Timeline
December 2020: The original Pfizer trial, upon which approval was based, had the following outcomes:
In the intervention group (vaccine recipients) there were 20 deaths, 9 of which were cardiovascular.
In the placebo group there were 14 deaths, 5 of which were cardiovascular.
June 2021: Peter Doshi (Associate Professor of the University of Maryland School of Pharmacy, and Senior Editor of the British Medical Journal) pointed out that the increased risk of myocarditis in children following the mRNA vaccines was known about in April of 2021.
September 2021: 12-15 year olds included in New Zealand’s vaccine rollout.
September 2021: Starship hospital published guidelines for health professionals regarding diagnostic procedures for post-vaccinal myocarditis. It included a chart showing the expected cases-per-million for post-vaccinal myocarditis across age groups. The numbers in this chart are dwarfed by the actual figures reported by Medsafe in New Zealand.
October 2021: Dr Jin Russell (a New Zealand paediatrician who has been a high profile promoter of covid vaccination for children) reassured parents that post-vaccinal myocarditis only affects about 1 in every 25,000 young people and that:
"The important thing to say about myocarditis after the Pfizer vaccine is that it is rare and it's generally mild and self-limiting. In other words, it doesn't need any specific treatment people do recover [sic]...However, what people need to know is that the risk of having myocarditis after being infected by Covid-19 is much higher."
Russell expressed her concern about “misinformation spreading on social media.” Jacinda Ardern has repeated the “mild and self-limiting” reassurance in her communications with parents.
December 2021: A study from Oxford University showed that the risk of myocarditis from the Pfizer vaccination outweighed the risk of myocarditis following SARS-CoV-2 infection in anyone under 40 years old. The risk was most concentrated in young men in their teens and twenties.
December 2021: Director General of Health, Dr Ashley Bloomfield, sent an urgent warning letter to health care providers, urging them to promptly diagnose and treat post-vaccinal myo- and pericarditis, which he described as a serious adverse event.
January 2022: New Zealand rolled out the Pfizer vaccine to children aged 5-11. Over a quarter of a million children in this age group have received at least one dose. The uptake of a second dose has been considerably lower in this group relative to other ages.
Is myocarditis mild and self-limiting?
Myocarditis is inflammation of the myocardium (heart muscle) with necrosis (death) of cardiomyocytes (heart muscle cells). The dead cells are replaced by fibrous tissue (scarring). The non-contractile scarring replaces previously functioning contractile muscle, thus reducing the functioning of, and increasing the load on the heart. The heart has a limited lifespan. If the load is increased, the lifespan of the heart will decrease. This is apparent in studies investigating the prognosis for children who suffer myocarditis.
A review in the Journal of Cardiovascular Development and Disease (2016) reported on a long-term study examining the prognosis of children who suffered from myocarditis. The study found that at 20 years post-diagnosis 44% of children had either required a heart transplant, or died.
“According to Peta and co-workers’ 20-year study of 175 children with myocarditis, survival free from death or transplantation was 74% at one year, 65% at five years, 62% at 10 years, and 56% at 20 years.”
Early diagnosis and treatment will preserve more functioning heart muscle. The symptoms of myocarditis mimic other conditions such as anxiety and reflux. When he sent his letter, Dr Bloomfield was no doubt aware that young people were presenting with these symptoms, and not being worked up for a myocarditis diagnosis. Many people will have experienced symptoms such as a fluttering heart beat, or fatigue, and not sought or received medical help. There may be a significant number of undiagnosed and subclinical myocarditis cases in the community, which could have important impacts on future disease morbidity and mortality.
The Medsafe Safety Report #41
Safety Report #41 included a section on myocarditis and pericarditis. This section is absent in the other reports. Report 41 explains that:
Most myocarditis is from viral infection.
The New Zealand data from the Global Vaccine Data Network (GVDN) indicates a background rate of non-infective myocarditis (thus potentially vaccine-induced) from 2011-2019 of 1.81/100,000 person-years. The GVDN provides data from 2008-2019, for which the overall expected rate was 1.95. I have used the 2008-2019 range for the comparisons below.
CARM had received 360 reports of myocarditis / pericarditis / myopericarditis (up to March 1st 2022). Reports were only accepted if they happened within 30 days of vaccination.
Safety Report #41 lumped myo- and pericarditis together, so the suggested background rate for myocarditis in the report is of little use unless we tease out the myocarditis data.
According to the Medsafe AEFI data sheet (accessible via the link at the end of Safety Report #41, current to 28th February, 2022) there were actually 687 reports (262 myocarditis, 347 pericarditis, and 78 myopericarditis). This is considerably more than the 360 reports mentioned in Safety Report #41. It is unclear as to what has caused the discrepancy, and I can not find an explanation. The AEFI data is summarised below:
The data for myocarditis and pericarditis from the Medsafe AEFI data sheet can be viewed here. It shows a considerable increase in myocarditis risk (relative to expected rates) following the Pfizer vaccination. This has been seen in other countries around the world. A Nordic study was published in JAMA last month demonstrating the increase in observed rates in Denmark, Sweden, Finland and Norway:
“Results of this large cohort study indicated that both first and second doses of mRNA vaccines were associated with increased risk of myocarditis and pericarditis. For individuals receiving 2 doses of the same vaccine, risk of myocarditis was highest among young males (aged 16-24 years) after the second dose. These findings are compatible with between 4 and 7 excess events in 28 days per 100 000 vaccinees after BNT162b2, and between 9 and 28 excess events per 100 000 vaccinees after mRNA-1273.”
The following two figures, from Safety Report #41, are a summary of myo/pericarditis following Pfizer vaccination in New Zealand, according to Medsafe.
The Medsafe AEFI Spreadsheet Data
AEFI stands for ‘Adverse Events Following Immunisation’. Presumably this data relates to adverse events following vaccination, rather than just immunisation. Vaccination precedes immunisation, and immunisation does not necessarily occur following vaccination. Bear in mind that there is an Underreporting Factor (URF) inherent in adverse event data collection. In his letter to health professionals, Bloomfield warned that the true incidence is unknown due to being “potentially underreported.” There is enough international research on adverse event reporting to know that underreporting is a certainty. This means that the observed rates graphed below will be an underestimate.
Figure 1: Observed myocarditis rates /100,000 within 30 days of Pfizer vaccination
While the distribution is similar to the graphic published in Safety Report #41, the numbers are considerably higher. Most countries seem to have found a higher risk in males. This risk difference is small in New Zealand. Is this because males are less likely to develop this adverse event in New Zealand, or less likely to report it?
Figure 1
Figure 2: Observed rates by dose number
Fewer people have received dose 3 at this stage, so these proportions may change over time.
Figure 2
Figure 3: OBSERVED rates alongside EXPECTED rates of myocarditis
Observed rates are from the Medsafe AEFI report. Expected rates are from the GVDN New Zealand data (2008-2019).
Every age group saw an increased risk. Young people were disproportionately affected.
Figure 3 is an important graph. It shows that myocarditis has been reported at a rate many times more than what was expected. Bear in mind that only a small percentage of myocarditis cases are reported to Medsafe - thus the observed rate would be many times higher if we had the true data. A recent study presented at the European Society of Cardiology found that 2.8% of people experienced myocardial injury (as evidenced by troponin levels) following receipt of the booster. Most cases were mild, however neither the long term implications, nor the cumulative effect of continual vaccinations are known. On a per-dose basis in NZ that would translate to over 300,000 incidences of heart damage so far. It will be interesting to see in coming years whether there is an uptick in cardiovascular related deaths.
We can see in Figure 3 that there were 6.41 reports of myocarditis per 100,000 doses. If the true incidence were actually 2.8% we would have seen 2,800 reports. This would mean that we are undercounting by a factor of 437 times. We do not know what the true figure is in New Zealand, so these calculations are highly speculative at this point.
The MoH repeatedly reassures us that the incidence of myocarditis following the mRNA vaccine is significantly less than the incidence of myocarditis subsequent to Covid-19 infection. A statement to that effect can be found in multiple places on their website. A large study published in the Journal of Clinical Medicine (2022) looked at nearly 800,000 unvaccinated people. The authors compared the incidence of myocarditis and pericarditis in those who had experienced a Covid-19 infection with those who had not. There was no difference between the groups. The conclusion: “Our data suggest that there is no increase in the incidence of myocarditis and pericarditis in COVID-19 recovered patients compared to uninfected matched controls.” This was a large and well-run study. It calls into question the veracity of the MoH’s information. I have been unable to find an instance in which the MoH have provided a reference for their belief that Covid-19 is a significant cause of myocarditis, so it is unclear as to where they are getting their evidence.
Figure 3
THIS IS AN IMPORTANT GRAPH (bear in mind the significant under-reporting factor)
Figures 4 and 5: Female and Male rates
Figure 4
Figure 5
Figure 6: All adverse event MORTALITY reports
Figure 6 graphs the Medsafe adverse events reports of deaths following the Pfizer vaccine (for 2021, and for the first two months of 2022) alongside the last 12 years of post-vaccine deaths following the flu jab in New Zealand (this data is also from the Medsafe website). The deaths are converted into ‘per million doses’ so that they can be easily compared.
Figure 6
An excellent scholarly standard summary! Thank you!