The US Food and Drug Administration has granted priority review designation to Pfizer and BioNTech’s full approval of the COVID-19 vaccine, the vaccine makers said on Friday, according to US media reports. 

Furthermore, an unnamed FDA official told CNN that a decision on full approval is likely to come within two months. The agency considers this matter a priority, the official further added.

In May, Pfizer and BioNTech began the application for full approval of their COVID-19 vaccine — called a Biologics License Application — and have already completed the submission.

The two-dose vaccine series will be used for people age 16 and older, and the company expects to apply for approval for people ages 12 to 15 when the data are available.

Meanwhile, Moderna has also begun submitting data for approval of its two-dose coronavirus vaccine, and Johnson & Johnson is expected to seek FDA approval.

While the FDA must make its decision by January, it’s likely to come much sooner, acting FDA commissioner Dr Janet Woodcock said. “…the review of this BLA has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the … Goal Date,” Woodcock tweeted.

Currently, all three vaccines have emergency use authorization from the FDA.

In a letter to the New York Times this month, Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, wrote that the review of applications for full approval of the Covid-19 vaccines is “one of the highest priorities” at the FDA, but it requires the evaluation of extensive manufacturing and clinical information.

“Any vaccine approval without completion of the high-quality review and evaluation that Americans expect the agency to perform would undermine the F.D.A.’s statutory responsibilities, affect public trust in the agency and do little to help combat vaccine hesitancy,” Marks wrote.  

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Vaccination manufacturers first sought emergency use authorisation since it takes less time than full approval, but the vaccines’ safety and efficacy were verified in big trials and validated by millions of doses delivered since the vaccine rollout began late last year.

According to data from the US Centers for Disease Control and Prevention, more than 160 million people — 48.3% of the US population — are fully vaccinated against COVID-19.