Kids Aren’t Just Littler Adults – Here’s Why They Need Their
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Now that two-thirds of all adults in the United States have received at least one dose of a SARS-CoV-2 vaccine as of mid-July 2021, life seems to be returning to some semblance of pre-pandemic times. Yet for parents of children under the age of 12, who are not yet eligible for COVID-19 vaccines, there is still no collective sigh of relief.

Clinical research studies of the mRNA-based vaccines for children under 12 are ongoing, and authorization of a vaccine for this younger age group is still at least several months away. These trials are necessary because children have important differences in physiology and responses to vaccines from those of adults. Conducting separate studies in children under age 12 is a vital step toward ending the pandemic.

~ How kids’ bodies differ from grown-ups’

Children are not just littler grownups; their bodies differ from adults’ in important ways. Their brains are developing rapidly, and their immune systems have important differences too, particularly in toddlers and babies. For the first few months of life, infants’ immune systems still possess the antibodies they received from their mothers across the placenta during late pregnancy.

This changes how newborns respond to pathogens and makes them less able to mount an immune response to some vaccines. Young children’s bodies gradually ramp up their own immune systems as their protection from mom wears off. So vaccines often need to be tailored specifically for young children. Even when a vaccine for adults is proven safe in children, there can be important differences in how their bodies respond to it.

The vaccine dose that works best in adults might cause a high fever in children, for instance. So one key goal of the COVID-19 vaccine clinical trials in children will be to determine the optimal dosage for each age group. Researchers need to be on alert for side effects that might only occur in youngsters and didn’t appear during vaccine tests on adults.

~ Clinical trials for kids

After setting up a new clinical trials space and gathering all the staff and necessary equipment, the Trials Unit at the University of Pittsburgh was ready to host phase 3 clinical trials with volunteer participants. Beginning in August 2020 and into the fall, researchers ran phase 3 adult clinical trials for both the Moderna and Johnson & Johnson vaccines. They recently enrolled kids ages 6-11 as well as 6 to 24 months of age in phase 2 of the pediatric Moderna trials, focusing on whether the vaccine is safe to use in these kids and at what dosages.

Their site is set to move to phase 3 of the pediatric trials, currently slated to begin in mid-August for children age 6-11, throughout the U.S. and Canada. This final stage of the clinical trials will determine how well the vaccine really works to keep kids from getting COVID-19. They expect early results of these studies by this fall, after which it will be reviewed by the FDA.

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