Pfizer and its partner BioNTech have announced positive topline results from a pivotal trial of their Covid-19 vaccine in children aged 5 to 11 years.
The Phase II/III trial was conducted using a two-dose regimen of 10 µg administered 21 days apart, which is a smaller dose compared with the 30µg dose given to subjects aged 12 years and above.
This showed that the vaccine was safe, well-tolerated and indicated robust neutralizing antibody responses.
The antibody responses in the younger subjects immunized with 10 µg doses were roughly same as those recorded in a previous trial conducted in people aged 16 to 25 years with higher doses.
Side effects were also comparable to those observed in the older participants.
The Phase II/III trial is enrolling children aged 6 months and 11 years.
The current data was obtained from the study conducted on 2,268 participants aged 5 to 11 years, who received 10-µg dose in a two-dose regimen.
The Pfizer stated that the SARS-CoV-2 neutralizing antibody geometric mean titer (GMT) was 1,197.6, which showed strong immune response in children one month after the second dose.
Pfizer chairman and CEO Albert Bourla 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 authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.
“Since July, paediatric cases of Covid-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Furthermore, companies are planning to share the new data with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible.
They are also expecting to include these findings in a forthcoming submission for Emergency Use Authorization (EUA) in the US.