By Erin Onder PharmD, BCPS, 
Nov. 4, 2021

Pediatric Vaccine Approved for Children 5-11

On November 2 the CDC (Centers for Disease Control and Prevention) endorsed the ACIP’s (Advisory Committee on Immunization Practices) recommendation that children 5-11 years old be vaccinated against COVID-19.   This now allows vaccine providers across the country to begin vaccinating this age group (about 28 million children) as soon as possible.

As a vaccinating health care provider, I urge parents to be patient with their pediatrician’s office and pharmacies. There are a lot of hoops to work through getting the pediatric vaccine ready to administer. Not to mention the staffing shortages that are now commonplace in many healthcare settings. The offices and pharmacies still have sick patients to care for (their “normal” work) and flu vaccinations in addition to this new COVID-19 vaccine roll out. Pharmacies also are still working on vaccinating adults and offering the newly approved booster vaccines.  We are also excited about this approval however safety is our first priority and often times that requires some patience from the public.

The dose approved for use in children between 5-11 years old is a two-dose series of the Pfizer-BioNTech 10 microgram injection given 21 days apart. The dose is one-third the dose of the vaccine authorized for those 12 and older.

Any parents on the fence about getting their child vaccinated, please talk to your child’s pediatrician about the benefits/risks of the vaccine compared to COVID-19 to make an informed decision. Even if your child previously contracted COVID-19, natural immunity is good but may decrease over time. Please see the resources listed below for more information.

The Approval Process & Timeline

In September 2021 the results of the Pfizer/BioNTech trial with participants aged 5-11 were released. The trial showed that the vaccine was safe, well tolerated, and provided excellent protection against COVID-19.  

The trial included children from the United States, Finland, Poland, and Spain from 90 clinical trial sites. They enrolled 2,268 participants (1,518 that received the vaccine).  Data showed that those who received the vaccine demonstrated a strong immune response one month after their second dose and that the vaccine was well tolerated. This efficacy and safety data was compared to those that received the vaccine aged 16-25 years old.

On October 26, the VRBPAC (Vaccines and Related Biological Products Advisory Committee) voted to authorize the Pfizer/BioNTech vaccine for emergency use. The FDA took VRBPAC’s recommendation into consideration when making its decision. On October 29, the FDA authorized the vaccine for emergency use in 5-11 year olds.  Finally, on November 2 the CDC (Centers for Disease Control and Prevention) endorsed the ACIP’s (Advisory Committee on Immunization Practices) recommendation that children 5-11 years old be vaccinated against COVID-19.   This now allows vaccine providers across the country to begin vaccinating this age group (about 28 million children) as soon as possible.

Children Under 5

For children under 5, data is coming! The Pfizer/BioNTech study included children as young as 6 months. An even lower dose (3 micrograms) was studied in this age group. Data from that part of the trial is still being reviewed and evaluated. Hopefully by the end of 2021 we will have more information.

For adolescents and children under 18, the data for the Moderna vaccine is also still being collected and reviewed.

Booster Vaccinations

Evidence from all of the trials reviewed for COVID-19 boosters are straightforward – boosters are safe, effective, and vital for some.

As of October 28, only some COVID-19 vaccine recipients are eligible for a booster shot. Those eligible include people 65 years and older, those 18 years and older who live in a long-term care setting, have underlying medical conditions, or who work or live in a high-risk setting. To review the list of underlying medical conditions or high-risk settings please see link from CDC below.

Mixing Vaccine Brands

If you are eligible, you are approved to mix brands (Moderna, Pfizer/BioNTech, J&J/Janssen). The ACIP reviewed data and presented data on mixing. The largest benefit was seen for those with a primary J&J shot and Moderna or Pfizer/BioNTech booster. For those who received a primary Moderna series, equal benefit was seen with another Moderna or Pfizer/BioNTech booster. For those who received a primary Pfizer/BioNTech series, the greatest benefit was seen with a Moderna booster (however a Pfizer/BioNTech booster was not bad).

Booster Timing

Timing of booster shots are important as well. If you received J&J as your primary vaccine, you must wait at least 2 months to receive a booster. If you received Pfizer/BioNTech or Moderna primary vaccine, you must wait at least 6 months after your second shot to receive a booster.

If you are eligible for a booster the CDC highly recommends getting one. Talk to your physician or vaccinating pharmacist about the benefits/risks. 

Additional Resources

Pediatric vaccine availability: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/adolescents.html

Pfizer/BioNTech Pediatric Vaccine trial information: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-topline-results

Booster CDC Link (high risk occupations / underlying medical conditions): https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html