Covid-19 vaccine maker Pfizer-BioNTech says it is ready to seek regulatory approval after trial results revealed that their vaccine is safe and produces a robust immune response in children aged five to 11.
US pharma giant Pfizer and its German partner said the vaccine would be administered at a lower dosage than for people aged above 12 years.
“In participants five to 11 years of age, the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses,” the statement said.
It added they plan to submit their data to regulatory bodies in the European Union, the US, and around the world “as soon as possible.”
The trial results are the first of their kind for children below 12 for widely used vaccines, with a Moderna trial for six to 11-year-olds still ongoing.
Last week, Cuba announced that it had begun vaccinating children as young as two with its homegrown vaccines, which its health officials said had been found to be safe for younger people.
Both Pfizer and Moderna vaccines are already being administered to adolescents above 12 and adults in countries around the globe.
The update, however, comes as countries continue to grapple with the highly contagious Delta variant and vaccine hesitancy in some adults, which continue to prolong the pandemic.
It also comes as health authorities weigh whether booster shots of the available vaccines are needed for adults.
Pfizer CEO Albert Bourla noted that although children are considered less at risk of severe COVID-19, there are concerns that the Delta variant could lead to more serious cases.
“We are eager to extend the protection afforded by the vaccine to this younger population,” he said.
Kids in the five to 11 age trial group received a two-dose regimen of 10 microgrammes in the trial, compared with 30mg for older age groups, the companies said. The shots were given 21 days apart.
The 10mg dose was “carefully selected as the preferred dose for safety, tolerability and immunogenicity” for that age group, the statement said.
Pfizer-BioNTech is also trialing their vaccine on infants aged six months to two years, and on children aged two to five, with the main results expected “as soon as” the fourth quarter of this year.
In May, the European Medicines Agency (EMA) approved the Pfizer vaccine for 12 to 15-year-olds. Since then, different EU countries have moved at different speeds.
Altogether, 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.
Children in the UK aged 12 to 15 are set to get a Covid jab, following advice from the UK’s chief medical officers, who recommended the youngsters should be offered one dose of the Pfizer vaccine.
Further, Denmark (12 to 15-year-olds) and Spain (12 to 19-year-olds) have both now vaccinated most of their child population with at least a single dose.
France too has been moving quickly with 66 per cent of those aged 12 to 17 now getting a single jab, and 52 per cent fully vaccinated.
In June Germany’s scientific advisers recommended the vaccine should only be offered to children aged 12 to 15 with underlying health conditions, a move that was reconsidered in August, after the Delta variant started spreading more widely, extending the rollout to all those over 12 years old.
In Sweden, children aged 12 to 15 are only eligible for a vaccine if they have lung disease, severe asthma, or another high-risk medical condition.
In May, US and Canadian regulators were the first to approve the Pfizer jab for use in children from 12 years and older.
In Kenya, the vaccinations are still for adults above the age of 18 years.