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Agence France-Presse

The US Food and Drug Administration on Monday fully approved the Pfizer-BioNTech Covid vaccine, a move that triggered a new wave of vaccine mandates as the Delta variant batters the country.
Around 52 per cent of the American population is fully vaccinated, but health authorities have hit a wall of vaccine-hesitant people, impeding the national campaign.
“This is a pivotal moment for our country in the fight against the pandemic,” acting FDA Commissioner Janet Woodcock told reporters in a call.

“This FDA approval should give added confidence that this vaccine is safe and effective. If you’re not vaccinated yet, now is the time,” tweeted US President Joe Biden.
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 (EUA) that was 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 per cent effective in preventing Covid.
“Overall, approximately 12,000 recipients have been followed for at least six months,” the FDA said in its statement.
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Most commonly reported side effects are mild and include pain and swelling at the injection site as well as headache, chills and fever.
The FDA is continuing to investigate safety data regarding the more concerning 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 individuals recover but some require intensive care.
The US military said soon 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 the 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, doctors may prescribe it to children under 12 if they believe it will be beneficial.
Woodcock, however, recommended against so called “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.
“Hopefully now you’ll see people who said that they were waiting for full approval line up to get vaccinated.”
A recent survey by the Kaiser Family Foundation found 30 per cent of adults said full approval would make them more likely to get vaccinated.
Coronavirus: from Europe to Asia, alarming drop in blood donations as more get vaccinated
Experts had been urging full approval for months.
But FDA scientist Peter Marks told reporters the agency had to first review hundreds of thousands of pages of patient data, monitor clinical trial sites to ensure they were collecting information accurately, and inspect manufacturing facilities.
Approval comes as the highly contagious Delta variant pummels the country, with around 80,000 Americans hospitalised with Covid-19 and more than 700 dying every day.
The hardest hit regions include southern states Florida, Alabama, Mississippi and Louisiana.

The number of people rolling up their sleeves for a shot has risen in these states in recent weeks, but the national rate is still well below its peak from spring.
Some 628,000 people have died from coronavirus infection in the United States, making it officially the hardest hit country in the world – though experts say it is possible that India may in fact hold the record.
Vaccines are less effective against the Delta variant than they were against previous strains, particularly against infection, making the goal of high population level vaccination critical.
The Biden administration announced last week plans to make a booster shot immediately available for immunocompromised individuals, and recommended all vaccinated people get a third shot eight months after their second.


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Coronavirus pandemic

Pfizer-BioNTech coronavirus vaccine receives full US FDA approval

A vial of the Pfizer-BioNTech coronavirus vaccine. The shot has been given full approval in the US. Photo: Reuters

U.S. President Joe Biden gives an update on the evacuation of American citizens, SIV applicants and their families, and vulnerable Afghans in the Roosevelt Room of the White House in Washington, D.C., on Aug. 22, 2021. (Ken Cedeno/Pool/ABACAPRESS.COM/TNS)

FILE PHOTO: Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), speaks during a Senate Health, Education, Labor, and Pensions Committee hearing at the Dirksen Senate Office Building in Washington, D.C., U.S., July 20, 2021. Stefani Reynolds/Pool via REUTERS/File Photo

Dr. Steven Florman medical director of Stacy Medical Center administers a dose of the Pfizer COVID-19 vaccine to Randy Eves, Production Manager of Broadleaf Specialty Meats in Vernon, California, as employees are receiving their second dose of the Pfizer COVID-19 vaccine on Tuesday, March 23, 2021. (Al Seib/Los Angeles Times/TNS).

Canada approves Pfizer coronavirus vaccine for children aged 12 to 15

More than 34 per cent of Canadians have received at least one Covid-19 vaccine dose. Photo: Reuters

Coronavirus vaccines: largest study yet confirms Pfizer-BioNTech’s ‘95 per cent protection’ after second shot

Protection was considerably lower when people received just a single vaccine dose, instead of two. Photo: AFP

Amid Delta variant surge, Israel to offer Pfizer Covid-19 vaccine booster shots to adults at risk

An Israeli medical worker prepares a dose of the Pfizer/BioNTech Covid-19 vaccine. Photo: AFP

News

World

United States & Canada

Coronavirus

US & Canada

Health & Medicine

The Covid-19 vaccine, made by Pfizer and its partner BioNTech, may now be marketed under its brand name Comirnaty
It is the first to receive full approval in the US, and the Food and Drug Administration said it hopes the move will instil more confidence in the vaccine


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