After the announcement of the EMA, the steps before the arrival of the vaccine from Sanofi Pasteur

It is a decision paving the way for a possible application for future authorization in the European Union. The European Medicines Agency (EMA) announced on Tuesday the launch of a “continuous review” procedure for the Covid-19 vaccine from the French pharmaceutical company Sanofi Pasteur.

“The EMA’s Committee for Medicinal Products for Human Use has launched an ongoing review of Vidprevtyn, a vaccine against Covid-19 developed by Sanofi Pasteur,” the Amsterdam-based European regulator said in a statement. The EMA’s decision to start the continuous review is based on preliminary results from laboratory studies and clinical studies in adults, the regulator explains. These results “suggest that the vaccine triggers the production of antibodies that target Sars-CoV-2, the virus that causes Covid-19, and could help protect against the disease,” adds the EMA.

Vidprevtyn is based on the same recombinant protein technology as Sanofi’s influenza vaccines. This is combined with an adjuvant intended to stimulate the immune system and manufactured by GSK.

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A vaccine available by December?

On May 27, the laboratory announced in a press release the start of phase III clinical trials, the final phase before possible authorization on the European market. In this international phase III, randomized, double-blind, placebo-controlled study, more than 35,000 volunteers aged 18 and over were to be recruited from different countries, including the United States and several countries in Asia. , Africa and Latin America, specified Sanofi and GSK. The study firstly evaluates “the effectiveness of the vaccine formulation targeting the original D.614 virus” then “a second formulation targeting the B.1.351 variant (or South African variant)”.

The continuous review procedure allows the EMA to study the safety and efficacy data of vaccines as they become available and to speed up the assessment of a formal marketing authorization application. . The European agency will continue its procedure until it has sufficient information for the laboratory to be able to submit a formal application for marketing authorization. “The EMA cannot foresee an overall timetable but the assessment of a possible application should take less time than usual due to the work carried out during the continuous review”, according to the agency. Sanofi France President Olivier Bogillot said in early July that the vaccine should be available by December.

Another vaccine against Covid-19 – this time with messenger RNA technology – is being developed by Sanofi with the American biotech Translate Bio, with which it has been collaborating since 2018. But it is only at the beginning human trials. To live up to its ambitions, the group will intensify its partnership with Translate Bio. Per tranche of 400 million per year by at least 2025, Sanofi is preparing to invest massively in messenger RNA, a technology now well known to the general public because it is used for the development of the first vaccines against Covid-19 such as those of Pfizer-BioNTech and Moderna.

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Four vaccines are currently authorized by the EMA in the EU: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson – the latter two are used under certain age conditions in most European countries.



Column Donner CREDIT: LAURA ACQUAVIVAChristophe Donner


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