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Photo: Rafael Henrique/SOPA Images/LightRocket via Getty Images

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.

Go deeper

Jan 29, 2021 - World

EU grants conditional approval of AstraZeneca vaccine

Photo: Sunil Ghosh/Hindustan Times via Getty Images

The European Commission on Friday granted conditional approval of the Oxford-AstraZeneca coronavirus vaccine for people 18 years and older.

Why it matters: This is the third vaccine to receive approval from the commission, coming hours after the Emergency Medicines Agency recommended its authorization.

Jan 29, 2021 - Health

Ex-CDC director Tom Frieden on the next COVID-19 vaccines

Americans fortunate enough to receive COVID vaccines now, outside of clinical trials, are getting shots made by either Pfizer or Moderna. But newly released data from Novavax and Johnson & Johnson suggests that more vaccines could be on the way, with J&J's requiring a single dose.

Axios Re:Cap digs into the news and why it matters with Tom Frieden, former head of the CDC, as COVID-19 variants spread globally.

Jan 29, 2021 - Health

WHO says most pregnant women can now receive coronavirus vaccine

A doctor administering Moderna's coronavirus vaccine at a university hospital in Essen, Germany, on Jan. 18. Photo: Lukas Schulze/Getty Images

The World Health Organization has altered its guidance for pregnant women who wish to receive the coronavirus vaccine, saying now that those at high risk of exposure to the COVID-19 or who have comorbidities that increase their risk of severe disease, may be vaccinated.

Why it matters: The WHO drew backlash for its previous guidance that did not recommend pregnant women be inoculated with vaccines made by Pfizer-BioNTech or Moderna, even though data indicated that pregnancy increased the risk of developing severe illness from the virus.