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American Medical Association calls for COVID-19 vaccine development transparency

Organisation asks FDA to provide transparent information on review plans

The American Medical Association (AMA) has urged the US Food and Drug Administration (FDA) to work with the medical community to provide transparency around COVID-19 vaccines currently in development.

In a letter addressed to FDA Commissioner Stephen Hahn, the AMA asked to be ‘continuously informed’ of the FDA plans to review potential COVID-19 vaccines when they are filed with the agency.

The AMA added that the plans should also be revealed with the ‘utmost level of transparency’ with regard to the process for authorisation, as well as the standards for review and safety and efficacy data.

“While vaccine hesitancy among the public has been rapidly increasing in recent years, it appears to be reaching unprecedented levels due to a number of factors including concerns about the rapid pace of vaccine development and significant spread of misinformation through channels such as social media,” the AMA added in the letter.

In the US, the government has been racing to sign early supply deals with a number of companies developing COVID-19 vaccines under its Operation Warp Speed initiative.

The Trump administration-backed Operation Warp Speed aims to deliver 300 million doses of a COVID-19 vaccine to the American public by January 2021.

Among the companies selected to receive funding as part of the initiative includes Johnson & Johnson, AstraZeneca/Oxford University, Pfizer/BioNTech, GlaxoSmithKline/Sanofi, Moderna and Novavax.

Concerns have been raised that the rapid speed at which COVID-19 vaccines are being developed could indicate that some candidates are being advanced too quickly through the regulatory process.

In a call with reporters earlier this month, US National Institutes of Health (NIH) Director Francis Collins tried to soothe some of these concerns by maintaining that regulatory approval for a COVID-19 vaccine is unlikely to occur before November.

“I know there is some concern because of this warp speed label that maybe corners are being cut that shouldn’t be. I want to reassure you and everybody else that we will not allow that to happen,” Collins said.

In the same call, Collins added he is confident that at least one of the several candidates funded by Operation Warp Speed will be shown to be safe and effective by the end of the year.

Editor's note: Since being published, this article has been amended while we confirm which companies have received funding from Operation Warp Speed.

Article by
Lucy Parsons

28th August 2020

From: Regulatory



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