In children ages 5 to 11 years old, a two-dose regimen of the Pfizer/BioNTech Covid-19 vaccine—at a reduced dose—was safe, well tolerated, and effected robust neutralizing antibody responses, according to the first results from a trial of any Covid-19 vaccine in this age group. In fact, even at the reduced 10-μg dose, antibody responses were similar to those achieved in adolescents and young adults ages 16 to 25 years old who had been immunized with the larger 30-μg dose.
“Since July, pediatric cases of Covid-19 have risen by about 240% 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,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer, in a press release. “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.”
For this phase II/III study, 2,268 children aged 6 months to 11 years old were enrolled and received the 10-ug dose in two doses. One month after their second dose, children demonstrated a SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) indicative of a strong immune response that was not inferior to the GMT in control participants who were aged 16-25 years old who received a two-dose regimen of 30-μg (1,197.6 vs 1,146.5, respectively).
“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 5 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.”
These data will be shared with the FDA, the European Medicines Agency (EMA), and other regulators as soon as possible. In the U.S., they will be included in a near-term submission for Emergency Use Authorization (EUA).
Pfizer/BioNTech will continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group, and the company plans to submit a request to the EMA to update the EU Conditional Marketing Authorization. Data from the full phase III trial will also be submitted for scientific peer-reviewed publication.
Liz Meszaros, Deputy Managing Editor, BreakingMED™
Cat ID: 125
Topic ID: 79,125,730,933,125,190,31,520,926,138,139,44,192,561,927,925,934