Description:

Autopsy-based histopathological characterization of myocarditis after anti-SARS-CoV-2-vaccination

link.springer.com/article/10.1007/s00392-022-02129…

Likelihood assessment of vaccine-induced
(epi-)myocarditis

Causality or correlation?

Presence of myocarditis with temporal association to vaccination event

AND

Integration of histological phenotype, clinical presentation, and laboratory findings indicate no alternative differential diagnosis

Abstract infographic

Cases of myocarditis

Have been diagnosed clinically,

by laboratory tests,

imaging

(in the context of mRNA-based anti-SARS-CoV-2 vaccination)

Autopsy-based description

We describe,

Cardiac autopsy findings and common characteristics of myocarditis,

with vaccine-induced myocardial inflammation representing the likely or possible cause of death.

Our findings establish the histological phenotype of lethal vaccination-associated myocarditis.

Standardized autopsies

Performed on 25 persons

25 bodies found unexpectedly dead at home,

within 20 days following SARS-CoV-2 vaccination

Histology

Patchy, focal, interstitial myocardial T-lymphocytic and macrophage
infiltration,

predominantly of the CD4 positive sub- set, (T Helper cells)

associated with mild myocyte damage.

Autopsy findings indicated

Death due to acute arrhythmogenic cardiac failure.

Thus

Myocarditis can be a potentially lethal complication following mRNA-based anti-SARS-CoV-2 vaccination.

Our findings may aid in adequately diagnosing unclear cases after vaccination,

and in establishing a timely diagnosis in vivo, thus,

providing the framework for adequate monitoring and early treatment of severe clinical cases.

The official numbers.

The underlying figures:

Deaths for week 46. Ages 15-44 in 2022:

Same for 2019:

That’s 354 compared to 271 before pandemic.

The latest official slant is that it’s not COVID-19. So what is it then killing so many people?

Today’s statement from ONS:

The number of deaths involving COVID-19 in the UK continued to fall from 583 to 471 in the latest week (ending 18 November 2022).

There were a total of 13,236 deaths registered in the UK in the latest week, which was 7.7% above the five-year average.

Deaths involving COVID-19 accounted for 3.6% of all deaths in the UK in the latest week; this is a fall from 4.4% in the previous week.

Of all deaths involving COVID-19 registered in the UK in the latest week 401 were registered in England, 21 in Wales, 40 in Scotland and 8 in Northern Ireland.

In England, the number of deaths involving COVID-19 fell among those aged 25 to 44 years, and 65 years and over. Deaths remained similar among those aged 24 years and under, and those aged 45 to 64 years.

There were no deaths involving COVID-19 among those aged 24 years and under. COVID-19 deaths were low among those aged 25 to 44 years.

Deaths involving COVID-19 rose in Yorkshire and The Humber, fell in the North East, the North West, the East Midlands, the East of England, London, the South East and the South West, and remained stable in the West Midlands.

Our data are based on deaths registered in the UK and include all deaths where “novel coronavirus (COVID-19)” was mentioned on the death certificate. More information for England and Wales is available in our weekly Death registrations and occurrences by local authority/health board dataset.

“There were a total of 13,236 deaths registered in the UK in the latest week,” they say, “which was 7.7% above the five-year average” and it is far higher if one doesn’t count 2021 and 2020, two pandemic years. So many people are dying. Why? They need to investigate the root cause.

Dr. John Campbell has already responded to it:

ONS had an update earlier today:

The total numbers of deaths remain conspicuously big:

Increased deaths in England and Wales (blue is the total, red is the 2022 increase over pre-COVID-19 levels)

Data: Deaths by week (weeks 1-46) average (ODF)

Description: (research paper here)

Clear graphics from Italy, The decline of COVID-19 severity and lethality over two years of pandemic

www.medrxiv.org/content/10.1101/2022.07.01.2227713…

20 to 40-fold reductions during the period of dominance of Omicron compared to the initial acute phase.

Phase 1, Ancestral

Probability of hospitalization per infection of 5.4%

Probability of ICU admission of 0.65%

Probability of death of 2.2%

Phase 5, Omicron

Probability of hospitalization, 95.1% reduction in risk

Probability of ICU admission, 97.3% reduction in risk

Probability of death, 97.5% reduction in risk

Using epidemiological and genomic surveillance data

To estimate the number of daily infections in Italy in the first two years of pandemic.

Attack rate

Ascertainment of SARS-CoV-2 infections

Phase 1 (ancestral)

NPIs

Attack rate 2.8%

Phase 2 (ancestral)

Less stringent NPIs

Attack rate 11.4%

Phase 3 Alpha variant

Mid -February 2021 to early July 2021

Alpha infected about 10.1% of the Italian population

Phase 4, Delta

Second half of 2021

Progressive relaxation of NPIs

Attack rate 17.3%

Phase 5, Omicron

End of December 2021

Attack rate, 51.1% of the Italian population became infected with Omicron

Evolution of population susceptibility

Percentage of the population susceptible to SARS-CoV-2

End of first phase, 97.5%

February 20, 2022, 13%

By February 20th, 2022

a marked proportion of individuals unprotected against SARS-CoV-2 infection can be found among vaccinated subjects,

due to the waning of vaccine protection

Evolution of COVID-19 severity and lethality

Probability of hospitalisation

Probability of ICU admission

Probability of death

Evolution of population susceptibility

Natural, post infection immunity is now the main factor reducing population sensitivity

Vaccination protection is seen to be declining

Omicron natural infection had the largest protective effect

Repeat exposure to omicron (and sub variants) is likely to have the same effect going forward.

NPIs will reduce repeat exposures

NPIs will reduce exposure to other respiratory viruses such as RSV

Description:

This covid winter should be better than last

Dr. Anthony S. Fauci, President Biden’s chief medical adviser

www.nytimes.com/2022/11/22/us/politics/fauci-covid…

www.washingtonpost.com/health/2022/11/22/covid-biv…

Combination of infections and vaccinations,

enough community protection that we’re not going to see a repeat of what we saw last year at this time

Re bivalent effectiveness

It is clear now, despite an initial bit of confusion

United States

Nearly $5 billion to buy 171 million bivalent boosters

(Pfizer BioNTech, Moderna)

Hobson’s choice

Dr. Ashish K. Jha, White House’s Covid-19 response coordinator

Still heavily promoting vaccination

Nothing I have seen in the subvariants makes me believe that we can’t manage our way through it effectively, especially if people step up and get their vaccine

So far, 35 million people, (11% of over 5s) one bivalent shot

www.cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm?s_cid=…

Effectiveness of Bivalent mRNA Vaccines in Preventing Symptomatic SARS-CoV-2 Infection — Increasing Community Access to Testing Program, United States, September–November 2022

This is the clinical trial, previous work had only been based on antibodies

Benefits are mentioned, adverse reactions are not

Any adverse reactions not reported

v-safe

www.cdc.gov/mmwr/volumes/71/wr/mm7144a3.htm?s_cid=…

Systemic symptoms

Fatigue (30.0%–53.1%)

Headache (19.7%–42.8%)

Myalgia (20.3%–41.3%)

Fever (10.2%–26.3%)

Reported inability to complete normal daily activities

10.6% among aged over 65 years

19.8% among aged 18–49 years

Bivalent boosters provided significant additional protection against symptomatic SARS-CoV-2 infection

Relative vaccine effectiveness (rVE) of a bivalent booster dose,

compared with that of more than 2 monovalent vaccine doses,

30% and 56% aged 18–49

with relative benefits increasing with time since receipt of the most recent monovalent vaccine dose.

Staying up to date with COVID-19 vaccination, including getting a bivalent booster dose when eligible, is critical to maximizing protection against COVID-19

350,000 tests at almost 10,000 retail pharmacies between Sept. 14 and Nov. 11

Relative risk given

Absolute risk not given

What about protection from severe disease?

Paul Offit, director of the vaccine education center, professor of pediatrics, Children’s Hospital of Philadelphia

The only reasonable goal is to prevent serious illness,

We are still waiting for one shred of evidence that this bivalent vaccine or any bivalent is better than what we had

Virus continues to evolve

This should be a cautionary tale for what happens when you try to chase these variants

Celine Gounder, infectious-disease specialist, Kaiser Family Foundation

It doesn’t show the bivalents are better than the original boosters

(but still advocated the bivalent shot)

Pei-Yong Shi, virologist, University of Texas Medical Branch

difficult to measure how well the updated boosters were working because so many people now had some immunity from earlier infections,

including people who were never vaccinated or boosted.

John P. Moore, virologist, Weill Cornell Medicine

Are the boosters working better than the original shots?

Personally, I doubt there would have been much, if any, difference, but we may never know

Dr. Roby Bhattacharyya, infectious disease physician, Massachusetts General Hospital

This winter should be better than last

we’re a more immune population

China

www.reuters.com/world/china/chinas-daily-covid-cas…

www.telegraph.co.uk/world-news/2022/11/24/iphone-f…

Record high COVID-19 infections

Rigid zero-COVID policy

Cities nationwide imposing localised lockdowns

Mass testing, masks

No furlough scheme

Description:

58% of covid US deaths now in the vaccinated

Kaiser Family Foundation vice president Cynthia Cox

www.cdc.gov/vaccines/covid-19/effectiveness-resear…

covid.cdc.gov/covid-data-tracker/#rates-by-vaccine…

www.cdc.gov/coronavirus/2019-ncov/vaccines/effecti…

data.cdc.gov/Public-Health-Surveillance/Rates-of-C…

www.washingtonpost.com/politics/2022/11/23/vaccina…

58% of coronavirus deaths in August were people who were vaccinated or boosted

(people who had completed at least their primary series of vaccines)

Therefore 42% coronavirus deaths in August were people who were unvaccinated

First time there were more deaths covid deaths in the vaccinated versus the unvaccinated

covid.cdc.gov/covid-data-tracker/#vaccinations_vac…

In September 2021
Vaccinated people, 23% of coronavirus fatalities

In January and February 2022

Vaccinated people, 42% of coronavirus fatalities

We can no longer say this is a pandemic of the unvaccinated

(who conducted the analysis on behalf of the Post)

www.cdc.gov/mmwr/volumes/71/wr/mm7144a3.htm?s_cid=…

Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ?12 Years — United States, August 31–October 23, 2022

On August 31, 2022

FDA authorized bivalent, Pfizer-BioNTech and Moderna

mRNA encoding the spike protein from original strain of SARS-CoV-2,

and from Omicron BA.4 and BA.5

Advisory Committee on Immunization Practices (ACIP) recommended,

all persons ?12 years receive an age-appropriate bivalent mRNA booster dose

v-safe

a voluntary smartphone-based U.S. safety surveillance system,

established by CDC to monitor adverse events after COVID-19 vaccination

As of 3rd October, 10 million users

icandecide.org/press-release/breaking-news-ican-ob…

Vaccine Adverse Event Reporting System (VAERS)

Total data, August 31–October 23, 2022

14.4 million received a bivalent Pfizer-BioNTech

8.2 million adults (?18 years) a bivalent Moderna booster dose

v-safe, among the 211,959 registrants (aged ?12 years)

August 31–October 23, 2022

Reported in the week after vaccination

Injection site reactions, 60.8%

Systemic reactions, 54.8%

Fewer than 1% of v-safe registrants reported receiving medical care

Vaccine Adverse Event Reporting System (VAERS)

5,542 reports of adverse events after bivalent booster vaccination (?12 years)

95.5% of reports were nonserious

4.5% were serious events

Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses.

Relative risk

Absolute risk not given

Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2).

Relative risk

Absolute risk not given

This is their Reference 2

Block JP, Boehmer TK, Forrest CB, et al. Cardiac complications after SARS-CoV-2 infection and mRNA COVID-19 vaccination—PCORnet, United States, January 2021–January 2022. MMWR Morb Mortal Wkly Rep 2022;71:517–23. doi.org/10.15585/mmwr.mm7114e1 PMID:35389977

myocarditis; myocarditis or pericarditis; and myocarditis, pericarditis, or MIS,

within 7-day or 21-day risk windows after the index date

Comparisons between after vaccine and after infection

Relative risk

Absolute risk not given

Review of v-safe Data

During August 31–October 23, 2022

211,959 v-safe registrants had a bivalent booster

1,464 (0.7%) were aged 12–17 years

68,592 (32.4%) were aged 18–49 years

59,209 (27.9%) were aged 50–64 years

82.694 (39.0%) were aged ?65 years

Fourth dose

96,241; 45.4%

Fifth dose

106,423; 50.2%

In the week after receipt of the bivalent booster dose

Local injection site reactions

49.7% among aged ?65

72.9% among aged 18–49

Systemic reactions

43.5% among aged ?65

67.9% among aged 18–49

Systemic symptoms

Fatigue (30.0%–53.1%)

Headache (19.7%–42.8%)

Myalgia (20.3%–41.3%)

Fever (10.2%–26.3%)

Reported inability to complete normal daily activities

10.6% among aged ?65 years

19.8% among aged 18–49 years

Receipt of medical care

Reported by 0.8% of registrants