Wednesday, June 30, 2021

Many medical organizations "cosign" CDC/HHS baloney about myocarditis being rare, mild. Institutional capture on steroids

This statement alone is enough to make one give up entirely on American medicine.  It drips with corruption.  It provides no data, no useful information.  It simply tells us that our tax dollars have been used to buy all these people and the once-upon-a-time meaningful organizations they represent. Whenever the spin doctors tell you "the facts are clear" and then omit the facts, run for your life!

I can't tell you exactly what the HHS agenda is.  I can't tell you why they want us all jabbed, over and over again.  I can only tell you it makes no medical sense, they are hiding the side effects, and these people are lying to us.  Over and over.  These people hid the effective treatments for Covid. They insisted we wear ineffective masks.  They pretended there was no aerosol spread. They are not here to help us. 

Statement Following CDC ACIP Meeting from Nation’s Leading Doctors, Nurses and Public Health Leaders on Benefits of Vaccination

The following statement has been co-signed by the U.S. Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), American Academy of Family Physicians (AAFP), American Academy of Pediatrics (AAP), American College of Obstetricians and Gynecologists (ACOG), American College of Physicians (ACP), American Heart Association, American Hospital Association (AHA), American Medical Association (AMA), American Nurses Association (ANA), American Public Health Association (APHA), Association of Public Health Laboratories, Association of State and Territorial Health Officials (ASTHO), Big Cities Health Coalition, Council of State and Territorial Epidemiologists, Infectious Diseases Society of America, and National Association of County and City Health Officials (NACCHO):

“As physicians, nurses, public health and health care professionals, and, for many of us, parents, we understand the significant interest many Americans have in the safety of the COVID-19 vaccines, especially for younger people. Today, the CDC Advisory Committee on Immunization Practices (ACIP) met to discuss the latest data on reports of mild cases of inflammation of the heart muscle and surrounding tissue called myocarditis and pericarditis following COVID-19 vaccination among younger people.

“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination. Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.

“The vaccines are safe and effective, and they prevent COVID-19 illness. They will help protect you and your family and keep your community safe. We strongly encourage everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated, as the benefits of vaccination far outweigh any harm. Especially with the troubling Delta variant increasingly circulating, and more readily impacting younger people, the risks of being unvaccinated are far greater than any rare side effects from the vaccines. If you get COVID-19, you could get severely ill and be hospitalized or even die. Even if your infection is mild, you or your child could face long-term symptoms following COVID-19 infection such as neurological problems or diminished lung function.”

“We recommend getting vaccinated right away if you haven’t yet. It is the best way to protect yourself, your loved ones, your community, and to return to a more normal lifestyle safely and quickly.”

Dr. Rachel Levine, Assistant Secretary for Health, U.S. Department of Health and Human Services
Dr. Rochelle Walensky, Director, U.S. Centers for Disease Control and Prevention
Dr. Ada Stewart, MD, FAAFP, President, American Academy of Family Physicians
Dr. Lee Savio Beers, MD, FAAP, President, American Academy of Pediatrics
Dr. Maureen G. Phipps, MD, MPH, FACOG, Chief Executive Officer, American College of Obstetricians and Gynecologists
Dr. George M. Abraham, MD, MPH, FACP, FIDSA, President, American College of Physicians
Dr. Mitchell S. V. Elkind, M.D., M.S., FAAN, FAHA, President, American Heart Association
Richard J. Pollack, President and Chief Executive Officer, American Hospital Association
Dr. Gerald E. Harmon, M.D., President, American Medical Association
Dr. Ernest J. Grant, PhD, RN, FAAN, President, American Nurses Association
Dr. Georges C. Benjamin, MD, Executive Director, American Public Health Association
Scott J. Becker, MS, Chief Executive Officer, Association of Public Health Laboratories
Dr. Michael Fraser, PhD, CAE, FCPP, Chief Executive Officer, Association of State and Territorial Health Officials
Chrissie Juliano, MPP, Executive Director, Big Cities Health Coalition
Janet Hamilton, MPH, Executive Director, Council of State and Territorial Epidemiologists
Dr. Barbara D. Alexander, MD, MHS, FIDSA, President, Infectious Diseases Society of America
Lori Tremmel Freeman, MBA, Chief Executive Officer, National Association of County and City Health Officials

For more information and resources on this rare side effect, visit CDC’s website here.

Delta variant mildest of all 7 variants tracked in the UK 

Data current to June 11, official UK government report

Table 2. Number of confirmed (sequencing) and probable (genotyping) cases by variant as of 14 June 2021


Confirmed (sequencing) case number

Probable (genotyping) case number*



case number

Case Proportion*



Case Fatality

Cases with 28 day follow up


among those with 28 day follow up

Case Fatality among those with 28 day follow up







1.9% (1.8 to 2.0%)



2.0% (1.9 to 2.0%)







1.4% (0.7 to 2.4%)



1.5% (0.8 to 2.6%)







0.1% (0.1 to 0.2%)



0.3% (0.2 to 0.5%)







2.7% (1.4 to 4.7%)



2.8% (1.5 to 4.8%)







0.0% (0.0 to 1.7%)



0.0% (0.0 to 2.4%)







0.2% (0.0 to 1.3%)



0.2% (0.0 to 1.4%)







0.0% (0.0 to 41.0%)



0.0% (0.0 to 52.2%)

Nature and NYT say Covid mRNA vaccine boosters are not necessary, despite the CDC push to start them in the absence of supportive data

 Last week, live-blogging the ACIP meeting, I learned to my dismay that CDC wanted its advisory committee to sign off on frequent Covid vaccine booster doses--in the absence of supportive data!  Perhaps the CDC was anxious to avoid data because the data suggest that boosters are unnecessary?  Here are excerpts from a June 28 NYT article describing a study just publiched in Nature:

The vaccines made by Pfizer-BioNTech and Moderna set off a persistent immune reaction in the body that may protect against the coronavirus for years, scientists reported on Monday.

The findings add to growing evidence that most people immunized with the mRNA vaccines may not need boosters, so long as the virus and its variants do not evolve much beyond their current forms — which is not guaranteed. People who recovered from Covid-19 before being vaccinated may not need boosters even if the virus does make a significant transformation...

The results suggest that a vast majority of vaccinated people will be protected over the long term — at least, against the existing coronavirus variants. But older adults, people with weak immune systems and those who take drugs that suppress immunity may need boosters; people who survived Covid-19 and were later immunized may never need them at all.

Exactly how long the protection from mRNA vaccines will last is hard to predict. In the absence of variants that sidestep immunity, in theory immunity could last a lifetime, experts said. But the virus is clearly evolving.

“Anything that would actually require a booster would be variant-based, not based on waning of immunity,” Dr. Bhattacharya said. “I just don’t see that happening.” 

Boris Johnson wanted to reduce the global population

... It is time we had a grown-up discussion about the optimum quantity of human beings in this country and on this planet. Do we want the south-east of Britain, already the most densely populated major country in Europe, to resemble a giant suburbia?

* Actually, in Europe, Belgium and the Netherlands have greater population density than the UK--Nass

This is not, repeat not, an argument about immigration per se, since in a sense it does not matter where people come from, and with their skill and their industry, immigrants add hugely to the economy.

This is a straightforward question of population, and the eventual size of the human race.

All the evidence shows that we can help reduce population growth, and world poverty, by promoting literacy and female emancipation and access to birth control. Isn’t it time politicians stopped being so timid, and started talking about the real number one issue?

Tuesday, June 29, 2021

The law on Emergency Use Authorized (EUA = experimental, investigational) products

* I wrote the following on March 29, 2021.  It is important for those fighting vaccine mandates under EUA to understand the legal background for EUAs. 

1.  Are Americans who receive vaccines under EUA experimental subjects?

·      Definitely yes.  An EUA product is not a law unto itself.  According to 21CFR Subchapter D Part 312:  "an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

EUA products are still considered investigational," FDA Commissioner Stephen Hahn told USA Today.

·  Medicines and vaccines are either licensed products or experimental products. There is no gray area between them in US law. Whether or not research is explicitly conducted, the use of experimental products (including those issued under an Emergency Use Authorization) falls under the Nuremberg Code and under US law regulating experimental drugs.  

·  Vaccines are drugs under FDA law:  "[V]accines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product," according to Marion Gruber, the current Director of FDA's Office of Vaccines Research and Review.

2.  US regulations (45 CFR 46 Subpart A) for the use of experimental products require:

·      Neither of these requirements have been met for Covid-19 vaccines supplied to Americans by the US government, even for civilians. This suggests that the federal government may be trying to carve out a gray area in which the laws governing investigational products do not apply.

3.  While the Nuremberg Code is not officially part of the US Code, it is important to remember that it was formulated by American judges at the Nazi Doctors Trial.  It has subsequently been interpreted to have the force of law by US judges. According to the New England Journal of Medicine:

      "[Nuremberg's] basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966).6,22 Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).23 ...Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations."  

4.  What information do we have regarding the safety, efficacy, necessity and manufacturing fidelity of the 3 Covid-19 vaccines currently authorized under EUAs and those expected to be authorized? 

·      Safety:  2,216 deaths have been reported to a passive reporting system, VAERS, as of March 22.  CDC says it does not have a method for tracking deaths following vaccination, since most of its safety surveillance relies on vaccines administered within the healthcare system. According to MSN, "The struggle to find a way to complete the key vaccination mortality study highlights a growing frustration among officials working on the pandemic response that the federal government is still falling short in collecting, analyzing, and reporting of COVID-19 data." 

·      Yet CDC has assured the public that not a single death has been shown to be due to a vaccination. According to Elisabeth Rosenthal in the LA Times, "we still don't have a uniform national digital database that can track who is getting the vaccine." The bottom line is that we don't have the safety data we need, after over 100 million doses of unlicensed vaccines have been administered.

·      Meanwhile, the Astra-Zeneca vaccine has been found to cause serious, rare blood clots, especially in the brain, in perhaps one in 25,000 young recipients.

·      Data adequacy:  The Emergency Use Authorizations for the Covid-19 vaccines were issued with only a median of 2 months of data Only two months.  While the trials were originally expected to continue for 2 years, when vaccine became publicly available, the vaccine manufacturers offered vaccine to the subjects in their trials who had received placebos. Thus, the anticipated datasets from the clinical trials, in which placebo recipients would be compared to vaccine recipients in terms of long-term side effects and infection rates for 2 years, will be greatly abbreviated.  

·       According to Brownlee and Lenzer, "A decision [was] made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will." 

·      Efficacy:  We still do not know to what extent the vaccines are efficacious and to what extent they prevent transmission, both to current strains of Covid-19 and to newer variants.

·      Necessity:  On November 4, 2020, Stars and Stripes revealed that only one active duty servicemember had died as a result of Covid-19.  So had 8 reservists.  There were 59,000 Covid-19 cases documented in the military at that time.  In general, soldiers are young and healthy and unlikely to suffer severe illness or death.

·      Manufacturing fidelity:  The FDA is not required to inspect manufacturers of EUA products, as it is for licensed products.  Whether Good Manufacturing Practices are met is uncertain.  Emergent BioSolutions, which is the subcontractor for the production of the Johnson and Johnson, Astra-Zeneca and Novavax Covid-19 vaccines for the US market, continues to face delays receiving authorization from FDA for its J and J vaccine. This is the company that produces all US anthrax vaccine.  Furthermore, the DHHS Secretary has the authority to waive Good Manufacturing Practice (GMP) requirements for EUA products, and GMP waivers have been issued for other Covid-19 EUA products.

5.  What has the President said previously about Covid-19 vaccine mandates?

·      President Biden told reporters in December that he would not make Covid-19 vaccines mandatory.

6.  What benefits might be available for anyone who is injured as a result of a Covid-19 vaccination? 

·      Under PREPA, Covid vaccines have been designated as "covered countermeasures" by the DHHS Secretary, granting their manufacturers, distributors, healthcare workers and program planners a virtually complete waiver of liability. The single avenue to obtain benefits is the Countermeasures Injury Compensation Program, an administrative program of the DHHS. While benefits are potentially available only for lost wages and medical care, less than 10% of the injured who have applied to the program since it began 11 years ago have received any funds.  There is no court or special master; there is a one-year statute of limitations; and one must be able to prove that one's injury was caused by the vaccine.  The maximum benefit is about $370,000.  The average benefit paid has been about $200,000.  It is funded by Congressional appropriation.

CDC bribes medical organizations to back vaccinations for kids despite heart inflammation, lies about the stats

1.  CDC Director Walensky uses extremely flawed, inaccurate "statistics" to claim benefit far outweighs risk of myocarditis in children.

2.  CDC Director then claims she has "cosigners" from many other medical organizations that agree with the vaccinations. The "cosigners" include the American Hospital Association.  What did they sign?

My guess is that CDC postponed its ACIP meeting on myocarditis for 5 days in order to write the following document and get medical organizations to "sign on" to cover CDC's derriere on this horrible recommendation:

3.  Here is the 1.5 minute clip of Director Walensky's  interview on Good Morning America with the bogus stats:

3. How does CDC get all these medical organizations to "sign on"?  By bribing them, of course.  Here is one example of how the American Hospital Association was bribed by CDC to push Covid vaccines:

WASHINGTON (February 24, 2021) – The American Hospital Association (AHA) announced today that it has received two grant awards totaling $6 million from the Centers for Disease Control and Prevention (CDC) to advance public health and infectious disease prevention initiatives.   

The first grant for $2 million builds on the #MyWhy Campaign, vaccine toolkits and other efforts to encourage Americans to take advantage of opportunities to receive COVID-19 vaccinations. The work aligns with the CDC’s National Strategy to Reinforce Confidence in the COVID-19 Vaccine and has three key objectives: 

  1. Build Trust: Share clear, complete and accurate messages about COVID-19 vaccines and take visible actions to build trust in the vaccine, vaccinator and the system in coordination with federal, state and local agencies and partners.
  2. Empower Healthcare Personnel: Promote confidence among healthcare personnel in their decision to get vaccinated and to recommend vaccination to their patients.
  3. Engage Communities and Individuals: Engage communities in a sustainable, equitable and inclusive way, using two-way communication to listen, build trust and increase collaboration.

A second grant for $4 million will support collaboration between the AHA, CDC and community colleges through Project Firstline, CDC’s national training collaborative for infection prevention and control. Community colleges play a critical role in the health care workforce pipeline, training more than half of all new nurses and other health workers nationally. Through this initiative, current and future generations can start their careers with a more solid understanding of infection control. The initiative will also promote connections between hospitals, learning institutions and other parts of the health care system.

How CDC lowers the number of myocarditis cases by using a restrictive case definition, even though CDC had a perfectly good case definition when smallpox vaccine caused myocarditis in 2003

Go to slide 23 for the current 2021 CDC myo/pericarditis case definition

Below is a better, more inclusive case definition used by CDC in 2003.  What is CDC's justification for changing it?

Box 1

Dr. Harvey Risch explains much of the fraud used to sink HCQ--video presentation to Marseille last week

Monday, June 28, 2021

Singapore doctors call to HALT Covid vaccination of teens as unexplained death of 13yo boy probed in US

A group of medics have penned an “urgent open letter” to Singapore’s expert committee on Covid-19 vaccination, calling for the inoculation of youths to be ceased until the US CDC clarifies why a teenage jab recipient died.

Written on “on behalf of many concerned pediatricians, primary care physicians, specialists, surgeons and GPs” and signed by a number of Singaporean medical professionals, the letter was posted on Facebook on Saturday. Its authors urged the authorities to “consider a short delay” in vaccinating youths with messenger ribonucleic acid (mRNA) jabs in view of the recent incident in the US.

The medics who signed the letter argued that that the CDC should be given “a few weeks to produce robust and convincing data” on the teen’s death and the possibility of a link to the inoculation. They insist the issue is urgent because Singapore is pursuing “one of the most aggressive” mRNA programs in the world, in which at least 200,000 teenage boys are expected to be vaccinated.

“Certainly, we do not want to see any more suspected vaccine-related deaths in any young persons in the prime of their life,” the letter said.

As concerns spread, Singaporean parents have also launched a petition, asking the authorities of the island city-state to suspend the vaccination of those under 30, especially school kids from 12 to 15 years of age, until the CDC probe is complete. It has so far been signed by some 2,000 people.

Sunday, June 27, 2021

A deeper analysis of data presented By CDC to ACIP to hide huge rates of children's myocarditis and gain approval of childhood Covid vaccinations

Tricks used by CDC to minimize vaccine injury rates

CDC has become very enamoured of the VAERS database for Covid shots.  This is very curious, because CDC used to claim this database was only good for identifying signals, and not for calculating the rates of adverse vaccine reactions.  I have previously cited the CDC's own VAERS website, which says you cannot calculate adverse event rates using VAERS (because of the high but unknown extent of underreporting).  

VAERS is a 30 year old federal vaccine safety surveillance system.  It collects data supplied voluntarily by patients, doctors, and relatives regarding adverse events occurring after vaccinations.  

CDC created the V-Safe system as a new way to collect adverse event data on Covid vaccines.  V-safe has enrolled several million people receiving Covid vaccinations, who receive text messages asking them to report certain adverse events. For some reason, CDC does not collect the answers directly, but instead the reports go to the Oracle company.  Oracle aggregates the data and sends the results weekly to CDC. 

Inexplicably, CDC instructed Oracle to identify serious adverse events in the reports it receives, and send them to VAERS. This causes the serious V-Safe reports to be doubly reported.  Taking data reported to one database and adding it to a different database seems to me to serve the purpose of confusing the statistical analysis of the data, and making it impossible to estimate how the reporting rate to VAERS compares with the actual occurrence rate of adverse events, and with previous VAERS reporting rates.

Past studies of VAERS underreporting (prior to the V-Safe additions) have estimated that only between 1 in 13 and 1 in 100 adverse events gets reported to the system. See:

But now CDC suddenly claims that "VAERS is the nation’s early warning system for vaccine safety," according to slides 9 and 15 of CDC's presentation.  The identical slide seems to have been repeated for emphasis in the presentation to CDC's Advisory Committee for Immunization Practices by CDC's Tom Shimabukuro on June 23.

The missing CDC databases

While VAERS is useful, but should not be used to calculate adverse event rates, CDC has a number of other databases that have statistical validity, which VAERS lacks.  In fact, CDC claimed to be using many such databases to assess the safety of Covid vaccines.  Here is a list that CDC's Immunization Center Director presented last December:

If the CDC seriously wanted to assess the actual rate of myocarditis following Covid vaccinations, an excellent place to start would be the military's Defense Medical Surveillance System (DMSS).  It is listed as one of the surveillance systems CDC would be using in the graphic above.  

Every military servicemember's vaccinations, outpatient visits and hospitalizations are included in this database, so if CDC told us what the DMSS data showed, there would be no need for guesswork regarding the actual rates of adverse events in US soldiers. But instead, CDC keeps these more valid data hidden, and falls back on VAERS, improperly calculating "observed vs expected rates" from a database with an acknowledged huge rate of underreporting. The only explanation for why this is done is to reduce the apparent adverse event rate.

Preliminary myocarditis/pericarditis reports to VAERS following dose 2 mRNA COVID-19 vaccination, Exp. vs. Obs. using 21 day- risk window (data thru Jun 11, 2021)

Age groups



Doses admin



Doses admin



12–17 yrs







18–24 yrs







25–29 yrs







30–39 yrs







40–49 yrs







50–64 yrs







65+ yrs







Not reported



* Assumes a 21-day post-vaccination observation window (i.e., symptom onset from day of vaccination through Day 20 after vaccination)

Based on Gubernot et al. U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines. Vaccine. 2021 May 14:S0264- 410X(21)00578-8. Expected counts among females 12–29 years adjusted for lower prevalence relative to males by factor of 1.7 (Fairweather, D. et al, Curr Probl Cardiol. 2013;38(1):7-46). 

Using the VAERS self-reported data, the rate of reported myocarditis in boys in the 12-17 year old group, after the second Pfizer shot, is about 1/15,000.  These data are presented in slides 27 and 28.  However, if the actual rate is 10 times greater than the reported rate, then about 1 in 1500 boys got myocarditis after their second shot.  If the rate is 100 times greater than the VAERS reporting rate, then about 1 in 150 boys aged 12 through 17 got myocarditis after their second shot.

But we also need to consider those (about 20% of the total) who got myocarditis after their first Pfizer shot.  If we add them to the boys who developed myocarditis after their second shot, then our estimated chance of boys aged 12-17 getting myocarditis is in the range of about 1 in 120 to 1 in 1200.

The younger you are, the more likely you are to get myocarditis after a Covid shot.

And then there is the fact that if you are going to compare the expected rate with the observed rate of myocarditis post-vaccination, you need to be using comparable groups to compare the rates.  But the VAERS database is not a database that can be used quantitatively, since we do not know much about the characteristics of the VAERS-reporting population.  

Finally, there is a backload of VAERS reports that have not been input into the system.  Some say the backload is up to 2 months of data--we really do not know how much missing data there is.

Now, I really don't want to use VAERS (+/- V-Safe) data to come up with these estimates.  I would much prefer to give you real numbers. But CDC is hiding the real numbers from all those databases they listed above, and pretending that VAERS, V-Safe and a tiny cohort from the VSD is all they've got.  

Hiding the actual adverse event rates while using psychological, financial, educational and other methods to pressure people into taking an experimental vaccine ought to be a crime.  It probably is a crime, and the US public health agencies are co-conspirators.

UPDATE June 29:  I just listened to Dr. Robert Malone's interview with Del Bigtree last week.  Malone is the MD, PhD who first began using mRNA technology in vaccines.  He pointed out that myocarditis may be causing heart attacks in older age groups... where the diagnosis may be incorrectly attributed to coronary artery disease, rather than to inflammation resulting from a Covid-19 vaccine.

It is important to remember that smallpox vaccinations were stopped in the US decades ago because of high adverse reaction rates.  Especially cardiac reactions.  Myo/pericarditis as a consequence of vaccination is not new.  It has been observed for many decades.

There have been no natural smallpox cases in the world since 1977.

However, US smallpox vaccinations were restarted in 2003, congruent with the Bush administration program to demonize Saddam Hussain over the risk of biological warfare.  After 50,000 smallpox vaccinations were given there were many cardiac events and some deaths reported, and the civilian vaccinations stopped, as the medical personnel targeted for them refused to accept them.

But the smallpox vaccinations were continued for the military, where servicemembers continued to have high adverse reaction rates.  Malone referenced a 2015 paper written by military physicians (the first 3 authors are people whose work I respect) documenting high rates (214 times the baseline rate) of myocarditis-pericarditis in those being vaccinated.

Below is the abstract from this paper. And here is one of at least 8 reports on smallpox vaccine and the resulting cardiac complications, published by CDC, in its 2003 Morbidity and Mortality Weekly Reports.

What CDC appears to have learned from the 2003 smallpox program is that it needed to cover up the severe adverse reactions, in order to keep up the vaccinations.

2015 Mar 20;10(3):e0118283.
A prospective study of the incidence of myocarditis/pericarditis and new onset cardiac symptoms following smallpox and influenza vaccination
 doi: 10.1371/journal.pone.0118283. eCollection 2015.

Background: Although myocarditis/pericarditis (MP) has been identified as an adverse event following smallpox vaccine (SPX), the prospective incidence of this reaction and new onset cardiac symptoms, including possible subclinical injury, has not been prospectively defined.

Purpose: The study's primary objective was to determine the prospective incidence of new onset cardiac symptoms, clinical and possible subclinical MP in temporal association with immunization.

Methods: New onset cardiac symptoms, clinical MP and cardiac specific troponin T (cTnT) elevations following SPX (above individual baseline values) were measured in a multi-center prospective, active surveillance cohort study of healthy subjects receiving either smallpox vaccine or trivalent influenza vaccine (TIV).

Results: New onset chest pain, dyspnea, and/or palpitations occurred in 10.6% of SPX-vaccinees and 2.6% of TIV-vaccinees within 30 days of immunization (relative risk (RR) 4.0, 95% CI: 1.7-9.3). Among the 1081 SPX-vaccinees with complete follow-up, 4 Caucasian males were diagnosed with probable myocarditis and 1 female with suspected pericarditis. This indicates a post-SPX incidence rate more than 200-times higher than the pre-SPX background population surveillance rate of myocarditis/pericarditis (RR 214, 95% CI 65-558). Additionally, 31 SPX-vaccinees without specific cardiac symptoms were found to have over 2-fold increases in cTnT (>99th percentile) from baseline (pre-SPX) during the window of risk for clinical myocarditis/pericarditis and meeting a proposed case definition for possible subclinical myocarditis. This rate is 60-times higher than the incidence rate of overt clinical cases. No clinical or possible subclinical myocarditis cases were identified in the TIV-vaccinated group.

Conclusions: Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization. Evidence of subclinical transient cardiac muscle injury post-vaccinia immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.