Pfizer submits data to FDA for Covid-19 vaccine in younger children
Pfizer and BioNTech on Tuesday submitted initial trial data for their Covid-19 vaccine in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.
The American Academy of Pediatrics data shows that Coronavirus infections in children have skyrocketed, reaching their highest level in September.
According to the companies, on Sept. 20, the vaccine was approved in adolescents aged 12-15 and is fully approved for adults 16 years and older.
Pfizer BioNTech’s vaccine for kids 12-15 years old was approved in the month following authorization. Children younger than 12 years old could be given their shot if they follow the same process as for this application. This would allow them to start treatment as early October.
With schools opening across the country, a rapid authorization may help to reduce the potential for a surge in cases.
Although children are less likely to contract severe Covid-19 than adults, it is possible for them to spread the virus to other people, especially to vulnerable groups that may be more susceptible.
According to the companies, they will submit data to regulatory agencies such as the European Medicines Agency.
Two-shot vaccinations generated immune responses in children. This was in line with what was seen in previous studies in 16-25-year-olds. Pfizer also said that safety profiles were comparable for older patients.
Drugmakers also tested the vaccine on children between the ages of 2 and 5, as well as those 6 months and older, data for which is expected to be available in the fourth quarter.
ModernaWhile the Covid-19 vaccine in America isn’t yet approved for adolescents, authorization has been granted for Europe in that age bracket.