An Open Letter to The Lancet

Concerns regarding data integrity and analysis

The retrospective, observational study of 3.8 million Australians of over 65 years, during eleven months of 2022, has reached the following broad conclusion:

“COVID-19 vaccination is highly effective against COVID-19 mortality among older adults although effectiveness wanes with time since the last dose.

Our findings emphasise the importance of continuing to administer booster doses, particularly to those at highest risk.”

This paper and its conclusion have been cited by the Australian Chief Medical Officer in an Australian Senate Estimates inquiry [1] to support government policy of continued vaccination for older adults.

The research has been funded by the Australian Government through various government agencies and by pharmaceutical companies.

As it stands, the conclusion of the paper is unclear, if not invalid, because it states that vaccination is “highly effective”, but “wanes over time”. Can a vaccine be “highly effective” only for a limited time? How limited?

The time limit to effectiveness is one of the key issues to be discussed below.

In the June to November period of Figure 1, the “Dose2 8-90 days” group had 1.218 mortality rate per 100 PY, compared to 0.49 for the unvaccinated. This shows that even in the short-term of less than three months, that vaccinated group (second shaded cell from the bottom) had 2.5 times higher risk of dying from COVID than the unvaccinated.

How could the authors claim for that case (second last column in the above table) a positive VE of 13.9 percent in their paper?

The paper needs to disclose the sorts of adjustments used to achieve positive “COVID-19 VE (percentage)” for those cases where the vaccinated groups had higher mortality rates than the unvaccinated. Those negative relative risk reduction results calculated here for those cases, if unexplained, would invalidate the main conclusion of paper that COVID-19 vaccination is highly effective.

Similar criticisms can be raised against the analysis in Figure 2 and Figure 3, where the method of adjustment for obtaining VE results for all-cause mortality is also not transparent, even though the raw all-cause data would be more accurate than COVID-19 data for reasons explained and discussed above.

On all-cause mortality the authors made unsubstantiated comments such as “COVID-19 vaccines also appeared effective against other specific causes of death…those who are more likely to get multiple vaccine doses, or to be vaccinated earlier are healthier and less likely to die from any cause…”. Emphasis added.

On Pfizer/BioNTech’s COMIRNATY vaccines alone, the TGA’s DAEN database [5] recorded (subject to underreporting) over 82,000 adverse events associated with many different diseases. Moreover, those comments are contradicted by the authors’ own analysis.

Figure 3 of the paper shows clearly that the authors’ own calculated VE against all-cause mortality (rates not shown) are all negative for those cases shown in the above table (last column).

Therefore, COVID-19 vaccination was ineffective and had increased all-cause mortality among some groups of older adults. Their evidence of ineffectiveness is consistent with Australian macro-data where all-cause mortality have increased significantly for older Australians vaccinated since 2021 [4].

Summary of Critique

• The approach of this study depends on official COVID data which have integrity issues, which the paper does not acknowledge.
• Only 11 months in 2022 of official data out of possibly more than 24 months have been selected for the study.
• The “death by vaccination status” data which link dosages with mortality data have not been discussed or disclosed. The key data used need to be publicly available for replication of the findings.
• The unseen key data collection has been selectively analyzed, by dividing into separate time periods, dose groups and survival durations, producing 18 comparisons. The method of analysis is unsound and has led apparently to random results, without identifiable regularity.
• The vaccination effectiveness results were not simply calculated, but adjusted. The details of the adjustments need to be disclosed.
• The unadjusted results contradict the general conclusion that “COVID-19 vaccination is highly effective against COVID-19 mortality among older adults”.
• Out of 18 comparisons of adjusted results, the most favourable and convenient findings have been selected and presented to draw the main conclusion which is not generally valid.

Conclusion

As it stands, the paper has serious deficiencies in data integrity, data selection bias, flawed methods of analysis, undisclosed adjustments of results, selective reporting of findings and the drawing of invalid conclusions.

The Australian Government has chosen to take this paper as authoritative evidence to justify its health policy, which has been associated with many excess deaths particularly in older Australians, but those deaths have been brushed off without investigation as coincidental, unrelated to vaccination.

The paper, in its currently published form, has serious methodological and analytical defects, resulting in errors and misleading conclusions.

Therefore, the paper needs substantial revision to address the issues raised or it should be retracted.

References

Header image: The Guardian

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