Full US approval for Pfizer vaccine expected by early September: report

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The US drug regulator is set to fully approve the Pfizer/BioNTech COVID-19 vaccine by early next month, the New York Times reported Tuesday.

The Food and Drug Administration has set an "unofficial deadline" of the September 6 Labor Day holiday "or sooner" to give the anti-COVID shot the final green light, the newspaper reported, citing sources familiar with the plan.

The is currently being administered via an emergency use authorization that was granted in December.

The FDA had said in a statement last week that granting the Pfizer vaccine final approval was one of the agency's highest priorities and anticipated being finished with the final review soon.

Full approval could boost vaccine-hesitant Americans' confidence in getting the shot as the ultra-contagious Delta variant sweeps through the country, driving daily case counts to levels not seen since the winter.

As of August 2, the United States had seen an average of 84,389 new cases daily over the previous seven days, according to the Centers for Disease Control and Prevention.

Some 192 million Americans have already received at least one dose of one of the three COVID vaccines available in the United States—58 percent of the total population.

Pfizer is the most widely administered shot in the US, followed by another two-dose mRNA shot from Moderna, which is also allowed under an emergency use authorization and is seeking full approval from the FDA, which is expected to come after Pfizer's.

The one-dose shot from Johnson & Johnson is the third and least popular COVID vaccine available in the United States. It has not yet sought full FDA approval, according to the Times.


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FDA to prioritize full approval for Pfizer COVID-19 vaccine

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Citation: Full US approval for Pfizer vaccine expected by early September: report (2021, August 4) retrieved 5 December 2021 from https://medicalxpress.com/news/2021-08-full-pfizer-vaccine-early-september.html
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