Topline
European drugmakers Sanofi and GSK kicked off Phase 3 clinical trials for their Covid-19 vaccine Thursday following promising results from earlier trials indicating “strong immune response(s)” and the potential for the vaccine to be used as a booster shot, meaning another Covid shot could be available later this year.
Sanofi and GSK are beginning Phase 3 trials for their Covid vaccine
Key Facts
The Phase 3 study will include more than 35,000 adults in the U.S., Africa, Asia and Latin America, the companies said in a statement Thursday.
The two-part trial aims to assess the vaccine’s effectiveness against the original strain of Covid-19 and the B.1.351 variant first identified in South Africa.
Sanofi said there is recent evidence suggesting protection against the South African variant possibly helps protect against other variants of the virus as well.
Assuming favorable trials and regulatory review, the shot could be approved in the last quarter of 2021, Sanofi said.
In addition to the broader vaccine trial, Sanofi said a separate trial exploring the vaccine’s potential as a booster shot is due to start in the coming weeks “to complement” the Phase 3 trial.
The trial marks a change in fortunes after disappointing results prevented the companies from joining the first coterie of Covid-fighting vaccines.
Crucial Quote
The vaccine has been developed based on “forward-looking considerations as the virus continues to evolve,” the head of Sanofi’s vaccine unit Thomas Triomphe said. Triomphe added the companies were “anticipating what may be needed in a post-pandemic setting,” alluding to the concurrent booster shot trial.
Key Background
Sanofi and GSK didn’t manage to bring a Covid-19 vaccine to market in time for the first wave of inoculations after disappointing early trials, a source of embarrassment for one of France’s most lauded companies and a big setback to the European—and global—vaccine drive. The companies were expected to be a major supplier and had arrangements in place for hundreds of millions of doses in the U.S., the EU, and the U.K. While developing the shot, Sanofi agreed to help a number of other manufacturers produce approved shots.
Big Number
1 billion. Earlier estimates by the companies expected that this many doses of vaccine could be produced a year. It is unclear whether this figure is accurate in light of the assistance each is providing to other vaccine-producing companies.
Further Reading
GSK And Sanofi Pledge 200 Million Vaccine Doses To Covid-19 Alliance (Forbes)
Sanofi-GSK Covid-19 Vaccine Delayed After Trials Show Poor Immune Response In Elderly (Forbes)
