EU watchdog says supports fast development of Omicron-only vax

The European Union’s drug regulator said on Thursday it would support a filing for approval of an upgraded COVID-19 vaccine targeting only the new Omicron variant if that is the quickest way to broaden the offering of available shots.

Speaking to journalists in a briefing, the European Medicines Agency’s (EMA) head of vaccines strategy, Marco Cavaleri, reiterated that he encouraged pharmaceuticals companies to explore not only a monovalent shot tailored to the Omicron variant but also versions that address a combination of variants.

Testing several vaccines in clinical trials would be “the most robust way forward,” said Cavaleri.

“But at the same time, if an Omicron monovalent vaccine can be put into clinical trials rapidly, I think we can only support that.”

Pfizer and partner BioNTech last month started a clinical trial to test a new version of their vaccine specifically designed for Omicron, which has eluded some of the protection provided by the original two-dose vaccine regimen.

In the briefing, Cavaleri added that it was uncertain whether vaccine candidates from French biotech firm Valneva and by a partnership of Sanofi and GlaxoSmithKline could win approval by Easter, or mid-April.

“We need really to look into the results of such clinical trials and to make an assessment, including having a good understanding of whether the data will be covering the entirety of the adult population or if they will be restricted,” he said.

The vaccines, if they pass muster, would broaden the availability of shots based on more conventional medical technology such as Novavax’s Nuvaxovid, which won EU clearance in December.

The widely used Pfizer/BioNTech and Moderna shot are based on novel mRNA technology. CGTN