The Pfizer/BioNTech Covid-19 vaccine is safe and produces good responses in children under 12, the company has announced.
Data from clinical trials of 5- to 11-year-olds found the vaccine was well-tolerated with similar side effects to those seen in young adults and produced ‘robust antibody responses’, Pfizer said.
Volunteers had two jabs three week apart but the doses used were 10 µg rather than the 30 µg doses used for teenagers and adults.
‘The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,’ the company said in a statement.
Responses to the vaccine after one month compared well to those seen in trials of 16 to 25 year olds who had received the larger dose.
Pfizer said it plans to submit data to regulators worldwide urgently to provide access to the vaccination ahead of this winter.
The clinical trial of the vaccine initially enrolled up to 4,500 children aged six months to 11 years in the US, Finland, Poland, and Spain.
After initial dose studies, children under age five received a lower 3 µg dose for each injection in the Phase 2/3 trials. Data on children aged six months to five years is expected later this year, Pfizer said.
‘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 authorisation, especially as we track the spread of the Delta variant and the substantial threat it poses to children,’ said Albert Bourla, Pfizer chairman
‘These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.’
Vaccinations for 12- to 15-year-olds are currently being rolled out in England and are due to finish by October half-term.
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