Vaccine Safety

https://unherd.com/2022/01/we-need-to-talk-about-the-vaccines/

Last week, a group of scientists, doctors, and academics published an open letter calling on Spotify “to take action against the mass-misinformation events which continue to occur on its platform”. Specifically, they were objecting to two recent episodes of Joe Rogan’s podcast, in which he interviewed the prominent vaccine sceptics Dr. Peter McCullough and Dr. Robert Malone. “By allowing the propagation of false and societally harmful assertions,” the letter claimed, “Spotify is enabling its hosted media to damage public trust in scientific research.”

I am an associate professor of epidemiology and biostatistics, as well as a practising physician, and I firmly believe that it would be a mistake to censor Rogan under the guise of combating “misinformation”.

Rogan is not a scientist, and, like everyone else, he has his biases. But he is open-minded, sceptical, and his podcast is an important forum for debate and dialogue. It is not enough, moreover, to simply dismiss Malone and McCullough as conspiracy theorists. They are controversial and polarising figures, but they do have real credentials. Malone is a physician who has worked in molecular biology and drug development for decades, while McCullough was, until recently, an academic cardiologist and researcher.

Both speakers made accurate and useful points on Rogan’s podcast — as well as unsupported, speculative, alarmist, and false ones. The correct way to deal with incorrect ideas in biomedicine, if they rise to a level of prominence that warrants rebuttal, is to rebut them.

In what follows, I attempt to assess their main claims, explaining what they get right and what they get wrong. I cannot address every point that the two of them made — both episodes are close to three hours long — but I hope that I can provide some clarity in a debate that often lacks it.

Claim: The risks of mRNA vaccination are underdiscussed and boosters should be debated

Early in his interview, Malone is critical of the scientific and media discussion of vaccine safety, noting that “no discussion of risk is allowed”. Later, he says that the pejorative label of “anti-vaxxer” is used to stifle legitimate debate over vaccines. Malone and McCullough both warn that mRNA vaccines, such as Pfizer and Moderna, can cause myocarditis, especially in young men who are at low risk from the virus. Given these and other alleged risks, they warn against recommending — or requiring — boosters for the general population.

I believe they are correct in these sentiments. In April 2021, the first reports of myocarditis were noted in Israel, with the majority of cases occurring in young men who had recently received an mRNA vaccine. Since then, the evidence for vaccine-related myocarditis has grown. We know now that boys are more likely to be affected than girls. We know that Moderna has higher rates than Pfizer. We know that dose two causes more myocarditis than dose one. The precise estimate of risk is now thought to be between 1 in 3,000 to 6,000 for males in the target range (roughly age 12 to 30), and researchers have shown that the CDC’s method to study this underestimates myocarditis risk.

Such concerns are not limited to the fringe. Marion Gruber and Phil Krause, the former director and deputy director, respectively, at the US Food and Drug Administration, resigned last autumn over White House pressure to green-light boosters. Paul Offit, a prominent vaccine advocate and the director of vaccine communication at the Children’s Hospital of Philadelphia, recently told the Atlantic that he advised his own 20-something son not to get boosted. Other nations are taking the myocarditis concern seriously, too. Several have banned or discouraged the use of Moderna in young men. Others advise two doses spaced further apart, and some have held off on a second dose entirely for younger age groups.

It is perfectly valid to question the wisdom of boosters, at least in young people, though I do think they are beneficial for older and more vulnerable people. Like Malone, I have seen researchers smeared as “anti-vaxxers” for simply suggesting that myocarditis is a real safety concern, or that we don’t know the optimal duration and dosing strategy of vaccination, particularly for young and healthy people and those who have recovered from infection. Malone and Rogan are correct that the media dismisses concerns over myocarditis by claiming that most cases are “mild”, when in fact it is too early for us to know the full effects.  And I agree that this is an area of live debate that has not been adequately covered by the media.

Claim: Vaccines have lots of other dangerous side effects

At other points in his interview, Malone alludes to many potential side effects of vaccination, claiming it can result in seizure and paralysis, and that the menstrual irregularities associated with the vaccine suggest it is a “major threat to reproductive health” for women. He suggests that vaccination can suppress T cells, raising the risk of unusual cancers.

To date, I have seen no evidence to support any of these claims, and I believe it is a mistake to raise them. First, they are irresponsible — Malone’s rhetoric verges on fear-mongering — and second, they distract from his legitimate points on myocarditis in young men.

McCullough suggests that vaccine-related deaths and injuries in the US are severely underreported by the Vaccine Adverse Event Reporting System (VAERS). While I agree that there are problems with VAERS, I find it difficult to believe the numbers McCullough offers of 45,000 dead and 1 million injured. Here is why.

VAERS is a voluntary collection network that is prone to two types of biases. First, it may undercount vaccine-related events because providers did not recognise them or lacked motivation to report them. But it can also overcount them. Bad things can happen after vaccination, such as heart attack, that are entirely coincidental but that still might be reported.

Trying to find safety signals due to vaccination requires comparison against base rates, or how many events are expected to occur without vaccination. Even very unusual events, such as the blood clots that happened after the Johnson & Johnson vaccine, stand out fast. Similarly, elevated myocarditis rates in young men, especially after dose two of Moderna, jump out of the data.

Death signals are trickier to parse, and require knowledge of the ages and medical problems of people getting vaccinated. Even then, they must be weighed against data that shows vaccines reduce a big cause of death — death from Covid-19. For these reasons, I think it is premature and misleading to talk suggest that the vaccine caused 45,000 deaths. If McCullough wishes to make this case, the best forum would a scholarly publication, where other researchers can examine and critique his methodology.

Claim: US vaccine policy ignores the science on natural immunity

Malone and McCullough both make valid points that vaccine policy has not accommodated scientific knowledge of natural immunity. Should vaccines be required for people who have already been infected with Covid? If a healthy young person had one dose of the vaccine and then got Omicron, do they need a second? What if a person had two doses and Omicron — should they need to receive a booster, as some workplaces now require? These are open and legitimate questions.

Proponents of vaccines and boosters for those with a prior Covid-19 infection often point to antibody titers — blood tests showing that a recently vaccinated or boosted person has higher levels of Covid-19 antibodies than someone with natural immunity. But this is not persuasive.

Antibodies are a means to a clinical end, which is preventing someone from getting re-infected, becoming very sick, becoming hospitalised, or dying. Antibodies, especially in the short term, are bound to be higher the more you dose an individual, but the scientific burden is to show that these doses further improve the clinical endpoint in randomised studies. This burden has not yet been met.

Yet, here too, Malone goes over the top. He and Rogan refer to “multiple studies” showing that those who get vaccinated after being infected with Covid are at a two-to four-times greater risk of having an adverse reaction to the vaccine; later, Malone describes Rogan’s friends who are encouraging him to get vaccinated as asking Rogan to put himself “at higher risk” and “take more risk for your health in order to join their club”. There is a dialogue to be had about whether Rogan might benefit from zero, one, or two doses, but the overall risks of vaccination remain low, particularly for a 54-year-old man such as Rogan.

At times, Malone refers to accurate studies, but I worry the audience draws the wrong inference. Malone, for instance, claims that natural immunity is six to 13 times more effective than the vaccine at preventing hospitalisation and 27 times more effective against developing symptomatic disease. I assume he is referring to this August 2021 study from Israel. This study does indeed suggest that natural immunity is more protective than vaccines against the Delta variant, though it also suggests that natural immunity plus a single vaccine dose is more protective than natural immunity alone.

While this has implications for the number of doses a Covid-19 survivor might consider getting, it should not be misconstrued to mean that infection is preferable to vaccination for an adult who has yet to experience either. Vaccination is almost surely preferable for most un-immune adults.

At one point in his interview, Malone says: “Think twice about giving these jabs to your kids.” While I can understand how many will be angered by this statement, the truth is other nations, such as the United Kingdom, are thinking twice — at least for healthy 5 to 11-year-olds, the group with the lowest risk of bad outcomes from Covid. As of this moment, the UK’s advisory panel has said that only 5 to 11-year-olds with comorbidities should get vaccinated.

Claim: Effective early treatments, including hydroxychloroquine and ivermectin, are being suppressed

McCullough and Malone are proponents of early treatment for Covid-19, specifically with ivermectin and hydroxychloroquine. Both allege that public health authorities have intentionally suppressed the use of these drugs. McCullough states that early in the pandemic, “there was no focus on sick patients”, while Malone speculates that hospitals don’t want early treatments because they profit when people are hospitalised and claims that “probably half a million excess deaths” have happened in the United States through the intentional blockade of early treatments.

These are entirely false and insulting allegations, and Malone’s in particular are flat-out conspiratorial. Academic hospitals attempted all sorts of disparate treatment protocols in the hopes of helping sick patients. Many physicians did not wait for randomised control trials — the gold standard of medicine — to act; they simply acted. In fact, a Harvard hospital recommended hydroxychloroquine prior to randomised data.

The problem was not that there was no appetite for early treatment. The problem was that when the randomised trial data came in, they suggested the drugs favored by Malone and McCullough were ineffective. A pooled analysis of all such studies by Axfors and colleagues suggests patients treated with chloroquine and hydroxychloroquine had increased risk of death.

And ivermectin has not shown persuasive evidence of benefit in randomised trials to date. Of course, a randomised trial cannot prove that a therapy can never work under any circumstances, just as you cannot prove that Santa Claus doesn’t exist. But the burden is on proponents to show when and how their therapy helps, and they have not met it.

Rogan, Malone and McCullough are wrong to claim that ivermectin and hydroxychloroquine are known to be secretly effective, but they are correct that these drugs have been unfairly demonised. The truth is that they are neither particularly dangerous nor effective. The media labelling ivermectin a “horse drug” or “horse dewormer” was particularly absurd. Ivermectin is a well-known drug taken by humans all over the world.

Claim: Public debate over Covid-19 is often unfairly censored

Malone, Rogan, and McCullough are all correct on one topic: there is an effort to suppress information and censor debate on social media. The clearest example is that for more than a year, Facebook banned all discussion of the lab-leak hypothesis, until articles by Nicholson Baker, Nicholas Wade, and Donald McNeil broke the dam. This was a remarkable suppression of free speech.

Previously, I investigated the mechanism by which Facebook polices pandemic “misinformation” through third-party investigators. I found, in several cases, that the expert designated to fact-check a claim had already stated their opinion on it prior to being selected. This is a deeply problematic mechanism, as the person who selects the fact-checkers can scour the Internet to an expert who agrees with them, and there is no external review, appeal or oversight.

Malone discusses a controversial October 2020 email from National Institutes of Health director Francis Collins to Anthony Fauci in response to the Great Barrington Declaration. In it, Collins called three of the declaration’s authors “fringe” epidemiologists and demanded a “quick and devastating published take down of its premises”. I completely agree this was problematic.

As I have argued elsewhere, 2020 was a time of deep uncertainty about the science surrounding Covid-19 and the appropriate policy response to the pandemic. Collins is not an epidemiologist, and he has no standing to decide what counts as a “fringe” view within that field. As NIH director, his job is to foster dialogue among scientists and acknowledge uncertainty. Instead, he attempted to suppress legitimate debate with petty, ad hominem attacks.

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The efforts to censor Malone and McCullough have massively backfired, with both men gaining prominence and publicity from the attempts to shut down their speech. More generally, I strongly disagree with efforts to censor scientists, even if they are incorrect, and no matter the implications of their words, as I believe the harms of censorship far exceed any short-term gains.

One problem, which has been on full display in this controversy, is that censorship may draw more attention to incorrect ideas. Another is that in the middle of any crisis, the answers to many scientific and policy questions will be uncertain. Disagreement on these questions is natural, and attempts to suffocate “harmful” speech run the risk of stifling critical debates, including by silencing third parties who may have important contributions but who fear the professional or reputational consequences of speaking up.

Perhaps the most serious objection to censorship is that the censors themselves are not fit for the task. Censors are unaccountable. They may be biased, misinformed or undereducated. They may lack perspective. In short, they are as fallible as the people they are trying censor. This is especially true in science, where, as history shows us, consensus views can turn out to be false, while controversial or heretical ideas can be vindicated.

Finally, in the modern world, where the censor is so often a giant technology company, there is tremendous potential for abuse. The same tools used to suppress scientific “misinformation” may someday be used to solidify political power and stifle dissent.

https://hatchardreport.com/relationship-between-covid-19-vaccination-and-all-cause-mortality/

Relationship between vaccination and all cause mortality for the 60+ cohort in New Zealand.

A look at the New Zealand data released under OIA

Hundreds of deaths associated with vaccination

Lessons can be learned. National reconciliation is possible.

This release presents the association between weekly vaccination totals and all cause mortality for the 60+ age cohort.

This has only been possible because of our unique situation in NZ. Protected at our borders, we have a very low incidence of Covid and therefore the short-term impact of vaccination on health can be reviewed in isolation from the confounding factors of Covid infections and deaths.

This has been a painful release to write because it involves personal tragedies affecting families and loved ones.

Some of whom are not actually aware of the causes of their loss or in other cases have been misled through preventable mistakes of government and civil servants.

For some time it has been clear that the rate of adverse effects proximate to mRNA Covid vaccination is unprecedented throughout NZ vaccination history.

Adverse effects reported to CARM are running at 30 times that of flu vaccines. It is also apparent that many of the adverse effects are very serious indeed.

Medsafe has continued to maintain that they are unable to determine which effects and deaths are related to vaccination.

I have previously written about indications pointing to a causal relationship between a wide range of adverse effects and vaccination.

Effects range from those already admitted such as myocarditis to others recognised in a leaked Pfizer document dated April 30th 2021 including

• respiratory illness
• internal bleeding
• kidney and liver disease
• neurological disease
• thrombotic events including stroke
• immune suppression
• and many more.

This is not an exhaustive list.

What Does Dr. Ashley Bloomfield Have to Say?

On the 28th October I wrote to Dr. Ashley Bloomfield pointing to the unusually high level of adverse effects and requesting that reporting of adverse effects should be mandatory rather than voluntary.

Yesterday, December 17th, I received a tardy reply from Astrid Koorneef, Director of the National Immunisation programme writing on behalf of Dr Ashley Bloomfield.

In this, Astrid specifically rejects my request saying: “An accurate measurement of all adverse events is not required” and further suggested I confine myself to trusting MoH websites, rather than public domain sources. Her letter offered this view of the determination of causal relationships:

“We are aware of reports circulating in social media where an adverse event has a temporal association with the vaccination.

This is not indicative of a causal relationship to the vaccine. Causal relationships between AEFIs and the vaccine are established through robust pharmacovigilance examinations that take into consideration global reporting of the adverse event, the background rate for the condition, and safety signal analysis.”

In other words, Ashley Bloomfield wants us to believe that an adverse effect rate 30 times that of the flu vaccine is coincidence.

Yet Hill’s standard criteria of medical causality includes repeated temporal association as a criteria of greatest importance. He discusses this first, in his seminal text still in use today.

It cannot be reasonably held, as Astrid asserts on behalf of MoH, that such associations are not indicative.

Speaking as a scientist, the first evidential alert to causality is always temporal association.

Of necessity association should prompt further investigations.

Scientists then ask questions such as:

• Is the association plausible?
• Does it occur in different settings?
• and Are rates of occurrence significant?

To answer these questions mandatory reporting is essential.

Astrid refers to the need for robust pharmacovigilance, this is the name given to safety and assessment protocols used in drug trials.

In drug trials, mandatory reporting is always required. Astrid also states:

“The Cominarty [Pfizer mRNA vaccine] has completed all testing requirements.”

This is not the case.

The Pfizer vaccine only has emergency or provisional approval worldwide.

The purpose of a long time period of pharmacovigilance (always several years) includes the need to ascertain the extent of secondary health effects of the vaccine.

Without mandatory reporting, the identification of related adverse effects will remain incomplete.

There is an obvious need to investigate vaccine safety here in NZ because overseas trials are as yet incomplete—the long term effects of mRNA vaccines are unknown and the short term effects are incompletely assessed.

The Data Released Under OIA

Grant Dixon obtained figures from Medsafe through an OIA request graphed here:

The temporal association between all cause deaths and vaccination for the 60+ age cohort during the roll out of the mRNA vaccine in NZ between the beginning of March 2021 to the end of October 2021 is graphically rather obvious even to a lay person.

As weekly vaccination numbers rise to a peak, deaths peak.

As vaccination numbers begin to fall, deaths also fall.

The number of excess deaths in the weeks following vaccination is consistent with reports of 670 suspicious deaths proximate to vaccination submitted voluntarily to NZDSOS and NZ Health Forum and could actually be larger.

Further investigation requires a comparison between adverse effect rates and normal incidence of disease by category and also an examination of the potential mechanisms for disease creation in so far as they are known.

Medsafe recently rejected any association because it compared death rates by disease categories to prior years 2008 to 2019 and found them to be similar.

Our review of the historical data reveals that Medsafe’s comparison was not the appropriate choice because it went back too many years when death rates were historically higher and crucially ignored the conditions of lockdown.

2020 deaths rates, when conditions were similar to 2021, are much lower than historical data.

As to mechanisms, the actions of the mRNA vaccine and the spike protein it produces are still the subject of copious ongoing research, vigorous debate, and publication.

The graphical association is therefore a preliminary indication, but a very robust indication.

We are commenting on the data because of the urgent need to inform the public and strike a note of caution that up until now has been absent from government vaccination publicity.

The Data Raises Important Questions for the Government:

Why has Medsafe failed to take seriously enough the obvious association between vaccination and all cause mortality and the very high adverse event tally?

This is hard to understand but par for the course.

A letter sent by Dr. Ashley Bloomfield and Dr. Andrew Connolly to DHB organisers dated December 15th 2021 pressed the emergency button concerning incidence of myocarditis and pericarditis and also admitting underreporting.

https://www.rnzcgp.org.nz/gpdocs/new-website/membership/covid19/vaccine-associated-myocarditis-and-pericarditis_MOH 151221.pdf

What is important here is that the MoH has known about the risk of such cardiac illness since early in the year, but it took ten long months before they wrote to DHBs to alert them that the risk was serious enough for them to organise a concerted response.

Why did Medsafe, MoH and Dr. Ashley Bloomfield promote the obviously incorrect idea that temporal association is not an indication of causality?

A false premise which bolstered their public narrative that the high tally of deaths proximate to vaccination was and is coincidental.

Why didn’t MoH instruct GPs and hospital staff to report all adverse effects?

In fact, in the absence of clear advice, the opposite has happened.

The Medsafe mRNA vaccine fact sheet mentions only 21 side effects, all except three of which are mild.

This has resulted in a high percentage of vaccine injury cases going unreported and the injured themselves being told by GPs and hospital staff they are suffering from anxiety or imagination or new unrelated conditions.

Why have GPs been reluctant to report adverse effects or inform their patients of risks?

The fault lies with a government policy to discourage and discipline doctors questioning vaccine safety.

GPs are very understandably afraid to speak out, when they see their colleagues being disciplined for striking a cautious note with their patients. Moreover, their customary role to grant exemptions was taken away from them.

In Medsafe’s case by case investigation of deaths, why didn’t they recognise that our knowledge of mRNA vaccine adverse effects and the mechanisms that cause them has been growing, especially in the field of genomics?

Why did Medsafe, government advisors, and Jacinda Ardern choose to not only ignore the huge volume of social media reports of adverse effects, but also dismiss them as inconsequential and accuse those reporting of unreliability or worse?

After all, Jacinda Ardern and the government can certainly dish out social media myths, why regard public feedback as irrelevant?

Why is our government still blasting out a message of complete safety over the airwaves, especially considering the alarmed tone of the private DHB message from Dr. Bloomfield?

How did the government come to think it was ethical to mislead the population?

This has caused confusion among those adversely affected by vaccination.

In some cases it has prevented individuals from realising they urgently needed medical assistance.

What are the Lessons to be Learned?

It was because of NZ border controls that we are able to assess vaccine effects in isolation from Covid itself, but it was inappropriate and disappointing to receive the reproving message from MoH yesterday which was worthy of a crime scene drama—move along sir, there is nothing to be seen here.

There was no acknowledgement of vaccine harm. Comparing the two letters: one sent to me and one to DHB heads on the same date, the intent is clear—try to dampen public disquiet with misleading messaging while privately giving way to something close to an emergency.

Were the continuing efforts to keep the public message on vaccine safety separate from the science, the result of a political decision taken by Jacinda Ardern’s government or was it a result of MoH advice?

Was this policy adhered to because of a perceived need to promote a public good?—the arguments for which have long since left science behind (something we have argued elsewhere).

We are a small country.

We talk to one another.

How could the government think that contradictory messaging could be maintained without public knowledge?

What are key lessons to be learned?

Firstly, numerous scientists were warning our government about the need for caution and constant review, these included members of the Skegg Committee, Michael Baker, and others.

Certainly they should have gone further, but even so why did the government decide to mandate vaccination as a virtually stand alone solution?

Was it because vaccination was presented to them as the only possible solution?

Did our government and Medsafe surrender too easily to commercial vaccine narratives originating overseas?

Did they ignore the growing catalogue of adverse effects recorded around the world?

Secondly, why did the government proceed to double down with vaccine mandates while the research was showing that vaccines were less and less effective?

Why did they not cast around for other more promising or complementary public messaging?

Clearly, the single most important message of the pandemic has been that serious Covid illness is connected to comorbidities.

Given that we had some protection at our border which gave us time, why did my government correspondents reject a strong public health campaign and legislative programme that emphasised preventive health measures?

Thirdly, it is now clear that vaccine hesitant people had good reason to be hesitant. Why was this not acknowledged as soon as the virtual tsunami of adverse effects became apparent?

It is hard to escape the notion that resolutely maintaining that the vaccine was absolutely safe in the public messaging was a coordinated conspiracy of silence.

It is not at all clear why people experiencing an adverse reaction to the first vaccine dose were refused an exemption for the second—a policy Dr Ashley Bloomfield has personally and rigidly enforced.

This is especially egregious considering the government was well aware of overseas research findings that the second dose causes a stronger reaction.

Fourthly, we have resources in NZ devoted to genetic research at the Liggins Institute and the Malaghan Institute.

During the last decade they have made interesting discoveries demonstrating the diversified feedback loops and communication within the body’s genetic network.

They could have alerted the government to possible effects of mRNA vaccines on immune responses and organ systems.

Certainly there were many other geneticists overseas issuing such warnings.

The simple point is that well known cautionary gene therapy research findings should have alerted our government advisors to the possibility of serious adverse reactions to genetically active vaccines.

Finally, there have clearly been problems generated through the overreach of government authority.

Power is not a problem in itself, but if the government has the power to favour those supporting its views and punish those dissenting then there is an imbalance in power that can be exploited.

If media independence and information can be controlled and the protections of the Bill of Rights also are ignored, if autonomous regulators are required to agree with government information, if the courts feel obliged to accept the assurances of safety provided by government alone, political disinformation can become institutionalised into the fabric of everyday administration of society.

A Time for National Reconciliation

I am writing this release before Christmas because many kiwi families are doing it hard.

Some have lost their breadwinner or mother, a few have lost a child. Others are struggling with debilitating adverse effects and an uncertain future.

All were good people who trusted government messaging about safety. Thousands of people have become ill with new health conditions.

Their predicament is unsung because apparently the government craves a clean sheet for public consumption.

Others were forced or ‘persuaded’ into it by mandates. Seven people have died this year from Covid while the graphical data points to hundreds of individuals having died in the 60+ cohort in the week following vaccination.

Certainly more than our largest historical disasters outside of wartime. Tens of thousands more have experienced adverse effects.

Their long term prognosis is unknown.

Now is the time to acknowledge their sacrifice and make amends.

This will involve the asking of a lot of searching questions within the MoH and the government.

It will require reexamination of cases and data. Certainty was forcefully expressed to the public when science actually dictated caution.

It could involve a Royal Commission of Inquiry, but this lengthy process will not address immediate concerns. Certainly the NZ Bill of Rights should be ‘entrenched’ as a constitutional provision that is beyond the reach of parliament alone to alter.

This will strengthen the individual rights that the judiciary can protect.

A change of heart among a strangely compliant mainstream media is also required.

An honest statement of apology and a commitment to immediately address the serious short-comings discussed here is called for.

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