US grants Pfizer Covid-19 vaccine full approval, triggering new mandates

President Joe Biden calls the US Food and Drug Administration decision the ‘gold standard’ in evidence the jab is safe.

Alessandro Roque, 12, receives the Pfizer vaccine in Arleta, Los Angeles, on Monday. Picture: Reuters

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

About 52 per cent of the US 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 authorisation that was granted on December 11 last year.

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 per cent ­effective in preventing Covid.

The FDA tracked data from 12,000 vaccine recipients six months out. 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 has been detected in boys aged 12 to 17, with available data suggesting most recover but some require intensive care.

The US military said after the announcement that 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 authorisation to children aged 12 to 15, but because it has now been fully ­approved, physicians may prescribe it to children under 12.

Acting FDA commissioner Janet Woodcock recommended against “off-label” use in younger children until clinical trials report their data, which is expected later this year. “We need to get the information and data on usage in younger children – they are not just small adults,” she said, emphasising that knowing the correct dosage for this group was key.

Amesh Adalja of the Johns Hopkins University Centre for Health Security hailed the development as “good news” that may sway people still on the fence.

“One of the talking points of the anti-vaccine movement which has falsely claimed that this was an ‘experimental vaccine’ has been removed,” he said.

Eric Topol, director of the Scripps Research Translational Institute, said he expected to see “tens of millions more Americans vaccinated” as a result of new mandates.

The approval came as the ultra-contagious Delta variant pummels the country, with about 80,000 Americans in hospital with Covid and more than 700 dying every day.

The Biden administration announced last week plans to make a booster shot immediately available for immunocompromised people, and recommended all vaccinated people get a third shot eight months after their second.

AFP