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Sanofi and GlaxoSmithKline pushed back the timeline for rolling out their coronavirus vaccine after finding it didn’t work as well in older people.
The drugmakers’ Friday announcement created a roadblock in its race to produce a safe and effective inoculation for COVID-19 — the same day Health and Human Services Secretary Alex Azar said the FDA will grant emergency use authorization for Pfizer’s vaccine.
Sanofi and GlaxoSmithKline now expect their shot to be available in the fourth quarter of next year rather than mid-2021 following a disappointing early-stage clinical trial in the US, where the feds have ordered 100 million doses of the vaccine.
“We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data,” Thomas Triomphe, head of Sanofi’s vaccine business, said in a statement.
“We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine.”
The shot generated an immune response comparable to the one mounted by patients who had recovered from the coronavirus in people aged 18 to 49, but the response was “insufficient” in participants who were older than 50, likely because of an “insufficient concentration” of the antigen in the vaccine, the companies said.
Sanofi and GlaxoSmithKline say they’re working to improve the shot’s antigen formulation as they plan a new study that’s expected to start in February with support from the US’ Biomedical Advanced Research and Development Authority. That study will include a proposed comparison with an authorized COVID-19 vaccine, the companies said.
A large-scale, global Phase 3 trial could follow in the second quarter of next year if the new study goes well, potentially leading to regulatory submissions for the vaccine in the second half of next year, according to the companies.
Sanofi and GlaxoSmithKline said they’ve updated governments on the status of the shot along with the European Union’s European Commission, “where a contractual commitment to purchase the vaccine has been made.”
The delay puts Paris-based Sanofi and UK-based GlaxoSmithKline well behind other drugmakers that have COVID-19 shots in the works.
The Pfizer vaccine news comes a day after the FDA’s vaccine advisory committee recommended emergency approval for the shot — which could now be rolled out as early as Monday.
The committee is set to discuss Moderna’s vaccine next week, potentially allowing officials to start vaccinating Americans by the end of the year.
Sanofi’s US-listed stock price was down about 2.8 percent in premarket trading Friday at $48.34 as of 6:46 a.m., while GlaxoSmithKline’s was recently down about 0.5 percent at $37.77.