Pfizer has submitted an application to the US Food and Drug Administration (FDA) to approve the use of its COVID-19 vaccine in children aged 5-11. This age group is currently not eligible for the vaccine, which is only authorized for individuals 12 years and older. The company’s application is based on a study of over 2,200 children in this age group, which showed that a lower dose of the vaccine (one-third of the standard dose) was safe and effective in producing a strong immune response.
The study found that the lower dose of the vaccine produced similar antibody levels in children aged 5-11 as the standard dose produces in teenagers and adults. Pfizer reports that there were no serious side effects observed in the study, although it notes that the study was not large enough to detect extremely rare side effects.
If the FDA approves the application, vaccinations for children aged 5-11 could begin within a matter of weeks. However, there are additional steps that must be taken before vaccinations can start. An independent expert panel will review the evidence and debate it publicly on October 26, and the Centers for Disease Control and Prevention (CDC) will also need to weigh in and make a recommendation.
Many parents and pediatricians are eager for a vaccine to be available for younger children, as COVID-19 can still cause serious illness in this age group, and the virus has been spreading rapidly in communities with low vaccination rates. According to the CDC, COVID-19 cases in children have skyrocketed in recent months, particularly with the spread of the delta variant.
One child, Sebastian Prybol, 8, from Raleigh, North Carolina, is participating in Pfizer’s study at Duke University and is eager to see the vaccine approved. His mother, Britni Prybol, says she will be “overjoyed” if the FDA clears the vaccine, but emphasizes the importance of ensuring its safety for children. The approval of a vaccine for children aged 5-11 would be a significant step forward in the fight against COVID-19, and could help to reduce the spread of the virus in schools and communities.