Good news for Sanofi Pasteur’s Covid-19 vaccine. The European Medicines Agency (EMA) announced on Tuesday, July 20, 2021, the launch of a continuous review procedure for the pharmaceutical laboratory’s vaccine. This could pave the way for a future authorization request in the European Union.
The EMA announces the launch of a continuous review procedure for the Sanofi Pasteur vaccine
Yesterday, the European Medicines Agency (EMA) announced that it had started a continuous review procedure for the Covid-199 vaccine developed by the French Sanofi Pasteur. In a press release, the European regulator declared: “ EMA’s Committee for Medicinal Products for Human Use has launched an ongoing review of Vidprevtyn, a Covid-19 vaccine developed by Sanofi Pasteur “.
This decision follows preliminary results from studies that have been conducted in the laboratory and clinical studies performed in adults. According to the EMA, 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 “. As a reminder, the vaccine called Vidprevtyn is based on the same recombinant protein-based technology as the influenza vaccines developed by the pharmaceutical group Sanofi. An adjuvant intended to stimulate the immune system and manufactured by GSK is associated with it.
The French vaccine available at the end of the year?
The continuous review procedure launched by the European Medicines Agency will enable it to study the safety and efficacy data of the Sanofi Pasteur vaccine and to speed up the assessment of a formal application for authorization to use it. on the market. Indeed, the EMA explained that it would continue its procedure until it has sufficient information for the laboratory to be able to submit a formal application for marketing authorization.
Regarding the dates, the European regulator declared that “ The EMA cannot foresee an overall timeline but the assessment of a possible application should take less time than usual due to the work carried out during the continuous review “. At the beginning of July, the president of Sanofi France, Olivier Bogillot had indicated that the Sanofi Pasteur vaccine should be available on the market by December. Which would make it the fifth vaccine authorized in the European Union. So far, only four vaccines have been approved for use in Europe: Pfizer-BioNTech, Moderna, AstraZeneca and Johnson & Johnson.
