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FDA greenlights Pfizer boosters for young teens

As many as 13.5 million 12- to 17-year-olds will soon be eligible to receive their third Pfizer shot as coronavirus cases continue to rise

Tying a neat bow on a holiday season that barreled through the U.S. alongside a winter surge of the coronavirus Omicron variant, the Food and Drug Administration moved Monday to allow children as young as 12 to receive booster shots of Pfizer's vaccine against the deadly respiratory disease.

Emphasizing that the FDA’s decision-making during the pandemic has always been based on “the best available science," the agency’s acting commissioner Janet Woodcock pressed Tuesday that this move was made with the safety of the American public in mind.

According to data collected by John Hopkins, the United States has seen more than 6 million cases of COVID-19 and 36,000 deaths from it in the last 28 days.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19,” Woodcock said.

Albert Bourla, chairman and chief executive officer of Pfizer, echoed this Monday.

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” Bourla said in a statement. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”

The Centers for Disease Control and Prevention is expected to decide later this week whether to give the FDA's move its stamp of approval and also recommend younger teens get boosters.

Before approving Pfizer-BioNTech’s boosters for teens, the FDA reviewedhow more than 6,300 children in Israel, aged 12 through 15 years old, responded to booster jabs administered at least five months after their two-dose regimen. The agency says that data shows the protective health benefits from serious COVID-19 outweighed the risks of an additional shot, and that young teens may get their boosters as soon as five months after their initial doses, rather than waiting six months.

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As many as 13.5 million 12- to 17-year-olds have received two doses of the Pfizer shot, according to the CDC.

While children are less likely to experience serious illness from COVID-19 than adults, there has been a rise in infections among children, particularly among those who are unvaccinated, during the Omicron wave.

Children 12 to 15 first became eligible for vaccination in May, meaning those first to get their vaccines may now be eligible for boosters.

Smaller doses of Pfizer's vaccine for 5- to 11-year-olds just became available in November. While experts say that those in this age group with healthy immune systems should be protected for a while, the FDA also granted a third dose Monday for immunocompromised groups in this age.

Children who have received an organ transplant or are considered immunocompromised may not get adequate protection from the normal two-dose regimen, the FDA said Monday, allowing those who fit under this category to get a third dose as soon as 28 days after their second — mimicking the system already implemented for immune-compromised teens and adults.

In mid-December, the FDA recommended Pfizer booster shots for ages 16 and up. No other vaccines are available in the United States for children to boost their immunity against the novel virus.

While early studies suggest that the omicron variant may cause less severe COVID-19 symptoms as compared with the delta variant, the nation's top infectious disease expert Dr. Anthony Fauci warned Americans on CNN earlier this week that hospitalizations in the U.S. could still increase because it is spreading more rapidly.

"When you have so many, many cases, even if the rate of hospitalization is lower with omicron than it is with delta, there's still the danger that you're going to have a surging of hospitalizations that might stress the health care system," said Fauci, director of the National Institute of Allergy and Infectious Diseases.

Trials are still underway for Pfizer vaccines in even smaller doses for children under 5 years old.

Overall, the U.S. has seen more than 55 million COVID-19 cases and more than 800,000 COVID-19 deaths, according to John Hopkins data.

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