(Bloomberg) — Older teens who have previously taken the Pfizer Inc.-BioNTech SE vaccine can receive a booster dose, U.S. regulators said, making millions more Americans eligible for extra protection as scientists race to study the rapidly spreading omicron variant.
The emergency use authorization allows 16- and 17-year-olds to get booster doses at least six months after receiving their second Pfizer shot, the U.S. Food and Drug Administration said Thursday in a statement. The Centers for Disease Control and Prevention quickly followed up with a recommendation for the booster in the same age group.
President Joe Biden’s administration has leaned hard into making boosters broadly available as the highly mutated omicron variant has emerged following the delta strain. Earlier this month he called on health providers to expand the availability of coronavirus vaccines and boosters in a bid to hold off omicron and combat a winter surge of infections.
“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 the statement. “With both the delta and omicron variants continuing to spread, vaccination remains the best protection against Covid-19.”
People age 5 and older in the U.S. have been able to receive the messenger RNA vaccine. Until now, however, the companies’ booster shots had only been cleared for adults.
“We know that Covid-19 vaccines are safe and effective,” Centers for Disease Control and Prevention Director Rochelle Walensky said in a separate statement, “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 booster didn’t undergo consideration by outside experts on CDC’s Advisory Committee on Immunization Practices before the recommendation for older teens, as most other Covid vaccine authorizations have. The additional shots are the same formulation and dosage strength as those in the primary series.
More than 24%, or 48 million, of fully-vaccinated adults have received a booster as of Thursday, according to the Centers for Disease Control and Prevention.
In an emailed statement, Pfizer’s Chief Executive Officer Albert Bourla described the decision as a “critical milestone” in addressing the pandemic.
“While new variants, including omicron, emerge across the globe, we believe that the best way to minimize the spread of Covid-19 and any future variants is getting all eligible people fully vaccinated with the first two dose series and a booster dose as recommended,” Bourla said.
(Updates with CDC recommendation in second paragraph)
More stories like this are available on bloomberg.com
©2021 Bloomberg L.P.
