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Infection Fatality Rates (IFR) Higher in Flu Vaccine Than Covid-19

As more and more people are tested for COVID-19, the percentage of predictable deaths continues to shrink to mortality rates below what FLUZONE manufacturers predict in their own literature.

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FLUZONE HIGH-DOSE HIGHLIGHTS OF PRESCRIBING INFORMATION

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

Two clinical studies have evaluated the safety of Fluzone High-Dose.

Study 1 (NCT00391053, see http://clinicaltrials.gov ) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Fluzone High-Dose to those of Fluzone. The safety analysis set included 2573 Fluzone High-Dose recipients and 1260 Fluzone recipients.

Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Fluzone High-Dose compared to Fluzone.

Table 1: Study 1*: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Fluzone High-Dose or Fluzone, Adults 65 Years of Age and Older

	Fluzone High-Dose (N†=2569-2572) Percentage			Fluzone (N†=1258-1260) Percentage
	Any	Moderate‡	Severe§	Any	Moderate‡	Severe§
* NCT00391053 † N is the number of vaccinated participants with available data for the events listed ‡ Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site swelling: ≥2.5 cm to <5 cm; Fever: >100.4°F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activities § Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever: >102.2°F; Myalgia, Malaise, and Headache: prevents daily activities ¶ Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Fluzone High-Dose; and 98.6% and 1.4%, respectively, for Fluzone
Injection-Site Pain	35.6	3.7	0.3	24.3	1.7	0.2
Injection-Site Erythema	14.9	1.9	1.8	10.8	0.8	0.6
Injection-Site Swelling	8.9	1.6	1.5	5.8	1.3	0.6
Myalgia	21.4	4.2	1.6	18.3	3.2	0.2
Malaise	18.0	4.7	1.6	14.0	3.7	0.6
Headache	16.8	3.1	1.1	14.4	2.5	0.3
Fever¶ (≥99.5°F)	3.6	1.1	0.0	2.3	0.2	0.1

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Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29 – 180 post-vaccination: 16 (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

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Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Fluzone High-Dose or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Fluzone High-Dose to those of Fluzone. The safety analysis set included 15,992 Fluzone High-Dose recipients and 15,991 Fluzone recipients.

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Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Fluzone High-Dose recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Fluzone High-Dose recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Fluzone High-Dose recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Fluzone High-Dose recipients and 0 (0%) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Fluzone High-Dose.

 

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The CDC's New 'Best Estimate' Implies a COVID-19 Infection Fatality Rate Below 0.3%

That rate is much lower than the numbers used in the horrifying projections that shaped the government response to the epidemic.

Jacob Sullum | 5.24.2020 5:35 PM  (Source)

 

That "best estimate" scenario also assumes that 35 percent of infections are asymptomatic, meaning the total number of infections is more than 50 percent larger than the number of symptomatic cases. It therefore implies that the IFR is between 0.2 percent and 0.3 percent. By contrast, the projections that the CDC made in March, which predicted that as many as 1.7 million Americans could die from COVID-19 without intervention, assumed an IFR of 0.8 percent. Around the same time, researchers at Imperial College produced a worst-case scenario in which 2.2 million Americans died, based on an IFR of 0.9 percent.

 

Such projections had a profound impact on policy makers in the United States and around the world. At the end of March, President Donald Trump, who has alternated between minimizing and exaggerating the threat posed by COVID-19, warned that the United States could see "up to 2.2 million deaths and maybe even beyond that" without aggressive control measures, including lockdowns.

 

One glaring problem with those worst-case scenarios was the counterfactual assumption that people would carry on as usual in the face of the pandemic—that they would not take voluntary precautions such as avoiding crowds, minimizing social contact, working from home, wearing masks, and paying extra attention to hygiene. The Imperial College projection was based on "the (unlikely) absence of any control measures or spontaneous changes in individual behaviour." Similarly, the projection of as many as 2.2 million deaths in the United States cited by the White House was based on "no intervention"—not just no lockdowns, but no response of any kind.

 

Another problem with those projections, assuming that the CDC's current "best estimate" is in the right ballpark, was that the IFRs they assumed were far too high. The difference between an IFR of 0.8 to 0.9 percent and an IFR of 0.2 to 0.3 percent, even in the completely unrealistic worst-case scenarios, is the difference between millions and hundreds of thousands of deaths—still a grim outcome, but not nearly as bad as the horrifying projections cited by politicians to justify the sweeping restrictions they imposed.

 

"The parameter values in each scenario will be updated and augmented over time, as we learn more about the epidemiology of COVID-19," the CDC cautions. "New data on COVID-19 is available daily; information about its biological and epidemiological characteristics remain[s] limited, and uncertainty remains around nearly all parameter values." But the CDC's current best estimates are surely better grounded than the numbers it was using two months ago.

 

A recent review of 13 studies that calculated IFRs in various countries found a wide range of estimates, from 0.05 percent in Iceland to 1.3 percent in Northern Italy and among the passengers and crew of the Diamond Princess cruise ship. This month Stanford epidemiologist John Ioannidis, who has long been skeptical of high IFR estimates for COVID-19, looked specifically at published studies that sought to estimate the prevalence of infection by testing people for antibodies to the virus that causes the disease. He found that the IFRs implied by 12 studies ranged from 0.02 percent to 0.4 percent. My colleague Ron Bailey last week noted several recent antibody studies that implied considerably higher IFRs, ranging from 0.6 percent in Norway to more than 1 percent in Spain.

Methodological issues, including sample bias and the accuracy of the antibody tests, probably explain some of this variation. But it is also likely that actual IFRs vary from one place to another, both internationally and within countries. "It should be appreciated that IFR is not a fixed physical constant," Ioannidis writes, "and it can vary substantially across locations, depending on the population structure, the case-mix of infected and deceased individuals and other, local factors."

 

One important factor is the percentage of infections among people with serious preexisting medical conditions, who are especially likely to die from COVID-19. "The majority of deaths in most of the hard hit European countries have happened in nursing homes, and a large proportion of deaths in the US also seem to follow this pattern," Ioannidis notes. "Locations with high burdens of nursing home deaths may have high IFR estimates, but the IFR would still be very low among non-elderly, non-debilitated people."

 

That factor is one plausible explanation for the big difference between New York and Florida in both crude case fatality rates (reported deaths as a share of confirmed cases) and estimated IFRs. The current crude CFR for New York is nearly 8 percent, compared to 4.4 percent in Florida. Antibody tests suggest the IFR in New York is something like 0.6 percent, compared to 0.2 percent in the Miami area.

 

Given Florida's high percentage of retirees, it was reasonable to expect that the state would see relatively high COVID-19 fatality rates. But Florida's policy of separating elderly people with COVID-19 from other vulnerable people they might otherwise have infected seems to have saved many lives. New York, by contrast, had a policy of returning COVID-19 patients to nursing homes.

 

"Massive deaths of elderly individuals in nursing homes, nosocomial infections [contracted in hospitals], and overwhelmed hospitals may…explain the very high fatality seen in specific locations in Northern Italy and in New York and New Jersey," Ioannidis says. "A very unfortunate decision of the governors in New York and New Jersey was to have COVID-19 patients sent to nursing homes. Moreover, some hospitals in New York City hotspots reached maximum capacity and perhaps could not offer optimal care. With large proportions of medical and paramedical personnel infected, it is possible that nosocomial infections increased the death toll."  Ioannidis also notes that "New York City has an extremely busy, congested public transport system that may have exposed large segments of the population to high infectious load in close contact transmission and, thus, perhaps more severe disease."

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More speculatively, he notes the possibility that New York happened to be hit by a "more aggressive" variety of the virus, a hypothesis that "needs further verification."

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If you focus on hard-hit areas such as New York and New Jersey, an IFR between 0.2 and 0.3 percent, as suggested by the CDC's current best estimate, seems improbably low. "While most of these numbers are reasonable, the mortality rates shade far too low," University of Washington biologist Carl Bergstrom told CNN. "Estimates of the numbers infected in places like NYC are way out of line with these estimates."

But the CDC's estimate looks more reasonable when compared to the results of antibody studies in Miami-Dade County, Santa Clara County, Los Angeles County, and Boise, Idaho—places that so far have had markedly different experiences with COVID-19. We need to consider the likelihood that these divergent results reflect not just methodological issues but actual differences in the epidemic's impact—differences that can help inform the policies for dealing with it.