Pfizer gets one step closer to offering a vaccine for children ages 5 to 11.
RICHMOND—A “robust neutralizing antibody response.” That’s the type of report folks like to hear about a vaccine—especially if they’re a caregiver to a small child. And that’s exactly what Pfizer had to say about the impact of its COVID-19 vaccine in children ages 5 to 11.
While a vaccine protecting against death or severe illness from a coronavirus infection is not currently authorized for children under 12, Pfizer-BioNTech came one step closer this week to its potential rollout. On Sept. 21, the company released information about a vaccine trial involving 2,268 participants between the ages of 5 and 11, which found that it was safe and effective.
Now, the vaccine manufacturer plans to take the next step toward getting COVID-19 vaccines into the arms of younger children nationwide.
“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,” said Dr. Ugur Sahin, 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 those we have observed with our vaccine in other older populations at a higher dose.”
What’s Different About the Child Vaccine?
If you’ve ever gone out to eat with your family, you know that most restaurants have a separate menu geared toward kids. Generally speaking, adults are larger than children, so they require bigger portions. The same goes for the Pfizer COVID-19 vaccine.
The manufacturer focused its child-based study on a two-dose regimen of 10 μg, or micrograms. That’s .01 mL, or milliliters, compared to 0.3 mL in a dose designed for individuals 12 and older.
A Pfizer-BioNTech press release about the trial’s results noted that the dose was “carefully selected” for “safety, tolerability and immunogenicity in children five to 11 years of age.”
Like the adult version, Pfizer recommends that children receive the vaccine doses 21 days apart.
Brookie Crawford, Virginia Department of Health’s (VDH) public information officer for the Central Region, explained the importance of discovering the most effective dose.
“Just like any biologic—medicine, vaccine—the dose size is intended to minimize side effects while providing maximum benefit,” Crawford said. “Determining dosage size is part of the trials manufacturers go through to study the effectiveness and safety of the vaccine.”
While some vaccines require the same dose for both children and adults, giving kids a lesser dose of a vaccine isn’t unique to Pfizer’s rollout.
“Although not the case with the chickenpox vaccine, there are other vaccines that do have a different dosage size or different vaccine altogether to address different ages. For example, Hepatitis A and flu vaccines both have vaccines intended for certain populations,” Crawford said. “Once vaccines are fully licensed, they are continued to be reviewed over time by the [Centers for Disease Control and Prevention] to ensure their safety and efficacy profile continue.”
When Can My Child Get the Vaccine?
While the Pfizer vaccine doesn’t have an emergency use authorization (EUA) for younger children yet, experts believe it will happen soon. Last month, Dr. Danny Avula, state vaccine coordinator, projected an EUA in either September or October. While it appears too late for this month, next month is certainly still a possibility.
There are a series of different steps the proposed child vaccine will go through before the FDA will authorize an EUA. First, Pfizer-BioNTech must submit data and request an expansion of the authorization for children ages 5 to 11 years.
Once the FDA grants an EUA, the vaccine goes through additional processes. That involves going through the CDC’s Advisory Committee on Immunization Practices (ACIP). Experts on the ACIP will meet to discuss using the vaccine in the proposed age group. Once the group reaches a consensus, they will make a recommendation to the CDC to allow the vaccine. Next, the CDC director chooses whether or not to adopt the ACIP’s recommendations.
Once the vaccine completes the system of checks and balances and is authorized for use, children 5 and up will be eligible for a COVID-19 vaccine. From there, states will receive kid-friendly doses and begin the distribution process.
“Distribution of vaccines for this age group will be through a variety of pathways,” Crawford said. “The exact details of the distribution plan are being finalized.”
Now that the Pfizer vaccine appears on track for an EUA for school-aged kids, attention shifts to the even younger population. Pfizer announced on Sept. 20 that it expects results for two other age cohorts from the trial—children 2 to 5 years of age and children six months to 2 years of age—by the end of the year.
“Getting vaccinated remains the most important step in protecting yourself and others,” Crawford said. “In Virginia, vaccine breakthrough infections still represent a very small percentage of cases. As the percentage of the total population of vaccinated individuals rises, the likelihood of both infection and severe illness declines. At this time, the large majority of hospitalizations and deaths due to COVID-19 are in those who are not vaccinated.”
For those 12 and older, vaccines are readily available throughout the state. Simply visit vaccinate.virginia.gov or contact your doctor or local health department to find out more about vaccine opportunities in your area.
Amie Knowles reports for The Dogwood. You can reach her at firstname.lastname@example.org