Washington, DC—Now that Pfizer Inc. and BioNTech SE have released data indicating that a phase II/III trial of their mRNA vaccine showed a favorable safety profile and robust neutralizing antibody responses in children aged 5 to 11 years, how long will it be before a vaccine is available for that age group?
The companies announced that they tested a two-dose regimen of 10 µg administered 21 days apart in a smaller dose than the 30-µg dose used for people aged 12 years and older.
A press release stated that, in the first results from the trial, antibody responses in the participants given 10-µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people aged 16 to 25 years who received 30-µg doses. The companies said the 10-µg dose was selected as the preferred dose for safety, tolerability, and immunogenicity in the younger children.
The consensus among experts suggests the target date could be sometime between Halloween and nearly November. It is unknown, however, how long the FDA review might take.
Former FDA chief Scott Gottlieb told CNBC shortly after the Pfizer-BioNTech announcement that, assuming the data meets all of the FDA’s standards, the end of October or early November seemed likely. Anthony Fauci, MD, the White House’s chief medical advisor, agreed with that assessment, telling MSNBC, “I think there’s a really good chance it will be before Halloween.”
“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,” said Albert Bourla, Pfizer’s chairman and CEO. “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.”
Data came from a study involving 2,268 participants who were aged 5 to 11 years. The companies reported that the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI], 1,106.1, 1,296.6]), which signaled strong immune response 1 month after the second dose.
“This compares well (was noninferior) to the GMT of 1,146.5 (95% CI: 1,045.5, 1,257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg,” according to the press release. “Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.”
In the United States, the companies said they would soon seek FDA Emergency Use Authorization for the pediatric vaccine. Data for the other two age cohorts from the trial—children 2 to 5 years of age and children 6 months to 2 years of age—are not expected until the end of the year.
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