The European Medicines Agency (EMA) has greenlit two adapted mRNA COVID-19 vaccines targeting the original strain of COVID-19 as well as the BA.1 Omicron subvariant.

The variant-adapted vaccines are Comirnaty from Pfizer/BioNTech and Spikevax from Moderna, which were approved during an extraordinary meeting of EMA’s Committee for Medicinal Products for Human Use (CHMP) on Thursday (September 1).

Following the EMA’s decision, EU Health Commissioner Stella Kyriakides said in a statement that “we will now proceed with an accelerated authorisation of these vaccines to ensure that they can be rolled out quickly across the EU.”

“[The vaccines] 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,” she added.

Her statement included a call for EU member states to make sure to include the adapted booster vaccines in their vaccination campaigns, highlighting the importance of vaccination in the fight against coronavirus.

“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,” Kyriakides said, adding that the EMA and the European Centre for Disease Prevention and Control (ECDC) will publish their considerations on the roll-out of the adapted vaccines.

“We need to be ready to face another winter with COVID-19,” the health chief said.

Chasing the right variant

According to the ECDC’s latest overview of COVID-19, also published on Thursday, it is the Omicron sub-variant BA.5 which is currently driving infections on the European continent.

While the newly approved booster vaccines are not specifically targeted to this variant, but rather BA.1, UK authorities made clear that the adapted Spikevax vaccine has been “found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.”

The UK became the first country to approve a bivalent booster vaccine in mid-August when UK Medicines and Healthcare products Regulatory Agency (MHRA) gave the green light to Moderna’s variant-adapted booster shot targeting the original strain and the Omicron BA.1 subvariant.

It has been approved for use in the UK booster campaign from September onwards.

In the US, the Food and Drug Administration (FDA) authorised updated COVID-19 booster shots from both Pfizer/BioNTech and Moderna targeting both the original COVID-19 strain and the Omicron subvariants BA.4 and BA.5 on Wednesday.

In contrast to the booster vaccines against Omicron subvariant BA.1 approved by the EU and UK, the FDA approved vaccines against the BA.4 and BA.5 variants do not yet have an evaluation based on human data. The decision is instead made on data from the original vaccines as well as from the clinical trials for the boosters against the BA.1 Omicron subvariant.

[Edited by Nathalie Weatherald]

Source: Euractiv.com