CDC Advisory Committee presentation on the Risk of Myocarditis From the ‘Gay’ of the mRNA Vaccine • Protecting Children’s Health

On June 23, the CDC’s Advisory Committee on Immunization Practices met to discuss ongoing reports of myocarditis in adolescents, particularly young men, following a second dose of mRNA vaccines. However, the purpose of evaluating harms and benefits contains misleading statements and data.

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On June 23, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) meet to discuss ongoing reports on myocarditis of young people, especially young men, after the second dose of mRNA vaccines.

According to recent reports, the committee has been accused of weighing in potential damage and benefits associated with the second dose of mRNA vaccine.

Despite the importance and gravity of the topic, and the high level at which this discussion takes place, the presentation provided by the committee for the purpose of assessing damages and benefits initially deficient.

While misleading statements and data can be found throughout the slidedeck, we will focus on the two slides that are more relevant to decision faced by ACIP on June 23.

The first of these two slides, at the bottom, claims to have examined the “benefits and risks after dose 2,” presenting what “COVID-19-Associated Hospitalization Prevented” by dose 2, versus “ Cases of Myocarditis “expected cause of dose 2.

benefits and risks

The second of these slides, below, shows “Predictive cases of prevention versus myocarditis cases per million second vaccination doses.”

Men versus Women Myocarditis

The presentation contains erroneous analysis and misleading data plots. But more importantly, despite the fact that these slides seek to weigh the risks versus the benefits of “dose 2” mRNA vaccines, this analysis believes that a single dose of mRNA vaccines has 0 % effectiveness to prevent the associated drug with COVID-19, despite the fact that original Phase 3 trial found high recovery with a single dose even in prevention of infection, and real -world data confirmed the high efficacy of single doses to prevent hospitalization, including against current SARS-CoV-2 strains.

In particular, the counterfactual used for the analysis provided for this presentation did not delay the second dose in specific age groups or even though they banned them all, but suspended all vaccinations in this age group. , including children with conditions that put them at greater risk of serious consequences. and deaths, for a period of 4 months all showing the number of deaths and hospitalizations comparable to May.

ACIP could not have done its duty if it had not answered the question before it did, which is then, “do the benefits versus the harm of a second dose of mRNA vaccines be done to give the second dose to younger children? age groups today? “

Answering this question requires understanding not the difference between vaccinating children and not vaccinating, but between giving a second dose and not giving a second dose. The titles of these slides do not matter, these slides do not show any data related to that question.

It is possible, however, to also establish what it looks like to more carefully balance the harms and benefits. The first change we will make is simply to include an analysis of the benefit of a single dose of Pfizer vaccine for prevention of COVID-19 hospitalization.

It was recently estimated to be 83% against the alpha variety, and 92% against the more recent delta variety, by Public Health England. We conservatively had an efficacy dose of 83% versus hospitalization for this illustration, compared with a two-dose efficacy of 95%. With these assumptions, the first slide shown earlier shows very differently:

Benefits and risks after dose 2 age group A
Fewer hospitalizations were avoided in this re-analysis, where only the virtues of dose 2 of the avoided hospitalizations were not avoided at dose 1.

After this change, the balance of benefits versus harms is even more dangerous, with many cases of hospitalization expected from myocarditis vaccine in 12–17 years of age (even combined boys and female companions) than the restrained COVID-19 hospitalized.

We are considering another change. The case rate shown to the right of this figure represents the rate at which CDC -confirmed myocarditis cases were recorded through voluntary reporting systems. Naturally to expect this to be a little contemptible. In fact, Israel reports rate of myocarditis between 1 in 3000 and 1 in 6000 in 16-24 years of age, with a higher rate in about 16-19 years of age than in 20-24 years of age.

This is almost 5 times higher than the rate of CDC confirmed cases of myocarditis detected by voluntary reporting. If we use Israeli rates as a proxy for the expected rate of myocarditis, we obtain the following comparison (simply by multiplying by a factor of 5 the CDC -confirmed rate in each age group up to 29).

Benefits and risks after dose 2
In this re-analysis, we compared hospitalizations associated with COVID-19 avoided at the 2nd dose, with myocarditis rates expected to rates found in Israel.

In this analysis, the harm versus benefits of the second dose were found to be unfavorable for ages under 25. This is true even though:

  • This analysis was isolated on age only, regardless of gender, previous COVID-19 infection or health risk factors.
  • It still uses May hospitalization rates as baseline expected over the next 4 months.
  • It does not account for the fact that according to CDC’s own analysis, 45% of COVID-19-associated adolescent hospitalizations reported by COVID-NET (which is the source of hospitalization data in this number) have primary factors other than COVID-19.

The harms versus benefits are even worse for those aged 12-17 years, as illustrated if we change the second CDC slide from high to the expectation that a single dose of mRNA vaccine has 83 % VE against severe consequences, and use rate of myocarditis from Israel as a better estimate of the number of rates of myocarditis (the minimum estimate remains unchanged here):

Prevented predicted cases versus myocarditis
If we consider the small benefit of the 2nd dose over the 1st dose, rather than dedicating all the benefits of vaccination to the 2nd dose, the balance of harms and benefits appears to be much better. unfavorable to teenagers.

Remember more than 95% of cases of myocarditis detected by the CDC result in hospitalization -it is likely that second doses of mRNA vaccines cause more hospitalizations than they can prevent 12-17 year old men, and if this is also true for women relies heavily on the rate at which the CDC is undercounting cases of myocarditis.

In the meantime, keep in mind that this balance is especially unfavorable for the second dose if it is limited to healthy children without health factors that put them at greater risk for serious illness.

Meanwhile, the number of deaths from vaccine -related myocarditis cases remains uncertain. Under questioning during the meeting, Matthew Oster reports that for myocarditis unrelated to COVID-19 or COVID-19 vaccines, the mortality rate is estimated to be 4% –9% in the literature.

Fortunately, it is likely that the rate is not as high for the vaccine or COVID-19 associated with myocarditis. But the rate is probably not zero, and the The CDC is already investigating a possible death associated with a second dose of Pfizer vaccine in a 13 years old, at a period of time where no expected death could be avoided from a second dose of mRNA vaccines in this age group.

Originally published on Medium.

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