Franco-Austrian Covid jab under EU review

A Covid-19 vaccine developed by Franco-Austrian biotech company Valneva is being assessed by the European Medicines Agency with a view to roll it out. The EU has already ordered close to 60 million doses.

An illustration picture shows vaccines made by the French-Austrian biotech firm Valneva.
An illustration picture shows vaccines made by the French-Austrian biotech firm Valneva. The EU is assessing its safety with a view to eventually rolling it out. (Photo by JUSTIN TALLIS / AFP)

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.

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French government votes to allow return of Covid tests at border

The French parliament has passed the controversial health bill which updates France's emergency provisions for Covid - and allows the return of negative Covid tests for all travellers at the border, if the health situation requires.

French government votes to allow return of Covid tests at border

The Loi sanitaire was eventually approved by the Assemblée nationale on Monday after several variations and amendments added on its passage through the Assemblée and the Senate. It was voted on and passed Tuesday, May 26th. 

The bill replaces the State of Health Emergency that has been in place since March 2020 and puts in place provision for government actions should the health situation deteriorate or a dangerous new variant of Covid emerge.

The original text had a provision for the return of the health pass at the border, but this has now been scrapped and instead the government has the right to make a negative Covid test a condition of entry for all travellers.

At present negative tests are required only for unvaccinated travellers, and the new test requirement would only be put into force if a dangerous new variant emerges.

The government will be able to implement the testing rule by decree for two months, but a further parliamentary debate would be required to extend it beyond that.

From August 1st the State of Health Emergency will be formally repealed, which means that the government no longer has the power to introduce major limits on personal freedom such as lockdowns or curfews without first having a debate in parliament.

The bill also allows for an extension of data collection required for the SI-DEP epidemic monitoring tools such as the contact tracing app Tous Anti Covid until June 30th, 2023 and Contact Covid until January 31st, 2023. 

The most controversial measure in the bill was the reinstatement of healthcare workers who were suspended for being unvaccinated – this actually only involves a couple of hundred people but medical unions and the medical regulator Haut Autorité de Santé (HAS) have both been against it.

However the bill allows for the eventual lifting of the requirement for Covid vaccination for healthcare workers, when the HAS judges it is no longer necessary and once the requirement is lifted, the suspended healthcare workers will be reinstated “immediately”.

The bill was approved on Monday evening with 184 votes to 149, the result of a joint committee that was able to harmonise the versions of the Assembly and the Senate.

The final vote passed the Senate on Tuesday.