GlaxoSmithKline and Sanofi COVID-19 vaccine delayed until late 2021
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GlaxoSmithKline and Sanofi announced on Friday that their coronavirus vaccine program would be delayed until late 2021 in order to improve immune response in older adults.
Why it matters: It's a blow to hopes that the U.S. will have an array of vaccines available for distribution by early 2021. The Trump administration's Operation Warp Speed paid the companies $2.1 billion over the summer to cover some manufacturing costs and purchase an initial batch of 100 million doses.
The state of play: GlaxoSmithKline and Sanofi said they plan to launch another study in February that will include comparing its vaccines to an authorized one. If the results are promising, Phase 3 trials — which were scheduled to begin next month — could start in the second quarter of next year, moving the vaccine's possible availability to the third or fourth quarter.
- The companies said "interim results showed an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years."
- "Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups," they added.
- The new study will receive support from Operation Warp Speed and the Biomedical Advanced Research and Development Authority.
The big picture: At the moment, only Pfizer's and Moderna's vaccines await an emergency use authorization (EUA) from the Food and Drug Administration.
- An FDA advisory panel on Thursday recommended that the agency proceed with issuing an EUA, which could come as soon as this weekend.
- Earlier this week, it was revealed that the federal government had declined an offer from Pfizer to purchase more doses, saying it was "confident" they'd receive enough doses from Pfizer and other manufacturers, including Moderna.
What they're saying: "[W]e are disappointed by the delay announced today," Thomas Triomphe, head of Sanofi, said. "We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine."
- "The results of the study are not as we hoped ... It is also clear that multiple vaccines will be needed to contain the pandemic," Roger Connor, president of GlaxoSmithKline Vaccines, said.
