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Pfizer-BioNTech’s two-dose Covid-19 vaccine has become the first to receive full approval from the FDA.

The vaccine had initially been given emergency use authorization. Its two shots, three weeks apart, are now fully approved for those aged 16 and older.

The approval is expected to set off more vaccine mandates by employers and organizations across the US.

It comes amid lingering vaccine hesitancy among many Americans.

In a statement, the FDA said its review for approval included data from approximately 44,000 people. The vaccine, which will now be marketed as Comirnaty, was found to be 91% effective in preventing Covid disease.

Acting FDA commissioner Janet Woodcock said that the public “can be very confident” the vaccine meets high safety, effectiveness and manufacturing quality standards.

Pfizer vaccine still has emergency use authorization for children aged 12 to 15.

The vaccine is being provided at no cost to Americans.

The FDA initially gave Pfizer temporary authorization – a clearance given if the agency determines the benefits of a product outweigh potential risks during a public health emergency.

This full approval is essentially permanent. The licensing process requires companies to provide the FDA with information on how and where the product is made, as well as other clinical testing data.

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Critics had been calling on the FDA to speed up this approval process as the US struggled with dropping vaccination rates earlier this year. The spread of the contagious Delta variant has already given some hard-hit regions a bump in vaccination rates in recent weeks.

While the agency took steps to increase staff and resources, it had previously said it would take six months to get the required data.

The approval ultimately came less than four months after Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.

Polling data released at the end of June by the Kaiser Family Foundation found that about 30% of unvaccinated American results said they would be more likely to get a vaccine if it received full FDA approval. The number rises to nearly 50% among Americans taking a “wait and see” approach to vaccines.

In a TV address on August 23, President Joe Biden spoke directly to the “millions” of Americans he said were waiting for full and final FDA approval.

“The moment you’ve been waiting for is here,” he said.

“It’s time for you to go get your vaccination. Get it today.”

Additionally, President Biden called on private sector companies and nonprofits to require employees to get vaccinated or “face strict requirements”.

Companies, healthcare systems, universities and other organizations are now expected to announce vaccine requirements as the country embarks on a return to normalcy. The US military has also said the vaccine will become mandatory for 1.3 million active-duty troops upon FDA approval.

To date, more than 92 million vaccinated Americans – more than half of the total – have received the Pfizer vaccine.


Botox treatment for wrinkles around the corners of the eyes – also known as “crow’s feet” – was officially sanctioned by the Food and Drug Administration on Wednesday.

Crow’s feet are thought to be caused by repeated muscle contractions over a lifetime through facial expressions like frowning, smiling and squinting.

“This additional indication will provide people with a new FDA approved treatment option for those seeking a smoother appearance by temporarily minimizing the appearance of crow’s feet at the sides of the eyes,” said Susan Walker, director of the Division of Dermatology and Dental Products in the FDA’s Center for Drug Evaluation and Research, in the FDA statement.

Botox has been used for decades by opthalmologists to treat eyelid twitching, or blepharospasm, according to Dr. Jennifer Walden.

The Texas-based aesthetic plastic surgeon, told CBSNews.comthat this is one of the ways doctors discovered it could smooth the skin.

While this new FDA approval for Botox only came Wednesday, Dr. Jennifer Walden said: “Doctors have been using it off-label for years to smooth the crow’s feet.”

FDA approved Botox treatment for crow's feet and lines

FDA approved Botox treatment for crow’s feet and lines

The new FDA approval came following a study of 833 adults conducted by the drug’s manufacturer, Allergan Inc. of Irvine, California, where participants were randomly assigned to receive a Botox or a placebo injection.

People treated with Botox had greater reductions in crow’s feet.

Botox (onabotulinumtoxinA) is a protein and neurotoxin and is the most acutely toxic substance known.

However, when injected directly into a muscle in approved doses, Botox prevents muscles from tightening by temporarily paralyzing them, which in turn makes wrinkles disappear – for up to six months.

Botox was first approved as a cosmetic by the FDA in 2002 for temporary improvement of frown lines – the wrinkles between the eyebrows, also known as glabellar lines.

The most common side effect seen was eyelid edema, which causes the eyelids to become swollen due to fluid buildup.

Botox labels contain the strongest warning the FDA offers saying the effects of the toxin may spread from the area of injection to other areas of the body.

However, the FDA said there has never been a confirmed serious case of this happening when Botox is used at recommended doses.

According to Dr. Marco Harmaty, a plastic and reconstructive surgeon at The Mount Sinai Medical Center in New York City, Botox has been frequently used for crow’s feet and other unapproved areas of the face, like the side of the nose.

The FDA’s new approval “does give you an added benefit and safety of saying that I’m not doing anything illegal or potentially harmful”, he said to CBSNews.com.

Botox for cosmetic purposes still likely won’t be covered by insurers, given it is used for cosmetic purposes.

Insurers often cover people who have approved medical conditions treated by Botox, including chronic migraines, severe underarm sweating and others.