The FDA was set to fully approve the Pfizer vaccine in the US by early September, according to a report.
The Food and Drug Administration (FDA) was set to fully approve the Pfizer vaccine in the United States by early September, according to a report.
On Tuesday, the New York Times reported that the US drug regulator was set to fully approve the Pfizer-BioNTech COVID-19 vaccine by early .
Citing sources familiar with the plan, the Times reported that the Food and Drug Administration had set an “unofficial deadline” of the September 6 Labor Day holiday “or sooner” to give the said vaccine the final green light.
The said vaccine was currently being administered via an EUA (emergency use authorization) that was granted in the United States last December.
In a statement last week, the US FDA had said that granting the said vaccine final approval was one of the agency’s “highest priorities” and anticipated being finished with the final review soon.
Manila Bulletin reported that full approval could boost vaccine-hesitant Americans’ confidence in getting the said vaccine as the Delta COVID-19 variant swept through the United States, driving daily coronavirus case counts to levels not seen since the winter.
According to the Centers for Disease Control and Prevention (US CDC), the US had seen an average of 84,389 new coronavirus cases daily over the previous seven days as of August 2, 2021.
Manila Bulletin also reported that some 192 million Americans have already received at least one dose of one of the three COVID-19 vaccines available in the US — 58% of the total population.
Pfizer vaccine was the most widely administered vaccine dose in the United States, followed by Moderna vaccine, which was also allowed under an EUA (emergency use authorization) and was seeking full approval from the US FDA, which was expected to come after Pfizer’s.
The Janssen vaccine was the third and least popular COVID-19 vaccine available in the US. According to the Times, the Janssen vaccine had not yet sought full FDA approval.