European Regulator Willing To Use COVID-19 Boosters Targeting Omicron Variants

At a press briefing, the European Medicines Agency (EMA) said it is open to using updated COVID-19 vaccines that target older omicron variants this Fall, amid a rise in cases due to new omicron subvariants.

The agency notes that the existing vaccines provide good protection against hospitalization and death, but vaccine effectiveness has dwindled as the virus has evolved. 

The EMA expects new COVID vaccine boosters to be approved by September.

Related: Pfizer/BioNTech's Updated Omicron-Based COVID-19 Shots Show Improved Response Against Variant.

"Vaccines designed to target the newer BA.4 and BA.5 strains of omicron, currently driving a surge in new infections globally, have only recently entered clinical development, so how quickly any such vaccine could be made available is also a consideration," said Marco Cavaleri, EMA's head of health threats and vaccines strategy.

"That's why for the time being, we still think that it's very good to keep all options open and not to exclude any of these candidates from any potential approval," he told a press briefing.

EMA officials noted that vaccine makers have indicated they could run two production lines for the adapted vaccines in case of differing regulatory requirements in Europe and the U.S.

When asked about the vaccine update for babies aged six months - 5 years, the official said they are already reviewing Moderna Inc's MRNA vaccine. However, a decision is expected only after the summer break.

On Pfizer Inc PFE and BioNTech SE's BNTX vaccine, the official mentioned that the data assessment is starting now, and an opinion is expected at the beginning of Fall.

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