Currently, the US allows vaccination for children 12 years of age and older, but smaller groups do not. As pathologist Dr. James Versalovic at Texas Children’s Hospital (Houston, Texas) explained, children and adults have biological differences, so separate studies are needed.
And Dr. Emily Chapman, vice president of Children’s Hospital Minnesota (Minnesota), said that scientists need to calculate the dose to ensure safety and potentially stimulate an immune response in children.
However, to be able to develop a vaccine for children, scientists need to do an adult trial first and build on the results from there. Vaccines for children will have to go through three stages of clinical trials before being approved by the US Food and Drug Administration (FDA).
Children go to school on the first day of school at Heath Mount (Watton at Stone, England), September 3
The first phase assesses safety in about 20-100 healthy children. Since it is an accelerated test, stages 2 and 3 are combined and the steps are executed in parallel.
During this period, scientists monitor the safety and check the child’s immune system to react to the vaccine. The number of children participating in this stage can range from a few hundred to several thousand. Some were vaccinated and some were given a placebo to compare results. Once this step is complete, the company can apply for FDA approval.
Students at Woodrow Wilson High School in Los Angeles (California, USA) are vaccinated against Covid-19, August 30
Pfizer will likely submit vaccine data for 5-11 year olds in September and apply for emergency authorization as early as October. Moderna’s trial lags Pfizer by several months while Johnson’s. & Johnson may not begin testing on children until this fall.
The FDA will review the data, and the process is expected to take weeks. If the agency approves, the vaccine needs to go through another round of evaluation by the immunological advisory panel of the Centers for Disease Control and Prevention (CDC). CDC Director Rochelle Walensky will evaluate the advisory panel’s recommendations before deciding to approve them.