FDA Could Approve Pfizer-BioNTech COVID-19 Vaccine by September


Would mark the first COVID-19 vaccine to gain full FDA approval.

This article was originally published in ContagionLive.

The first COVID-19 vaccine to gain Emergency Use Authorization (EUA) could be the first to garner full US Food and Drug Administration (FDA) approval, potentially as soon as Labor Day.

In the coming weeks the agency is expected to look at the full approval for the Pfizer-BioNTech vaccine, which received an EUA in December 2020.

“The FDA’s unofficial deadline is Labor Day or sooner, according to multiple people familiar with the plan. The agency said in a statement that its leaders recognized that approval might inspire more public confidence and had “taken an all-hands-on-deck approach” to the work,” according to a report in the NY Times.

The report also stated that if full approval is authorized, there is an expectation that medical centers, the Defense department and San Francisco will mandate vaccinations for their employees.

The emergence of the Delta variant, which has become the predominant strain in the US, has pushed public health officials and the federal government to act. There has been a renewed push for both vaccination as well as a recommendation to wear masks again—even for the fully vaccinated.

US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, noted the change due to new data in an address last week.

"In recent days I have seen new scientific data from recent outbreak investigations showing that that Delta variant behaves uniquely differently from past strains of the virus that cause COVID-19," Walensky, said. "This new science is worrisome and unfortunately warrants an update to our recommendations."

The federal agency’s new recommendations specifically asked vaccinated people to wear masks again when indoors in public settings in parts of the US with “substantial” to “high” transmission. The CDC created a monitor on its site to help the public determine the level of transmission in the county they live in.

The CDC also reversed its recommendations on mask wearing in schools, stating that all teachers, administrators, staff, students, and visitors should wear a mask indoors regardless of vaccination status.

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