FDA set to issue full approval for Pfizer vaccine on Monday

The US Food and Drug Administration is on track to give full approval to the Pfizer-BioNTech coronavirus vaccine on Monday.

The New York Times reports that the Pfizer shot will be the first of the coronavirus jabs to be cleared by the FDA.

According to the report, the FDA originally had planned to approve the vaccine before Labor Day, but decided to accelerate its ruling.

The development is significant as some Americans hesitant to take the vaccines have rooted their opposition to the shot in the fact that it was not fully approved by the US FDA. The full approval of the shot also paves the way for employers and private companies to mandate employees and patrons to be vaccinated.

More Americans have taken the Pfizer vaccine than any other company's shot, with more than 200 million doses administered since the shot received emergency authorisation by the USFDA in December of 2020.

Currently 52 per cent of Americans have been fully vaccinated.

The development comes as the coronavirus is well into its fourth wave, driven largely by the highly contagious Delta variant.

Covid-19 cases have increased across the country, though some states – particularly those with low vaccination rates –have sharper increases than others. In states like Florida and Texas, ICU beds are at or near full capacity, and hospital staff are overwhelmed by the influx of patients.

Daily Covid-19 cases have increased by 600 per cent. In July, health officials reported 20,000 cases per day. By mid-August, that number grew to 140,000 per day.

The surge in cases has increased demand for the vaccine in recent weeks, with healthcare workers reporting incidents in which hospital-bound individuals suffering from advanced Covid-19 symptoms have asked for the shot. The full approval of the Pfizer vaccine will likely increase the demand further.

Debates over mask and vaccine mandates have been particularly heated as students return to classrooms for the academic year. Republican governors, like Florida's Ron DeSantis and Texas' Greg Abbott, have preemptively banned school districts from enforcing mask mandates for students.

Those decisions have been criticised as childhood Covid-19 diagnoses have increased with the arrival of the Delta variant. The US Centers for Disease Control and Prevention have recommend all students, teachers and staff wear masks while in schools, and the American Academy of Pediatrics have noted an 85 per cent increase in childhood coronavirus infections.

The AAP also has urged the USFDA to fast-track emergency authorisation of the coronavirus vaccines for children under 12, noting the sharp increase in childhood cases. More than 10,000 students in Florida have been isolated or quarantined during just the first week of school.

On Friday, Alabama set a record for the number of children hospitalised with Covid-19. According to state health officials, 50 children were hospitalised with Covid-19 as of Thursday, a significant increase over the previous record of nine.