Pfizer/BioNTech say data shows Covid vaccine safe for kids aged 5-11
They plan to seek permission to use shots on five- to 11-year-olds in the US, Europe and elsewhere soon
WASHINGTON: Pfizer and BioNTech said yesterday their Covid-19 vaccine induced 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 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 comparable with the older age group, they said.
"Since July, paediatric cases of Covid-19 have risen by 240 per cent in the US - underscoring the public health need for vaccination," Pfizer chief executive albert Bourla said in a news release. "These trial results provide a strong foundation for seeking authorisation of our vaccine for five- to 11-year-olds, 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.
Covid-19 hospitalisations and deaths have surged in the United States in recent months due to the highly contagious Delta variant.
The companies' vaccine, called Comirnaty, is already authorised for use in children as young as 12 in many countries, including the US.
The five- to 11-year-olds were given two shots of a 10-microgram dose of the vaccine, one-third the dose size that has been given to people 12 and older.
The companies expect data on how well the vaccine works in twoto five years of age and children six months to two years of age as soon as the fourth quarter of this year.
Unlike the larger clinical trial the drugmakers previously conducted in adults, the 2,268-participant paediatric trial was not primarily designed to measure the vaccine's efficacy by comparing the number of Covid-19 cases in vaccine recipients to those who received a placebo.
Instead, the trial compares the amount of neutralising antibodies induced by the vaccine in the children to the response of older recipients in the adult trial.
Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, particularly young men. - REUTERS
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