Children aged five to eleven years old received a third dosage of Pfizer and BioNTech’s Covid vaccine in a clinical trial conducted by the companies on Thursday. After the results, the companies said they will seek regulatory approval for the vaccine.
Individuals over the age of 12 should have a third dosage of the vaccine, and a fourth dose has recently been suggested for adults over the age of 50.
More vulnerable to infection from Omicron and its BA.2 subvariant are younger children, who have not been eligible for the third vaccination, with the exception of those with immune weakening diseases, and are therefore more susceptible to infection.
BA.2 is now the most prevalent strain in the world, and it is believed to be responsible for a recent rise in cases in the northeastern United States.
A phase 2/3 trial was conducted in which the firms reviewed data from 140 children ages five to eleven, about six months after the second dose was administered.
The dosage in this group is 10 micrograms, which was chosen for its safety, as children are more vulnerable to adverse effects than adults and adolescents. The recommended dose for children aged 12 and up is 30 micrograms.
The third dose was well tolerated by the 140 children who participated in the study, and no additional safety issues were discovered.
Using blood sera from a sample of 30 people, the researchers found that, when administered three times, a third dose induced a 36-fold rise in the levels of infection-blocking neutralising antibodies against Omicron, compared to when administered two doses.
Pfizer and BioNTech want to submit the data to the United States Food and Drug Administration (FDA), the European Medicines Agency, and other regulatory agencies as soon as possible, according to the company.
In most countries, including the United States, vaccinations for newborns and very young children have not yet been approved by the Food and Drug Administration (FDA).
Moderna announced last month that it was pursuing FDA approval for its vaccine, which would be administered in two doses to children aged six months to five years.
The FDA was supposed to review Pfizer’s vaccine for this group in February, but the agency postponed the hearing because it needed additional evidence on how well it would operate after three doses.