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Pfizer Vaccine for 5-11 Year Old Children is Approved

The CDC ACIP Advisory Committee voted yesterday (14 to 0) to approve the Pfizer Covid Vaccine for 5 to 11 year old children.  Dr. Rochelle Walensky, CDC Director, approved it last evening and now the vaccinations can begin.  On Oct. 27th I reported on the FDA VRBPAC Committee Meeting and summarized the vaccine efficacy (90.7%) and safety data (Paper and Threads: FDA Approves Pfizer Covid Vaccine for 5-11 Year Olds).  At today's full day meeting a Pfizer scientist, CDC scientists, and other investigators reviewed the vaccine again in depth and did a formal benefit vs risk assessment before the committee ended the day with a unanimous vote for approval.

There have been >1.9 million cases of Covid in 5-11 yr. old children, more than 8,300 hospitalizations, 2,316 cases of MIS-C and over 100 deaths during the pandemic.  Many of the children are asymptomatic, but others develop Multisystem Inflammatory Syndrome - Children (MIS-C) which is an inflammatory response to a Covid infection which occurs 2-6 weeks after a case of Covid.  More than 60% of these children are admitted to the ICU and 1-2% of them die.  As many as 8% of children can also have mild or moderate  Covid symptoms lasting more than 12 weeks according to a UK study.  Children will receive only 10ug of vaccine instead of 30ug which the 12-15 and 16+ groups receive.  The caps on the vials for the 10ug dose, parts of the label, and all shipping boxes are bright orange.  The doses for all of the 30ug vaccine vials have purple caps and labels so no errors can be made.     See Below   

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There is a very rare incidence of myocarditis with the mRNA vaccines - mostly in 16-29 year old males. The current incidence of this side effect is 1:10,000 -1:20,000 of vaccine doses.  Myocarditis is an inflammation of heart muscle and in most cases it appears within 7 days after the 2nd dose of vaccine.  Cases have been very mild and recovery is fast - usually with no treatment or non-steroidal anti-inflammatory meds.  There are no deaths.  It is important, however to know that myocarditis also occurs with Covid-19 infection, in greater numbers and severity, so prevention of Covid infection is even more important.  There are other causes of myocarditis and most of the cases occur in males, with fewer occurring below the age of puberty.  So 5-11 year old children may have an even lower incidence than older males.  There were no cases in the clinical trial of over 3000 5-11 year old children.    

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