Pfizer announced Monday that its COVID-19 vaccine, Comirnaty, is safe for children 5 to 11 years old, with a "robust" antibody response in a smaller dose than that given to those 12 and older.
According to the results of a test phase 2/3 trial, he said, there is a favorable safety profile and robust neutralizing antibody responses in children aged 5 to 11 years, with a two-dose regimen of 10 µg ?micrograms? given 21 days apart, a lower dose than the 30 µg dose used for people 12 years and older.
The antibody responses in participants who received 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in 16- to 25-year-olds immunized with 30 µg doses, the drugmaker said in a statement.
He noted that the 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children aged 5 to 11 years. "These are the first results from a pivotal trial of a COVID-19 vaccine in this age group."
"Over the past nine months, hundreds of millions of people aged 12 years and older around the world have received our COVID-19 vaccine. We look forward to extending the protection it provides to the younger population, subject to regulatory clearance, especially as we track the spread of the Delta variant and the substantial threat it poses to children," said Albert Bourla, president and CEO of Pfizer.
He noted that since July, pediatric cases of COVID-19 have increased by approximately 240 percent in the United States, underscoring the public health need for vaccination. "The results of these trials provide a strong basis for seeking licensure of our vaccine for children 5 to 11 years of age, and we plan to submit them urgently to the FDA and other regulators.
"We are pleased to be able to send data to regulatory authorities for this group of school-aged children before the start of the winter season," said Ugur Sahin, Ph.D., 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 what we have observed with our vaccine in other older populations at a higher dose," he added.
Summary data from this Phase 2/3 study, enrolling children 6 months to 11 years of age, included 2,268 participants who were 5 to 11 years of age and received a dose level of 10 µg in a two-dose regimen.
In the trial, the geometric mean titer of SARS-CoV-2 neutralizing antibodies was at a 95 percent confidence interval, demonstrating a strong immune response in this group of children one month after the second dose.
Pfizer and BioNTech plan to share this data with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators as soon as possible.
For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization as they continue to accumulate the safety and efficacy data needed to apply for full FDA approval in this age group.
Pfizer and BioNTech also plan to submit data from the full Phase 3 trial for peer-reviewed scientific publication.
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