EMA Starts Rolling Review of Sanofi-GSK Covid Shot
The human medicines committee of the European Medicines Agency, CHMP, has begun a rolling review of the Covid-19 vaccine developed by Sanofi Pasteur, which following approval is planned to be marketed by drugmaker Sanofi and UK pharma Glaxo SmithKline.
The committee said it decided to begin the review based on preliminary results from non-clinical data (lab results) and early clinical studies with the shot, now branded as Vidprevtyn, in adults that suggest the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes Covid-19.
If the EMA body determines that the benefits of the vaccine outweigh the risks, the manufacturer can apply for conditional marketing authorization. Other Covid-19 vaccine candidates currently in the EU's rolling review process include candidates made by CureVac (Germany), Novavax (US,) Sinovac (China) and Sputnik V (Russia).
Late-stage global trials for the protein-based coronavirus vaccine candidate began in May, and Sanofi and GSK hope to gain approval by the end of 2021. Sanofi said other rolling reviews are about to start in the UK, Canada and Singapore, as well as with the World Health Organization. Brazil has just given the go-ahead for a trial there. Vidprevtyn, which uses the same technology as one of Sanofi's seasonal influenza vaccines, will be coupled with an adjuvant made by GSK.
In May, the French drugmaker said the Phase 3 trials with an10 µg dose would assess the efficacy of two vaccine formulations, including the original Wuhan virus and the beta variant first observed in South Africa.
In parallel, the companies plan to launch booster studies with various variant formulations to see whether a lower dose of the vaccine will generate a strong booster response regardless of the initial vaccine platform received.
The US Biomedical Advanced Research and Development Authority (BARDA), the emergency preparedness arm of the US Department of Health and Human Services and the Defense Department, are financially backing the joint effort of the two European players to the tune of $2.1 billion.
Separately, Sanofi is developing an mRNA-based vaccine in cooperation with US biotech Translate Bio.
Author: Dede Williams, Freelance Journalist
