What’s the news: With the highly transmissible COVID-19 Omicron variant spreading across the United States, Pfizer-BioNTech mRNA vaccine booster shots for 12–15-year-olds received emergency use authorization (EUA) from the Food and Drug Administration (FDA) and they also were recommended by the Centers for Disease Control and Prevention (CDC). This is the first COVID-19 vaccine booster to receive EUA for this age group.
The agency had previously recommended that 16- and 17-year-olds may receive a booster but stopped short of saying they should get them. The CDC now recommends that adolescents 12–17 years old should get a booster shot five months after completing their primary series of the Pfizer-BioNTech COVID-19 vaccine.
The Moderna booster interval has also been shorted from six months after the primary series to five months after the primary series. For people who received the Johnson & Johnson (J&J) primary series, the booster interval recommendations have not changed. According to the CDC, mRNA COVID-19 vaccines are preferred over Johnson & Johnson’s COVID-19 vaccine, for both the primary series and booster dose. This came after the FDA revised the fact sheets for J&J COVID-19 vaccine providers and recipients, which now include a contraindication for people with a history of thrombosis with thrombocytopenia (TTS) following the J&J vaccine. Women 30–49 years old are at highest risk, with one in 100,000 developing TTS after J&J vaccination. About one in seven cases has been fatal.
Data examined by the FDA and CDC showed no new safety concerns following a Pfizer-BioNTech mRNA vaccine booster in 12–15-year-olds. There were also no new cases of myocarditis or pericarditis in these individuals.
Additionally, the CDC recommends that children 5–11 years old who have moderately or severely compromised immune systems get an additional primary dose of the Pfizer-BioNTech vaccine 28 days after completing their Pfizer-BioNTech 2-dose primary series. The Pfizer-BioNTech COVID-19 vaccine is the only one authorized and recommended for 5–11-year-olds. This is consistent with the CDC’s previous recommendation for adults with compromised immune systems.
Learn more about what to tell patients with compromised immune systems about COVID-19 vaccines.
Why it’s important: The EUA for boosters for 12–15-year-olds comes as the U.S. has seen a spike in pediatric hospitalizations driven by the COVID-19 Omicron variant. The broadened access to COVID-19 vaccine boosters shots strengthens protection—especially against the Omicron variant—while posing minimal risk for this age group.
It is part of a broader effort to expand protection as schools, airlines and businesses struggle with disruptions caused by the more transmissible COVID-19 Omicron variant, which has led to more remaining home sick with SARS-CoV-2.
“Given the data suggesting a booster dose provides greater protection against new SARS-CoV-2 variants, recommending a booster dose for this population will help reduce their risk of infection, hospitalization and death and help prevent the further spread of the virus to parents, loved ones and the community at large,” said AMA President Gerald E. Harmon, MD.
Effectiveness against infection for two doses of an mRNA COVID-19 vaccine is about 35%, according to CDC data gathered from South Africa and the United Kingdom. But with a COVID-19 booster dose, vaccine effectiveness is restored to about 75%.
These “recommendations ensure people are able to get a boost of protection in the face of Omicron and increasing cases across the country and ensure that the most vulnerable children can get an additional dose to optimize protection against COVID-19,” said CDC Director Rochelle P. Walensky, MD, MPH. “If you or your children are eligible for a third dose or a booster, please go out and get one as soon as you can.”
Learn more: The AMA has developed frequently-asked-questions documents on COVID-19 vaccination covering safety, allocation and distribution, administration and more. There are two FAQs, one designed to answer patients’ questions (PDF), and another to address physicians’ COVID-19 vaccine questions (PDF).
“We encourage parents to speak with their child’s physician and review trusted resources, such as getvaccineanswers.org, to get the information they need to make an informed decision,” said Dr. Harmon. “As this global pandemic continues to rage, we are hopeful that more and more children and adults will get vaccinated in the weeks ahead to help limit the spread of COVID-19, and the illness and death it causes.”
Visit the AMA COVID-19 resource center for clinical information, guides and resources, and updates on advocacy and medical ethics.
Also find the latest information on COVID-19 booster doses from the CDC.
