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Pfizer Data On Child CoVid Vaccination Presented to the FDA
Vidcast: https://youtu.be/dk1FqpAEIQg
Let’s take a look at the data submitted by Pfizer to the FDA in support of an Emergency Use Authorization for Pfizer vaccine use in children 5 to 12 years of age. Pfizer studied 2250 children 1518 of whom were vaccinated and 750 of whom served as placebo controls. An additional 2250 children were studied to add additional safety data.
The vaccinated children received 10 ug of mRNA, one-third the adult dose, twice 3 weeks apart. Their levels of anti-CoVid antibodies were comparable to those elicited from vaccinating young adults 16 to 25 years of age. A supplemental analysis of sera from 38 randomly selected vaccinated children showed equivalent potency against the Delta variant compared with the original CoVid strain.
The real-life vaccine effectiveness during the tine of Delta was 90.7%. There were no cases of severe CoVid and no cases of Multisystem Inflammatory Syndrome, MIS-C. This indicates a high level of protection for children without an undue risk of side effects.
The safety data showed mild to moderate reactions during the first 2 days after vaccination. The most common local reaction was injection site pain and the most common systemic reactions were fatigue, headache, muscle pain, and chills. There were no cases of myocarditis.
https://www.fda.gov/media/153409/download
#CoVid #pfizer #children #vaccine
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By Howard G. Smith MD, AM
Vidcast: https://youtu.be/dk1FqpAEIQg
Let’s take a look at the data submitted by Pfizer to the FDA in support of an Emergency Use Authorization for Pfizer vaccine use in children 5 to 12 years of age. Pfizer studied 2250 children 1518 of whom were vaccinated and 750 of whom served as placebo controls. An additional 2250 children were studied to add additional safety data.
The vaccinated children received 10 ug of mRNA, one-third the adult dose, twice 3 weeks apart. Their levels of anti-CoVid antibodies were comparable to those elicited from vaccinating young adults 16 to 25 years of age. A supplemental analysis of sera from 38 randomly selected vaccinated children showed equivalent potency against the Delta variant compared with the original CoVid strain.
The real-life vaccine effectiveness during the tine of Delta was 90.7%. There were no cases of severe CoVid and no cases of Multisystem Inflammatory Syndrome, MIS-C. This indicates a high level of protection for children without an undue risk of side effects.
The safety data showed mild to moderate reactions during the first 2 days after vaccination. The most common local reaction was injection site pain and the most common systemic reactions were fatigue, headache, muscle pain, and chills. There were no cases of myocarditis.
https://www.fda.gov/media/153409/download
#CoVid #pfizer #children #vaccine