COVID-19 Vaccines Potentially Authorized for Children
The US Food and Drug Administration (FDA) announced today it had scheduled a meeting of the Center for Biologics Evaluation and Research (CBER) to convene a virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
During this meeting on June 10, 2021, the FDA will provide a status update on its approach to Emergency Use Authorization (EUA) for COVID-19 vaccines intended for use in individuals 12 through 17 years of age.
The VRBPAC will also discuss the data needed to support an EUA and a biologics license application (BLA) for a COVID-19 vaccine intended for use in children less than 12 years of age.
The VRBPAC will not discuss any specific products during this meeting.
Peter Marks, M.D., Ph.D., director of the FDA’s CBER, commenting in a related press release, “Vaccines continue to be an important public health measure in fighting the COVID-19 pandemic.”
“To date, the FDA has authorized three COVID-19 vaccines for emergency use that have met our rigorous standards for quality, safety, and effectiveness – two are authorized for individuals 18 and older, and one is authorized for individuals 16 and older.”
“We recognize that the next critical step is having vaccines available for use throughout the pediatric population.”
“As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range.”
While fewer children have been sick with COVID-19 than adults, children can be infected with the virus that causes COVID-19, get sick from COVID-19, and spread the virus that causes COVID-19 to others, stated the U.S. CDC on March 17, 2021.
Most children with COVID-19 have mild symptoms or have no symptoms at all. However, some children can get severely ill from COVID-19.
As of May 6, 2021, over 3.85 million children have tested positive for COVID-19 since the onset of the pandemic in early 2020.
At this time, it still appears that severe illness due to COVID-19 is rare among children, stated the American Academy of Pediatrics. Children were 0.00%-0.21% of all COVID-19 deaths (about 325), and nine US states have reported zero child deaths.
Additionally, the FDA intends to issue a Federal Register notice as soon as possible with details of the meeting, including information about the availability of a public docket for comments. At that time, public comments can be submitted for consideration by the committee and FDA.
The FDA intends to make background material available to the public, including the meeting agenda and committee roster, no later than two business days before the meeting.
Recently, Health Canada authorized using the BioNTech - Pfizer COVID-19 vaccine in children 12 to 15 years of age.
In general, FDA advisory committees include a Chair, members with scientific, medical, and public health expertise, and a consumer and industry representative. Additional experts with specific expertise may be added for individual meetings as needed. The FDA intends to live-stream the VRBPAC meeting on June 10th via the agency’s YouTube, Facebook, and Twitter channels and from the FDA website.
PrecsionVaccinations publishes research-based vaccine news.
- FDA to Hold Meeting of its Vaccines and Related Biological Products Advisory Committee to Discuss Pediatric Use of COVID-19 Vacc
- Children and COVID-19: State-Level Data Report
- Health Canada authorizes use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age
- COVID-19 Vaccines in the USA