When Can We Anticipate a Vaccine for Children Under 12? Trials Advance to the Next Stage

Exciting developments are on the horizon for parents of children under 12. While adolescents aged 12 and older can already receive the COVID vaccine, those younger are still waiting. With COVID-19 case numbers decreasing in regions with high vaccination rates, many parents are eager for a solution to protect their younger kids. In early June, Pfizer released updates on their COVID-19 vaccination trials for children, having completed Phase I clinical trials and now moving forward into Phase II and III trials with lower doses for children aged six months to 11 years.

What Does the Next Phase Entail?

Children are significantly less likely to suffer severe consequences from COVID-19 compared to adults, which has led pharmaceutical companies to seek the optimal balance between maximizing vaccine effectiveness and minimizing side effects. Consequently, Pfizer and its partner BioNTech are investigating lower doses for children compared to those given to teenagers, with even lower doses being tested for the youngest age group. This method, known as “age de-escalation,” is standard in drug development. Initially, vaccines are tested in healthy adults, and once deemed safe, trials progressively include younger children to ensure safety and efficacy at generating antibodies, ultimately aiming to determine safety for infants.

Given that COVID-19 can indeed be fatal for children, especially those with pre-existing health conditions or limited access to healthcare, ensuring their health is crucial as the U.S. gradually loosens restrictions this summer.

What Will Be Assessed?

Pfizer-BioNTech has already obtained authorization to vaccinate adolescents in the U.S. after studying the vaccine’s effectiveness in 2,260 kids aged 12 to 15. Their trials demonstrated that the vaccine was effective in generating an antibody response, was safe, and prevented infections without intolerable side effects. A preliminary Phase I study involving around 100 children was also completed to find the best dosage that balances immune response and manageable side effects. However, results from this study are not yet available, and the company plans to request Emergency Use Authorization from the FDA around September or October.

As is typical in child clinical trials, participants are divided into groups: 5 to 11 years old, 2 to 5 years old, and 6 months to 2 years old. The doses being tested for these younger groups are lower than those used for adults and teens, as various dosages are evaluated to find the lowest effective dose for each age category. Pfizer-BioNTech is currently enrolling about 4,500 children aged 5 to 11 in Phase II and III trials across the U.S., Finland, Poland, and Spain. Trials for the 6-month to 4-year age group are also set to begin shortly. If you’re interested in enrolling your child in a Pfizer-BioNTech trial, more information can be found here.

The other authorized COVID vaccine manufacturers, Moderna and Johnson & Johnson, are also conducting trials for children.

When Can We Expect a Vaccine for Younger Kids?

Pfizer-BioNTech has indicated they will submit the results of the Phase II and III trials to the FDA in September or October. This submission will provide further insights into the vaccine’s safety, efficacy, and side effects for children aged 6 months to 11 years. While it is unlikely that the vaccine will be available before the start of the 2021-2022 school year, there is a possibility it could be ready by the end of 2021.

Once Pfizer submits for Emergency Use Authorization, the FDA will hold an emergency meeting of independent experts to evaluate the safety and efficacy data from the trials. The review will likely begin with the 5 to 11 age group before moving to younger children. If the FDA concludes the benefits outweigh the risks, an expert panel at the Centers for Disease Control and Prevention (CDC) will also assess the data. If authorized, state-level panels will determine whether to broaden eligibility requirements.

The authorization process for COVID vaccines across different age brackets is expected to be staggered, starting with older children. The entire review and approval process could span several weeks, so patience will be essential.

In the meantime, ensure your younger children are protected against COVID by keeping their vaccinations up to date. Adhere to CDC guidelines, encourage mask-wearing, avoid crowded places, prefer well-ventilated areas, especially outdoors, and ensure frequent handwashing or the use of hand sanitizer containing at least 60% alcohol.

For the most current information regarding COVID-19 and vaccinations, refer to local health department resources, the Centers for Disease Control, and the World Health Organization.

This article was originally published on June 29, 2021.

Summary

Vaccination trials for children under 12 are progressing, with Pfizer moving into Phase II and III studies for younger age groups. The FDA is expected to receive results by late 2021, but vaccines may not be available before the new school year. Parents should continue to follow health guidelines to protect their children.