NATIONWIDE — With children across the country returning to in-person learning during the current phase of the COVID-19 pandemic, the FDA addresses parents’ concerns regarding availability of vaccines for children younger than twelve.
On Friday, Sept. 10, the FDA issued a statement regarding the current progress of opening COVID-19 vaccines for younger children.
The FDA said that the department is still closely studying how the vaccine could react in younger persons. It points out that, because young children are still growing and developing, robust and thorough study and clinical trials encompassing an adequate sized group is necessary to evaluate the immune response in this age population.
“Children are not small adults — and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations,” the statement read.
The FDA provided the following guidelines that it takes to ensure that products are safe and effective for children:
- First, vaccine manufacturers have reported that the necessary clinical trials involving children as participants are currently underway. Some have stated that they are still enrolling, and some are still administering doses or following participants. This process is expected to include a follow-up period of at least about two months, to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients.
- Once the manufacturers complete the relevant portion of their clinical trials, they have to complete the analysis of the data from the studies to understand how safe the vaccine is and how well it works in the clinical trial participants. The FDA will work closely with each manufacturer to ensure this data analysis is robust and meets regulatory standards. After manufacturers analyze their clinical trial data, they will compile the information and may request an emergency use authorization (EUA) or submit for approval a biologics license application (BLA), as appropriate, for this young population to the FDA.
- When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months. However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.
“Just like you, we [the FDA] are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” the statement reads. “We have to let science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children.”
Currently, the Comirnaty vaccination (formerly known as the Pfizer-BioNTech COVID-19 vaccine) is available for persons ages twelve and older. The Moderna and Johnson & Johnson vaccines are approved only through an emergency use authorization (EUA) for ages 18 and over.