Europe's drug watchdog launched an accelerated review Thursday of a COVID-19 vaccine by Franco-Austrian biotech firm Valneva, for which the EU has already signed a deal for up to 60 million doses.
The jab—which uses "inactivated" viruses rather than the new mRNA technology of the Pfizer or Moderna shots—showed in trials that it produced antibodies against coronavirus, the European Medicines Agency (EMA) said.
"EMA's human medicines committee has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva," the Amsterdam-based regulator said in a statement.
"While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review," it said.
It typically takes a few months for vaccines to go from the review stage to approval, although some such as those developed in Russia and China have been waiting longer.
The European Commission announced a deal with Valneva on November 10 to provide about 27 million doses in 2022 and 33 million in 2023.
Valneva's shares rose on that announcement, but have not completely eclipsed their losses from September, when Britain cancelled an order for 100 million doses of the jab, wiping out more than half the stock market valuation.
The Nantes-based firm has received backing from the French government, which was embarrassed by the country's failure to produce a COVID-19 jab following setbacks for national pharma champion Sanofi and the renowned Pasteur Institute.
The EMA said Valneva's studies "suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease."
"EMA will evaluate data as they become available to decide if the benefits outweigh the risks," it added.
Valneva's jab uses the same inactivated virus method as most flu and many childhood vaccines, which health officials hope could reduce vaccine scepticism about some of the newer-technology jabs.
The EMA has so far approved four vaccines for use for adults in the EU.
The US-German jab by Pfizer-BioNTech and the shot by US pharma firm Moderna use messenger RNA technology. The British-Swedish AstraZeneca-Oxford jab and Johnson & Johnson vaccine use viral vector technology.
A decision on a bid for approval by US pharma firm Novavax is expected within weeks.
https://medicalxpress.com/news/2021-12-franco-austrian-firm-valneva-covid-jab.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.