Editor’s note: The FDA meetings referenced below have been rescheduled for June 14-15. For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.
The Centers for Disease Control and Prevention (CDC) has released new information to help pediatricians prepare to vaccinate children under 5 years against COVID-19.
Both Moderna and Pfizer-BioNTech have adapted their COVID-19 vaccines for young children, and one or both could be available in June.
“There’s a lot of data here that FDA (Food and Drug Administration) is going through. I think we all feel the sense of urgency,” White House COVID-19 Response Coordinator Ashish K. Jha, M.D., M.P.H., said Wednesday. “We want to get this done as quickly as possible, but I think we also all agree we want to get it done right.”
There are roughly 20 million children in the U.S. under 5 years, the only remaining age group still ineligible for vaccination. The vaccines under consideration would cover those as young as 6 months. A recent Kaiser Family Foundation poll found about 18% of parents of children under 5 years plan to vaccinate their child right away, while about 38% said they would wait and see.
Those figures could change if COVID-19 cases in children continue to rise. More than 93,000 cases in children and adolescents were reported during the week ending May 12, a 76% increase over two weeks prior, according to data from the AAP and Children’s Hospital Association.
The CDC has outlined the following steps pediatricians and other vaccinators can take to prepare:
- Enroll as a COVID-19 vaccine provider.
- Prepare scheduling systems and increase website and call center capacity.
- Update immunization information systems to allow for younger ages groups.
- Ensure staff is equipped and trained to respond to possible severe allergic reactions in young children.
- Be prepared to recommend and co-administer influenza vaccine and other childhood vaccines.
- Consider offering COVID, flu and other routine vaccines to family members.
- Educate yourself and your staff about vaccine specifications for young children, since the products for other age groups can’t be used (see below).
Moderna’s vaccine for children ages 6 months through 5 years is a two-dose series. Doses are 25 micrograms (µg) each. The vaccine does not require diluent.
The vaccine ships at -20 degrees Celsius and is expected to come in 10-dose vials in cartons of 10 vials each with ancillary supplies included.
In April, Moderna released a summary of clinical trial data from 6,700 children that found vaccine efficacy of 51% in preventing infection for those ages 6 months through 1 year and 37% for children ages 2 through 5 years. Both age groups had similar immunogenicity to adults 18 to 25 years, meeting the noninferiority criteria.
Most adverse events were mild or moderate. About 17% of children 6 months through 1 year and about 15% of those 2 through 5 years experienced a fever greater than 38 degrees Celsius (100.4 degrees Fahrenheit). About 0.2% of each group experienced a fever greater than 40 degrees Celsius (104 degrees Fahrenheit). There were no cases of myocarditis or pericarditis and no deaths.
The Pfizer-BioNTech vaccine for children ages 6 months through 4 years will have a maroon cap to differentiate it from vaccines for other age groups. It is given as a three-dose series with 3 µg doses. The vaccine will require diluent, which will be provided.
The vaccine ships at -80 degrees Celsius. Packaging is expected to be 10-dose vials in cartons of 10 vials each with ancillary supplies included.
The Pfizer-BioNTech vaccine can be stored in an ultra-low temperature freezer for nine months, a refrigerator for 10 weeks and at room temperature for 12 hours before the first puncture. It must be discarded 12 hours after the first puncture.
This vaccine initially was tested as a two-dose series. In December 2021, however, the manufacturers announced it did not meet noninferiority criteria for those ages 2-4 years, leading the company to study a third dose. It then was scheduled to go before the FDA’s Vaccines and Related Biological Products Committee (VRBPAC) in February, but that meeting was postponed to give the FDA more time to review the third dose data.
Vaccine authorization process
The FDA has tentatively scheduled VRBPAC meetings on June 8, 21 and 22 to discuss Moderna and Pfizer-BioNTech vaccines for children. If the FDA grants emergency use authorization (EUA) to a vaccine, it will go to the Centers for Disease Control and Prevention (CDC) for consideration.
“If the determinations are that kids should be getting these vaccines, we will make sure those vaccines are widely available as quickly as possible for kids under 5,” Dr. Jha said.
The CDC is encouraging jurisdictions to preorder vaccines and coordinate with local health departments and partners on a distribution plan that balances equitable access with capacity. Shipping will begin as soon as the FDA issues an EUA, but vaccines can’t be given until the CDC approves.
- CDC’s Pediatric COVID-19 Operational Planning Guide
- AAP COVID vaccination resources
- CDC clinical considerations for administering COVID-19 vaccines
- Information from the CDC on COVID-19 vaccine boosters
- Information from HealthyChildren.org on preparing children for a COVID-19 vaccine