Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Cardiovascular Effects of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents

Version 1 : Received: 7 August 2022 / Approved: 8 August 2022 / Online: 8 August 2022 (10:40:23 CEST)

A peer-reviewed article of this Preprint also exists.

Mansanguan, S.; Charunwatthana, P.; Piyaphanee, W.; Dechkhajorn, W.; Poolcharoen, A.; Mansanguan, C. Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. Trop. Med. Infect. Dis. 2022, 7, 196. Mansanguan, S.; Charunwatthana, P.; Piyaphanee, W.; Dechkhajorn, W.; Poolcharoen, A.; Mansanguan, C. Cardiovascular Manifestation of the BNT162b2 mRNA COVID-19 Vaccine in Adolescents. Trop. Med. Infect. Dis. 2022, 7, 196.

Journal reference: Trop. Med. Infect. Dis. 2022, 7, 196
DOI: 10.3390/tropicalmed7080196

Abstract

This study focuses on cardiovascular effects, particularly myocarditis and pericarditis events, after BNT162b2 mRNA COVID-19 vaccine injection in Thai adolescents. This prospective cohort study enrolled students from two schools aged 13–18 years who received the second dose of the BNT162b2 mRNA COVID-19 vaccine. Data including demographics, symptoms, vital signs, ECG, echocardiography and cardiac enzymes were collected at baseline, Day 3, Day 7, and Day 14 (optional) using case record forms.We enrolled 314 participants; of these, 13 participants were lost to follow up, leaving 301 participants for analysis. The most common cardiovascular effects were tachycardia (7.64%), shortness of breath (6.64%), palpitation (4.32%), chest pain (4.32%), and hypertension (3.99%). Seven participants (2.33%) exhibited at least one elevated cardiac biomarker or positive lab assessments. Cardiovascular effects were found in 29.24% of patients, ranging from tachycardia, palpitation, and myopericarditis. Myopericarditis was confirmed in one patient after vaccination. Two patients had suspected pericarditis and four patients had suspected subclinical myocarditis. Conclusion: Cardiovascular effects in adolescents after BNT162b2 mRNA COVID-19 vaccination included tachycardia, palpitation, and myocarditis. The clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days. Hence, adolescents receiving mRNA vaccines should be monitored for side effects. Clinical Trial Registration: NCT05288231

Keywords

BNT162b2 mRNA COVID-19 vaccine; COVID-19 vaccine; cardiovascular effects; myocarditis; adolescents; Thailand

Subject

MEDICINE & PHARMACOLOGY, Cardiology

Comments (28)

Comment 1
Received: 12 August 2022
Commenter: Dr Rosamond Jones
The commenter has declared there is no conflict of interests.
Comment: This article is hugely concerning. Well done to the authors for prospectively looking for cardiac side effects, where most regulators have simply chosen to rely on voluntary schemes such as VAERS and then say that reports are co-incidences.
But I take issue with the conclusion - in normal times the conclusion would have been to withdraw this drug urgently, but now the authors advise that adolescents are monitored after vaccination. Only Denmark has had the courage to say we got this wrong boriquagato.substack.com/p/danish-national-board-of-health-admits
Response 1 to Comment 1
Received: 18 August 2022
Commenter: Paul King
The commenter has declared there is no conflict of interests.
Comment: Links to unreliable sources has no place in the discussion here.
Response 2 to Comment 1
Received: 19 August 2022
Commenter:
The commenter has declared there is no conflict of interests.
Comment: Paul King,
Here is the original source for the claim, direct from the Danish health authority:
www.sst.dk/da/corona/vaccination
English translation:

“Children and young people only very rarely become seriously ill from covid-19 with the omicron variant. Therefore, from 1 July 2022 it will no longer be possible for children and young people under the age of 18 to get the 1st jab, and from 1 September 2022 it will no longer be possible to get the 2nd jab."
Comment 2
Received: 12 August 2022
Commenter: Ruth Anne Chisholm-Davin
The commenter has declared there is no conflict of interests.
Comment: With the "alarming symptoms" found in almost a third of adolescents receiving the injections in your study, I humbly suggest a stronger conclusion than, "adolescents receiving mRNA vaccines should be moni­tored for side effects."
I suggest that all injections for adolescents in Thailand be stopped immediately until longer term harmful effects of the mRNA injection are studied (especially since recovery rate from Covid is estimated to be over 99%, and new studies have found the immunity from the injection wanes quickly).
Response 1 to Comment 2
Received: 18 August 2022
Commenter: Terry W Anderson
The commenter has declared there is no conflict of interests.
Comment: "The rrisks far outweight the benefits" would be a more appropriate conclusion.
Comment 3
Received: 12 August 2022
Commenter: Dr Paul Spradbery, MRSB
The commenter has declared there is no conflict of interests.
Comment: The sentence, "The clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days" could be misleading. Myopericarditis leads to cardiac tissue scarring and hence impaired ability to pump blood. Given that long-term prognosis is often poor, a "full recovery" would be unlikely and, therefore, dangerous to predict.
The data in general are quite disturbing, particularly in the light of the facts that: (a) the risk of SARS-CoV-2 to adolescents is statistically zero; and (b) the drugs are not vaccines, prevent neither infection nor transmission, do not reduce individual viral load and are proven uniquely dangerous. It is, in my view, about time the entire medical and scientific professions echoed the admirable Christine Anderson, Member of the European Parliament:
"This vaccine campaign will go down as the biggest scandal in medical history. Moreover, it will be known as the biggest crime ever committed on humanity."
Response 1 to Comment 3
Received: 18 August 2022
Commenter: Dr Janice Sheringham
The commenter has declared there is no conflict of interests.
Comment: Dr Spradbery, you are commenting about the after effects of viral myocarditis, which follows a much more active course, both in duration and outcomes, to that seen after this, and other, immunisations! The risks of SARS COV 2 infection in adolescents is definitely NOT zero, as clearly shown by the Big Ten prospective study of College athletes which examined the cardiac effects of confirmed infection, including asymptomatic cases. And with respect, Ms Anderson has no medical or relevant scientific qualifications to provide reliable commentary on this topic in or out of the European Parliament.
Response 2 to Comment 3
Received: 19 August 2022
Commenter:
The commenter has declared there is no conflict of interests.
Comment: Dr Janice Sheringham,
With all due respect, not just this one study, but several studies asking this same question have found similar answers - high myocarditis rates, particularly in adolescent boys, that do in fact exceed the rates found in COVID infection in that group. Here are a few:

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2793551?resultClick=1 https://pubmed.ncbi.nlm.nih.gov/35749115/
https://www.medrxiv.org/content/10.1101/2021.12.21.21268209v1
This Nature study compares post-COVID and post-vaccine myo/pericarditis rates directly.
https://www.nature.com/articles/s41591-021-01630-0
The analysis there is favorable to the vaccine in the population at large but does not stratify on age and sex. The authors performed a stratified analysis by age and sex in this follow-up study and found higher rates of myo/pericarditis in young males post-vaccine than post-covid:
https://www.medrxiv.org/content/10.1101/2021.12.23.21268276v1
"Associations were strongest in males younger than 40 years for all vaccine types with an additional 3 (95%CI 1, 5) and 12 (95% CI 1,17) events per million estimated in the 1-28 days following a first dose of BNT162b2 and mRNA-1273, respectively; 14 (95%CI 8, 17), 12 (95%CI 1, 7) and 101 (95%CI 95, 104) additional events following a second dose of ChAdOx1, BNT162b2 and mRNA-1273, respectively; and 13 (95%CI 7, 15) additional events following a third dose of BNT162b2, compared with 7 (95%CI 2, 11) additional events following COVID-19 infection."
Comment 4
Received: 13 August 2022
Commenter: Robert Thompson MD
The commenter has declared there is no conflict of interests.
Comment: I would have liked to see DOI information with the references. It would make it more efficient in consulting the references while reading online.
Comment 5
Received: 13 August 2022
Commenter: José Ramón Perurena
The commenter has declared there is no conflict of interests.
Comment: Myopericarditis should never be addressed as or considered "mild".
Response 1 to Comment 5
Received: 18 August 2022
Commenter: Laurenion
The commenter has declared there is no conflict of interests.
Comment: When flu or cold symptoms are considered potentially very dangerous, a Myopericarditis is considered mild... what wonderful time times we live in...!
Comment 6
Received: 13 August 2022
Commenter: Stewart Trickett
The commenter has declared there is no conflict of interests.
Comment: "Myopericarditis was confirmed in one patient after vaccination."

"The clinical presentation of myopericarditis after vaccination was usually mild, with all cases fully recovering within 14 days."

These two sentences in the abstract seem to be in conflict.
Comment 7
Received: 14 August 2022
Commenter: Christopher Pringle
The commenter has declared there is no conflict of interests.
Comment: Looks like jab is working. Young have nothing to fear from flu but lives shortened with toxic gene therapy. Time will ravage the sheep like nothing in history. Sad.
Response 1 to Comment 7
Received: 18 August 2022
The commenter has declared there is no conflict of interests.
Comment: MODERATORS: the above commenter has no place in serious discourse and is in clear violation of your terms.
Comment 8
Received: 14 August 2022
The commenter has declared there is no conflict of interests.
Comment: Nothing like a small, uncontrolled, non-peer-reviewed study out of Thailand to make the anti-vaxx crowd sit up and take notice! I'm only commenting because the likes of Simone Gold (@drsimonegold) are posting stuff like "cardiovascular adverse effects in around a third of teens" based on this preprint.

Here are some highlights from this "bombshell" report:
- 301 participants evaluated
- "None of the participants died, required mechanical ventilation, or required inotropic support."
- "Three patients diagnosed with myopericarditis and pericarditis were treated with nonsteroidal anti-inflammatory drugs (NSAIDs) for 2 weeks with no residual symptoms and complete follow-up."

The study's introduction acknowledges the need for controlled studies in order to say anything conclusive about causality: "Although cardiovascular events have been reported with the COVID-19 vaccine, causality has yet to be established, because such cardiovascular adverse events are also common among the general public who do not receive the intervention [13]."

And yet the authors made no attempt to conduct a controlled study here! They instead relied mainly on diary-based self-report of symptoms such as elevated heart rate, shortness of breath, and elevated blood pressure to produce their key finding that 29.24% of patients had "cardiovascular effects."
Response 1 to Comment 8
Received: 18 August 2022
The commenter has declared there is no conflict of interests.
Comment: 100% agreed, such a small study cannot be hugely relied upon. But I think the most interesting factor is not this actual study, it's the fact that it's the only one of it's kind, small or large. These jabs have been dolled out like there's no tomorrow, to kids even, with little to no regard for their long-term well-being. This one study is small, but it's badly needed, it's the only one, & it's produced worrying results.
There is a fact the pro-vaxxers love to ignore. These new vaccines are unprecedented in human use. Animals testing was foregone altogether. Various trial phases were merged & then even control subjects were vaccinated, completely nullifying the results.
Pointing to the old SARS & MERS research as evidence the coronavirus vaccines have been undergoing research for decades as evidence that these new ones are safe is disengenuous. The SARS & MERS trials failed thanks to Pathogenic Priming/Antibody Dependent Enhancement. "All subject mice suffered histopathalogic changes", SARS-I.
And it turns out the ADE produced by a Covid-19 vaccine will be indistinguishable from an actual Covid infection except of course that the immune system has turned on the host instead of turning on the virus, making symptoms much more rapid in development, much worse & death more likely. This easily explains the otherwise inexplicable uptick in cases, hospitalistions AND fatalities from so-called Covid in the wake of the vaccine rollouts. These patients are victims of Pathogenic Priming/ADE which is impossible either by observation or by clinical study or by biopsy, to differentiate from a normal infection. They have been vaccinated, just like the mice & ferrets etc in the SARS & MERS research, then when exposed to wild virus have become gravely ill &/or died.
Response 2 to Comment 8
Received: 18 August 2022
Commenter: Gina M.
The commenter has declared there is no conflict of interests.
Comment: I do appreciate the information you provided but regardless of your comment the point that many seem to miss, including you, are young kids have an almost ZERO chance of dying from CV19 and the mRna is neither a vaccine: it does it prevent someone from getting CV19 or spreading it. So why would anyone in their right mind be part of this EXPERIMENT?

Why do people who questions this specific injections called Anti-Vaxxers, when most people who fall in this category have had all their childhood vaccines and make sure their children get their vaccines? They simply do not see the cost-benefit of getting the mRna injection. It is illogical to get the mRna injection, really. Personally I believe the only ones truely benefiting from the mRna injections are those who sell it and those who get a commssion from fooling their patients into thinking its a vaccine. Just because the CDC changed the definition of vaccine on their website to fit the mRna injections, does not make this injection a true vaccine. And on top of this, those who unfortunately got the jab and were injured from it are ignored and censored and left to deal with the suffering alone...no help from the government, no one to sue since big pharma is protected, these poor people (thousands of people) get no compensation to help with medical bills and loss of job...nothing but a big FU from big pharma, medical establishment, doctors, etc. So anyway you slice it, getting the mRna injection is illogical and very dangerous.
Response 3 to Comment 8
Received: 19 August 2022
Commenter: Peter Evans
The commenter has declared there is no conflict of interests.
Comment: Perhaps you may be interested in this larger study from April 2022 then?

https://jamanetwork.com/journals/jamacardiology/fullarticle/2791253
SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents

CONCLUSIONS

"In this cohort study of 23.1 million Nordic residents aged 12 years or older, the risk of myocarditis was higher within 28 days of vaccination with both BNT162b2 and mRNA-1273 compared with being unvaccinated, and higher after the second dose of vaccine than the first dose. The risk was more pronounced after the second dose of mRNA-1273 than after the second dose of BNT162b2, and the risk was highest among males aged 16 to 24 years. Our data are compatible with 4 to 7 excess events within 28 days per 100 000 vaccinees after a second dose of BNT162b2, and 9 to 28 excess events within 28 days per 100 000 vaccinees after a second dose of mRNA-1273. The risk of myocarditis associated with vaccination against SARS-CoV-2 must be balanced against the benefits of these vaccines."
Comment 9
Received: 16 August 2022
Commenter: Dr. Hans-Joachim Kremer
The commenter has declared there is no conflict of interests.
Comment: Interesting article!
It is a pitty that you started data collection only after the first does. I acknowledge your rationale, although I am wondering, that you were unable collect cases already after the first dose later on.
I searched myself VAERS for similar events after 1st and 2nd dose of Comirnaty in that age class, yielding 232 after 1st, 486 after 2nd, and 652 after 1st or 2nd, i.e. some overlap or recurrences. Please elaborate yourself from VAERS and estimate a rate of the incidence after 1st dose (including recurrences) based on the terms you investigated (here about 50%).
It is quite unclear whether "baseline" is to be understood, as usual, as prior to exposure. The sentence in 2.1 "after receivin the second dose ..." suggests the contrary. Please state clearly.
It is unclear how much time elapsed between informed consent and vaccination.
The exclusion criteria are interesting: What would have happened, if the informed consent process or the medical history at baseline would have revealed e.g. pericarditis or severe allergic reaction? Would these participants have been vaccinated? But not included in the study? Please tell. Otherwise Pfizer and many governments are very keen in not stating any contraindication...
The high rate of lost to FU (13 or 314 = 4%) is not good! Did you not call them back for at least a telephone interview?
Figure 1
The box "Informed consent (process)" is misplaced and should be ordered in the vertical line. Maybe it could be shown instead of the "Approval of EC", which does not refer to any individual flow.
Write in "Baseline" "Complete medical history" leaving out the "taking and"
I wonder what "complete history" could be in any of the following visits. Please replace by, e.g., adverse events.
Table 1 I would not present coloumn with the p-values. They are of no relevance, and for the difference in sex I do not need a p-value; but this criticsm is not important!
Table 2: Write "Presentation of cases with ..."
Discussion: Please either erase the sentence "By contrast, the incidence of ...", as it is not true and the references do not support the statement, or elaborate thoroughly!
Comment 10
Received: 16 August 2022
Commenter: Edo McGowan, PhD/PA
The commenter has declared there is no conflict of interests.
Comment: Informative. Here is my experience:

Although this is neither an adolescent or cardiac case, the vaccine's impact on the endothelial cells generally warrants an expanded analysis. Those planning to undergo vascular surgery may wish to consider the following case which relates to vascular surgery in the lower limb arteries. Following the first Pfizer vaccine, I underwent vascular surgery to improve flow and reduce claudication on the left leg. Following that surgery my pedal pulses improved and hiking, when resumed, saw a considerable reduction in claudication to allow resumption of hiking in the steep terrain behind Santa Barbara. I still had claudication in the right leg and thus had surgery on both legs within 2 days following the second Pfizer vaccine. The previously easily palpable pedal pulses in the left leg diminished within a week remained greatly depressed, requiring a doppler to locate. I mention this because I believe that there is some common issue relating to an endothelial tissue response to the vaccine.

Dr Edo McGowan
Comment 11
Received: 16 August 2022
Commenter: Dr. Hans-Joachim Kremer
The commenter has declared there is no conflict of interests.
Comment: Introduction: The sentence "Common findings observed ..." refers to the wrong citation. It must be the 17.
Comment 12
Received: 17 August 2022
The commenter has declared there is no conflict of interests.
Comment: This seems to be the first prospective study I have seen that looks at adverse reactions. Why are there not many more of these prospective studies with larger sample sizes, various age groups, and boosted or 4th dose demographics? Why have these studies have not been on-going since day one? Why are Pharma companies and the health agencies not taking initiative to preforming these studies?
Comment 13
Received: 17 August 2022
Commenter: BIJON KUMAR SIL
The commenter has declared there is no conflict of interests.
Comment: It's well written article supported with very well structured data and analysis. I truly believe their findings cos in second vaccination, spike proteins which synthesized from mRNA can easily follow the entry process into the targets cells having ACE2, Furin and TMPRSS2 and heart is one of them. Following attachment of Spike protein, antibodies specific ( either developed during first vaccination and/or quick production following second dose from memory cells ) to the protein make immunocomplexes which invites complements and initiate complement cascade. This process will release inflammatory molecules like 3a, 4a and 5a and hence developed inflammatory reactions followed by clinical findings which were observed by authors among adolescents group of people. In first vaccination due to lack antibodies during first 2 weeks such reactions may not be visible. Many thanks to authors for presenting such as great report which could drive other researchers to making similar research plan.
Comment 14
Received: 17 August 2022
Commenter: Jim Jones REV
The commenter has declared there is no conflict of interests.
Comment: It was set as an intelligence test for Critical Thinking Skills - those that got it sadly failed the test.
That's why Phd's are the lowest % of people to get the "vaccine".
Comment 15
Received: 17 August 2022
Commenter: Concerned Pharmacist
The commenter has declared there is no conflict of interests.
Comment: Why do we have to rely on studies from other countries instead of doing our own studies? This lack of interest is very disturbing to say the least.
7 cases of myocarditis/pericarditis in 202 boys sound extremely alarming and if this is not a "safety signal", then I don't know what is.
Comment 16
Received: 18 August 2022
The commenter has declared there is no conflict of interests.
Comment: This study has a potential to be a very important study, the first out of at least four others (two in the US, one in Israel and one in Singapore) that promised to test Troponin levels in a cohort of newly vaccinated young people but never published the results to this day.
That's why I was extremely disappointed to discover while reading the preprint that you actually didn't publish the average Troponin levels of the entire cohort at all 3 visits: day 0, day 3, day 7 and those who tested on day 14. That is the most important data you collected and the most important data needed to publish in detail, including the average, standard deviation, median, full range and interquarantile range in every visit. You also didn't publish the reference values of the Troponin tests, what is the normal range of the lab? It is also extremely important.
If you include those details, then it would be a very important study. The only thing you did publish was Troponin levels in 7 patients, and on table 1 where you didn't even clarify at what visit (0? 3? 7?) those levels were measured. Though the separation of age groups 13-15 and 16-18 was a good idea, and it seams the troponin levels are higher in the 16-18 groups.
Comment 17
Received: 21 August 2022
Commenter: Sally Clark
The commenter has declared there is no conflict of interests.
Comment: Please advise if any effort has been made to find the 13 students who were lost to follow-up?
Given the gravity of the findings presented and the short time frame of the investigation, I would be concerned in case any of the lost student were lost due to death! Or to such severe side effects that they could not present for any followup!
Response 1 to Comment 17
Received: 24 August 2022
Commenter:
Commenter's Conflict of Interests: I declare no conflict of interest
Comment: Thank you for your question, All of the 13 participants who loss to follow up are healthy condition. Principle investigator and study team call more than 2 time to complete follow up and because of every participants can drop off any time.They loss to follow up because some parents concern about the blood check for troponin-T and CK-MB even the nurse had more experience on that. Parents does want to repeat blood check even I consent and informed already. Another reason parents not convenient to bring student to school as schedules.
Thank you very much for your concern

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