The Food and Drug Administration authorized COVID-19 booster shots on Tuesday for healthy 5-11-year-old at least five months after their primary series to enhance protection against infection.
This action comes as cases are on the rise nationwide. Federal regulators determined a third shot of the Pfizer-BioNTech COVID-19 Vaccine can help boost protection for children in this age group.
“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 long term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D
While the virus is statistically more fatal among adults than among children, the Centers for Disease Control and Prevention reported more than 350 children ages 5 to 11 have died due to the virus.
A single booster dose for individuals 12 through 15 received approval on Jan. 3 after having received their primary series. Some people, including those 50 and older, can choose a second booster.
The FDA authorized the primary series of the COVID-19 vaccine in October 2021 for children as young as five years old. The Centers for Disease Control and Prevention (CDC) must decide whether to formally approve the vaccine for this age group.
According to the Director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, M.D., Ph.D. said emerging data suggested that vaccine effectiveness against COVID-19 wanes after the second dose in all authorized populations.
Scientists evaluated the Antibody responses among 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of Pfizer-BioNTech vaccines. The antibody level against COIVD-19 one month after the booster dose increased compared to before the booster dose.
Approximately 400 children received the booster dose five to nine months after completing a two-dose series to determine the safety of booster doses. According to the FDA, the most commonly reported side effects were pain, redness, swelling at the injection site, fatigue, headache, muscle or joint pain, fever, and chills.
Pharmaceutical giants Pfizer and Moderna have studied their vaccines in the youngest age group. The FDA expects to evaluate data from either or both companies in June.
The CDC said the U.S. death toll from COVID-19 reached 1 million, less than 2 ½ years into the pandemic, as reported by the Associated Press. As of May 16, the CDC predicts 2,000-5,300 new COVID-19 deaths to be reported during the week ending June 11. That would bring the grim landmark death toll to 1,008,000-1,018,000.
