The Food and Drug Administration on Thursday expanded authorization of the Pfizer coronavirus booster shot to include young people ages 16 and 17, citing concerns about waning vaccine efficacy and the spread of variants.
“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,” acting FDA Commissioner Janet Woodcock said in a statement. “With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
The FDA expanded booster shots to all adults last month and recently strengthened their recommendation in the face of the omicron variant. The Pfizer shot is the only one currently authorized for people under the age of 18.
“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” Peter Marks, FDA’s top vaccine official, said in a statement. “A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”
The Centers for Disease Control and Prevention signed off on the booster expansion hours after the FDA’s authorization, allowing the shots to be administered.
“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 6 months post their initial Pfizer vaccination series.”
The news comes just a day after Pfizer announced preliminary data showing that two doses of its coronavirus vaccine “may not be sufficient to protect against infection with the omicron variant.” It reported that three doses increased virus-fighting antibodies 25-fold in blood samples tested in a lab.
But the World Health Organization this week said that booster shots are likely not the answer to the omicron variant.
“The boosters are, unfortunately, probably not the solution to this,” WHO chief scientist Soumya Swaminathan said, adding that the data from “country after country” shows that most people in intensive care units who are getting severely ill or dying are unvaccinated.