Pfizer says low dose of its COVID-19 vaccine works in younger children
COVID-19 cases among children are becoming more common, heightening the need for vaccines, CEO says.
Photo by Marko Geber/Getty Images
Pfizer and BioNTech, makers of the Food and Drug Administration-approved COVID-19 vaccine Comirnaty, shared today that their vaccine is effective among children ages 5 to 11 and that they will seek regulatory approval "as soon as possible."
While the data has yet to be peer-reviewed, it shows that smaller doses (10 µg compared to the 30 µg dose used for people 12 and older) given 21 days apart elicited a similar antibody response as seen among people 16 to 25 years of age.
This younger cohort also experienced side effects comparable to those of the older group, including sore arms, fatigue and fever.
"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," Dr. Ugur Sahin, CEO and cofounder of BioNTech, said by statement.
"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."
The data is based on a study of 2,268 participants in that age range who received two rounds of the lower-dose version of Comirnaty.
Pfizer and BioNTech are seeking U.S.-approval first, saying they'll first submit for an FDA emergency use authorization while they continue to gather the safety and efficacy data needed for a full FDA approval in this age group. The drug developers are also planning to share the results with the European Medicines Agency (EMA) and other regulators in the near future.
In addition to today's announcement, the companies said they will share safety and efficacy data of the vaccine among children 2 to 5 years of age and children six months to 2 years as soon as the fourth quarter of this year.
WHY THIS MATTERS
Even though nearly three-quarters of Americans 12-years-and-older have received at least their first COVID-19 vaccine dose, new cases, hospitalizations and deaths are on the rise, according to the Centers for Disease Control and Prevention.
Unlike past surges, this one is being driven in part by cases among children. For instance, while children have represented 15.5% of cases since the pandemic began, they made up 28.9% of new cases during the week of September 9, according to the American Academy of Pediatrics.
More than 243,000 cases among children were reported that week, representing the second-highest number of child cases in a week since the pandemic began, according to the AAP.
Although the likelihood of severe illness, hospitalization or death among child COVID-19 patients is small, getting vaccines to this younger age group is an important public health measure, according to Pfizer's CEO and Chairman Albert Bourla.
"Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. – underscoring the public health need for vaccination," Bourla said in a statement. "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."
THE LARGER TREND
While elementary school-aged kids could soon be the next age group rolling up their sleeves to get the jab, President Biden recently issued a sweeping vaccine mandate for a number of federal, private and healthcare workers.
Aside from the potential health risks of COVID-19, a recently released analysis from the Kaiser Family Foundation illustrates its systematic financial burden. It found that the U.S. health system spent $5.7 billion on preventable COVID-19 hospitalization between June and August of this year.
Much of the recent vaccine debate has centered on booster shots. Pfizer, Moderna and Johnson & Johnson have all shared data in support of booster shots, but the World Health Organization and others say booster shots should wait until greater vaccine equity is achieved.
Regardless, last week the FDA issued a EUA for a Pfizer vaccine booster shot for individuals 65 years and older, and for individuals of any age at high risk of severe COVID-19.
Twitter: @HackettMallory
Email the writer: mhackett@himss.org
