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FDA Looking at Potential Approval of Pfizer-BioNTech COVID-19 Vaccine by September

A report says the timetable is for Labor Day or sooner.

For some who were concerned that the COVID-19 vaccines were only given an Emergency Use Authorization by the Food and Drug Administration (FDA) and not a full approval, it appears that is going to change.

Starting with the Pfizer-BioNTech vaccine, the federal agency is looking at potential full approval of it in just a few weeks.

“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.

And with the full FDA approval, there is an expectation that medical centers, the Defense department and San Francisco will mandate vaccinations for their employees the report stated.

The emergence of the Delta variant, which has become the predominant strain in the United States, 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.

Last week, the Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, noted the change due to new data. "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.

The release of the report Walensky referenced was from a study that showed COVID-19 breakthrough infections that were associated with large public gatherings in Barnstable County, Massachusetts.

Within the 469 documented cases in the Massachusetts study, 346 (74%) occurred in fully vaccinated individuals. Genomic sequencing of specimens from 133 of those cases demonstrated that 119 (89%) of them were found to be the Delta variant.

This variant appears to be more infectious than previous COVID-19 mutations, and hospitals and medical centers, especially in Florida and Texas, are seeing a surge in admissions.

News of another Delta variant, Delta Plus, is making its way across the globe with cases in the US, Canada, India, Japan, Nepal, Poland, Portugal, Russia, Switzerland Turkey, and South Korea.