PFIZER COVID JAB SAFE FOR KIDS—DRUGMAKER
FRANKFURT— Pfizer and BioNTech on Monday said trial results showed their coronavirus vaccine is safe and produces a robust immune response in children aged 5 to 11, adding that they would seek regulatory approval shortly.
The vaccine would be given at a lower dosage than for people over 12, they said.
“In participants 5 to 11 years of age, the vaccine was safe, well tolerated and showed robust neutralizing antibody responses,” Pfizer and BioNTech said in a joint statement.
They plan to submit their data to regulatory bodies in the European Union, the United States and around the world “as soon as possible.”
Moderna’s trial for 6 to 11 year olds is still ongoing.
Both the Pfizer and Moderna jabs are already being administered to adolescents over 12 in several countries, as well as to adults around the globe.
Delta worries
Although children are considered less at risk of severe COVID, there are concerns that the highly contagious Delta variant could lead to more serious cases.
“We are eager to extend the protection afforded by the vaccine to this younger population,” said Pfizer CEO Albert Bourla, noting that “since July, pediatric cases of COVID-19 have risen by about 240 percent in the United States.”
Kids in the 5 t0 11 age group received a two-dose regimen of 10 micrograms in the trial, compared with 30 micrograms for older age groups, the companies said. The shots were given 21 days apart.
The 10 microgram dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity” for that age group, the statement said.
The side effects were “generally comparable to those observed in participants 16 to 25 years of age,” it added.
Among the most commonly reported side effects in the past have been pain and swelling at the injection site as well as headache, chills and fever.
The Pfizer-BioNTech statement made no mention of the rare side effect of myocarditis, an inflammation of the heart muscle that has been linked to the vaccine, mostly among younger males.