The Pfizer-BioNTech COVID-19 vaccine has been shown to be safe and generate a “robust” antibody response in children ages 5 to 11, according to Pfizer who performed a highly anticipated trial to confirm if the jabs were safe for children.
According to CNN, these are the first trial results released for this age group for a COVID-19 vaccine, and although the results of the trial have yet to be peer-reviewed and published, Pfizer says it intends to submit them to the US Food and Drug Administration (FDA) for emergency use authorization.
2,268 participants aged 5 to 11 took part in the trial, which saw the use of a two-dose regimen of the vaccine administered 21 days apart. The trials use a 10-microgram dose which is notably smaller than the 30-microgram that has been used on children 12 and older.
“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said.
The participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to those of a control group in which a group of 16 to 25 year-olds were given a two-dose regimen with larger 30-microgram doses.
Pfizer said the immunity levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said. A Pfizer spokesperson in fact said that there were no instances of myocarditis, a heart inflammation often linked with mRNA vaccines like the Pfizer Comirnaty jab.
The Pfizer/BioNTech vaccine is currently approved for people 12 and older in South Africa. Pfizer is expecting trial data for children as young as 6 months “as soon as the fourth quarter of this year.”
COVID-19 cases in the US have been especially prevalent amongst children in the last few months, buoyed primarily by the Delta variant. This has led to ramping up efforts to approve the vaccination for children.
“Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination. 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,” Albert Bourla, chairman and CEO of Pfizer, said in the statement.