LONDON – Drugmakers Sanofi and GlaxoSmithKline said Wednesday they will seek regulatory approval for a new COVID-19 vaccine after human trials showed it provides a high level of protection. against this disease.
Late-stage trials show two doses of the vaccine to be about 58% effective at preventing infection and 75% effective at preventing moderate to severe illness, the companies said in a statement. . A separate study using the vaccine as a booster found that it “caused a significant increase in neutralizing antibodies,” they said.
Roger Connor, president of GSK Vaccines, said in a statement: “The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines.
“The Sanofi-GSK vaccine uses ‘a good practice that has been widely used to prevent infection with other viruses including pandemic influenza,'” he said. can play an important role as we continue to tackle this pandemic and prepare for the post-pandemic era.”
The drugmakers said they plan to seek regulatory approval from both the US Food and Drug Administration and the European Medicines Agency, the regulator of medicines in the European Union. Europe.
The companies planned to have their vaccines ready last year, but early trials showed the vaccine produced an “insufficient” immune response in people over 60 because it did not contain enough. material that activates the production of antibodies against disease.
Late-stage trials of the current vaccine formulation have been conducted in 10,000 adults in the US, Asia, Africa and Latin America. The companies did not provide a breakdown of vaccine effectiveness for different age groups. Full results from the study will be published later this year.
Authorizing vaccines will boost efforts to combat a pandemic that has killed more than 5.9 million people worldwide as existing vaccine makers struggle to produce enough. Dosage meets need. GSK and Sanofi have signed agreements to supply millions of doses of the drug to the US, EU, Canada and developing countries.
