European Medicines Agency gives green light to Sanofi booster shot

Sanofi’s VidPrevtyn Beta serum has received the green light from the European Medicines Agency after positive results were recorded against the Omicron variant in clinical trials.

It’s the epilogue of a soap opera that will last two years: a vaccine against Covid-19 from the French laboratory Sanofi was approved by the European Union on Thursday, joining several other sera already approved. The European Commission has given the green light as a booster dose to VidPrevtyn Beta, based on recombinant protein technology jointly developed by Sanofi and Britain, following a positive opinion from the European Medicines Agency (EMA) on Thursday. GlaxoSmithKline. This vaccine, which showed positive results against the Omicron variant in clinical trials, was formulated with the Beta variant antigen and GSK adjuvant.

VidPrevtyn Beta is indicated for booster vaccination in adults who have previously received a messenger RNA or adenovirus vaccine against Covid-19, the lab shows. According to him, the doses are ready for distribution in the European Union countries and the United Kingdom in accordance with pre-purchase agreements covering 70 million doses.

“A booster dose of VidPrevtyn Beta should be at least as effective as Comirnaty (from Pfizer) in restoring protection against Covid-19,” the EMA said.

Two-year delay in Moderna and Pfizer/BioNtech

This new serum joins the German-American tandems Pfizer-BioNTech, Moderna, AstraZeneca, Janssen, Novavax and Valneva already approved in Europe. But before he got there, his journey was full of pitfalls. It also drew a lot of criticism for Sanofi, as the world’s vaccine specialist lab fell behind its rivals. He originally promised one billion doses by 2021, but that never materialized due to dosing issues during clinical trials. At the same time, Sanofi also tried to develop an anti-Covid vaccine using messenger RNA technology before finally giving up.

In contrast, Moderna and Pfizer/BioNtech brought their vaccines to market in record time. By the end of 2020, their serum, which uses innovative RNA technology, was approved in Europe nearly two years ahead of Sanofi. “It’s a failure compared to the speed it needs to be (…),” Sanofi president Serge Weinberg admitted before a general meeting of shareholders in May. The group responded by investing heavily in messenger RNA, with a key research center for RNA vaccines being developed in the Lyon region.

Already a very crowded market

If this epilogue was expected, could the newly approved vaccine find its way into a market already dominated by other labs? Moderna, Pfizer and BioNTech have already cut the lion’s share. For example, Pfizer made $36 billion in 2021 for a Covid vaccine. Worldwide production has even reached such a level that manufacturers such as Serum Institute of India have already stopped production due to lack of demand. In France, as the eighth wave of Covid continues, health authorities are only recommending a booster dose for people at risk of a severe form of the disease. In summary, there is already a struggle for specialists in the pharmaceutical sector.

Even Moderna lowered its 2022 sales forecast for its Spikevax vaccine a few days ago to $18-19 billion, two to three billion less than originally expected. For its part, the Franco-Austrian laboratory Valneva announced on Thursday that it would cut its workforce, cutting up to a quarter of its posts, after halting production of its own Covid-19 vaccine approved by the European Union. . If not sharpening their guns for a potential combination flu/Covid vaccine, a project that others like Sanofi, Pfizer and Moderna have already started.

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