The Phase II/III trial showed a favorable safety profile and “robust” neutralizing antibody responses in children five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
Initial results from a recent vaccine trial today showed that Pfizer and BioNTech‘s COVID-19 vaccine might be safe for use in children under 12 years old.
The ongoing Phase II/III trial on the Pfizer-BioNTech COVID-19 vaccine showed a favorable safety profile and “robust” neutralizing antibody responses in children aged five to 11 years old who received two 10 µg doses of the vaccine at 21 days apart.
The results were reportedly similar to those observed in a previous trial when the same vaccine, but at 30 µg doses, was given to participants aged 16 to 25 years old. The researchers said that the 10 µg dose is preferred because of its tolerability, safety, and immunogenicity in the five to 11-year-old participants.
“Since July, pediatric 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,” said Albert Bourla, chairman and chief executive officer of Pfizer, in a statement.
“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,” Bourla added.
The Phase II/III study involves participants aged six months to 11 years, of which 2,268 are in the five to 11 year age range and received a 10 µg dose in a two-dose regimen. The trial enrolled up to 4,500 children across over 90 clinical trial sites in the United States, Finland, Spain and Poland. It is designed to evaluate safety, tolerability, and immunogenicity.
In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer (GMT) had a 95 percent confidence interval one month after the second dose. This meant a strong immune response. The results are comparable to the participants aged 16 to 25 years old who received 30 µg.
The FDA-approved COMIRNATY has the same formulation as the EUA-approved Pfizer-BioNTech COVID-19 vaccine and is based on BioNTech’s proprietary mRNA technology and was developed alongside Pfizer’s resources and expertise.
It is initially approved as a two-dose series for preventing COVID-19 infection in individuals aged 16 years and older. It also has emergency use authorization for individuals aged 12 to 15 years and as a third dose for individuals aged 12 years and older who have been diagnosed with certain kinds of immunocompromise.
Pfizer and BioNTech are preparing to share their findings with the top regulators soon, including the U.S. Food and Drug Administration and the European Medicines Agency. The companies intend to apply for full FDA approval to use this vaccine for the five to 11-year-old age group. It also expects to release topline results for other age groups, particularly two to five years and six months to 12 years, by the fourth quarter of 2021.
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