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Sanofi and GlaxoSmithKline have launched a new study of their coronavirus vaccine after a previous trial produced disappointing results.
The drugmakers pushed back the rollout of their experimental COVID-19 shot in December because a study found it generated an “insufficient” immune response to the virus in people older than 50 years.
The companies have now tweaked the vaccine’s formulation and plan to test three different dosages in the new Phase 2 study of 720 adults in the US, Honduras and Panama, according to a Monday news release.
“We are confident that our vaccine candidate has strong potential and we are very encouraged by the latest preclinical data,” Thomas Triomphe, the head of Sanofi’s vaccine business, said in a statement. “This new Phase 2 study will enable us to identify the final vaccine formulation for adults of all ages.”
If the study goes well, Sanofi and GlaxoSmithKline plan to launch a large-scale Phase 3 trial in the spring and seek regulatory approval in the second half of this year.
The vaccine — which will be administered in two shots given three weeks apart in the Phase 2 study — would be made available in the final three months of 2021 if it’s approved, the European companies said.
Sanofi and GlaxoSmithKline are trailing other drugmakers in the race to distribute COVID-19 inoculations despite being two of the world’s biggest vaccine businesses.
Sanofi separately said Monday that it will help Johnson & Johnson manufacture its one-dose coronavirus vaccine, which is currently awaiting an emergency use authorization from the Food and Drug Administration.
Sanofi expects its factory in Marcy l’Etoile, France to churn out about 12 million doses of Johnson & Johnson’s shot per month.
The Paris-based company has also announced plans to help Pfizer and BioNTech produce more than 125 million doses of their vaccine, which is currently being distributed in the US.
Sanofi’s stock price dropped 0.2 percent in premarket trading Monday to $46.53 as of 7:39 a.m., while GlaxoSmithKline shares were recently trading roughly flat at $34.42.