Science Guides the FDA’s COVID-19 Vaccine Decisions for Children

The US Food and Drug Administration (FDA) issued a Statement clarifying lt ‘will follow the science regarding COVID-19 vaccine authorizations for use by young children.’

On September 10, 2021, Dr. Janet Woodcock, Acting Commissioner of FDA, and Peter Marks, M.D., Ph.D., Director - Center for Biologics Evaluation and Research, stated, ‘We know there have been questions and public commentary on the process surrounding vaccines for young children.’

‘So we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort.’

Excerpts from this FDA Statement are inserted below:

‘It’s important that the public recognize that, because young children are still growing and developing, thorough and robust clinical trials of adequate size must be completed to evaluate the safety and the immune response to a COVID-19 vaccine in this 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 of vaccines already used for adults.’

The FDA is taking the following steps to ensure the safety and efficacy of these COVID-19 products 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 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 analyze 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 the FDA has received a completed request for EUA or approval, 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 rapidly review these submissions will depend partly on the quality and timeliness of the submissions by manufacturers.  

Like every vaccine decision we’ve made during this pandemic, our data evaluation on the use of COVID-19 vaccines in children will not cut any corners. 

Conducting clinical trials to determine an appropriate vaccine dose in children requires additional work over that done in the adult studies, including ensuring that the vaccine dosage and formulation strength used is the appropriate one from the perspective of safety and generating an immune response. 

Our multi-disciplinary teams of doctors, scientists, statisticians, and other experts will thoroughly assess this complex data in making any determination about COVID-19 vaccines in young children. 

We may also consult with our Vaccines and Related Biological Products Advisory Committee on any questions that warrant a public discussion by external experts. Importantly, once a decision to authorize or approve a vaccine for a younger population has been made, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss further clinical recommendations. 

Parents may be wondering if they can ask their health care providers to go ahead and vaccinate their kids using one of the currently available vaccines outside of the FDA-authorized or approved uses. 

Parents need to remember that the vaccine doses currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older. 

Different dosing regimens are being investigated. 

The clinical trials need to be completed before vaccinating young kids, so the FDA’s team can conduct a thorough evaluation and ensure the data show that the vaccine under consideration is likely to work to prevent COVID-19 in young children and doesn’t cause unexpected safety issues separate from those that have already been observed in adolescents and adults.

Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. 

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. 

As outlined above, this process is complex. It relies on robust manufacturer trials and data. While we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need. We very much hope to have pediatric COVID-19 vaccines available in the coming months. 

Until we authorize or approve a vaccine for this younger population, it’s especially important that parents and others who interact closely with children follow recommended precautions so that we can protect those who cannot yet protect themselves through vaccination.

The FDA published updated Frequently Asked Questions https://www.fda.gov/emergency-preparedness-and-response/coronavirus-dise... on COVID-19 and Vaccines.

Note: As of September 8, 2021, the U.S. CDC confirmed 412 deaths attributed to COVID-19 in people under the age of 18 since January 2020.

PrecisionVaccinations publishes fact-check research-based vaccine news.