Ema, the European drug agency, has started the rolling review, the continuous review of clinical data, of the anti-Covid vaccine Vidprevtyn, developed by Sanofi Pasteur. The EU agency reports this via social media
The European Commission had signed a pre-purchase agreement with the French pharmaceutical company and the British Gsk on 18 September 2020, the second contract signed by the EU executive after the one with AstraZeneca, to purchase up to 300 million doses. The trial had not initially given satisfactory results and the Franco-British vaccine process had stopped.
Now the EMA Committee for Medicinal Products for Human Use (CHMP) has decided to launch the ongoing review based on non-clinical laboratory data and clinical trials in adults, which “suggest” that the vaccine stimulates production of antibodies against Sars-CoV-2, and which “could” therefore protect against Covid-19, the disease caused by the virus.
The rolling review, continues the European Medicines Agency, “will continue until sufficient evidence is available” to request conditional authorization for marketing in the EU. Sanofi’s vaccine is protein-based: it contains a lab-grown version of the ‘spike’ protein, the one that allows the virus to enter human cells, and also an adjuvant, a substance that helps boost the immune system’s response to the vaccine. .
When a person receives the vaccine, their immune system recognizes the ‘spike’ protein as foreign and creates antibodies against it. If, later, the same person comes into contact with Sars-CoV-2, the immune system recognizes the ‘spike’ protein and is therefore able to protect the vaccine from the virus.