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In interviews with CNN, several U.S. government vaccine advisers said there are many questions to be expected when and if AstraZeneca applies to the U.S. Food and Drug Administration for emergency use authorization for its vaccine. Covid-19.
Advisers did not question the fact that AstraZeneca’s vaccine would ultimately gain emergency use clearance from the FDA. They said, however, that the company’s app would likely raise issues that did not arise when the three Covid-19 vaccines currently in use in the United States – manufactured by Pfizer, Moderna and Johnson & Johnson – called for their own emergency. . use permissions.
“It is clear that more questions have been raised about the AstraZeneca vaccine than any of the other vaccines that are now authorized in the United States,” said Dr. Arnold Monto, Acting Chairman of the Vaccine Advisory Board and related biologics from the FDA.
More than a dozen European countries have suspended their AstraZeneca vaccine deployments over concerns over blood clots, although many are now relaunching the programs after the European medicines regulator said it was safe to use it Thursday.
There were also concerns about a mistake made in their clinical trial last year and efficacy data that raised questions. In addition, South Africa has suspended use of the vaccine because health officials said it was not effective enough against the variant identified there.
“It was the vaccine that had one problem after another,” said Dr. William Schaffner, liaison member of the CDC’s Advisory Committee on Immunization Practices.
As more and more European countries have suspended their AstraZeneca vaccine deployments, the company, as well as international health agencies, has defended it.
“Everyone’s safety is our top priority,” an AstraZeneca statement said on Wednesday. “Around 17 million people in the EU and UK have now received our vaccine, and the number of blood clot cases reported in this group is lower than the hundreds expected in the general population.
The World Health Organization, UK health authorities and the European Medicines Agency have all expressed support for the AstraZeneca vaccine, saying its benefits outweigh any risks.
AstraZeneca plans to ask the FDA to clear its Covid-19 vaccine for emergency use in March or early April, sources familiar with the company’s ongoing clinical trial told Reuters.
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