The coronavirus vaccine jointly developed by Pfizer and BioNTech was found to be safe and produced a robust immune response in children aged five to 11 in Phase 2/3 trials. The vaccine would be administered to this age group in a two-dose regimen of 10 micrograms, given 21 days apart, as opposed to 30 micrograms given to beneficiaries aged 12 and above, they said.
“The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” US pharma major Pfizer and its German partner said in a joint statement on Monday.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said BioNTech CEO Dr Ugur Sahin. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The Pfizer-BioNTech combine plans to submit its data to regulatory bodies in the European Union, the United States and around the world “as soon as possible”.
The trial results are the first of their kind for children under 12, with a Moderna trial for six-11 year olds still ongoing. Both the Pfizer and Moderna jabs are already being administered to adolescents over 12 and adults in countries around the globe.
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. Innoculating children is also seen as key to keeping schools open and helping end the pandemic.
“We are eager to extend the protection afforded by the vaccine to this younger population,” said Pfizer CEO Albert Bourla, noting that “since July, paediatric cases of COVID-19 have risen by about 240 percent in the US”.
For the trials initially 4,500 children of ages 6 months to 11 years were enrolled in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech Covid vaccine on a two-dose schedule (approximately 21 days apart) in three age groups – ages 5 to 11 years; ages 2 to 5 years; and ages 6 months to 2 years.
Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to 11 years received two-dose schedule of 10 micrograms each while children under age 5 received a lower 3 micrograms dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
The side effects were “generally comparable to those observed in participants 16 to 25 years of age”, the company statement 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.
Israel has already given special authorisation to vaccinate children aged 5-11 who are “at significant risk of serious illness or death” from Covid, using the Pfizer jab at the lower dosage.
Pfizer and BioNTech are also trialling their vaccine on infants aged six months to two years, and on children aged two to five.
The topline results for those trials are expected “as soon as” the fourth quarter of this year, the companies said.
All together, up to 4,500 children aged six months to 11 years have enrolled in the Pfizer-BioNTech trials in the US, Finland, Poland and Spain.
Like its Moderna rival, the Pfizer jab is based on novel mRNA technology that delivers genetic instructions to cells to build the coronavirus spike protein, in order to evoke antibodies when bodies encounter the real virus. Mint