Topline
European pharma heavyweights Sanofi and GlaxoSmithKline on Wednesday said their hotly-anticipated Covid-19 vaccine will be delayed until 2022 to complete a clinical trial, adding the shot works as a booster—but the companies are yet to demonstrate how well their vaccine works against Covid-19 infection.
Sanofi and GSK announced positive results for their booster shot trial.
Key Facts
A single booster dose of the Sanofi and GSK Covid-19 vaccine provokes a “strong immune response” and has “a good safety and tolerability profile,” according to early data from a clinical trial, the companies said.
The companies said they plan to file booster data with regulators following results from main clinical trials, expected in the first quarter of 2022.
Regulators often require data on how well the shot can protect against infection when used on its own before approving it as a booster, the companies explained.
An advisory board recommended the companies delay the late-stage trial until more participants contract Covid to get more data on the shot’s efficacy.
Key Background
Sanofi and GSK are two of the biggest hitters in the pharmaceutical world and could still play a significant role in tackling the pandemic. Their failure to bring a vaccine to market during the first wave of shots was, in Sanofi’s case, a source of embarrassment to France and a major dent to the global vaccine drive. The two were expected to be a major supplier of shots and had arrangements in place for hundreds of millions of doses in the U.S., the EU, and the U.K. The shot relies on an older vaccine technology that differs from the newer technology used in vaccines by Moderna, Pfizer and AstraZeneca.
Crucial Quote
Thomas Triomphe, who heads Sanofi Pasteur, the company’s vaccines division, said: “These preliminary data show we have a strong booster candidate, whatever primary vaccine you have received.” Triomphe said it was a challenge pursuing late-stage clinical trials in a “quickly shifting environment” but added the booster findings are relevant to “evolving public health needs.”
