Flawed Analysis of New Zealand Data Doesnt Show COVID-19 Vaccines Killed Millions – FactCheck.org

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Data from around the world support the general safety of the COVID-19 vaccines. Some people online, however, incorrectly claim that illegally obtained data from New Zealand show the vaccines have killed 13 million people worldwide. Experts say the analysis is bogus.

How safe are the COVID-19 vaccines?

More thanhalf a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.

A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, accordingto the CDC.

To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldnt receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.

There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.

Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.

Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated responded well to medicine and rest and felt better quickly.

The Johnson & Johnson vaccine has been linked to anincreased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination andincludesevere or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.

According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April,the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldnt get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021,the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js.

The J&J vaccine has also been linked to an increased risk of Guillain-Barr Syndrome, a rare disorder in which the immune system attacks nerve cells.Most peoplewho develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.

Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.

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Numerous studies have found the COVID-19 vaccines are quite safe, with only a few rare serious side effects. Theres nothing to support the notion that the COVID-19 vaccines are killing large numbers of people, as some people online have claimed for years. Despite the lack of evidence, the claims remain popular,revivedperiodicallybyvariouspseudoscientific analyses.

Most recently, Steve Kirsch, a tech entrepreneur who has become amajorsourceof COVID-19 vaccine misinformation, hasclaimedthat leaked data from the New Zealand government prove that the vaccines have killed on average 1 person for every 1,000 doses or when extrapolated to the entire world, about 13 million people.

There is no possible way that this data is consistent with a safe vaccine, Kirschwrotein his Substack.

Experts say this is wrong. Even if the underlying data are accurate, they cant be used to make causal claims about the vaccines,Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvanias Perelman School of Medicine, told us. On top of that, he said, Kirschs methods areflawedand based on invalid assumptions and his interpretations run counter to existing evidence.

His methodology is extremely ad hoc and arbitrary and wrong in very specific ways, Morris said of Kirsch.

Kirsch debuted his claims in a Nov. 30presentationat the Massachusetts Institute of Technology, his alma mater, where he had been invited to speak by a student group. He also shared them in a Substack post, which has beensharedon social media. Others havepicked uphis claimsor circulated related claims about the New Zealand data online.

Adatabase administratoremployed by Te Whatu Ora, or Health New Zealand, illegally gave Kirsch the underlying data he uses in his analysis. On Nov. 30, the workerappeared in a videowith Liz Gunn, a New Zealander known for spreading conspiracy theories and her opposition to the COVID-19 vaccine, discussing the vaccine database information and making claims similar to Kirschs.

Soon after, the employee, a man named Barry Young, wasarrested and chargedfor his role in the data breach, according to the New Zealand Herald. Te Whatu Orasaidin a statement that there is no evidence whatsoever that vaccination is responsible for excess mortality in New Zealand, adding that Young has no clinical background or expert vaccine knowledge and that [w]hat he is claiming is completely wrong and ill-informed and his comments demonstrate this.

Te Whatu Ora was alsogranted an injunctionto remove any database information that remains online to protect peoples privacy. In his Substack, Kirsch had posted the data, which he said had been anonymized, andencouragedothersto download it to perform their own analyses. In some cases, people who have done so have had their file hosting accountssuspended.

Kirsch and others have tried to spin the arrest of the database administrator and subsequent removal of the data as evidence of government efforts tohidethe truth. But Morris said Kirsch was downplaying legitimate legal issues.

Its a very serious thing to share identified data, he said, adding that the information given to Kirsch had the birth dates of the individuals, the dates they got their vaccines, the dates they died, which could uniquely identify every single person.

Kirsch has argued that his sharing of the data is not a problem because it was anonymized, but its not necessarily clear yet whether the data contains any identifying information. Morris said he would have performed and presented his own analysis of the data, but did not feel comfortable doing so because of potential legal and privacy concerns.

There are multiple problems with Kirschs analysis that Morris andothershave noted, as well explain in more detail below. And tellingly, even many people who have spread misinformation about the COVID-19 vaccines before and believe the vaccines are killing people have pushed back on Kirschs claims.

But Morris also suggested looking atexcess death graphsfor New Zealand and other countries just to see whether Kirschs claims pass a basic sniff test and they do not.

In much of the world, spikes in excess deaths closely correspond to when countries experienced COVID-19 deaths. There is no evidence that millions of people died from the vaccines.

New Zealand is a little different in that during much of the pandemic, the country actually had a deficit of deaths, likely due to the mitigation measures the island took and the success the nation had in keeping the coronavirus out. Those measures may have also reduced flu deaths and other kinds of deaths.

But there, too, the only real period of excess deaths occurs during the two waves of COVID-19 New Zealand experienced in March and August 2022, a year or so after vaccination began. Some excess deaths in 2022 could also be a kind of catch-up, Morris said, from older people who avoided dying in 2020 and 2021.

Regardless, the pattern is clear, Morris said, and part of what happened in 2022 in New Zealand was a return to a baseline level of death after a couple of years of fewer deaths.

What hes saying is implausible, Morris said of Kirsch.

According to his description, Kirschs analysis consists of what he calls a time-series cohort analysis of record-level data from 4 million out of the 12 million COVID-19 vaccine doses given in New Zealand. These doses, he says, were part of a pay-per-dose program in the country, which he claims were randomly administered.

Kirsch uses the data to plot death rates from any cause over time since vaccination, claiming that if the vaccine is safe, the graph should level off and be flat or decline three weeks after vaccination. If its not, he says, any increase reflects deaths caused by the vaccine. Using this flawed logic, he then calculates a death rate for all ages of 1 death per 1,000 doses, which he applies globally to arrive at his 13 million estimate of the number of people killed by the vaccines, and an estimate of 675,000 for the U.S.

There are numerous problems with this approach. To start, Morris said many of Kirschs assumptions are simply not true.

Theres nothing in the literature that says, oh, these plots should be completely flat. And if theyre not flat, the only explanation can be that the vaccine is causing death, he said. Theres no such thing.

In theory, Morris said, the curve for a safe vaccine would be flat if theres a constant death rate that never varies throughout the year, and if the decision to get vaccinated or additional doses is completely random. But thats not the situation with real data. So in fact, Morris said, there are many reasons why a curve might increase, even if a vaccine is not killing people.

Susan Oliver, an Australian scientist who corrects misinformation, similarly explained in a YouTube video critiquing Kirschs claims that such curves are not expected to be flat for seasonal vaccines. The reason for this is because deaths [due to any reason] dont occur uniformly throughout the year, she said. They follow a seasonal trend with higher deaths in the winter months.

The same could be true during a pandemic if many people are vaccinated around the same time, and then COVID-19 restrictions are lifted and a COVID-19 wave hits, as occurred in New Zealand. Or, as also happened in New Zealand, an abnormally low mortality rate rebounded to a normal level after a period of intense COVID-19 restrictions.

Kirsch has simply claimed that the vaccination records he has represent a random sample of the 12 million doses given in New Zealand. But he provides no evidence that this is true, instead arguing that others have to prove him wrong, incorrectly reversing the burden of proof.

There is little public information about the pay-per-dose program, and Te Whatu Ora told us it could not provide further comment given the ongoing investigation and injunctions. However,it appearsthe pay-per-dose system was for reimbursing providers such as primary care practices, which would have been separate from mass vaccination clinics, for example. It is hardly clear that the populations served by both groups would be identical. And in any case, there remain important differences between the populations that get a different number of doses.

Additionally, while Kirsch is aware of whats called the healthy vaccinee effect a phenomenon in which, especially at first, vaccinated people will have an artificially lower rate of death than the overall population because very sick people would not be getting vaccinated Morris said Kirsch arbitrarily decided that it ends after exactly three weeks. Theres no basis for that, he said.

Kirsch then uses the rate of death at three weeks as the baseline for death and counts all deaths above that as excess deaths caused by the vaccines. Again, Morris said its invalid to just assume that all excess deaths would be vaccine-caused but also, the baseline may be completely incorrect.

Morris suspects that this is the case, noting that while Kirschs main analysis misleadingly focuses on all ages and all doses, when the rising death rates only exist for older people, one would really need to break the data down by age and by dose, and then use actuarial data for each age group to get some idea of an accurate baseline. The baseline Kirsch uses is much too low, he said.

The entire increase in deaths could simply be a recovery back to the actual baseline. He hasnt ruled that out at all, Morris said of Kirsch.

This gets at another fundamental problem with Kirschs analysis: the lack of an unvaccinated group. Kirsch claims this isnt needed for his type of analysis, but as Morris told us, Kirsch has no idea how the death rates in vaccinated or unvaccinated people compare.

When you dont even have the unvaccinated, then you have no calibration point because its possible that whatever youre looking at in the vaccinated, its possible that their death rate is lower than the unvaccinated across the board, Morris said. So if thats the case, how can you argue that the vaccine is killing people on the basis of this data?

Indeed, while Kirsch presents his analysis as iron-clad proof that the vaccines have killed millions of people, its incorrect to even say that this data could provide that degree of certainty.

The data that he got, even if its fully legitimate and accurate, cannot be used to answer the question that he wants to answer about causal effects of vaccines on death, Morris said.

Kirsch also hypes the data, misleadingly claiming that [n]o State or country has ever released record-level public health data on any vaccine and casting his analysis as special.

Morris said that in fact, while no one else uses the term record-level data, such information has been used in numerous COVID-19 vaccination studies around the world, which have turned up no evidence of mass vaccine-related death.

But unlike in Kirschs case, those researchers have a legal right to use the data, and the raw data are not shared because of privacy reasons. In addition, Morris said, that data usually include information on confounders, or other variables that might be associated with an outcome of interest such as death precisely the data that would help make a causal connection, but something that is lacking in Kirschs dataset.

Clarification, Dec. 15: We updated the story to clarify Morris comment about not performing his own analysis of the New Zealand data.

Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.

Morris, Jeffrey S. Director, Biostatistics Division and Professor of Public Health and Preventative Medicine at the University of Pennsylvania, Perelman School of Medicine. Zoom interview with FactCheck.org. 8 Dec 2023.

UPDATE: Unauthorised data breach and attempt to spread misinformation. Statement. Te Whatu Ora/Health New Zealand. 8 Dec 2023.

Plummer, Benjamin and Lincoln Tan. Police arrest man in connection with alleged Te Whatu Ora mass privacy breach of Covid vaccination data. New Zealand Herald. 3 Dec 2023.

Griffiths, Ethan. Te Whatu Ora employee charged with Covid-19 vaccination data breach granted bail. New Zealand Herald. 3 Dec 2023.

Reminder of vaccine safety and effectiveness following release of misinformation. Statement. Te Whatu Ora/Health New Zealand. 1 Dec 2023.

Investigation ongoing into release of data and spread of misinformation. Statement. Te Whatu Ora/Health New Zealand. 3 Dec 2023.

Gorski, David. Steve Kirschs mother of all revelations about the deadliness of COVID-19 vaccines goes poof. Science-Based Medicine. 4 Dec 2023.

Steve Kirschs claim that New Zealand data shows COVID-19 vaccines killed millions is based on a flawed analysis. Health Feedback. 8 Dec 2023.

First batch of COVID-19 vaccine arrives in NZ. Press release. New Zealand government. 15 Feb 2021.

Back to the Science. Record level stupidity Steve Kirsch and the New Zealand data. YouTube video. 13 Dec 2023.

Te Whatu Ora/Health New Zealand. Email to FactCheck.org. 12 Dec 2023.

Briefing on the Governments response to COVID-19. New Zealand Parliament. 26 Aug 2021.

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Flawed Analysis of New Zealand Data Doesnt Show COVID-19 Vaccines Killed Millions - FactCheck.org