Pfizer Inc and BioNTech SE say their COVID-19 vaccine induces a robust immune response in five to 11 year olds and they plan to ask for authorisation to use the vaccine in children in that age range in the US, Europe and elsewhere as soon as possible.
The companies said the vaccine generated an immune response in the five-to-11 year olds in their Phase II/III clinical trial that matched what they had previously observed in 16-to-25 year olds.
The safety profile was also generally comparable to the older age group, they said.
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“Since July, pediatric cases of COVID-19 have risen by about 240 per cent in the US - underscoring the public health need for vaccination,” Pfizer Chief Executive Albert Bourla said in a news release on Monday.
“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.”
Top US health officials believe regulators could make a decision on whether the shot is safe and effective in younger children within three weeks of the companies submitting a request for authorisation, two sources told Reuters earlier this month.
COVID-19 hospitalisations and deaths have surged in the United States in recent months due to the highly contagious Delta variant.
Pediatric cases are also up, particularly as children under 12 are all unvaccinated, but there is no indication that, beyond being more transmissive, the Delta virus is more dangerous in kids.
A rapid authorisation could help mitigate a potential surge of cases in the colder months, especially with schools already open nationwide.
The companies’ vaccine, called Comirnaty, is already authorised for use in children as young as 12 in many countries, including the United States.
A Pfizer spokesperson said the companies may later disclose vaccine efficacy from the trial but there had not been enough cases of COVID-19 yet among the participants to make that determination.
The vaccine was around 95 per cent effective in the adult clinical trial, but Pfizer has said that immunity wanes some months after the second dose.
US regulators are expected to authorise a third, booster dose of the vaccine for older and high-risk Americans early this week.