FDA approves Pfizer-BioNTech booster shots for ages 16-17

Dec. 9 (UPI) -- The Food and Drug Administration announced on Thursday it has approved a booster shot of the Pfizer-BioNTech coronavirus vaccine for ages 16-17 six months after their primary two doses.

This follows the FDA approval of Pfizer-BioNTech booster shots for adults 18 and older last month. The news comes after Pfizer announced fully vaccinated people with a booster shot of its vaccine can neutralize the new Omicron variant of the coronavirus.

"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 Dr. 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."

Pfizer said Wednesday that a third dose of its vaccine can offer much better protection against the Omicron variant while two doses alone may not be enough protection from severe disease caused by it.

"Ensuring as many people as possible are fully vaccinated with the first two-dose series and a booster remains the best course of action to prevent the spread of COVID-19," Pfizer Chairman and CEO Albert Bourla said in a statement Wednesday.

The FDA said its assessment of the effectiveness of a booster dose for individuals 16 and 17 years of age is based on its earlier data for individuals 18 and older. It said the benefit outweighed the risk of the conditions of myocarditis and pericarditis. It said Pfizer is continuing its research on those risks.

After the FDA's announcement, the Centers for Disease Control and Prevention Thursday revised its recommendations for booster doses to indicate that everyone age 16 and older should get the extra shot.

"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 Dr. 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 6 months post their initial Pfizer vaccination series," she said.

Only the Pfizer-BioNTech COVID-19 vaccine is authorized and recommended for adolescents ages 16 and 17 years.