Updated on January 3, 2022.
As new U.S. cases of COVID-19 surpass the highest levels on record, the Food and Drug Administration (FDA) took three steps to broaden use of the Pfizer-BioNTech vaccine. The Centers for Disease Control and Prevention (CDC) has signed off on all three measures.
First, the FDA authorized the use of a Pfizer booster in children ages 12 to 15-years old. The booster is the same dosage (30-µg) as the first two shots in the series for this age group as well as older teens and adults. The CDC signed off on the decision two days later on January 5, following a nearly unanimous recommendation by its Advisory Committee on Immunization Practices (ACIP). This group of medical and pubic health experts voted 13 to 1 in favor of recommending the Pfizer booster for children and teens between 12 and 17-years old.
During its deliberatings the ACIP noted that the risk for hospitalization is 11 times higher for unvaccinated young people in this age group.
“It is critical that we protect our children and teens from COVID-19 infection and the complications of severe disease," said CDC director, Rochelle Walensky, MD, MPH, in a January 5 news release. "This booster dose will provide optimized protection against COVID-19 and the Omicron variant. I encourage all parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations.”
The FDA's decision was made following a review of data from Israel, which included 6,300 young people between the ages of 12 and 15-years old who received a Pfizer booster at least five months after their first two doses. The study showed no new cases of two concerning but rare side effects—myocarditis (inflammation of the heart) and pericarditis (inflammation of the tissue surrounding the heart). Based on all available evidence, regulatory officials concluded the benefits of the booster, including stronger protection against hospitalization and death, outweigh any potential risks for kids as young as 12.
“A booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research in a January 3 news release. “In particular, the Omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines.”
The FDA also cut the amount of time that must pass before people who are fully vaccinated with the Pfizer vaccine can get their booster. Dr. Walensky also approved this decision, enabling all those who are fully vaccinated with the Pfizer COVID vaccine to get the Pfizer booster five months after their second jab. Previously, those ages 16 and older could not get a Pfizer booster until at least six months had passed since their second shot.
Pfizer noted that real world data from the Ministry of Health of Israel on more than 4.1 million third doses of the Pfizer vaccine given at least five months after the first two shots revealed no new safety concerns in children and teens between 12 and 17-years old.
The FDA adds that peer-reviewed data from multiple labs shows that a booster dose of the Pfizer vaccine significantly bolsters people’s antibody response, which can help protect against Omicron. Allowing those eligible to get their booster one month earlier can help bolster protection against this variant even sooner, the agency explains.
This shortened interval for Pfizer booster eligibility also affects those who received the Moderna COVID vaccine. Shortly after it's decision on the Pfizer vaccine, the FDA extended the move to the Moderna shot. If the CDC approves the decision, those who got two doses of the Moderna shot will also be able to get a booster five months later. Adults who got the Johnson & Johnson vaccine can get a booster at least two months later. The FDA says it will continue to review all evidence on all vaccines and provide updates as they become available.
Lastly, the FDA says immunocompromised children ages 5 to 11-years old can also get a third dose of the Pfizer vaccine as part of their primary series. This move also received a green light from the CDC. As a result, kids in this younger age group who have undergone a solid organ transplant or who have been diagnosed with conditions that are considered to have an equivalent level of immunocompromise are able to get a third dose of the Pfizer vaccine at least 28 days after their second shot.
These more vulnerable children may benefit from the additional dose since they may not have a sufficient immune response to the first two doses. The FDA says prior analyses conducted as part of the authorization process for healthy kids showed the benefits of a third dose for immunocompromised children in this age group outweigh any potential risks.
Children ages 5 to 11 who are not immunocompromised do not need a third dose at this time, the FDA advises, noting it will continue to review all data as it becomes available.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said acting FDA commissioner, Janet Woodcock, MD in a January 3 news release. “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.”
As 2021 came to an end, new COVID cases in the U.S. hit an all-time high of 486,428. And as of January 1, the highly transmissible Omicron variant accounts for hte vast majority, or 95, percent of all new infections while 4.6 percent of new cases involve the more severe Delta variant. Meanwhile, roughly 74 percent of the U.S. population received at least one dose of a COVID vaccine, 62 percent is fully vaccinated, and 35 percent is boosted.
