A Pfizer-BioNTech COVID-19 vaccine trial for children aged between five and 11 has produced “positive results” and has shown a “robust immune response”, the two firms have said.
They said the results are the first to emerge from any vaccine trial for children aged below 12 and would “provide a strong foundation” for seeking the authorisation of its potential rollout across the world.
Pfizer and BioNTech said the data will be submitted to health regulatory bodies and that they believe the trial provides a “great opportunity” to prevent COVID-19 in younger age groups.
Bill Gruber, the senior vice president of vaccine clinical research and development at Pfizer, told Sky News: “This is really great news. We have been able to demonstrate a robust immune response as well as a satisfactory safety profile for the Pfizer-BioNTech COVID-19 vaccine in children five to 11 years of age.
“This is intensive research where we have been very meticulous about defining the best dose that gives us the appropriate level of immune response and reduces as much as possible the common sorts of reactions that we see with vaccines, like fever, a sore arm, maybe headache and sometimes chills.
“What people need to understand is there’s been a concerted effort. Given that we are in the middle of a pandemic and hospitals are filling up, to get information out that can allow public health authorities to make good decisions about giving vaccines to children.”
He said there is plenty of evidence within hospital intensive care units (ICUs) to show that children can become “quite sick” from COVID.
“I think it’s an incorrect assertion to say that they (children) don’t have a chance of dying,” he added.
“We do have deaths – it is true that deaths are less common than they are in older individuals, but here in the United States, and I expect it’s true in the UK and Europe as well, the ICUs contain quite sick children.
“In fact, about a quarter of all children that end up in the hospital are ending up in the intensive care unit.
“So, although less common, if it affects your child, it’s a hundred percent and it’s a significant illness.
“Here’s a great opportunity to try to prevent that from happening, whether you are talking about 12 to 15-year-olds or you’re talking about five to 11-year-olds.”
The trial involved 2,268 participants who were aged five to 11 and given two doses, each one administered 21 days apart. The dose was smaller than the one for people aged 12 and older.
Trials were carried out in the US, Finland, Poland and Spain across more than 90 sites.
Results for vaccine trials involving children aged under five are expected later this year, the two firms said.
Pfizer CEO, Albert Bourla, added: “Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory approval, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”