EU Approves Sanofi/GSK Covid Booster
The partners said they had been working with European regulators for more than a year. In July 2022, the EMA initiated a rolling review.
Advance purchased quantities of VidPrevtyn Beta, the first of the next-generation protein-based vaccines to be approved in Europe, are ready to be distributed to 20 EU member states, Sanofi and GSK said.
The companies, which are recommending the vaccine as a booster for active immunization of adults aged 18 and older who have previously received an mRNA or adenoviral Covid shot, have also contracted to supply the UK and Canada. The size or price of the orders has not been revealed.
The monovalent recombinant-protein vaccine developed by Sanofi is modeled on the Beta variant of Covid and includes GSK’s adjuvant. The French drugmaker said it is based on the same recombinant-protein technology used for its seasonal flu vaccines approved in Europe.
According to the development partners, the vaccine is designed to provide broad protection against multiple variants of the SARS-CoV-2 virus. In registration studies carried out when predominantly omicron stains were in circulation, they said the shots induced a strong immune response.
The studies included a Phase 3 primary efficacy trial and two separate immunogenicity studies, including one comparative study with an approved mRNA booster as comparator.
In the independent Coviboost study, a Paris hospital investigated the efficacy of the Sanofi/GSK booster following primary vaccination with two doses of Pfizer/BioNTech’s originally approved Covid vaccine BNT162b2. Sanofi said VidPrevtyn Beta generated a higher immune response in the 247 adult subjects aged 18 to 73 years than Pfizer/BioNTech’s approved booster or the Sanofi-GSK first-generation booster.
Author: Dede Williams, Freelance Journalist