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HomeCoronavirus WatchUS and EU approval sought for new Sanofi-GSK COVID-19 vaccine

US and EU approval sought for new Sanofi-GSK COVID-19 vaccine

Sanofi and GlaxoSmithKline are applying for United States and European Union regulatory approval of a new COVID-19 vaccine after human trials showed it provided a high level of protection against the disease.

Late-stage trials found that two doses of the vaccine were about 58% effective in preventing infection and 75% effective in preventing moderate to severe disease, the companies said in a statement, reports AP News.

A separate study on the vaccine’s use as a booster showed that it “induced a significant increase in neutralising antibodies”, they said.

“The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” said Roger Connor, president of GSK Vaccines, in a statement.

The Sanofi-GSK vaccine uses “a well-established approach that has been applied widely to prevent infection with other viruses, including pandemic flu,” he said.

The drugmakers will seek regulatory approval from both the US Food and Drug Administration and the European Medicines Agency, which regulates drugs in the European Union.

The companies had planned for their vaccine to be ready last year but early trials showed it produced an “insufficient” immune response in people over 60 because it didn’t contain enough of the material that triggers the production of disease-fighting antibodies.

Late-stage trials of the current formulation of the vaccine were conducted on 10,000 adults in the US, Asia, Africa and Latin America. Full results will be published later this year.

GSK and Sanofi have signed agreements to supply millions of doses to the US, EU, Canada and developing countries.

 

AP News article – Sanofi, GSK to seek authorization for COVID-19 vaccine (Open access)

 

See more from MedicalBrief archives:

 

Sanofi/GSK trials boosts vaccine hopes; turns to SA variant

 

GSK and Sanofi plan on joint COVID-19 vaccine ready for testing this year

 

WHO: List of all global COVID-19 vaccine development projects

 

 

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