The Food and Drug Administration (FDA) on Monday authorized Pfizer’s COVID-19 booster for people aged 12 to 15, as well as a third shot for 5- to 11-year-old who are immunocompromised.
The FDA also shortened the time between the second dose of Pfizer and its booster shot from six months to five months.
The updated regulations come as students return to school amid a surge in COVID-19 cases over the holidays. COVID-19 cases and hospitalizations are especially high among children and adolescents. In the week ending January 1, hospitalizations for children increased 96% nationwide from the week prior, compared to about 46% for all age groups.
“This newest surge with the new variant seems to be really fueled by infections and transmissions among younger people, which makes sense for a number of reasons: They're not as vaccinated and they’re gathering in schools and such,” Deborah Lehman, MD, a pediatric and infectious disease specialist at University of California, Los Angeles, told Verywell.
While the vaccines are still highly effective at protecting against serious outcomes of COVID-19, early studies showed that Omicron can more easily evade vaccine-induced immunity than prior variants.
But booster shots appear to restore antibodies to protective levels. Health officials are urging eligible individuals to receive a booster shot to protect against mild infections and minimize transmission to vulnerable people.
“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
The Centers for Disease Control and Prevention (CDC) still have to sign off on the recommendation. An advisory panel to the CDC is scheduled to meet on Wednesday.
The FDA reviewed real-world data from more than 6,300 12- to -15-year-olds in Israel who received a booster shot at least five months after their second dose. There were no reported cases of myocarditis or pericarditis, and the FDA said there are no new safety concerns.
Myocarditis is an inflammatory disease affecting the heart muscle (or myocardium), most often caused by infections, immune diseases, or toxins.
Pfizer’s booster dose is 30 micrograms—the same dose as the first two shots of the company’s primary series.
Young people—especially those who are unvaccinated—may face severe outcomes of infection. In data reported by the CDC last week on more than 700 children hospitalized with COVID-19, nearly 30% were admitted to the ICU, 14.5% required mechanical ventilation, and 11 of the patients died.
In mid-May, adolescents aged 12 to 15 became eligible for vaccination. About half of 12- to 17-year olds are now fully vaccinated in the United States. About 5 million of those received their second shot five or months ago and are now eligible for a booster.
Severely immunocompromised children aged 5 to 11, such as those who underwent a solid organ transplant, may not mount a sufficient immune response from the initial two shots of vaccine. Another dose of the vaccine for this group can offer an added layer of immunity, Lehman said.
“Parents of children who are immunocompromised are sort of living in daily fear—as are all people who are living with anyone who's immunocompromised, or those people that are immunocompromised themselves—that their child's going to come in contact with someone who's just mildly symptomatic or even asymptomatic and is able to spread this virus to their really vulnerable child,” Lehman said.
The third dose for this group is 10 micrograms—the same pediatric dosage that is administered for the first two doses. It’s recommended they receive the third shot 28 days after the second.
The FDA said that those who are not immunocompromised do not need a booster shot at this time. If new data emerges indicating they’ll benefit from a booster, the agency will review the policy.
The agency has also updated the recommended timeline for booster shots for all individuals older than 12 years. Americans are now eligible for a booster dose of Pfizer’s COVID-19 vaccine five months after finishing their original regimen, down from six months.
In Israel, more than 4 million people 16 years and older received a booster dose at least five months after their primary regimen. Among these people, there were no new safety concerns.
According to the CDC’s side effects reporting system, most side effects following a booster or third dose are mild and include fatigue, headache, muscle or joint pain, and chills. Swollen lymph nodes appeared to be more common following a booster dose than the second shot of a two-dose primary series.
“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,” Janet Woodcock, MD, Acting FDA Commissioner said in a press release.
Nearly 66% of people in the U.S. 5 years or older are fully vaccinated against COVID-19, per the CDC. A third of the population has received a booster shot.
With the surge in cases driven by the highly transmissible Omicron variant, public health experts are urging all eligible people to receive a booster shot. Though two doses of mRNA vaccine or one of Johnson & Johnson’s vaccine lose efficacy against Omicron, an additional mRNA dose has been shown to restore antibodies to protective levels.