There is a fear and questions as well as safety dilemma about getting young children vaccinated. FDA and Center of Disease Control and Prevention are scheduled to meet November 2-3 in order to determine a final sign off on vaccinating young children.
The story goes about vaccinating 5 years old and Pfizer is looking to roll out Covid19 vaccines. It may be 2 doses of 10 milligram of vaccine projected to go as shots in 5-11 years old young children. Dr. Leslie Ball gave a detailed presentation during FDA live session today about Covid 19 vaccines for children 5-11 years old, 12 years or older and 16 years old. Critical dose projected is as under-
Two doses of vaccines with orange cap (10 mcg) for 5-11 years old vaccines for young children with 3 weeks gap.
Pfizer plans for 2 doses of purple cap (30 mcg) for 12-15 years or older with 3 weeks gap
BNT 162b2 two vaccine doses for 16 years old with 3 weeks gap
However, there is a regulatory test and Advisory Committee of FDA to meet and sign their final decision. This information is derived today from the live Q&A from FDA.
There is some data collected that show promising results. Nonetheless, there is a need for independent scientific review to validate the results. The Biden administration supports 15 million vaccines form Pfizer to roll out if the decision is made to vaccinate young children.
During the interview, there has been several questions that were responded with not much confidence from Pfizer due to lack of not enough research data or evidence for efficacy of the vaccines shots for young children.
Study Design: Random, blinded Placebo controlled, immunogenicity, efficacy and safety study
Phase 1: 5-11 years. Sample size 3100. Randomized 2:1 (2 doses-3 weeks gap) Cohort 1/2
12-15 years and 16 years old: Sample size 1581
Phase 2/3: Case for Safety Analyses:
12-15 years and 16 years old: Sample size 1581 Randomized 2:1 (2 doses-3 weeks gap) Cohort 2/3
Final dose 5-11 years as 10 mcg mRNA(0.2ml) 12-16 years as 30 mcg mRNA
There has been detail reports on side effects from Pfizer presented during FDA live session today morning. Inflammation of the layers of the heart wall has been witnessed as a side effects. There has been many questions that were not addressed due to lack of time during the live session.
Demographics and baseline characteristics:
52 males and 48 females participated in the study. The median age is 8 years. 91% were without prior covid19 infection.
Countries enrolled: US (71 %) . Finland, Poland and Spain (29%)
20% subject shad existing underlying conditions. Obesity-12%, Asthma 8%, Neurologic disorder- around 1% and Congenital diseases accounted for greater than 1%.
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I am an educator and entrepreneur. I am blessed by a couple of certifications and a few degrees but my goal is to be a life-long learner. My purpose of life is to serve the community, the society at large. The one path that I chose is education-isn’t it a lethal combination to have a techy-business head and being an educator and a woman :). In short I want to do and offer more than I even I think I can. Remember money is not the first thing I choose, I choose service, respect and integrity over money, I choose spreading goodness and knowledge around in the most humble way possible.
About the author:
Mona Chowhan
President
Check My Universe®
Dream Product: Social Media for Education™
Introduction
I am an educator and entrepreneur. I am blessed by a couple of certifications and a few degrees but my goal is to be a life-long learner. My purpose of life is to serve the community, the society at large. The one path that I chose is education-isn’t it a lethal combination to have a techy-business head and being an educator and a woman :). In short I want to do and offer more than I even I think I can. Remember money is not the first thing I choose, I choose service, respect and integrity over money, I choose spreading goodness and knowledge around in the most humble way possible.
