Pfizer-BioNTech mRNA-based Vaccine Authorized on Emergency Basis for Adolescents (12-15) in USA & Europe with Safety Notices

Pfizer-BioNTech mRNA-based Vaccine Authorized on Emergency Basis for Adolescents (12-15) in USA & Europe with Safety Notices

TrialSite recently shared some data prompting a need for at least a quality and safety review of mRNA-based vaccines. The Pfizer-BioNTech vaccine has been approved for adolescents aged 12-15 in both the United States and now Europe. Just a couple weeks after the May 10 Emergency Use Authorization (EUA) in America was announced, various state departments of health, including Maryland, communicated to licensed physicians to make them aware that the Centers for Disease Control and Prevention (CDC) recently identified increased cases of myocarditis and pericarditis in the United States after mRNA-based COVID-19 vaccination (e.g. Pfizer-BioNTech and Moderna) especially in adolescents and young adults. The CDC generated a report called “Clinical Considerations Myocarditis and Pericarditis after Receipt of mRNA COVID-19 Vaccines Among Adolescents and Young Adults,” which was made available online here. In both cases, the body’s immune system is responding to an infection or some trigger and is directly related to the jabs. The incidents, typically occurring within several days after mRNA COVID-19 vaccination, seem to concentrate in male young adults 16 years old and up and seem to occur more after the second dose. The CDC recently communicated that in “most” cases, these mostly young male patients respond well to medication and rest, evidencing prompt improvement of symptoms. The CDC’s risk-benefit calculus still favors vaccination for everyone 12 years and up considering the risk of other serious complications, including death, with COVID-19 infection.  

Reported Issues

Myocarditis represents an inflammation of the heart muscle, and the symptoms can include shortness of breath, chest pain, decreased ability to exercise, and irregular heartbeat. Complications can lead to heart failure due to dilated cardiomyopathy or cardiac arrest. While Pericarditis represents inflammation of the pericardium (fibrous sac around the heart) and symptoms can include a sudden sharp chest pain, which can also reverberate down the shoulders, in the neck or back.

For more on the CDC advisory, see the link

Current Risk Levels Reported by CDC

According to the CDC in “COVID-19 Trends Among Persons Aged 0-24 Years—United States, March 1—December 12, 2020,” COVID-19 cases were already on the rise by January 2021. During one reporting period, a total of 2.87 million laboratory cases of COVID among ages 0-24 were confirmed in America. The breakdown among age was as follows:

  • 18-24 (57.4%)
  • 14-17 (16.3%)
  • 11-13 (7.9%)
  • 5-10 (10.9%)
  • 0-4 (7.4%)

Among this age group (again 0 to 24 years of age), actual adverse event data was available in 41.9%, 8.9% and 49.1%  of cases for hospitalizations, intensive care unit (ICU) admissions, and deaths respectively.

So for the data that was available for these adverse events, the CDC was able to report the following outcomes:

  • Hospitalization (30,229 or 2.5% of the data available)
  • ICU Admission (1,973 or 0.8$)
  • Death (654 or <0.1%)
  • Among the age group of 0-24, the largest percentage of hospitalizations (4.6%) and ICU admissions (1.8%) occurred among children aged 0-4 years).

Given the data available, the CDC recommends COVID-19 vaccination at this stage for everyone 12 years and above given what the agency describes as “the greater risk of other serious complications related to COVID-19, such as hospitalization, a multisystem inflammatory syndrome in children (MIS-C) or death.”

Equity & Healthcare

Recently, the Acting Deputy Administrator and Director for the Center for Medicare and Medicaid Services issued a CMCS briefing titled “COVID-19 Vaccine Update,” which reminded states that the vaccine is available for adolescents aged 12 through 15 and that states must be mindful of the importance of health equity, that is the “important role outreach and education can play in ensuring equitable access to a COVID-19 vaccination for those newly able to receive the Pfizer-BioNTech COVID-19 vaccine.”

According to the Kaiser Family Foundation (KFF)’s “Latest Data on COVID-19 Vaccinations Race/Ethnicity,” the vaccination programs have been not quite representative of the U.S. population as a whole. 

As of May 25, the CDC has identified the race/ethnicity for 56% of those who have received at least one dose of a COVID-19 vaccine. In total, 62% have been administered to whites, while 14% have been Hispanic/Latino and 9% Black and 6% Asian for example. Among the total U.S. population, about 18% are Hispanic/Latino and approximately 13% of the population is Black. Hence the proportion of COVID-19 vaccinations in total for the available data is not quite near parity with the overall population.

Responses

  1. The CDC’s comments are somewhat confusing. In the one paragraph the CDC mentions the growing incidence of myocarditis after the Vaccine but later on, advises its use for adolescents. This after the fact that adolescents recover completely from the infection with treatment and rest .

  2. I find the middle section of this report somewhat confusing.

    For starters, the post is talking about adolescents, teens and tweens, yet the CDC data is blurred by including adults in their early 20s. In NJ, the hardest hit state, the number of cases in their 20s is double the number who are in their teens. This if obfuscation, especially since the actual number of people of every age is known, whether they’re 13, 18, 19, 11, or 57. Ok, they put little kids in there too, but I guess that’s more reasonable, since this data is covering young people in general. But young adults should not be part of it, and this age cohort is tabulated separately in every other data set everywhere.

    Next, up until now I have only heard the term “adverse events” used in relation to post-vaccination events. Adverse in this usage means both negative and unexpected. OF COURSE getting this illness and winding up in the hospital, or in the ICU at the hospital, or dying either in the hospital or elsewhere, are “adverse events”. And given that the illness can express itself in so many different ways, what kind of illness symptom – an “event” – can be “adverse”? This does not make sense to me.

    Now let’s look at the percentages. 654 deaths from 2.87 million cases is 1 in 4389, or 0.022787%. Rounding this up to a one decimal place reported 0.1% is almost 5 times higher than reality. What we’re looking at is a survival rate of 99.978%, and that includes the young adults who are more susceptible than teens. Applying the nebulous “adverse event” percentage of 49.1% gives us 654 deaths from 1,409,170 cases, 1 in 2155, or 0.046%. Again, listing this as 0.1% is more than doubling the real percentage, and we’re now talking about a survival rate of 99.954%, still including the young adults.

    Given that the kids in the 11-19 brackets add up to 24.2% of the overall numbers, and (falsely) assuming an even age distribution of “adverse events”, the actual death rate for them is less than 1/4 of what the numbers show. In all this time, not one teen in NJ has died from this illness. Not one. This data is not a valid rationalization for vaccination of people in the 12+ age range whatsoever, especially given that the 18+ and now the 16+ groups have had the green light to get the jabs for some time. The CDC is pimping for the vaccine makers, pushing the 12-16 age bracket to get the shots.

    There is no point in looking at the hospitalization rate, as everyone who reads TSN is aware of the nearly complete lack of out-patient treatments. Going to the hospital is the only course of action for those feeling more than slightly ill.

    The ICU % is only rounded up a little bit from 0.77%, but is based on highly limited data, the 8.9% adverse event number. This reduces the 2.87 million cases down to 255,430, and again we have to assume an even age distribution, knowing full well the CDC has the exact data for every age and every age group. Odd that adverse event data for general hospitalization and death is roughly 5 times higher. I guess nothing much adverse goes on there, other than death, tabulated seperately.

    I am grateful to TSN for reporting this, but given TSN’s awareness of the manipulative efforts going on with every aspect of this pandemic, I would kind of expect you to be able to smell a rat at this point and mention it.