Real-World Bombshell: Pfizer mRNA Vaccine Fades–No Protection Against Hospitalization Even Boosters Fall Short

By on Jun 26, 2024

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Staff at TrialSite | Quality Journalism

Jun. 26, 2024, 9:30 a.m.

Are the COVID-19 mRNA vaccines durability improving? No, they are not, and in fact, even if an individual followed public health instructions, getting three doses of the primary series to bolster protection with a mutating virus and a vaccine truly lacking in durability such as the Pfizer BNT162b2 product consumers are afforded absolutely no protection against hospitalization unless they get annual boosters. This is the clear message taken from the latest research led by researchers at Kaiser Permanente, Department of Research & Evaluation, Pasadena and other locations. The team of physicians and epidemiologists pondered whether administration of the Pfizer BNT162b2 XBB vaccine offers additional protection against COVID-19 hospital admissions and ambulatory visits for US adults compared with not receiving a BNT162b2 XBB vaccine of any kind and whether older versions of the COVID-19 vaccine still provide any protection compared with being unvaccinated. Executing a case-control study targeting 2854 cases and 15, 345 controls, the Pfizer BNT162b2 XBB vaccine provided statistically significant additional protection against a range of COVID-19 outcomes during the early part of the 2023 to 2024 viral respiratory season according to the study outcomes. Older versions of COVID-19 vaccines offered no additional protection compared with being unvaccinated, including against COVID-19 hospital admissions, regardless of the number or type of prior doses received. Sara Y. Tartof, PhD, MPH and colleagues report their study outcomes support the current recommendations of the Centers for Disease Control and Prevention (CDC) for annual updates. Put another way, the COVID-19 mRNA vaccine durability continues to be a challenge, with waning effectiveness, necessitating the recommendation of an annual booster for any protection of hospitalization whatsoever. What is not contemplated are the potential long-term consequences of repeated mRNA boosters, year after year. This impact has not been studied.

Tartof and colleagues at Kaiser Permanente, one of the nation’s largest health systems, report that the last COVID-19 vaccine version uptake was low. By December 22, 2023, only 19% and 37% of all adults 18 years and older and 65 years and older, respectively, actually opted to receive the XBB vaccine.

Now, the authors report, based on the results of this Pfizer-funded study, “Current COVID-19 vaccine coverage considerably lags that of seasonal influenza vaccines, despite both vaccines being made available during the autumn and winter and current CDC guidelines that support co-administration of the 2 vaccines.” 

Why such low vaccination rates? The authors list the usual reasons but do not point to the government, its mishaps in communications and overreach during the pandemic. 

The Study

The Kaiser Permanente team designed and executed the test-negative case-control study to estimate the effectiveness of the Pfizer BNT162b2 XBB vaccine against COVID–19–associated hospitalization and emergency department (ED) or urgent care (UC) encounters among adults in the Kaiser Permanente Southern California health system between October 10, 2023, and December 10, 2023. Cases were those presenting with an acute respiratory illness and who had a positive SARS-CoV-2 polymerase chain reaction test; controls had an acute respiratory illness but tested negative for SARS-CoV-2.

Tartof and colleagues analyzed patients and controls separately for COVID-19 hospital admissions and ED/UC encounters. Applying estimated odds ratios and 95% CIs as well as multivariable logistic regression models adjusted for patient demographic and clinical characteristics, the study team calculated estimated vaccine effectiveness as 1 − odds ratio × 100%.

Findings

Out of 2854 cases (patients) and 15,345 controls (median [IQR] age, 56 [37-72] years; 10,658 [58.6%] female), adjusted estimation of effectiveness of the BNT162b2 XBB vaccine received a median of 34 days prior vs not having received an XBB vaccine of any kind was 62% (95% CI, 32%-79%) against COVID-19 hospitalization, and 58% (95% CI, 48%-67%) for ED/UC visits. Compared with being unvaccinated, those who had received only older versions of COVID-19 vaccines did not show statistically significant reduced risk of COVID-19 outcomes, including hospital admission, meaning that there were no latent, residual benefits from the Pfizer mRNA vaccine despite claims to the contrary by multiple studies and government declarations.

A Critical View

At many times during the pandemic, American society was informed by public health agencies and experts in academia and industry that getting at least the primary series offered more protection against hospitalization and death endpoints than those unvaccinated.

The results of this study shatter such a myth, demonstrating just how short-lived the Pfizer mRNA vaccine really is in real-world use. The results of this important study reveal literally, that the SARS-COV-2 virus mutates and the original vaccine durability wanes, and that there is no difference between vaccinated and unvaccinated states.

Relative Estimation of Effectiveness for BNT162b2 XBB Vaccine Against COVID-19–Associated Hospitalization and Emergency Department/Urgent Care Visits by Comparison Group

Source: JAM Internal Medicine

One must commit to getting a COVID-19 vaccine every year for the product to have any probability of protecting against hospitalization and other encounters such as emergency department visits.

And even for those cases that received the Pfizer BNT162b2 XBB vaccine as compared to not receiving an XBB vaccine for any kind the vaccine effectiveness equaled 62% but was as low as 32% in protecting against hospital admission at day 34.

Figure 3. Absolute Estimation of Effectiveness for Older (Non-XBB) Versions of COVID-19 Vaccines Against COVID-19–Associated Hospitalization and Emergency Department/Urgent Care Visits vs Being Unvaccinated

Source: JAM Internal Medicine

Tartof and colleagues shared in the entry:

“Thus, analogous to influenza, although older versions of COVID-19 vaccines once provided high levels of protection, the combination of waning vaccine-induced immunity and continuous SARS-CoV-2 strain evolution eventually rendered prior versions of vaccines ineffective. This, in turn, warrants routine updates to COVID-19 vaccines—also like influenza—so long as SARS-CoV-2 continues to circulate and cause disease.”

This study did not look at the waning attributes of this last version of the vaccine. But based on these findings, the answer is clear regardless.

In concluding the study, Kaiser Permanente looked for the rosiest of possible outcomes one could glean from such data.

But the reality of this story: persons who received three doses of previous vaccines (no XBB) “had little, if any, additional protection compared with unvaccinated individuals against COVID-19 endpoints, including hospital admission, regardless of the number or type of prior doses received.”

While yes, the “receipt of a BNT162b2 XBB vaccine, however, was associated with statistically significant reduced risk of developing a range of COVID-19 outcomes during the early part of the 2023 to 2024 viral respiratory season—with the strongest protective effects seen against hospital admission,” the reality is that all of those elderly persons that didn’t opt for the booster promotions previously were no worse off than those individuals that went and got a third jab. Moreover, because the Kaiser Permanente team only looked at day 34 what we do not see in this data is the inevitable decline in effectiveness that occurs with each and every iteration.

The authors conclude that A) they reaffirm CDC recommendations for “broad age-based use of annually updated COVID-19 vaccines”; B) uptake of the last year’s vaccine version was low and C) health authorities should employ a “targeted and tailored intervention” to improve COVID-19 vaccine uptake.

Limitations

Of course, all of these observational studies have inherent limitations, but when they showed some form of positive impact they were heavily promoted on mainstream media and by government agencies.

TrialSite summarizes the key limitations of this study.

Residual confounding associated with unaccounted-for differences in the likelihood of exposure or severity of SARS-CoV-2 infection between vaccinated and unvaccinated individuals must be factored into the study outcomes.

The median time since receipt of a BNT162b2 XBB vaccine was only 34 days, and future studies are needed to evaluate the durability of protection. Why the authors could not analyze with different dates it’s not clear. The design could have been modified for that purpose.

Sara Y. Tartof, PhD, MPH, Corresponding Author

Lead Research/Investigator

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