Pfizer asked Thursday the US government to allow Covid-19 vaccination in children aged 5-11 years old. If regulators agree shots could be given within weeks.
Parents and pediatricians alike are calling for protection for children under 12 years old, the current age limit for vaccines made by Pfizer and BioNTech. Children can become seriously ill and it can be difficult to keep them in school due to the coronavirus that is still rampant in low-vaccinated areas.
Pfizer tweeted that it had filed its formal application with the Food and Drug Administration.
The FDA must now decide whether there is sufficient evidence to show that the shots are safe for children younger than teen and adult age. The evidence will be debated publicly by an independent panel of experts on 26 October.
Pfizer has made a big change in its research. It says that younger children should receive a third of what is being given to all others. The five- to eleven-year-olds received their second dose and developed the same virus-fighting antibodies as teenagers and young adults who receive regular-strength shots.
Although children are less likely to die from severe illness or death than those who are older, Covid-19 can sometimes cause death in children. The number of cases among younger people has increased as the extra-contagious Delta variant has spread through the country.
Sebastian Prybol, an eight-year-old from Raleigh, North Carolina, stated, "It makes me very happy that it is helping other children get the vaccine." He is currently enrolled at Duke University's Pfizers program and does not know if he has received the vaccine or dummy shots.
Britni Prybol, Sebastian's mother, stated that they want to ensure it is safe for them. She said that she would be thrilled if the FDA cleared the vaccine.
Pfizer tested the lower dose on 2,268 children aged five to 11 years old. They found no side effects. Although the study was not large enough to detect rare side effects such as heart inflammation, which can sometimes occur after regular-strength vaccinations, it is still possible to identify them in young men.
The FDA may authorize emergency use of kid-sized doses. This will be another hurdle that must be cleared before vaccines for this age group can start. The Centers for Disease Control and Prevention's advisory board will decide whether to recommend shots for younger patients. The CDC will then make a final determination.
