According to Pfizer, “The pediatric burden of COVID-19 likely exceeds that of seasonal influenza.” It also wants to vaccinate all 30 million 5-11 year olds in the United States with BNT162B2. A thread...
The FDA uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. In this case, the FDA Vaccines and Related Biological Products advisory committee will meet on October 26, 2021 to discuss Pfizer’s request. 2/
The committee will “discuss whether based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID-19 Vaccine when administered as a 2-dose series (10 μg each dose, 3 weeks apart) outweigh its risks for use in children 5-11 years of age.” 3/
The vaccine is not FDA-approved for anyone under 16, so Pfizer must apply to amend its existing Emergency Use Authorization (EUA) to include this age cohort. 4/
The FDA may issue an EUA if: the agent can cause a serious or life-threatening disease or condition; the product may be effective to prevent or treat it; the benefits outweigh the risks; and there is no adequate, approved, and available alternative. 5/ fda.gov/emergency-prep…
Pfizer recently submitted an amendment request for younger kids. “On October 6, 2021, Pfizer submitted a request to FDA to amend its EUA to expand use of BNT162b2 for prevention of COVID-19 in individuals 5 through 11 years of age...” 6/
Approval requires "clear and compelling evidence." Per FDA: “An EUA allowing for rapid and widespread deployment of the vaccine to millions of individuals would need to be supported by clear and compelling evidence of effectiveness and adequate safety follow-up...” 7/
Pfizer wants to vaccinate all 5-11 year olds. Per Pfizer: “Vaccination strategies in this group of children should not be restricted to those living with underlying comorbidities and should include the entire 5 to <12 years of age population...” 8/
Pfizer cites indirect benefits including social development. Per Pfizer: “Preventing COVID-19 will provide direct health benefits to children and indirect educational and social development benefits can be anticipated..." 9/
Pfizer also cites a need to vaccinate kids to reach herd immunity. Per Pfizer: “Reaching herd immunity thresholds or attaining meaningful reductions in the force of infection are unlikely without vaccinating children.” 10/
In any event, Pfizer says there’s a "significant unmet medical need." Per Pfizer: “COVID-19 continues to be a serious and potentially fatal or life-threatening infection for children and there is a significant unmet medical need in the 5 to <12 years of age population.” 11/
Virus risk and hospitalizations per Pfizer: “In this same age group, there have been 8622 COVID-19 related hospitalizations...” while acknowledging that “...approximately one-third of children who are hospitalized for COVID-19 do not have any underlying comorbidities...” 12/
Comorbidities redux per FDA: “The most common underlying medical conditions among hospitalized children were chronic lung disease (29%), obesity (25%) and neurologic disorders (23%). A total of 68% of hospitalized children had more than one underlying condition.” 13/
That is to say, there have been about 2,759 hospitalizations of 5-11 year olds with no comorbidities. This equals ~0.009% of the age cohort, or ~1/10,000. 14/
Virus risk and MIS-C, per Pfizer: “Through 04 October 2021, 5217 children in the US were diagnosed with Multisystem Inflammatory Syndrome (MIS-C), half of whom were children 5 to 13 years of age.” 15/
That is to say, the number of MIS-C cases among 5-11 year olds is an estimated 2,028. This equals ~0.007%, or less than 1/10,000. 16/
Virus risk of death per Pfizer: “...among children 5 to <12 years of age there have been ... 143 COVID-19-related deaths in the US through 14 October 2021.” 17/
Bear in mind, this is not necessarily 143 deaths from COVID, but 143 deaths with COVID. 18/
Nevertheless, 143 deaths is equal to ~0.0005%, or about 1/200,000. 19/
Per CDC Underlying Cause of Death data from 1999-2019 for 5-9 year olds: accidents (7x); malignant neoplasms (3-4x); congenital malformations, deformations and chromosomal abnormalities (2x); and homicide (1-2x) are all more likely causes of death. 20/
In any event, the FDA notes that “...children and adolescents appear less susceptible to SARS-CoV-2 infection and generally have a milder COVID-19 disease course as compared with adults...” 21/
And Pfizer characterizes the risk like this: “The pediatric burden of COVID-19 likely exceeds that of seasonal influenza.” 22/
OK, so that answers the part of the EUA about the "serious or life threatening" disease, but what about the efficacy of the vaccine? 23/
Pfizer study includes ~2,250 kids per FDA: “...safety data from 1,518 BNT162b2 recipients and 750 placebo recipients 5-11 years of age who are enrolled in the Phase 2/3 portion of an ongoing randomized, double-blinded, placebo-controlled clinical trial, C4591007.” 24/
Study demographics per Pfizer: “...most participants were White (74.2%), with 9.7% Black or African American participants and 12.9% Asian participants... There were 6.5% Hispanic/Latino participants. The median age was 9.0 years and 48.4% were male.” 25/
So what happened? A small share of participants got COVID per FDA: “Totals of 3 cases of COVID-19 occurred in the BNT162b2 group and 16 in the placebo group... At the time of the data cutoff, none of these cases met the criteria for severe COVID-19.” 26/
Repeat, none of the cases were severe. Per Pfizer. “No severe COVID-19 cases or MIS-C were reported in the 5 to <12 years of age group per protocol definition or per CDC definition as of the date cutoff date (08 October 2021).” 27/
And no participants who previously had COVID got it again per Pfizer: “No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.” 28/
What about the risks of the vaccine? Vaccine safety concerns per FDA: “Important Identified Risks: anaphylaxis, myocarditis, and pericarditis... “Important Potential Risks: Vaccine-associated enhanced disease, including vaccine-associated enhanced respiratory disease.” 29/
Second dose adds risk per Pfizer: “In the population of Phase 2/3 pediatric participants 5 to <12 years of age, systemic events showed increased frequencies for Dose 2 compared to Dose 1 for most events.” 30/
There is insufficient data to determine risk of myocarditis per Pfizer: “The size of the safety database is not large enough to detect any potential risks of myocarditis associated with vaccination.” 31/
But myocarditis probably won’t be as big a deal in younger kids per Pfizer: “...it is reasonable to predict that post-vaccine myocarditis rates are likely to be even lower in 5 to <12 years of age than those observed in adolescents 12 to 15 years of age.” 32/
So do benefits outweigh risks? Pfizer concludes 1M kids must be vaxxed to prevent 170 hospitalizations: “the estimated number of COVID-19 hospitalizations prevented over 120 days per million of fully vaccinated children 5 to <12 years of age is 170” 33/
The FDA took a different approach to answering the risk-benefit question. It offers 6 scenarios, and concludes vaccine prevents 1 death for every 1 million kids vaccinated in 4 of 6 scenarios, prevent no deaths in 1 scenario, and prevent 3 deaths in 1 scenario. 34/
However, the FDA only considered the risk of myocarditis/pericarditis, and excluded risks cited elsewhere including anaphylaxis as an identified risk and vaccine-associated enhanced disease as a potential risk. 35/
Upcoming FDA Vaccines and Related Biological Products Advisory Committee meeting information and materials. 36/ fda.gov/advisory-commi…
In sum, EUA requires (1) serious or life-threatening disease; (2) an effective product to prevent or treat it; (3) product benefits outweigh the risks; and (4) no adequate, approved and available alternatives. Herein lies the evidence, you be the judge. #InformedConsent #DoNoHarm
Postscript: Pfizer will generate $1.2B in revenue assuming 30M 5-11 year olds receive 2 doses at $20 per dose. Boosters would simply turn that into an annuity stream.
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