FDA One Step Closer to Approving EUA for COVID Vaccine for Children Ages 5 – 11

by | Oct 29, 2021 | Analytics, Compliance, Consulting Group, COVID-19, Data, FDA, Guidance, ISO, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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So many parents, who have been on a continuum of anxiousness since the beginning of the pandemic, were finally given hope earlier this week that we are very close to having vaccine approval for children younger than 12 years of age. The FDA advisory committee voted 17-0 with one abstention to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children ages 5 to 11. According to Acting FDA Commissioner Janet Woodcock, M.D., “We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults” (Jenco, 2021).

This is welcome news for parents as well as children who have had every aspect of their childhood impacted by the pandemic. We have watched our kids have to navigate online schooling, mask mandates as well as many typical childhood social activities such as birthday parties and team sports have been put on hold or cancelled.

Although hospitalizations and deaths are more common in adults, we cannot overlook the fact that COVID-19 can cause severe illness in children and adolescents resulting in needed ICU care and death. In Michigan, a state that was hit hard early in the pandemic saw, “Pediatric COVID-19 hospitalization rates increased 311% between Feb. 19 and April 20, 2021” (Mann, and Clarke, 2007).

It is an absolute fallacy that our children do not need vaccines. Families like mine who have exercised extreme caution will finally be able to resume some of our pre-covid activities such as traveling, group gatherings and play dates knowing the risk is much lower. Additionally, by inoculating our younger children we can protect them from adults who have unfortunately chosen not to be vaccinated putting those that are immunocompromised and not eligible for the vaccine at risk.  

On a recent visit to the pediatrician for a well-child visit I told my daughter, “No worries, no shots today”. I immediately saw her disappointment. My heart broke into a million pieces when she replied, “Aww, I was really hoping we were going to get my vaccine”. Our kids have had to endure unconscionable challenges due to COVID-19 and deserve this step closer to returning to a sense of “normalcy”.   

I also hope that public health officials will provide education not just in the safety of vaccines but also in the FDA EUA process. Those of us who work in the regulatory space have a duty to educate their communities on what an EUA is, so it is not scapegoated as an excuse to not get vaccinated. An EUA can be issued by the FDA during a public health emergency-like a pandemic, to allow the use of unapproved medical products to diagnose, treat or prevent serious or life-threatening diseases. Prior to issuing EUA, safety and efficacy must be demonstrated, and certain FDA criteria must be met. 

EMMA International’s team of FDA compliance experts has helped many companies that pivoted during the pandemic through the EUA process. If you have questions regarding your Medical Device EUA Transition Plan, contact us at 248-987-4497 or email info@emmainternational.com to see how we can help your organization today!

References:

Jenco, M. (2021, October 8).   Pfizer’s COVID-19 vaccine for kids would require different doses, dilution, storage. AAP News from https://www.aappublications.org/news/2021/10/08/pfizer-pediatric-covid-vaccine-prep-100821

Mann, P., and Clarke, K., (2007, April 23). We are in a public health crisis’: More children being hospitalized due to COVID. Click on Detroit from https://www.clickondetroit.com/health/2021/04/23/we-are-in-a-public-health-crisis-more-children-being-hospitalized-due-to-covid/.

Kira Jabri

Kira Jabri

Kira Jabri, MPH, MSW, PMP is the COO of EMMA International Consulting Group, Inc. She is responsible for designing and implementing EMMA International’s business operations, marketing, and strategy. Mrs. Jabri has over twenty years of experience as a healthcare professional and is an industry expert in company culture and diversity, organizational behavior management, organizational leadership, business strategy development, and contemporary challenges in business. Mrs. Jabri holds a Master of Public Health from Walden University, a Master of Social Work from Columbia University and Bachelor of Arts degrees in Social Work and Psychology from Cedar Crest College.

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