FDA Pledges Data Transparency for COVID-19 EUAs, Approves New At-Home Test


With Pfizer and Moderna lining up their COVID-19 vaccine candidates for Emergency Use Authorization (EUA), the U.S. Food and Drug Administration (FDA) announced it will make publicly available all data and information that will be used to consider authorization of vaccines and therapeutics against the virus.

“Our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response,” FDA Commissioner Stephen Hahn said in a statement.

The FDA’s commitment to transparency for responses to the ongoing pandemic is being made as the nation is on the brink of seeing at least two vaccine candidates given the green light under EUA, and the regulatory agency is hoping to boost public support. In the months leading up to the Nov. 3 election, many Americans were skeptical the FDA would be used as a political tool and rush out an unproven vaccine candidate in order to boost polling numbers.

“Today’s transparency action is just one of a number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential COVID-19 vaccines,” Hahn added. “We will also continue to follow the science and ensure that science remains the driver of the agency’s regulatory decision-making in our fight against COVID-19 and beyond on behalf of public health.”

This morning, Pfizer and partner BioNTech indicated they are ready to seek EUA for their vaccine candidate within a matter of days. A final analysis of data showed the vaccine candidate BNT162b2 has a 95% efficacy rating across all ages, races and ethnicities.

Earlier this week, Moderna announced its vaccine also showed similar efficacy to the Pfizer and BioNTech product following an interim review of Phase III data. If the data remains consistent, Moderna plans to seek EUA for its vaccine candidate within the coming weeks, the company said earlier this week.

Moderna’s vaccine candidate received an extra public relations boost this week when it was revealed that country music icon Dolly Parton had donated $1 million to the Boston-based company to support vaccine development. Parton also donated funds to support a convalescent plasma study at Vanderbilt University. Parton’s support for the Moderna vaccine will likely go far in earning public support for a vaccination program.

“I’m sure many, many millions of dollars from many people went into that [research fund] but I felt so proud to have been part of that little seed money that hopefully will grow into something great and help to heal this world – Lord knows we need it!” Parton told the BBC’s One Show, according to a report in The Guardian.

In addition to its pledge for data transparency for EUAs, on Tuesday, the FDA authorized the first rapid, at-home COVID-19 test. The FDA authorized the use of California-based Lucira Health’s COVID-19 All-In-One Test Kit, a single-use test designed to detect the SARS-CoV-2 virus. The test is authorized for at-home use, as well as for use in doctor’s offices and clinics in individuals age 14 and older.

The test works by swirling the self-collected sample swab in a vial that is then placed in a test unit that is part of the kid. Results are available within 30 minutes or less and can easily be read from the test unit’s light-up display, the FDA said.

“A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic. Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them,” Jeff Shuren, director of FDA's Center for Devices and Radiological Health said in a statement.

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