AstraZeneca could abandon US regulatory efforts for COVID-19 vaccine

pharmafile | March 18, 2022 | News story | Medical Communications  

The Oxford/AstraZeneca vaccine has not yet been approved in the US, and has not been submitted for Emergency Use Authorisation (EUA) to the FDA. There are suggestions that this will never happen.

In April 2020, AstraZenea and the University of Oxford appeared to be ahead of other major players in developing a COVID-19 vaccine. The Jenner Institute at Oxford had tested a vaccine for an earlier coronavirus in 2019, proved it was not harmful to humans and demonstrated its effectiveness in macaque monkeys in the National Institutes of Health’s Rocky Mountain Laboratory in Montana.

In March 2021, the company reported results from a US Phase III trial of the vaccine, demonstrating 79% efficacy at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalisation. However, there were then issues raised about the Data and Safety Monitoring Board (DSMB) that was supervising the trial, implying that some of the data was potentially outdated and incomplete.

There were also issues raised regarding rare blood clots in some patients after it had been authorised in other parts of the world. As a result, during April 2021, numerous countries put a pause on distributing the vaccine, whilst the blood clotting claims were evaluated.

“We don’t need to push it in places we are not needed or wanted,” Pangalos told the Financial Times. “If we don’t end up submitting it for a BLA (Biologics License Application), I don’t think it will have an impact around the world.”

Over 70% of the eligible US population has already been vaccinated with shots from Moderna, Johnson & Johnson, or Pfizer-BioNTech. AstraZeneca also indicated that it was going to focus on providing vaccines for low income countries.  

As it stands, AstraZeneca has delivered approximately 2.6 billion doses of its vaccine.

Lina Adams

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