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Home›Development agency›EU watchdog says it backs rapid development of an Omicron-only vaccine

EU watchdog says it backs rapid development of an Omicron-only vaccine

By Suk Bouffard
February 3, 2022
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  • Monovalent development welcome if it is the fastest option-EMA
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Feb 3 (Reuters) – The European Union’s medicines regulator said on Thursday it would support an application for approval of an improved COVID-19 vaccine targeting only the new Omicron variant if that is the fastest way expand the range of available vaccines.

Speaking to reporters at a briefing, European Medicines Agency (EMA) Head of Vaccine Strategy Marco Cavaleri reiterated that he encouraged pharmaceutical companies to explore not only a monovalent vaccine suitable for the Omicron variant, but also versions that deal with a combination of variants.

Testing multiple vaccines in clinical trials would be “the strongest path,” Cavaleri said.

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

Pfizer (PFE.N) and its partner BioNTech launched a clinical trial last month to test a new version of their vaccine specially designed for Omicron, which escaped some of the protection offered by the original two-dose vaccine schedule. Read more

In the briefing, Cavaleri added that he was unsure whether vaccine candidates from French biotech firm Valneva (VLS.PA) and a partnership between Sanofi (SASY.PA) and GlaxoSmithKline (GSK.L) can be approved by Easter or mid-April.

“We really need to look at the results of these clinical trials and make an assessment, including having a good understanding of whether the data will cover the entire adult population or whether it will be restricted,” he said.

The vaccines, if successful, would expand the availability of vaccines based on more conventional medical technologies such as Novavax’s Nuvaxovid (NVAX.O), which won EU clearance in December.

The widely used Pfizer/BioNTech and Moderna injections are based on new mRNA technology.

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Reporting by Ludwig Burger and Manojna Maddipatla; edited by Jason Neely, William Maclean

Our standards: The Thomson Reuters Trust Principles.

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