As schools across the country reopen to full-time education and families return to busy school schedules, PDA knows that many parents are concerned about the pandemic and protecting their children. Questions about COVID19 and when vaccines will be available for children under 12.
The Fda Will Oversee Research Into The Covid19 Infant Vaccine
The FDA also really wants the COVID19 vaccine to be available for young children. FDA knows that everyone is interested in ensuring that this process is carried out with safety in mind. As a regulator, they understand that there is an important challenge ahead of the world that requires them to act quickly to conduct extremely careful and thoughtful scrutiny when they receive the request for a vaccine for emergency use or to submit approval for the population.
FDA knows there have been many questions and comments from the public regarding the procedure for childhood vaccines, it is important to share information about the process and its considerations.
It is important for the public to recognize that as young children are still growing and developing, it is important to complete comprehensive and reliable clinical trials of the appropriate size to evaluate the safety and immune response to the COVID19 vaccine in this population. Children are not small adults, and questions that can be addressed in trials of childhood vaccines may include the need for different doses or formulations of vaccines with different potency, and whether the vaccine has been used in adults.
Children’s participation in the vaccine continues to take medications or monitor participants. This process is expected to include a follow-up period of at least two months to ensure adequate safety monitoring after vaccine doses have been administered to at least half of the recipients. People are requested to participate in clinical trials.
Once manufacturers have completed the relevant portion of a clinical trial, they must complete an analysis of the study data to understand how safe the vaccine is and how effective the vaccine is for clinical trial participants. After the manufacturer analyzes the data from its clinical trials, it gathers the information and can apply for an Emergency Use Authorization (EUA) or apply for a Biological
Authorization (BLA) for approval, for the young population at the FDA. Once the FDA receives a full application or approval from the United States, it will carefully, thoroughly, and independently review the data to assess benefits and risks and prepare to complete the review as quickly as possible, possibly within a few weeks, instead of monthly. However, the agency’s ability to review these applications quickly will depend in part on the quality and timeliness of the manufacturer’s submissions.
The multidisciplinary teams of doctors, scientists, statisticians, and other professionals will carefully evaluate this comprehensive data to make any decisions about the COVID19 vaccine for young children. They may also consult with the Advisory Committee on Vaccines and Related Biologicals on any matter that requires public consultation by external experts. Parents should bear in mind that vaccine doses currently being studied for young children do not have to match the vaccine doses licensed for children 12 years of age and older.