Think of this post as a continuation of a series related to COVID-19 vaccines. You might recall that, right before the holidays last December, I predicted an impending tsunami of adverse events (AEs) falsely attributed to COVID-19 vaccines that would be spread by the antivaccine movement as the Pfizer and Moderna COVID-19 vaccines found their way into more and more arms around the world and more and more bad things happened to people by coincidence soon after COVID-19 vaccination. I won’t take any credit for the prediction coming true, as anyone who’s followed the antivaccine movement for a while could have predicted it (and did). After all, every pre-pandemic antivaccine trope in the book had already been picked up, dusted off, and recycled for use with COVID-19. Examples abound, including the claim that the COVID-19 vaccine renders females infertile, permanently alters your DNA, causes autoimmune disease, or even kills. The only claim, it seems, not yet made by the antivaccine movement about COVID-19 vaccines is that they cause autism, but give them time – the vaccines are not approved for children yet. I fully expect that when young children start receiving the vaccines, antivaxxers will claim they cause autism just as they have for nearly every other vaccine.
To continue the series, I thought I’d survey how antivaxxers are spinning stories about possible adverse events after vaccination against COVID-19, as more and more vaccines are finding their way into more and more arms. As you might expect, antivaxxers are doing everything they can to use such stories to stoke fear, uncertainty, and doubt about the vaccine. Indeed, reading antivaccine social media and listening to antivaxxers about the vaccine rollout, I’m reminded of Bill Murray in Ghostbusters describing what was coming.
First, a brief update on the case I discussed last week.
Doctors, don’t give quotes like this to the press
Last week, I discussed the tragic case of an OB/GYN from Miami who died a little more than two weeks after receiving the Pfizer/BioNTech COVID-19 vaccine and whose story went viral as a result of a Facebook post by his widow Heidi Neckelmann. What made the case of Dr. Gregory Michael so dramatic and unusual was that he developed lesions on his skin three days after vaccination and then went on to have a case of immune thrombocytopenic purpura (ITP) so severe that it actually killed him. He died of a hemorrhagic stroke 16 days after vaccination.
At the time, I conceded that it is possible that Dr. Michael’s death could be related to the vaccine but also, as always, cautioned that it was impossible to tell from one anecdote whether there was an association between the vaccine and Dr. Gregory’s death. Also, given that there were tens of thousands of people in the phase III clinical trials that tested both the Pfizer and Moderna vaccines, even if the vaccine did cause Dr. Michael’s ITP, we can safely conclude that this is a relatively rare issue, given that no signal that the vaccines might cause ITP was observed in the clinical trials. Obviously, the antivaccine movement was nowhere near as…cautious…as I was in my assessment. Predictably, they immediately leapt on the story as “proof” that the vaccine kills.
There isn’t really any new news since last week other than further reactions of the antivaccine movement. I haven’t been able to find any news of the investigations or whether the FDA or Pfizer have yet concluded if there might have been causation. Unfortunately, not all physicians quoted in the press have been as cautious.
In The New York Times last week:
Dr. Jerry L. Spivak, an expert on blood disorders at Johns Hopkins University, who was not involved in Dr. Michael’s care, said that based on Ms. Neckelmann’s description, “I think it is a medical certainty that the vaccine was related.”
“This is going to be very rare,” said Dr. Spivak, an emeritus professor of medicine. But he added, “It happened and it could happen again.”
Predictably, Robert F. Kennedy, Jr.’s antivaccine group Children’s Health Defense, was all over it in an article entitled, “Johns Hopkins Scientist: ‘A Medical Certainty’ Pfizer Vaccine Caused Death of Florida Doctor“. They even used it to make this deceptive claim:
Redwood also pointed out that ITP has been reported to occur following exposure to drugs containing polyethylene glycol (PEG), a compound used in both the Pfizer and Moderna vaccines.
If you go to the actual study cited by antivaxxer Lynn Redwood, you’ll find that the drug was peg-interferon-alpha2a, in concert with ribavirin and telaprevir antiviral treatment and that Redwood failed to mention that ITP is a known issue with interferon treatment, with the PEG likely having nothing to do with the case of ITP reported.
My compulsion to mention even the little deceptions of antivaxxers aside, let me just say that I think it was highly irresponsible of Dr. Spivak to hand antivaxxers a veritable gift like a quote by him expressing such certainty. The antivax underground is running with it and likely will continue to do so.
The case of Dr. Michael, as tragic as it was, is only the beginning, though.
Does COVID-19 vaccination kill old people?
Regular readers here and anyone who follows me on Twitter knows that I’ve been predicting that, as the vaccines roll out to more and more people, starting with healthcare workers and nursing home residents and the elderly, there will be people who happen to die within a month of getting the vaccine. Sadly, the law of large numbers and the fact that on any given month far more elderly people die than young people make such occurrences inevitable. Look for antivaxxers to spin these coincidences as “definite proof” that the COVID-19 vaccine kills, just the way they’ve done for vaccines and sudden infant death syndrome (which is not caused by vaccines) and for the HPV vaccine and deaths of teenaged girls.
It’s happening now, with a very conscious effort to deny the possibility (likelihood, even, in the case of elderly nursing home patients.) that it is a coincidence that these people died relatively soon after receiving the vaccine. For example, on Twitter antivaccine physician Sherri Tenpenny is all over this story:
— Dr Sherri Tenpenny (@BusyDrT) January 16, 2021
However, to discuss this issue I return to RFK Jr.’s antivaccine group to show you an example, hot off the digital “presses” last Friday:
Norway health officials have “adjusted their advice” after reporting that 23 elderly people died shortly after receiving COVID-19 vaccines, according to the Associated Press (AP) and other media outlets.
Some officials told AP they’re “not alarmed” by the deaths and will continue to support the country’s vaccination program, though they will now recommended elderly patients consult their doctors before getting the vaccine.
The Norwegian Medicines Agency has so far assessed only 13 of the 23 reported deaths. All 13 occurred in people 80 or older living in nursing homes, and all were determined to be directly linked to the vaccine, the agency told Norway Today.
The agency didn’t disclose which vaccines were administered to those who died, but according to Bloomberg, the Pfizer-BioNTech vaccine, approved late last year in Norway, and Moderna’s vaccine, approved earlier this month, are the two being administered in the country.
So, basically Norway has reported the deaths of elderly patients after receiving vaccines. Let’s just say that RFK Jr. is…exaggerating…the certainty in the report by Norway’s health authorities. For example, that AP article cited by RFK Jr. reports the investigation this way:
The Norwegian Medicines Agency on Thursday reported a total of 29 people had suffered side effects, 13 of them fatal. All the deaths occurred among patients in nursing homes and all were over the age of 80.
The agency listed fever and nausea as side effects which “may have led to the deaths of some frail patients,” Sigurd Hortemo of the Norwegian Medicines Agency said in the body’s first report of the side effects.
More than 30,000 people have received the first shot of the Pfizer or Moderna coronavirus vaccine in the Scandinavian country since the end of December, according to official figures.
“We are not alarmed by this. It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients,” Steinar Madsen, medical director with the agency, told Norwegian broadcaster NRK.
So what we are looking at are the oldest and frailest of patients, patients over the age of 80 whose health was so bad that they lived in nursing homes. Now let’s go to the source, an actual press release from Statens Legemiddelverk, or the Norwegian Medicines Agency, dated last Friday and entitled “Covid-19 vaccination associated with adverse drug reactions in elderly people who are frail“.
So let’s take a look a look at what is arguably the most relevant part of the press release:
The reports suggest that common adverse reactions to mRNA vaccines, such as fever and nausea, may have contributed to a fatal outcome in some frail patients, says Sigurd Hortemo, chief physician at the Norwegian Medicines Agency.
The large studies on Comirnaty (BioNTec/Pfizer) did not include patients with unstable or acute illness – and included few participants over 85 years of age. In Norway we are now vaccinating the elderly and people in nursing homes with serious underlying diseases, therefore it is expected that deaths close to the time vaccination may occur. In Norway, an average of 400 people die each week in nursing homes and long-term care facilities.
All deaths that occur within the first few days of vaccination are carefully assessed. We cannot rule out that adverse reactions to the vaccine occurring within the first days following vaccination (such as fever and nausea) may contribute to more serious course and fatal outcome in patients with severe underlying disease.
The Norwegian Medicines Agency and the National Institute of Public Health jointly assess all reports of suspected adverse reactions. As a result, the Norwegian Institute of Public Health has updated the covid-19 vaccination guide with more detailed advice on vaccinating the elderly who are frail.
So, to boil it down, these were frail, elderly residents of nursing homes. These are exactly the sort of patients who, as the medical cliché goes, can’t take a joke, meaning that insults that younger healthier patients would brush off with little effort can lead to the deaths of elderly patients. Basically, because of the careful effort to monitor for any signal of adverse events or harm from the new COVID-19 vaccines, the Norwegian Medicines Agency investigated and had to admit that they couldn’t rule out that the vaccines might have contributed to the deaths of these patients.
That being said, the fundamental problem remains. 400 of these elderly patients die every week in Norway because they are old, frail, and have multiple medical conditions. Layer on top of that a mass vaccination program, and it is a virtual certainty that some of these deaths will occur within close temporal proximity to vaccination, say less than a month—or even less than a week.
Then, if you go to the report itself [PDF]:
- Patients in nursing homes represents a very frail group of elderly, and most of the patients have severe underlying diseases.
- In Norway we have a “reporting culture” for vaccines ADRs where the normal procedure is to report all suspected adverse reactions for new vaccines. Healthcare professionals have a low threshold for reporting possible adverse reactions, even when the causal relationships appears very unclear.
- The preferred and most used route of reporting is directly to the health authorities, not via the Marketing Authorisation Holders.
- The Norwegian ADR registry is a national health registry, obliged to report statistics to the public.
- At the highest political level the public has been promised full transparency of the reported ADRs of the covid-19 vaccines. The Norwegian Medicines Agency will publish weekly reports.
In other words, the Norwegian Medicines Agency is bending over backwards to be transparent and has a long history of encouraging the reporting of possible adverse events after vaccination even before the pandemic. Nothing new is happening, except that the Agency is adjusting its recommendations for mRNA COVID-19 vaccinations to take these observations into account, in what is an apparent abundance of caution:
It is the attending physician who, after an overall assessment and in consultation with the patient and any relatives, must decide whether the individual patient should be advised to take the vaccine.
Two factors must be included in this assessment. One is what life prospects the patient has, as many in nursing homes have short life prospects. The second is that for some of the most frail elderly, common side effects after vaccination – such as fever, malaise and poor appetite, can trigger a more serious course of the disease.
For the vast majority of people who are elderly and living with frailty, any side effects of the vaccine will more than be offset by a reduced risk of becoming seriously ill from covid-19. For those with the most serious frailty, however, even relatively mild vaccine side effects can have serious consequences. For those who have a very short remaining life, the benefit of the vaccine may be marginal or irrelevant. Therefore, for very frail patients (eg equivalent to Clinical Frailty Scale 8 or higher) and terminally ill patients, a careful weighing of benefit versus disadvantage of vaccination is recommended.
Again, we’re talking about the frailest and most fragile of patients here, the patients who “can’t take a joke”. They’re the ones for whom even mild expected side effects can be serious or deadly. In particular, it is useful to note, as Dr. Vincent Iannelli points out, that the Norwegian Medicines Agency has not reported more deaths than expected in the nursing home population since its COVID-19 vaccination campaign began, nor is Norway saying not to vaccinate the elderly. Rather, what it is saying is that the benefits of the vaccine in terms of not getting COVID-19 far outweigh the side effects for the vast majority of people, elderly people included, but that it might be wiser to forgo the vaccine in the cases of the very oldest and sickest patients and the terminally ill for whom even mild symptoms (such as side effects from a vaccine) can trigger a cascade of complications.
Particularly amusing is how antivaxxers are portraying a change in guidance for mRNA COVID-19 vaccination to give the attending physician more leeway and autonomy as something damning. After all, don’t they always champion “physician autonomy” when it comes to antivaccine doctors and their failure to vaccinate their patients? You know, if I didn’t know better, I’d think that it’s almost as though they aren’t operating in good faith. (Yes, that’s sarcasm.)
The bottom line is that the report of deaths after COVID-19 vaccination in elderly nursing home patients in Norway does not mean that the vaccine caused the deaths, although it is possible that symptoms from the vaccine might have contributed. Out of an abundance of transparency the Norwegian Medicines Agency made these reports public, and out of an abundance of caution it adjusted its recommendations for the vaccination of elderly nursing home patients. From a scientific and public health standpoint, this is a good thing, but no good deed goes unpunishe because, as I predicted that they would, antivaxxers are jumping all over these reports.
I’ve explained before how, to evaluate any claims of adverse events after vaccination, you have to understand what the background rate of that health issue is. If the background rate is high, then the likelihood of coincidence, in which that adverse event happens within a short time after vaccination by random chance alone even though it is not related to vaccination, is much higher. As an example, when discussing the issue of whether Bell’s palsy is related to COVID-19 vaccination, I brought up a calculation done on The Logic of Science demonstrating that, by random chance alone with vaccination being unrelated to autism, we would expect parents to notice the first signs of autism in 154 children within 24 hours of vaccination; 1,079 within a week, and 4,623 within 30 days. Careful epidemiology taking the background rate of autism diagnoses into account showed clearly that vaccines do not increase the risk of autism. The same sort of investigations will be required for COVID-19 vaccines to differentiate coincidence from true correlation and possible causation.
None of that stops antivaxxers, though. Again, on RFK Jr.’s website, there’s a post by him entitled “Death by Coincidence?” It is a lawyerly (of course) discussion trying to deny that such coincidence is common or even happens at all. He starts out by discussing the cases I just discussed of deaths among nursing home patients in Norway, scoffing:
These simple declarations — that deaths and injuries following vaccination are unrelated coincidences — are becoming a pattern.
Note the implication of nefarious intent on the part of public health officials, the FDA, physicians, and scientists. To RFK Jr., this is not scientific caution and recognition that coincidence is common when a common event (such as heart attacks in elderly patients) combines with a mass vaccination campaign. The law of large numbers guarantees that there a common event will happen after another common event by random chance alone a lot more frequently than the average person understands. (Another example that I like to use is being killed in a car crash, which is obviously not vaccine-related but shows up as an adverse event in many clinical trials because fatal car crashes are depressingly common.) Naturally, RFK Jr., in his effort to demonize COVID-19 vaccines, cannot accept that coincidence even happens at all—at least not with respect to anything bad happening to a person after vaccination.
That tactic is why RFK Jr. then sarcastically launches into a litany of anecdotes, including repeating the sad story of Dr. Michael’s death before listing reported deaths after COVID-19 vaccination occurring in Israel, Portugal, Switzerland, and Sweden. Of note, all of these patients, save one, a 41-year-old Portuguese nurse, were elderly, and ranged in age from 75-91. (Again, remember my prediction that, as COVID-19 vaccines were administered to millions of people over the age of 65, there would be reports of death simply because the elderly die at a much higher frequency during any given period of time than they young.) If you look at all the links, you’ll also soon see that the elderly people reportedly died of heart attacks, one of the most common causes of death in the elderly. All were already ill, and the 91-year-old Swiss man’s case was apparently publicized by a “coronavirus-skeptic doctor”, while in Israel one of the dead had had previous heart attacks. The 41 year old woman in Portugal was found dead two days after vaccination, and the government reported that an autopsy didn’t find any evidence of a link to the vaccine, although the Portuguese Ministry of Justice refused to divulge the cause of death, citing “secrecy of justice.” I wondered why the Ministry of Justice is involved, rather than the Ministry of Health; so I looked further. It turns out that the father insisted on an investigation because before her death she had been otherwise healthy.
Unsurprisingly, RFK Jr. then accuses the health establishment:
The routine of reflexively dismissing suspicious deaths and injuries as unrelated to vaccination not only calls into doubt the official data tallies on vaccine injuries, it also contrasts markedly with the habit among public health officials of authoritatively attributing every death to COVID-19 so long as the deceased tested positive for COVID within 60 days of death using a PCR test notorious for producing false positives.
In fact, the $48 billion COVID vaccine enterprise shares three defining features with every new vaccine introduced since 1986:
- Systematic exaggeration of risk from the target disease. (Pharma calls this project “Disease Branding.”)
- Systematic exaggeration of vaccine efficacy.
- Systematically downplaying vaccine risks.
This is a case of what I like to call “reverse projection”, a favored tactic of cranks in which they accuse scientists refuting their misinformation of the opposite deceptions in which they engage. Indeed, the tactics of the antivaccine movement are exactly the opposite exaggerations RFK is accusing provaccine advocates of:
- Systematic downplaying and outright denial of risk from infectious diseases vaccinated against.
- Systematic downplaying and outright denial of vaccine efficacy.
- Systematic exaggeration of vaccine risks (and making false claims of risks from vaccination that have not been proven or have even been disproven, such as claims that COVID-19 vaccines “reprogram your DNA” or cause female infertility).
Meanwhile, RFK Jr. claims conspiracy to hide deaths:
We don’t know the true risk of death from the vaccine since regulators have rendered virtually every death invisible by attributing them all to coincidence.
But researchers are unlikely to see all of the safety signals if a badly designed surveillance system allows local health officials and company employees the discretion to dismiss any serious injury as unrelated.
This will be the tactic of antivaxxers going forward: Blame every death or bad thing that happens after vaccination against COVID-19 on the vaccine, whether that bad thing was likely to have been caused by the vaccine or not, and then dismiss the careful, rational, scientific statements of caution or, in obvious cases, statements about the low likelihood that the death or adverse event was related to the vaccine, as a “cover-up,” while mocking any claim that the bad thing might have happened by coincidence. This is both an unintentional and intentional tactic. It’s unintentional in that antivaxxers do have the mindset of denying coincidence when it comes to anything bad happening after a vaccine. If something bad happens after vaccination, to them it is always the vaccine’s fault. Always. It’s intentional in that lawyers like RFK Jr. know that humans are pattern-seeking animals and that they are very quick to believe that a bad thing that happens after vaccination must have been due to the vaccination. The post hoc ergo propter hoc logical fallacy is hardwired into our brains and takes an effort (and skepticism) to overcome. Antivaxxers take advantage of the fact that most humans think coincidence is very uncommon when it comes to bad things happening after vaccination. It isn’t. It’s common, which is what makes the epidemiology of determining whether a given vaccine increases the risk of a given adverse event or whether the adverse event seen after vaccination is due to coincidence, much more difficult.
I expect to see a lot more of this coming from antivaxxers this year, as millions upon millions of people receive the vaccine. In reality, given the millions of doses of the Pfizer and Moderna vaccines already administered all over the world, the number of serious adverse events reported has thus far been quite small. You wouldn’t know it, though, from the story that RFK Jr. and his fellow antivaxxers are selling.