COVID19: EMA green-lights Omicron adapted booster jabs

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The European Medicines Agency (EMA) has recommended using two COVID-19 vaccines adapted against the Omicron variant by Pfizer/BioNTech and Moderna.

The so-called Comirnaty Original/Omicron BA.1 (from Pfizer/BioNTech) and Spikevax Bivalent Original/Omicron BA.1 (from Moderna) will now be sent to the European Commission for approval, after which the vaccines can be used for people aged 12 and above who have received at least primary vaccination against COVID-19.

In a statement, EU Health Commissioner Stella Kyriakides said that the two adapted vaccines are important because they will contribute to protecting Europeans against likely new waves of the virus in autumn and winter.

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

Kyriakides explained that the Commission would proceed with an accelerated authorisation of the two vaccines.

“The adapted versions of these vaccines are to be used as booster doses that target the original virus and the Omicron BA.1 sub-variant.

“They are developed to offer increased, broader protection against current and future variants.”

And the Commission expects an opinion on Omicron BA.4 and BA.5 adapted vaccines by the EMA in the coming weeks.

Its contracts with manufacturers were amended to ensure that all member states can access adapted vaccines.

“Everyone eligible for a vaccine or booster dose should get it as soon as possible.

“The pandemic is not over, but the swift development and adaptation of vaccines to respond to this virus are one of the greatest successes in the modern history of medicine.”

According to the EMA, studies showed the vaccines can trigger strong immune responses against Omicron BA.1 and the original COVID-19 strain in people previously vaccinated.

Side effects observed with the adapted vaccines were comparable to those seen with the original ones and were typically mild and short-lived.

“As the pandemic evolves, the EU’s strategy is to have a broad range of adapted vaccines that target different variants, so member states have a plurality of options to meet their needs when they design their vaccination strategies.

“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,” EMA said.

Other adapted vaccines which are supposed to protect better against other variants, such as the Omicron subvariants BA.4 and BA.5, are currently under review by the EMA.