US grants Pfizer vaccine full approval as Delta hits hard

The US Food and Drug Administration on Monday fully approved the Pfizer-BioNTech COVID shot, triggering a new wave of vaccine mandates as the Delta variant batters the country.

Around 52 percent of the American population is fully vaccinated, but health authorities have hit a wall of vaccine-hesitant people, impeding the national campaign.

In a televised address, President Joe Biden called FDA approval the "gold standard" in evidence.

"Today I'm calling on ... more companies in the private sector to step up with vaccine requirements that will reach millions more people," he said.

Pfizer's vaccine, which will now be marketed under its brand name Comirnaty, is the first to receive full approval.

More than 200 million Pfizer shots have already been administered under an emergency use authorization granted on December 11, 2020.

The decision to fully approve it among people aged 16 and up was based on updated data from the drug's clinical trial involving more than 40,000 people, which found the vaccine 91 percent effective in preventing COVID.

The FDA tracked data from 12,000 vaccine recipients six months out from their vaccine series.

Most commonly reported side effects were mild and included pain and swelling at the injection site as well as headache, chills and fever.

The agency is continuing to investigate safety data regarding the highly rare but more worrisome condition myocarditis (heart inflammation), particularly within seven days after the second dose. The highest risk is in boys aged 12 through 17, with available data suggesting most individuals recover but some require intensive care.

The US military said shortly after the announcement it would mandate the vaccine, and a slew of private businesses and universities are expected to follow.

New York City also said it would require all its department of education employees to receive at least one dose of vaccine by September 27, without the option for regular testing instead.

The vaccine remains available under emergency use authorization to children aged 12 to 15, but because it has now been fully approved, physicians may prescribe it to children under 12.