dominant variant of 2022
European Union member states are still using the same coronavirus vaccines approved two years ago for use against the original strain of the virus. They offer some protection against Omicron and its subvariants, which are less harmful but more contagious than the original strain, but the world is waiting for more targeted and effective vaccines, fearing a new wave this winter. Omicron and its sub-variants have been dominant throughout 2022, quickly taking the place of previous Alpha and Delta variants.
The BA.4 and BA.5 subvariants are notably responsible for a wave of new cases in Europe and the United States in recent months. All Omicron variants tend to have a milder disease course as they settle less in the lungs and more in the upper nasal passages, causing symptoms such as fever, fatigue and loss of smell.
The EMA said its review of the adapted Pfizer and Moderna vaccines focused on data from laboratory studies and tests on the immune response against the original strain and against the Omicron variant. “The side effects seen with the adapted vaccines are comparable to those seen with the original vaccines and are generally mild and short-lived,” the agency said.