Soon a Covid vaccine for Sanofi… The French drugmaker announced this Wednesday February 23, 2022, some positive results for the phase 3 of their clinical trial although they have not been made publilc yet, and intends to seek approval for marketing their vaccine to the FDA and the European Medicines Agency. "Sanofi and GSK will seek regulatory authorization for Covid-19 vaccine", the two laboratories announced in a joint statement.
A vaccine which effectiveness is said to be slightly over 50% against "all the infections causing symptoms", the AFP explains. The effectiveness is also "similar to the effectiveness of vaccines already available", Sanofi explains, at this point in time, as the latest variants made the vaccines less effective.
As for the first injections, they are to occur from ealry March, as the Health Minister explained this Tuesday February 22. In all, about 1.1 million doses are to be delivered to France in the coming days, "February 23, 24 or 25", the minister said.
In a press brief held this Tuesday November 30, Health Minister addressed the arrival of the French avccine on the market, explaining the likely "conditional marketing authorization by the end of the year" with "the first doses delivered in January 2022". According to Sanofi, the "plan remains unchanged", as said by our peers in Libération. But what a sudden development! The vaccine might actually be issued in the first six months of 2022, after the release of the final results. The phase 3 clinical trial is still on... It delivered the primary results this Wednesday December 15, 2021 showing: "an increase in neutralizing antibodies, for all vaccins given in prime-vaccination (mRNA or adenovirus), from 9 to 43 times, in all age groups including a good safe and tolerance profile", a release reads.
"These primary data show we have a solid booster shot candidate vaccine and whatever vaccine is given first", Sanofi head of vaccine unit Thomas Triomphe explains. Anyway, the production has started: "We did not wait for the results of phase 3 and the regulatory approvals to start producing", a Sanofi representative told CheckNews - Libération, adding: "we have launched the production of our vacine to immediately attend to the demand once it has been approved".
This Tuesday July 20, the EMA – European Medicines Agency – said they are to launch a rolling review of French laboratory candidate vaccine created in partnership with UK group GSK. A review leading to marketing issuance if results of the ongoing phase 3 of the clinical trial are good and meeting safety criteria required by the European Union. “EMA’s human medicines committee has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur”, the regulator said in a release.
A decision to launch the review also based on the trial’s primary results, revealed by the laboratory several weeks ago which “suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease”, as the European regulator explains. The review also aims at enabling Sanofi to seek approval for issuance as soon as possible.
“EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review”, the European Medicines Agency goes on. For the record, to date, four Covid vaccines have been approved for marketing in Europe: Pfizer/BioNTech, Moderna, Johnson & Johnson, and AstraZeneca. Sanofi vaccine could be the fifth. Marketing could occur from late 2021.