artificial insemination kit for humans
Good news for parents with kids under 12! While adolescents aged 12 and above can already receive the COVID-19 vaccine, younger children are still awaiting their turn. As COVID-19 rates decline in regions with high vaccination numbers—a crucial element in combating the pandemic—parents are keenly looking forward to the opportunity to safeguard their little ones.
Earlier this month, Pfizer provided updates on their COVID-19 vaccine trials for younger children. They have successfully completed Phase I clinical trials and are now moving into Phase II and III lower-dose trials for kids between six months and 11 years old.
What Does This Next Phase Entail?
Given that children are significantly less likely to experience severe outcomes from COVID-19 compared to adults—specifically, they are 8,700 times less likely to die than those over 85—the pharmaceutical companies are focused on determining the optimal dose that maximizes vaccine efficacy while minimizing side effects. Consequently, Pfizer and its German partner BioNTech are conducting trials with lower doses for school-aged children and even smaller doses for younger kids.
This approach, known as “age de-escalation,” is standard practice in drug development. Initially, vaccines are tested on healthy, non-pregnant adults. Once safety is established, trials expand to younger age groups to ensure safe and effective antibody production. Ultimately, researchers aim to confirm the vaccine’s safety for infants.
With COVID-19 still posing risks to children—particularly those with pre-existing health conditions or limited access to healthcare—it’s crucial for the well-being of our children as the U.S. continues to relax restrictions this summer.
What Will Be Tested?
Pfizer-BioNTech has already gained authorization to vaccinate adolescents in the U.S. after studying its effects in 2,260 individuals aged 12 to 15. Their trials indicated that the vaccine elicited a strong antibody response, was safe, prevented infections, and did not produce intolerable side effects.
They have also completed a small Phase I study involving about 100 children to establish the most effective dosage that triggers an immune response without significant side effects. Results from this study are pending, but Pfizer anticipates requesting Emergency Use Authorization from the FDA by September or October.
As with most pediatric clinical trials, participants are grouped into three categories: ages 5 to 11, 2 to 5, and 6 months to 2 years. The doses being tested for younger children are lower than those for adults or teens, as different dosages are evaluated to find the least effective dose for each age bracket.
Pfizer-BioNTech is currently enrolling around 4,500 children aged 5 to 11 for Phase II and III trials across the U.S., Finland, Poland, and Spain. Trials for children aged 6 months to 4 years are expected to kick off soon. If you’re interested in enrolling your child in a Pfizer-BioNTech trial, you can find more information here.
The other COVID vaccine manufacturers, Moderna and Johnson & Johnson, are also progressing with trials for younger populations.
When Can We Expect a Vaccine for Younger Kids?
Pfizer-BioNTech plans to submit their Phase II and III trial findings to the FDA in September or October, which will provide insights into the vaccine’s safety, efficacy, and side effects for children aged 6 months to 11 years. Although the vaccine is unlikely to be available for younger children before the 2021-2022 school year begins, it may be accessible by the end of 2021.
Once Pfizer requests Emergency Use Authorization, the FDA will hold an emergency meeting with independent experts to review the safety and efficacy data from the trials. It’s expected that the FDA will first evaluate the results for ages 5 to 11 before considering younger groups. If deemed beneficial, the CDC will also review the data. Following CDC authorization, various state panels will then determine whether to expand eligibility.
The authorization process for different age groups may occur in stages, starting with the older segments. Overall, this entire procedure is likely to take several weeks, so patience is essential.
In the meantime, ensure your younger children remain safe from COVID-19 by keeping their vaccinations up to date. Adhere to CDC guidelines by having them wear masks, avoid crowded places, choose well-ventilated areas (preferably outdoors), and regularly wash their hands or use hand sanitizer containing at least 60% alcohol.
For ongoing updates on COVID-19, consider reputable resources such as Resolve for insights on family-building options, or check out Make a Mom for advice on boosting fertility supplements.
Summary
As trials for COVID-19 vaccines in children under 12 advance, Pfizer-BioNTech is progressing through various phases to ensure the safety and efficacy of the vaccine. While the rollout for younger children may not coincide with the upcoming school year, there is hope for availability by late 2021. Parents are encouraged to stay informed and maintain safety measures for their children in the interim.