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While the University of Oxford and AstraZeneca announced on Monday that their coronavirus vaccine candidate has achieved up to 90% efficacy in an advanced clinical trial, the vaccine still requires regulatory approval before being distributed. .
In the United States, for example, the Food and Drug Administration (FDA) requires companies to submit at least two months of safety data for emergency approval.
Another company on the vaccine front, Pfizer, announced it reached that threshold last week and announced plans to file for emergency FDA approval last Friday. The FDA also announced a meeting scheduled for December 10 to discuss Pfizer’s Emergency Use Clearance Application, or EUA.
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Therefore, it is still too early to say for sure that the general public will benefit from the Oxford-AstraZeneca vaccine, as it has yet to receive regulatory approval.
Nevertheless, the results of a phase 2 trial published in the peer-reviewed journal The Lancet last week showed that the Oxford-AstraZeneca vaccine elicited an immune response and was better tolerated in older adults over 70 years of age. . fever and muscle pain more frequent at the injection site.
Additionally, the purpose 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 country’s leading infectious disease specialist, pointed out that now is the time to double up on public health measures, as it is unclear what impact the possible vaccine could have. on disease transmission.
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In a virtual discussion hosted by the Hastings Center on Thursday, Fauci explained that vaccines are being evaluated to see if they prevent clinically apparent disease in the individual, and also if it prevents serious disease in someone who was inoculated.
He compared it to trials of the annual flu shot. Jab can keep you from getting sick, but not necessarily getting infected, although the patient may not know they have been infected because they will not develop symptoms. The same concept applies to the COVID-19 vaccine, Fauci said.
“The problem is, you’re not going to be completely protected from a degree of infection that you might not even notice that you might be able to pass on to others,” he said. “This is why the message you may have heard me say over the past two weeks in the media is that getting vaccinated with a very effective vaccine does not mean that you are going to completely abandon the measures. public health.
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The University of Oxford and AstraZeneca are now preparing to submit data for emergency approval to the World Health Organization, as well as authorities around the world with conditional approvals in place.
Alexandria Hein of Fox News contributed to this report.
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