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FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.
In a news release attributed to acting commissioner Dr. Janet Woodcock and director of the FDA’s Center for Biologics Research and Evaluation Dr. Peter Marks, the FDA said it plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country.
The FDA leaders noted that they are “eager to see COVID-19 vaccines available for young children,” while safety remains a top priority in allowing for that to happen.
“As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population,” the FDA said. “It’s important that the public recognize that, because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are 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 news release outlines the steps the FDA plans to take in order to ensure safety and efficacy in COVID-19 vaccines for children as vaccine manufacturers have reported that the necessary clinical trials involving children as participants are currently underway. Those trials are expected to include a follow-up period of at least about two months, allowing for the proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients.
Once those trials are completed, the FDA will work closely with each manufacturer to ensure that the analysis of the data from the studies is robust and meets regulatory standards, after which the manufacturers will compile the information and potentially request emergency use authorization (EUA) or submit for approval a biologics license application (BLA) to the FDA.
After it receives a completed request for EUA or approval, the FDA will thoroughly and independently examine the data to evaluate benefits and risks, aiming to complete its review in a matter of weeks instead of months.
“Just like every vaccine decision we’ve made during this pandemic, our evaluation of data on the use of COVID-19 vaccines in children will not cut any corners,” the FDA said. “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.”
Additionally, the FDA suggested that, until a vaccine is authorized for the younger population, parents and others who interact closely with children under 12 years of age should get vaccinated, wear masks and follow other recommended precautions to protect the unvaccinated younger age groups.
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” the FDA concluded. “We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. … We can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months.”