AstraZeneca’s Coronavirus Vaccine Most Likely To Receive Emergency Use Authorization In October

The U.S. Food and Drug Administration (FDA) is likely to give emergency use authorization to AstraZeneca’s coronavirus vaccine that is licensed from Oxford University, according to recent reports.

The coronavirus vaccine, dubbed AZD1222, is currently in late-stage Phase III clinical trial. It is known that AstraZeneca is trying to enroll at least 30,000 people across the globe to test its shot and to prove its safety and efficacy in humans.

The FDA is said to be under immense pressure to approve the COVID-19 vaccine as soon as credible and positive data is submitted by any of the pharmaceutical giants who are competing in the race to come up with a safe and effective shot.

According to media reports, the FDA is considering a possibility to grant emergency use authorization to AstraZeneca for its vaccine once it successfully submits it’s findings based on the late-stage study already being carried out in the U.K. and involving almost 10,000 volunteers.

As per the FDA, an emergency use authorization can be only provided after "a determination by the FDA that the known and potential benefits of a product, when used to diagnose, prevent, or treat serious or life-threatening diseases, outweigh the known and potential risks of the product."

An authorization to use the shot in an emergency cannot be provided by the FDA based on Phase I clinical trial data. This is because the initial trial only assessed the safety to an extent and does not focus on the efficacy at all. The actual efficacy of the vaccine candidate can only be assessed in late-stage trials involving thousands of volunteers.

While there are speculations that FDA may consider providing emergency use authorization, AstraZeneca’s officials say that they are not in touch with any authority in the U.S. concerning the same.

"AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility," the company said in a statement on Monday.