(adds Valneva comment on Omicron variant)
Dec 2 (Reuters) - The European Union's drug regulator said
on Thursday it had started a rolling review of the protein-based
COVID-19 vaccine from French biotech firm Valneva,
weeks after the EU signed a deal with the company for supplies
of the shot.
The decision to start the real-time review - which could
speed up approval of the shot - was based on preliminary studies
that suggest the vaccine, VLA2001, triggers an antibody response
against the coronavirus, the European Medicines Agency (EMA)
said in a statement. https://www.ema.europa.eu/en/news/ema-starts-rolling-review-valnevas-covid-19-vaccine-vla2001
Valneva said it was hopeful its vaccine candidate would
cross protect people against variants of the virus, adding it
would test it specifically against Omicron.
"Valneva believes that VLA2001 can make an important
contribution to the global fight against the COVID-19 pandemic
and potentially play a role in protecting against the new
Omicron variant," the company said.
COVID-19 vaccines from Sinovac, Sanofi-GSK
and Russia's Gamaleya Institute are also under the EMA's
rolling review, which aims to speed up possible approvals by
studying data as it becomes available.
Unlike vaccines by Pfizer-BioNTech ,
AstraZeneca, Johnson & Johnson and vaccine
candidate Novavax, the Valneva shot exposes the immune system to
the entire coronavirus, not just the spike protein.
Experts hope that could potentially make the immune response
to that shot less sensitive to large mutations on the spike
protein.
The European Commission last month signed its eighth deal
for a COVID-19 vaccine https://www.reuters.com/business/healthcare-pharmaceuticals/french-company-valneva-wins-deal-with-european-commission-over-covid-19-vaccines-2021-11-10
with Valneva, under which the company would supply up to 60
million doses of the shot over two years.
Valneva said in October its vaccine demonstrated efficacy
"at least as good, if not better" than AstraZeneca's shot in a
late-stage trial comparing the two, with significantly fewer
adverse side effects.
AstraZeneca's vaccine is already approved in the EU, as are
shots from Pfizer-BioNTech, Moderna and Johnson &
Johnson.
(Reporting by Pushkala Aripaka in Bengaluru and Silvia Aloisi
in Paris; Editing by Susan Fenton)