Pfizer Inc (NYSE:PFE) has asked the U.S. Food and Drug Administration (FDA) to allow the use of its vaccine among children between 5 and 11 years old. Should it be approved, inoculation for this age group could start in a few weeks.
Safe and Robust
As reported by CNN, if authorization is given, it would be the first vaccine against COVID-19 for younger children. The Pfizer shot has been approved for those over 16 years of age while emergency use has been authorized between those aged 12 to 15 years.
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In the clinical trials that Pfizer developed in phase 2/3, results showed that it was “safe” and displayed a “robust” antibody production for children among the younger group.
The study was carried out with a sample of 2,268 participants and two shots were applied with an interval of 21 days, albeit in a 10 microgram dose –20 less than what is normally used for those over age 12.
According to the study, a lower dose concentration does not reduce the immune response. To do this, the level of antibodies in children aged 5 to 11 years was compared with those who received two doses of a 30-microgram shot.
"Pfizer said the levels compare well to those of older people who received the higher dose, demonstrating a strong immune response in this cohort of children one month after the second dose," CNN reports.
This is the first formal request Pfizer has made to the FDA for approval of its vaccine in infants aged 5 to 11 years.
The health agency will discuss the issue on October 26. “If approved by the FDA, a CDC vaccine advisory panel will meet to consider whether to recommend its use.”
Janet Woodcock, Acting Commissioner of the FDA, commented on the matter in a statement.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” she explained.
CBS reports that advisers to the Centers for Disease Control and Prevention will decide whether to recommend the shots for youngsters, and the entity will make a final decision.