the approved Sanofi vaccine, epilogue of a series with twists and turns

the approved Sanofi vaccine, epilogue of a series with twists and turns

This is the epilogue of a soap opera that will have lasted two years: the vaccine against Covid-19 from the French laboratory Sanofi was approved by the European Union on Thursday, joining several other serums already authorized.

In accordance with the positive opinion issued by the European Medicines Agency (EMA) on Thursday, the European Commission has given the green light as a booster dose to VidPrevtyn Beta, based on so-called recombinant protein technology, jointly developed by Sanofi and the British GlaxoSmithKline.

This vaccine, which has shown positive results against the Omicron variant in clinical trials, is formulated with the Beta variant antigen and GSK’s adjuvant.

VidPrevtyn Beta is indicated for booster vaccination in adults who have previously received a vaccine against Covid-19 with messenger RNA or adenovirus, indicates the laboratory. The doses are ready for distribution in European Union countries and the United Kingdom, in accordance with advance purchase agreements, covering 70 million doses, he said.

“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 in a statement.

This new serum joins those of the German-American tandem Pfizer-BioNTech, Moderna, AstraZeneca, Janssen, Novavax and Valneva, already approved in Europe. But before getting there, his journey was strewn with pitfalls. This has also earned many criticisms for Sanofi, as the laboratory, yet a world specialist in vaccines, has fallen behind its competitors.

While he originally promised a billion doses in 2021, these never materialized, due to a dosing issue during clinical trials. At the same time, Sanofi also tried to develop an anti-Covid vaccine using messenger RNA technology, before finally giving up.

Conversely, Moderna and Pfizer/BioNtech brought their vaccines to market in record time. By the end of 2020, their serums, using innovative RNA technology, were approved in Europe, almost two years before that of Sanofi.

“It is, it must be recognized, a failure (…) compared to the speed that was needed”, admitted the president of Sanofi, Serge Weinberg, before the general meeting of shareholders, in May. The group has in response invested heavily in messenger RNA, with the key to a research center for RNA vaccines in development in the Lyon region.

– What market? –

If this epilogue was expected, can the new vaccine just approved find its place in this market already largely dominated by other laboratories? Moderna, Pfizer and BioNTech have already carved out the lion’s share. For example, Pfizer earned $36 billion in 2021 for its Covid vaccine.

Production around the world has even reached such levels that manufacturers have already ceased production due to lack of demand, such as the Serum Institute of India. In France, while the eighth wave of Covid is underway, health authorities recommend a booster dose only for people at risk of a severe form of the disease. In summary, for specialists in the pharmaceutical sector, the battle has already been fought.

Even Moderna a few days ago lowered its sales forecast for its Spikevax vaccine for 2022, which will bring in 18 to 19 billion dollars, two to three billion less than initially expected.

For its part, the Franco-Austrian laboratory Valneva announced on Thursday that it was going to cut its workforce, to cut up to a quarter of the posts, after ceasing production of its own Covid-19 vaccine, authorized by the European Union in June.

Unless it is also for Sanofi to sharpen its weapons for a potential combined influenza / Covid vaccine, a project in which others have already embarked, such as Pfizer and Moderna.