Pfizer and BioNTech announced Monday that in a Phase II/III study, a smaller dose of its COVID-19 vaccine Comirnaty demonstrated robust neutralising antibody responses in children 5 to 11 years. The companies plan to submit the data, which are the first from a pivotal trial of a COVID-19 vaccine in this age group, to regulators in the US and Europe.
The trial enrolled 2268 participants 5 to 11 years of age who received a 10-mcg dose level of Comirnaty in a two-dose regimen administered 21 days apart. Top-line results showed that the SARS-CoV-2–neutralising antibody geometric mean titer (GMT) was 1197.6 one month after the second dose. The companies said this was non-inferior to the GMT of 1146.5 seen in a control group of participants aged 16 to 25 years old who were administered two doses of the mRNA vaccine at the 30-mcg dose level.
Pfizer and BioNTech added that Comirnaty was well tolerated in the study, with side effects generally comparable to those observed in the 16-to-25 age bracket. The drugmakers noted that top-line results from the trial in children <5 years of age are expected later this year.
A spokesperson for Pfizer suggested that the companies might disclose vaccine efficacy from the trial in the future, but there had not yet been enough cases of COVID-19 in the trial. The spokesperson added that at the request of regulators in the US, Pfizer and BioNTech have submitted a plan to add 2250 more children between the ages of 5 and 11 to their paediatric studies.
Albert Bourla, CEO of Pfizer, remarked "since July, paediatric cases of COVID-19 have risen by about 240% in the US," adding that the "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." The companies noted that in the US, they expect to include the data in a near-term submission for emergency-use authorisation (EUA), while they continue to collect evidence needed to seek full approval in this age group.
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