AstraZeneca says its coronavirus vaccine is up to 90% effective
Operation Warp Speed director says vaccinations could begin in mid-December; Laura Ingle reports.
While Oxford University and AstraZeneca announced Monday that their coronavirus vaccine candidate reached up to 90% efficacy in a late-stage clinical trial, the vaccine still requires regulatory approval before distribution.
In the U.S., for example, the Food and Drug Administration (FDA) requires that companies submit at least two months worth of safety data for emergency approval.
Another company on the vaccine front, Pfizer, announced that it reached this mark last week and disclosed plans to file for FDA emergency approval last Friday. The FDA also announced a meeting scheduled for Dec. 10 to discuss Pfizer's request for emergency use authorization, or EUA.
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Therefore, it is still too early to say with certainty that the larger public will benefit from Oxford-AstraZeneca’s vaccine, given it has yet to see regulatory approval.
Nevertheless, findings from a Phase 2 trial published in the peer-reviewed journal The Lancet last week showed that the Oxford-AstraZeneca vaccine induced an immune response and was better tolerated among older adults over age 70. Younger participants experienced side effects like pain at the vaccine's injection site, fever and muscle ache more often.
Further, the goal of the Oxford-AstraZeneca vaccine was to protect against COVID-19 disease, not necessarily SARS-CoV-2 infection.
In fact, last week, Dr. Anthony Fauci, the nation's leading infectious disease expert, stressed that now is the time to double-down on public health measures, as it is not clear what impact the eventual vaccine may have on disease transmission.
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In a virtual discussion hosted by The Hastings Center on Thursday, Fauci explained that the vaccines are being evaluated to see if they prevent clinically apparent disease in the individual, and also if it prevents severe disease in a person who was inoculated.
He compared it to trials involving the annual influenza vaccine. The jab can prevent you from getting sick, but not necessarily from being infected, although the patient may not know they have been infected because they won't develop symptoms. The same concept applies to the COVID-19 vaccine, Fauci said.
“The issue is that you’re not going to be completely protected against a degree of infection that you might not even notice that you might be able to spread to others,” he said. “Which is the reason why the message you may have heard me say over the last couple weeks in the media is that getting vaccinated with a highly efficacious vaccine does not mean that you’re going to abandon completely public health measures.”
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Oxford University and AstraZeneca are now preparing to submit data for emergency approval from the World Health Organization, as well as authorities worldwide with conditional approvals in place.
Fox News' Alexandria Hein contributed to this report.
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