The Food and Drug Administration (FDA) released a statement on Friday, September 10, 2021 as manufacturers of COVID-19 rush to submit clinical data aimed at obtaining regulatory approval for vaccines in children under 12.
FDA says clinical trials testing COVID-19 vaccines for children should include a follow-up period of at least about two months, “To allow appropriate safety monitoring after administration of vaccine doses for at least half of the subjects vaccinated in clinical trials”.
It comes after Pfizer-BioNTech said earlier Friday that it would seek global approval soon to use its COVID-19 vaccine in children as young as 5 years old. Pfizer said it was preparing to make smaller doses of the vaccine for younger people.
“We will be presenting the results of our study in children aged five to 11 to authorities around the world in the coming weeks,” Ozlem Tureci, co-founder of BioNTech and its chief medical officer, told Der Spiegel, a site German information, in a interview published on Friday.
The FDA has said that once manufacturers complete the relevant portion of their clinical trials, they must complete the analysis of study data to understand how safe the vaccine is and how well it works in clinical trial participants.
âThe FDA will work closely with each manufacturer to ensure that this data analysis is robust and meets regulatory standards. Once manufacturers analyze their clinical trial data, they will compile the information and may apply for an Emergency Use Authorization (EUA) or submit a Biologics License Application (BLA) for approval, as appropriate. , for this young population at the FDA, âread a press release. of the FDA.
When a complete application for EUA or approval has been received by the FDA, the agency “will carefully, thoroughly and independently review the data to assess the benefits and risks and be ready to complete its review as quickly as possible,” probably within a few weeks. rather than months. However, the agency’s ability to promptly review these submissions will depend in part on the quality and timeliness of submissions by the manufacturers, âthe FDA statement said.
Here is the rest of the declaration from the FDA on Friday, September 10:
âAs schools across the country reopen for in-person learning and families return to their busy school year schedules, we know many parents are concerned about the pandemic and protecting their children. . Many parents are wondering about COVID-19 and when vaccines will be available for children under 12.
Many of our team at the FDA are parents and grandparents themselves, and our team shares the same concerns as many in our country about protecting our loved ones from COVID-19. So we are also eager to see COVID-19 vaccines available for young children. We also know that we all share an interest in ensuring that this process takes place in a safe manner. As regulators, we recognize that we have an important task ahead of us that will require us to act quickly while undertaking an extremely careful and thoughtful review once we receive requests for authorization of a COVID-19 vaccine for use. emergency or submissions for approval of a COVID-19. 19 vaccine for this population.
We know there have been questions and public comments about the process surrounding vaccines for young children, so we believe it is important to share information about the process and the considerations needed to provide greater clarity. to the public on this effort.
It is important for the public to recognize that, because young children are still growing and developing, it is essential that extensive and robust clinical trials of adequate size be performed to assess the safety and immune response to a COVID-19 vaccine in this population. Children are not little adults – and Questions that can be addressed in pediatric vaccine trials may include whether there is a need for different doses or different strength formulations of vaccines already in use for adults.
As with all vaccine decisions we have made during this pandemic, our assessment of data on COVID-19 vaccine use in children will not compromise. Conducting clinical trials to determine an appropriate vaccine dose in children requires additional work over that done in studies in adults, including ensuring that the vaccine dosage and strength of formulation used are appropriate. from the point of view of safety and the generation of an immune response. Our multidisciplinary teams of physicians, scientists, statisticians and other experts will thoroughly assess this complex data to make any decision regarding COVID-19 vaccines in young children. We may also consult with our Vaccines and Related Biologics Advisory Committee on any matter that warrants public discussion by outside experts. It is important to note that once the decision is made to authorize or approve a vaccine for a younger population, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss other clinical recommendations.
Parents may wonder if they can ask their health care providers to immunize their children using any of the vaccines currently available outside of authorized or approved uses by the FDA. Parents should remember that vaccine doses that are currently being investigated in young children are not necessarily the same vaccine doses that have been authorized for people 12 years of age and older or approved for people 16 years of age and older – there are different study regimens. It is important that clinical trials be completed before vaccinating young children, so that the FDA team can conduct a thorough assessment and ensure that the data shows that the vaccine under consideration is likely to work to prevent COVID. -19 in young children and no. cause unexpected safety concerns distinct from those previously seen in adolescents and adults.
Like you, we look forward to seeing our children and grandchildren vaccinated against COVID-19 as soon as possible. We need to be guided by science and data. The FDA is working tirelessly to support the process of making COVID-19 vaccines available to children. As noted above, this process is complex and relies on solid manufacturer testing and data. as quickly as possible to meet this critical public health need and we very much hope that pediatric COVID-19 vaccines will be available in the coming months.
Until we authorize or approve a vaccine for this younger population, it is especially important that parents and others who interact closely with children under the age of 12 get vaccinated, wear masks and follow others. recommended precautions so that we can protect those who cannot yet protect themselves by vaccination.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.
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