- Pfizer and BioNTech formally requested emergency approval of their COVID-19 vaccines for children 5 to 11 years old.
- The Pfizer-BioNTech vaccine is fully approved for people 16 years old and older and is available under emergency use for adolescents ages 12 to 15 years old.
- Pfizer and BioNTech said in September that no serious side effects were found during the vaccine trial for 5- to 11-year-olds.
Pfizer and BioNTech asked the Food and Drug Administration (FDA) on Oct. 7 to authorize emergency use of their COVID-19 vaccines for children ages 5 to 11 years old.
The FDA’s vaccine advisory committee is expected to
“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against COVID-19,” Pfizer said Oct. 7 on Twitter.
The Pfizer-BioNTech vaccine is fully approved for people 16 years old and older and is available under an emergency use authorization (EUA) for adolescents ages 12 to 15 years old.
In September, the companies released results from a phase 2 and 3 trial showing that the vaccine was safe and generated a “robust” immune response in children 5 to 11 years old.
This study included 2,268 children from the United States and several other countries. They received two doses of the vaccine about 21 days apart.
The dose used in the trial — 10 micrograms — is a third of that used for people 12 years and older.
Researchers measured children’s immune response by looking at the level of neutralizing antibodies in their blood.
“These results — the first from a pivotal trial of any COVID-19 vaccine in this age group — were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 microgram doses,” the companies said in a statement.
They plan to submit the data from the full phase 3 trial to a scientific peer-reviewed publication.
Now that the FDA has the full data from the phase 2 and 3 trial, FDA scientists will carefully review them.
Pfizer and BioNTech said in September that no severe side effects were found during the vaccine trial for this age group.
However, the FDA and its advisory committee will look for potential concerns that the companies may not have identified.
One of these is heart inflammation —
Most cases have occurred in young males after the second dose.
Dr. Christina Johns, pediatrician and senior medical adviser for PM Pediatrics, said it’s important to put the risk of heart inflammation into perspective.
“So far, the risk of myocarditis from COVID-19 infection in the older [adolescent] age group appears to be more significant than it is with the vaccine,” she said.
In addition, most cases of heart inflammation after vaccination have been mild, with people recovering quickly with treatment.
“Those [older] children have done well,” she said, “so I would anticipate that if we see this side effect in the younger age group, it would follow a similar course.”
Some countries, such as the United Kingdom, have recommended a single dose of the mRNA vaccine for certain adolescent populations to minimize the risk of myocarditis.
The FDA and Centers for Disease Control and Prevention (CDC) might consider this approach for younger children during its review of Pfizer’s and BioNTech’s EUA application.
If the FDA issues an EUA of the vaccine for this age group, the CDC’s vaccine committee will meet to discuss whether to recommend its use.
If these reviews go smoothly, the agencies could make a decision between Halloween and Thanksgiving, although this timeline is subject to change.
Results from Pfizer’s vaccine trial in children 6 months to 4 years are not expected until later this year at the earliest.
Results from Moderna’s pediatric trial are also expected around the same time.
For many parents, a vaccine for this age group can’t come soon enough.
During the last week of September, children under 18 years old accounted for more than a quarter of new coronavirus cases, with more children ending up in hospitals and ICUs in recent weeks than earlier in the pandemic.
“COVID-19 doesn’t care if you’re young or old. It attacks any human,” said Dr. Ilan Shapiro, a pediatrician and medical director of health education and wellness at AltaMed Health Services in Los Angeles.
With children under 12 not yet eligible for vaccination, the virus has spread freely among this age group, especially in certain parts of the country.
“In states that do not have [school] mask recommendations, or vaccine recommendations [for older children], we are seeing more cases and more kids ending up in pediatric intensive care units,” said Shapiro.
Ongoing COVID-19 outbreaks among children are also disrupting their education as students, teachers, and staff have to be quarantined, or in some cases, schools close.