The antibody responses in participants given 10µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people aged 16 to 25 who were given 30µg doses. The 10µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children aged between five and 11. These are the first results from a pivotal trial of a Covid-19 vaccine in this age group.
“Over the past nine months, hundreds of millions of people aged 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, chairman and chief executive officer of Pfizer. “Since July, paediatric cases of Covid-19 have risen by about 240 per cent in the US – underscoring the need for vaccination. These trial results provide a strong foundation for seeking authorisation of our vaccine for children aged five to 11, and we plan to submit them to the FDA and other regulators with urgency.”
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged five to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The data summarised from this Phase 2/3 study, which is enrolling children six months to 11 years of age, was for 2,268 participants aged between five and 11 who received a 10µg dose level in a two-dose regimen.
In the trial, the SARS-CoV-2–neutralising antibody geometric mean titer (GMT) was 1,197.6 (95 per cent confidence interval [CI: 1106.1, 1296.6]), demonstrating a strong immune response in this group of children one month after the second dose.
This compares well (was non-inferior) to the GMT of 1146.5 (95 per cent CI: 1045.5, 1257.2) from participants aged 16 to 25, used as the control group for this analysis and who were administered a two-dose regimen of 30µg.
Further, the Covid-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Pfizer and BioNTech plan to share this data with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible.
For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorisation (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group.
A request to the EMA to update the EU Conditional Marketing Authorisation is also planned. Topline readouts for the other two groups from the trial – children two to five years of age and children six months to two years old – are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.
Published : September 21, 2021