Pfizer’s COVID-19 vaccine has been found to be safe and effective in children aged 5 to 11, the drugmaker said Monday.
The vaccine, created by Pfizer and German partner BioNTech, generated a “robust” immune response in young children during clinical trials, according to the company.
Pfizer now plans to use the data from the clinical trial to seek authorization from the US Food and Drug Administration and other health regulators for the 5 to 11 age group “as soon as possible”.
The vaccine is already available for anyone 12 and older in the United States after being granted emergency use authorization.
Pfizer said the 2,268 children participating in the trial were given two doses of the vaccine 21 days apart and they had comparable antibody results to teens that were included in an earlier trial.
The young children were given a much lower dose — about a third of the amount that is used for teens and adults.
The side effects of the vaccine, including sore arms, fever or achiness, were generally comparable to those found in a trial of those aged 16 to 25 years.
Unlike earlier vaccine trials that measured efficacy of the shot, this trial did not compare the number of COVID cases in vaccine recipients to those who had received a placebo.
The trial for young children compared the amount of neutralizing antibodies induced by the vaccine in kids to the response of those aged over 12 years.
Pfizer said it may disclose the vaccine efficacy from the trial at a later time but there hadn’t been enough COVID cases among those aged 5 to 11 to make that determination.
The vaccine was around 95 percent effective in the adult clinical trial.
The data from the latest trial hasn’t been submitted for peer review but Pfizer said it expects to include its finding in a submission to the FDA for emergency authorizations.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Pfizer’s CEO Albert Bourla said in a statement.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Pfizer’s announcement comes just as children returned to school and amid the spread of the highly contagious delta variant.
Moderna is also currently studying its vaccine shot in elementary school-aged children.
With Post wires