Pfizer and its partner BioNTech have provided data to the US Food and Drug Administration for authorization for the emergency use of its COVID-19 vaccine for children aged 6 months to 4 years, the companies said on Tuesday.
Data on the third dose of the vaccine for children under 5 will be available in the coming months, the companies said, and will complete the resolution of what is expected to be a series of three doses of vaccine for the youngest age group.
The commission, which advises the FDA, will meet on February 15 to discuss whether to allow Pfizer’s COVID-19 vaccine for children under 5, the agency said on Tuesday. After receiving the green light from the FDA, a committee that advises U.S. Centers for Disease Control and Prevention usually meets to discuss whether to recommend a series of vaccines. Then, if the CDC accepts the recommendation, parents of infants and preschoolers will be able to begin the process of vaccinating their children against COVID-19.
Children aged 5 and over already qualify for the COVID-19 vaccine.
While a previous study found that two doses of the vaccine were effective in children aged 6 months to 2 years, two injections failed to promote a strong immune response in children aged 2 to 4 years. This prompted the company to begin testing a three-dose version of the vaccine for children under 5 years of age. But while regulators are waiting for data to authorize three doses of the vaccine (with data probably not available until this spring), public health officials are moving to two permitted doses so that younger children can be fully vaccinated earlier.
The Pfizer vaccine for children under 5 years of age is 3 micrograms, or one tenth of the company’s vaccine for people 12 years of age and older. The vaccine for children aged 5 to 11 is one-third the size of adults.
No safety concerns have been reported in the Pfizer trial for children under 5, the company said in December. If three doses of the children’s vaccine prove effective, the company will provide these data to the FDA to authorize the full three doses.
Given the hiccups of the two-dose vaccine series in children ages 2 to 4, Pfizer’s submission to the FDA comes a little earlier than what public health officials have previously calculated. However, it reflects the extremely high number of cases of COVID-19 in children caused by the omicron variant and concerns about side effects after infection in young children, including long COVID and multi-inflammatory syndrome.
The information contained in this article is for educational and informational purposes only and is not intended for health or medical advice. Always consult a doctor or other qualified medical professional about any questions you may have about your medical condition or health goals.