Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News
Yesterday the U.S. Food and Drug Administration authorized the use of a single booster shot dose for children aged 5 through 11 years old. Still falling under “emergency use authorization,” the FDA is advising that the booster be given at least five months after the primary series of the Pfizer-BioNTech COVID-19 vaccine is administered.
The FDA commissioner Dr. Robert Califf acknowledge that children generally have fewer risk factors and better outcomes saying in a statement “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” and added that the FDA made this amendment to the EUA because “Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”
Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research also commented, saying “The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.” He explained that boosters doses are essential because “emerging data suggests that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations.”
The safety and efficacy of booster shots in this age group were evaluated in about 400 children who received a booster dose five to nine months after their primary series. The data suggested that a single booster dose increased antibodies produced by the vaccine when compared to the number of antibodies prior to receiving the booster shot. This would indicate that the vaccine provides adequate protection for a few months, as seen in adult populations, but suggests very poor durability. Just how many boosters will be recommended for both children and adults, based on the waning efficacy of the vaccines, is yet to be known.
In a recent interview with George Stephanopoulos on ABC’s This Week, Dr. Anthony Fauci urged parents to vaccinate their children saying, “If your child is 5 years of age and older, please get them vaccinated. We need to protect the children. This idea that children are not vulnerable at all is not so.” However, both Dr. Fauci and CDC director Rochelle Walensky acknowledged that many children that are hospitalized have coincidentally tested positive for COVID, meaning that they are hospitalized with COVID-19, but not from it.
According to CDC data, healthy children face very little risk of becoming infected and of the children who have died from COVID over the last two years, most were immunocompromised or had pre-existing conditions. In fact, according to the CDC’s National Vital Statistics System, children and adolescents are more likely to die from accidents, homicide, suicide, and cancer than from COVID-19.
While the FDA has granted this amendment to the EUA, the CDC must make a formal recommendation before booster doses can be administered to children. Many expect that the agency will make its recommendation later this week.