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* Monovalent development welcome if it is the fastest
option-EMA
* EMA continues to prefer research into several vaccine
upgrades
* Approval of Valneva, Sanofi vaccines before easter not
certain
(Adds details on vaccine developers)
By Ludwig Burger and Manojna Maddipatla
Feb 3 (Reuters) - 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.
(Reporting by Ludwig Burger and Manojna Maddipatla; editing by
Jason Neely, William Maclean)
