Morning Briefing
Summaries of health policy coverage from major news organizations
Sanofi, GSK To Seek Covid Vaccine Approval, Citing 100% Protection Against Hospitalization
The New York Times: A New Covid Vaccine Shows 100 Percent Efficacy Against Severe Disease And Hospitalizations, Its Makers Say
Two doses of a new Covid vaccine that is based on a conventional approach achieved 100 percent efficacy against severe disease and hospitalizations, and it could be an effective booster after other Covid shots, the vaccine’s manufacturers announced on Wednesday. The vaccine, made by the Europe-based pharmaceutical companies Sanofi and GSK, is one of four candidates that received billions of dollars for development from Operation Warp Speed, the Trump administration’s program to accelerate vaccines. (Mandavilli, 2/23)
AP: Sanofi, GSK To Seek Authorization For COVID-19 Vaccine
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. A separate study on the vaccine’s use as a booster showed that it “induced a significant increase in neutralizing antibodies,” they said. “The evolving epidemiology of COVID-19 demonstrates the need for a variety of vaccines,” Roger Connor, president of GSK Vaccines, said 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. “We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period.” (Kirka, 2/23)
Reuters: Sanofi, GSK To Seek Approval For Covid Vaccine Candidate That Prevents 100% Of Hospitalizations
The companies said on Wednesday they intended to submit data to regulators from a late-stage trial of the vaccine, and another testing it as a booster, with full results for both studies expected to be published “later this year.” Sanofi is hoping for a comeback after falling behind in the race for Covid-19 shots, while GSK, the world’s biggest vaccine maker by sales, has not developed its own candidate and is instead supplying its adjuvant technology to developers. (2/23)
Meanwhile a different GSK drug is in the news —
Reuters: U.S. FDA Limits Use Of GlaxoSmithKline-Vir COVID-19 Drug
The U.S. Food and Drug Administration said on Wednesday GlaxoSmithKline (GSK.L) and Vir Biotech's (VIR.O) COVID-19 antibody treatment should not be used in places with circulation of variants that are not susceptible to the drug. Vir has said the drug, sotrovimab, retains neutralizing activity against the emerging BA.2 form of the Omicron coronavirus variant. However, other recent research suggests that the variant showed resistance to nearly all of the monoclonal antibodies they tested, including sotrovimab. (2/23)
