This information is accurate as of August 11, 2021.
While COVID-19 is generally less severe in children and adolescents, a small number may be at risk for severe disease or disabling sequelae including multisystem inflammatory syndrome (MIS-C). Children can also contribute to transmission, further prolonging the pandemic until they’re eligible for vaccination. Here are answers to some common questions about COVID vaccines in children and adolescents:
What COVID-19 vaccines are authorized for children?
In Canada, the United States, the United Kingdom, Australia and New Zealand, the Pfizer-BioNTech vaccine is the only authorized vaccine for adolescents as young as 12 years of age. In Europe, both Pfizer-BioNTech and Moderna vaccines are authorized for this age group. Currently no vaccine is authorized for use in children under 12 years of age.
What do we know about the safety and efficacy of COVID-19 vaccines in adolescents?
In a trial of more than 2,000 adolescents aged 12-15 years, the Pfizer-BioNTech COVID-19 vaccine was highly effective at preventing symptomatic COVID-19 (zero COVID-19 cases in the vaccinated group compared to 18 in the placebo group). The vaccine also had a favorable safety profile. The most common systemic symptoms were similar to those observed in adults and included fatigue, headache, muscle pain, chills, and fever.
Furthermore, adolescents 12-15 years old produced a greater neutralizing antibody response in comparison to a separate trial of persons aged 16-25 years. These highly promising results led regulatory agencies in Canada, the United States, United Kingdom, and Europe to extend authorization for the Pfizer-BioNTech COVID-19 vaccine to this age group.
Moderna conducted a trial in more than 3,000 adolescents aged 12 to less than 18 years in the United States, which reported zero cases of COVID-19 among vaccinated participants compared to four cases in the placebo group.. No significant safety concerns were noted, and the majority of adverse events were mild or moderate. The European Medicines Agency (EMA) has authorized this vaccine in adolescents as young as 12 years of age and it is likely to receive authorization from other regions soon.
Johnson & Johnson is currently planning their study for adolescents 12-17 years of age with recruitment beginning this fall.
CoronaVAC is an inactivated SARS-CoV-2 vaccine developed by Sinovac Life Sciences in China. In a combined analysis of phase 1 and 2 safety and dose-escalation studies, CoronaVAC was found safe in children three to 17 years of age. CoronaVAC was also found to be immunogenic, eliciting dose-dependent neutralizing antibodies.
What about COVID vaccines for children under 12 years of age?
Trials including children as young as six months of age are currently ongoing, but it doesn’t appear that we will have data to inform authorization before the start of the school year for those younger than 12 years old. Pfizer is testing a reduced dosing regimen in groups of children six months to two years old, two to five years old, and five to 11 years old. A company spokesperson has estimated data from the five to 11 age group will likely be available in September. Moderna is also testing a reduced dosing regimen in young children and is likely to report results by the end of the year.
It was recently reported that the FDA issued a request to include more children in these studies before they would issue emergency use authorization, suggesting that the timeframe for authorization in the US may be longer than anticipated.
Can COVID vaccines be combined with other vaccinations?
In Canada, the National Advisory Committee on Immunization (NACI) recommends that COVID-19 vaccines should not routinely be given simultaneously with other vaccines (live or inactivated) due to lack of evidence regarding possible immune interference and to avoid confounding possible adverse events. NACI suggests waiting 28 days after a dose of COVID-19 vaccine before administering other vaccines, and waiting for 14 days after another vaccine before giving a COVID-19 vaccine.
Simultaneous administration of COVID-19 vaccines with other vaccines should only occur in certain circumstances including if a vaccine is required urgently for post-exposure prophylaxis, for accelerated vaccination schedules, or if a patient is unable to complete an immunization series due to limited access to health services or is unable to return at a later date. This advice may change as data become available.
The Canadian Paediatric Society also supports these recommendations.
How can we make school safer for children during the COVID-19 pandemic?
While vaccination remains the best prevention strategy, social countermeasures including masking, physical distancing, and improving ventilation are still useful tools and will be essential in schools this fall. The Public Health Agency of Canada recommends masking for all students, teachers, staff, and visitors in schools. Isolation of children testing positive for COVID-19 and quarantine of classrooms, while disruptive, can provide another layer of defense against spread in schools.
Extending vaccination to children and adolescents will be a critical step towards achieving herd (community) immunity and reducing opportunities for evolution of more variants.
For more information, see the topic COVID-19 (Novel Coronavirus) in DynaMed.
Original article published on EBSCO Health Notes. Written by:
- Vito Iacoviello, MD, Deputy Editor for Infectious Disease, Allergy, and Immunology at DynaMed; and
- Heather D. Marshall, PhD, Public Health Content Manager at DynaMed.
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