Pfizer and BioNTech say its COVID-19 vaccine works for children aged five to 11. They plan to ask for authorisation to use the vaccine in that age range in the US and Europe, and subsequently world-wide.
According to the firms, the new developed vaccine generated a strong immune response in children in a Phase II/III clinical trial that matched their observations previously seen in 16 to 25-year-olds.
They said the safety profile was similarly comparable to that of the older age group.
US health officials expect regulators will decide whether the jab is safe and effective in younger children within three weeks of the companies submitting a request for approval.
In recent months, the highly contagious Delta variant caused a surge of hospitalisations and deaths in the US. With children under the age of 12 unvaccinated, paediatric infections are also on the rise.
Pfizer Chief Executive Albert Bourla said on Monday that since July paediatric cases of COVID-19 have risen by about 240 per cent in the US, underscoring the public health need for vaccination.
“These trial results provide a strong foundation for seeking authorisation of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” he said.
The approval would help prevent a spike in cases during winter time since schools are already open across the US.
Pfizer is already permitted for use in children as young as 12 years old in many countries, including the US.
According to Pfizer, they may subsequently publish vaccine efficacy from the trial but leave it to the participants decision.
In an adult clinical trial, the vaccine was roughly 95 percent effective, but Pfizer claims that immunity begins to fade a few months after the second dosage.
Photo: Pfizer-BioNtech COVID-19 vaccine (2020) By US Secretary of Defence available HERE and used under a Creative Commons Attribution 2.0 Generic. The image has not been modified.