EFFECT OF EMERGENCY USE COVID-19 VACCINATION
The distribution of COVID-19 vaccine doses in early 2021, the vast majority of which used messenger RNA (mRNA) technology, was a public health intervention of unprecedented scale. The vaccination program was implemented nationwide in the first half of 2021, but not during the initial waves of the COVID-19 pandemic in 2020.
Per-capita COVID-related deaths among Mainers over the age of 60 in 2021 were double that of 2020. Why did Maine and the nation see the highest mortality rates ever recorded after the vaccines were available? The broad uptake of vaccines over 2021 should have contributed to lower death rates overall, or at least from COVID itself.
The concept of “survivorship bias” tells us that those most likely to succumb to the pandemic would have done so in the earlier waves, especially as the average severity of successive strains of the virus diminished, consistent with evolutionary tendency toward viral attenuation.
There are two different ways of judging the vaccines’ effectiveness against mortality, either specifically deaths related to COVID-19, or overall population mortality. One review of all-cause mortality within a small Mediterranean island nation between 2016 and 2021 found “a substantial increase of 9.7% in all-cause mortality in Cyprus in 2021 compared to 2020, with an overall mortality increase of 16.5% in 2021 compared to the mean mortality of the previous five years.” Specifically, they noted a “sharp increase” over the last half of 2021. In the conclusion of their analysis, authors ominous note that,
“The substantial increase in mortality in Cyprus in 2021 is not entirely explained by COVID-19 deaths and is parallel to the concurrent vaccination campaign. This concerning observation should be comprehensively investigated by the National and European public health authorities to identify and address the underlying causes.”
A preprint meta analysis in the journal Lancet, consisting of multiple randomized, placebo-controlled trials showed an overall mortality benefit from adenovirus-based vaccines like the products from J&J, AstraZeneca, and Sputnik, but not from mRNA vaccines such as those made by Pfizer and Moderna. Lancet researchers looked at studies of more than 122,000 adenoviral vector vaccine recipients and more than 74,000 mRNA vaccine recipients total (each including a placebo/control group), and found that those who took an adenoviral vaccine saw an overall decrease in both Covid and cardiovascular death, with an overall average reduction of more than 60%. On the other hand, mRNA recipients did not show any statistically significant benefit in overall, cardiovascular, or COVID-related mortality. These findings are supported by data from the UK Office of National Statistics (ONS) as well.
To “throw light on the potential differences in nonspecific effects between vaccine types,” Lancet researchers urged public health officials to conduct randomized-controlled trials ”comparing the mRNA vaccines and adenovirus-vector vaccines for their effect on overall COVID-19 mortality as well as non-COVID-19 mortality.” As of this writing, public health authorities in the US or UK have published no such study.
The vaccines were recommended by state, national, and global public health authorities for nearly everyone, regardless of age or individual risk profile. In some jurisdictions, including Maine, officials achieved widespread adoption through coercion and state mandates. Even though many aspects of the COVID-19 vaccines were new, and even though the Emergency Use Authorization (EUA) gave the manufacturers near-total legal immunity for any adverse reaction deemed to be caused by their products, state and public health officials cajoled millions to accept it.
As of September 2022, more than two-thirds of the US population, and three-in-four Maine residents are considered “fully vaccinated,” meaning having received at least two injections of an mRNA product, or one dose of the Johnson & Johnson adenovirus-based product. Including boosters, mRNA accounts for more than 95% of all doses administered in the state.
The initial claim from government and public health officials that vaccination would protect against COVID-19 infection have been false for many months, following extensive analysis of patients in Israel and Qatar in late 2021. Successive analysis of the period of Omicron variant prevalence published in The New England Journal of Medicine (NEJM) provided further confirmation that the COVID-19 vaccines cannot be relied on to prevent infection.
The Maine CDC repeatedly refused to grant exemptions for COVID-19 vaccination requirements based on immunity from previous infection, even though science has clearly shown that the vaccines are less durable and less protective than “natural immunity.” In one study published in NEJM by Goldberg et al showed at four to six months, and at six to eight months from last dose, the patients who had been previously infected and unvaccinated had 80% fewer cases than the uninfected and vaccinated cohort. Those who had been previously infected and had one dose had about the same case rates as the unvaccinated cohort.
If the vaccines are not effective against infection, as the public was told, is it reasonable to critique effectiveness against severe outcomes like hospitalization and death? The limited, real-world dataset provided by Maine CDC regarding “breakthrough” COVID-19 infections, hospitalizations, and deaths show that, between March 2022 and September 2022, “fully vaccinated” Mainers—those who received an initial series of COVID-19 vaccine products—made up about 73% of COVID-related hospitalizations and deaths. This is not far off from the 76% of the population who is fully vaccinated. Given the prevailing narrative around COVID-19 vaccination, one would expect to see this data favor the vaccinated. Instead, it shows a negligible difference.
It is important to note certain caveats when interpreting this data. For instance, it is more likely that hospitalized patients with COVID-19 are elderly, who are also more likely to be vaccinated. But, it is also more likely that vaccinated people engage in fewer risk behaviors, and thus may be healthier in general, despite other risk factors such as age. More comprehensive analysis of breakthrough data to account for confounding demographic factors is not possible given the limits Maine CDC has imposed on its own public data releases.
Excess mortality increased from 2020 to 2021, not only in Maine, but nationally as well. A preliminary review of the evidence indicates that the administration of the COVID-19 vaccines in 2021 failed as a strategy to stem premature death as a result of the pandemic. If the vaccines work, why didn’t they?
Regrettably, US government regulatory and scientific agencies have repeatedly given the public cause to doubt their honesty and integrity. In February 2022, The New York Times reported that the CDC had been withholding and obfuscating critical information on the effectiveness of COVID-19 vaccine “booster” doses for middle-age and younger Americans related to COVID-19 hospitalizations.
Following this revelation, Dr. Marty Makary raised an alarm in an April 2022 Wall Street Journal op-ed, accusing the FDA of cutting corners in order to recommend a second COVID-19 vaccine booster dose to all American adults age 50 or older, a fourth mRNA dose for many Americans. Makary noted that this led to the resignation of Marion Gruber, former director of the Office of Vaccine Research and Review, along with her deputy, Philip Krause, who both sat on the FDA advisory committee regarding vaccines and other related products. They were concerned with undue influence from political forces, expressing their skepticism for the recommendation in an article in The Lancet, that “If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”
Perhaps the near-universal recommendation of multiple doses of COVID-19 vaccine deserves more scrutiny from independent scientists. Dr. Makary and researcher Dr. Tracy Beth Hoeg wrote in July 2022 that the authorization of these products for children as young as six months old was “based on extremely weak, inconclusive data.” They note that, “Pfizer reported a range of vaccine efficacy so wide that no conclusion could be inferred. No reputable medical journal would accept such sloppy and incomplete results with such a small sample size.” Especially for an age group facing such low risks from SARS-CoV-2 infection, public health officials must have very high confidence in the safety of such products, confidence which cannot be reasonably derived from currently available data.
Government officials had early knowledge that safety and efficacy could be an issue with these new vaccines, yet they pressed ahead. They refused to take deep dive into reported adverse event signals, and refused to incorporate evidence of significantly waning vaccine efficacy into their guidance until August 2022. Instead, the White House and CDC continued to push and authorize additional doses for younger and younger age groups throughout 2021 and most of 2022, while state officials doubled-down on their own vaccine mandates.
In August, the US CDC updated its guidance on the coronavirus to recommend against testing people without symptoms, eliminate the “test-to-stay” strategy which kept children out of school for many days longer than necessary, and to declare that vaccinated and unvaccinated individuals should be treated the same. In this update, CDC recognized both the efficacy of naturally-acquired immunity against infection, as well as the COVID-19 vaccines’ inability to prevent infection or transmission. This update was significant, but issued much too late. The ill effects of persistent isolation, sustained public anxiety, and keeping children out of school for a virus for which very few face serious risk have already been wrought.
All in all, a review of data, official reports, and the medical literature shows that the COVID-19 vaccines were not as effective as the public was told they would be. Health officials had no way of knowing real-world effectiveness, whether they would stop transmission in the way traditional vaccines do, or whether they would actually save lives, yet pressed on with various mandates to ensure adherence to this story. The spike in excess mortality over the course of 2021, while the circulating strains of SARS-CoV-2 were presumably becoming less severe, leaves many questions unanswered, but ultimately casts doubt on the veracity of the narrative from state leaders like Dr. Shah and Gov. Mills.