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FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron [Updated]

FDA authorizes boosters for ages 16 and 17 ahead of holidays, omicron [Updated]

Update 12/9/2021, 2:55 pm ET: The Centers for Disease Control and Prevention has signed off on the FDA’s authorization and now recommends booster doses of the Pfizer-BioNTech COVID-19 vaccine for teens ages 16 and 17. This final step now means that boosting in this group can begin nationwide.

“Although we don’t have all the answers on the omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants,” CDC Director Rochelle Walensky said in a statement. “We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least six months post their initial Pfizer vaccination series.”

Original Story, 12/9/2021, 12:21pm ET: The Food and Drug Administration on Thursday authorized the Pfizer-BioNTech COVID-19 vaccine for use as a single booster dose in teens ages 16 and 17.

The authorization stands to expand access to boosters amid a crushing wave of delta transmission, fears over the looming omicron variant, and the approach of end-of-year holiday gatherings. Currently, boosters are open and recommended for all adults ages 18 and up.

Earlier this week, a crop of preliminary data suggested that boosters will likely be necessary to protect against the omicron variant, which appears to dodge protective immune defenses from both vaccination and prior infection. Previously, data indicated that vaccine effectiveness wanes against delta and previous variants after six months.

Still, not all experts agree that boosters are needed for healthy young people. Youth tend to have milder disease than adults, and two doses of vaccine are expected to protect against severe cases. However, teens are not completely immune to the worst outcomes, and they can also drive transmission of the pandemic virus to more vulnerable groups.

The Centers for Disease Control and Prevention must sign off on the use of the boosters in 16- and 17-year-olds before they will be available. CDC Director Rochelle Walensky is expected to sign off quickly.

In announcing its decision Thursday, the FDA emphasized that getting more shots in arms is critical to bringing the pandemic to an end, but other health prevention measures remain important as well.

“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” acting FDA Commissioner Janet Woodcock said in a statement. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”

As authorized, the boosters would be available as a single dose given at least six months after the second.

To date, 200 million Americans have been fully vaccinated, which is a little over 60 percent of the country. Of those, nearly 49 million—or 24 percent—have gotten a booster dose.

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