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September Plans

The US Food and Drug Administration is aiming grant full approval to the Pfizer-BioNTech SARS-CoV-2 vaccine by Labor Day, according to the New York Times.

The agency has been under pressure to fully approve SARS-CoV-2 vaccines, especially as the number of Delta variant-driven cases has increased. The vaccines in use in the US are currently available under Emergency Use Authorizations but Pfizer and BioNTech as well as Moderna are seeking approval for their vaccines. Pfizer and BioNTech, the Wall Street Journal noted the other day, have finished submitting the needed paperwork. According to the Washington Post, Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, the FDA is moving at a "sprint" to work toward approval.

The Times now reports that the agency has a deadline of early September in mind. It notes that approval requires additional data than an EUA — regulators, it adds, are interested in real-world data on how the vaccine has worked when administered under the EUA — and that a priority review generally takes six to eight months.

Full approval could spark additional vaccine mandates as well as give doctors the ability to prescribe additional shots for individuals with compromised immune systems, the Times adds. Pfizer is also expected soon to seek authorization for a vaccine booster, the need for which is still unclear.