Pfizer Inc and BioNTech SE said on Monday their Covid-19 vaccine induced a robust immune response in 5 to 11-year-olds, and they plan to ask for authorisation to use the vaccine in children in that age range in the United States, Europe and elsewhere as soon as possible.
The companies said the vaccine generated an immune response in the 5-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.
"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.
"These trial results provide a strong foundation for seeking authorisation of our vaccine for children 5 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.
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