Pfizer, BioNTech's COVID-19 vaccine generates robust antibody response in children

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.

Results in younger children upcoming

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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