My Notes on a Pandemic Response with more Questions than Answers

Norfolk Group pandemic response discussion document 

From Martin Kulldorff: Our 80-page report with key questions that a #Covid commission/hearing should ask government, media & public health scientists. Written together with Drs. Jay Bhattacharya, Tracy Beth Høeg, MD, Marty Makary M.D., M.P.H., PhD, Margery Smelkinson, Leslie Bienen, Steve Templeton and Ram Duriseti and Martin Kulldorff.

https://www.documentcloud.org/documents/23601038-norfolk-group-questions-for-a-covid-19-commission

My, David Lipschitz's, notes in [] and <>.

[An important document with more questions than answers. Note that I have left everything copied and pasted from the document so that the quotes remain consistent. My notes are in [] and <>]

The World Health Organization’s October 2019 publication “Non-pharmaceutical public health measures for mitigating the risk and impact of epidemic and pandemic influenza” stated that “home quarantine of exposed individuals to reduce transmission is not recommended because there is no obvious rationale for this measure, and there would be considerable difficulties in implementing it.”

In a Johns Hopkins document, “Preparedness for a High-Impact Respiratory Pathogen Pandemic”, the authors stated in September 2019 that “In the context of a high-impact respiratory pathogen, quarantine may be the least likely NPI to be effective in controlling the spread due to high transmissibility.” They also stated that “During an emergency, it should be expected that implementation of some NPIs, such as travel restrictions and quarantine, might be pursued for social or political purposes by political leaders, rather than pursued because of public health evidence.”

Another reason that denial of natural immunity led to misguided COVID-19 policies is that vaccines were assumed to have superior immunity compared to natural infection, an assumption that led to widespread vaccine mandates even in previously infected people. Prior infection and vaccines both provide a form of immunity. Acknowledgement of infection-acquired immunity is not an argument against vaccines. For example, the purpose of the measles vaccine is to prevent measles, but those who have already had measles do not need the vaccine. 

Since infection-acquired immunity offered superior protection compared to vaccine-acquired immunity, why did hospitals fire rather than hire unvaccinated nurses, physicians and other staff who had infection-acquired immunity? Why did hospitals implement vaccine mandates without providing exceptions for staff with infection acquired immunity? 

Vaccines are designed to mimic the immune response from a disease while avoiding the risks involved with being infected. Individuals are capable of understanding risks when given accurate information, and acknowledging that infection-acquired immunity is superior to vaccine-acquired immunity is not equivalent to promoting infection over vaccination. On its website, the CDC wrote that “the risk of severe illness and death from COVID-19 far outweighs any benefits of natural immunity.”  However, for people that have already survived an infection, the relevant question is whether they have acquired immunity, which they do in the vast majority of cases. For people without a prior COVID-19 infection, the relevant comparison is vaccine efficacy versus adverse reactions. Did the CDC damage vaccine confidence when they conflated these two issues?

1. The CDC Kentucky study from August 2021 did not evaluate symptomatic disease, hospitalizations or death, but it showed fewer positive COVID-19 tests in people who had combined immunity (from both Covid-19 infection and vaccination), compared to COVID-19 infection alone (both were very low, however). Since all participants in the study had infection-acquired immunity, why did the title of the CDC press release for this study falsely claim that “Vaccination Offers Higher Protection than Previous COVID-19 Infection.”? That question was not evaluated in the Kentucky study. Why did NIH director Francis Collins use this study to falsely claim that “it was more than two-fold better from the people who had the vaccine, in terms of protection, than people who had had the natural infection”?

Early reports indicate profound differences, with estimates suggesting that 75-80% of the excess deaths during the pandemic were not attributable to COVID-19 but to pandemic policies that led people to miss addiction treatment, to stay home when they were experiencing symptoms of a heart attack, and others. 

In 2006, a small group of Bush-administration health officials and computer modelers suggested lockdowns as a response to a future pandemic. Dr. Donald Henderson, a 78 year-old world-renowned epidemiologist who led the eradication of smallpox, went into action, responding that: ‘Experience has shown that communities faced with epidemics or other adverse events respond best and with the least anxiety when the normal social functioning of the community is least disrupted. Strong political and public health leadership to provide reassurance and to ensure that needed medical care services are provided are critical elements. If either is seen to be less than optimal, a manageable epidemic could move toward catastrophe.‘

A fundamental principle of public health is to consider all of health rather than focus on a single disease such as COVID-19.

Estimates of increase in Type 2 diabetes among children are ash igh as 182% during the first year of the pandemic, disproportionately affecting Black youth.

Young children need to be exposed to viruses in order to build up the immune system that will protect them for the rest of their lives. 

The pandemic and media messaging increased use of disinfectants. What consequences does this have on our microbiota? Has it led to more gut dysbiosis (a reduction in microbial diversity)? 

Between April of 2020 and December of 2021, excess deaths not due to COVID-19 exceeded excess deaths due to COVID-19 (29,000 vs 20,000) for ages 18-44. Why were more concerted efforts not made to anticipate and prevent non-COVID-19 excess deaths?  

After staying at or below 4% throughout 2018, 2019, and early 2020, U.S. unemployment rose to 15% in April 2020. It gradually declined thereafter, taking until the last month of 2021 to dip below 4% again. Pre-pandemic studies show that unemployment is linked to increased mortality in men. One study estimates a 6% increased mortality risk for each percentage point increase in unemployment. Did lockdown-induced rise in unemployment increase mortality in 2020 and 2021? Does this explain some of the  excess mortality seen among Americans below the age of 65? 

Lockdowns forced many small businesses to close permanently. How did this affect the health and well-being of small business owners and their employees? When small businesses were forced to close, much of their business was taken over by large corporations that were allowed to operate when small businesses couldn’t. Why were larger businesses provided this competitive advantage? Can this be reversed? If not, what are the long-term health consequences of having fewer small businesses?

Food insecurity increased during lockdowns, especially among families with children. With closed schools, some children lost their best source of nutritious food.

For many people, religious and spiritual activities are important for their mental health, whether it is partaking in mass at their church or doing yoga with a group of friends. To what extent did closing religious institutions and preventing spiritual activities contribute to increases in the nation’s mental health problems? How can religious organizations step in and help us recover? 

1. The pollution from billions of disposable face masks has harmed birds and other wildlife. What is being done to mitigate this problem? Are there other negative public health consequences from this environmental damage such as increased microplastics in the environment for humans?
2. Despite no evidence that COVID-19 is spread by fomites, hundreds of millions of people increased their use of disinfectants. What are the environmental effects of increased disinfectant exposures? 

The World Health Organization’s October 2019 publication “Non-pharmaceutical public health measures for mitigating the risk and impact of epidemic and pandemic influenza” stated that “home quarantine of exposed individuals to reduce transmission is not recommended because there is no obvious rationale for this measure, and there would be considerable difficulties in implementing it.”

 

In a Johns Hopkins document, “Preparedness for a High-Impact Respiratory Pathogen Pandemic”, the authors stated in September 2019 that “In the context of a high-impact respiratory pathogen, quarantine may be the least likely NPI to be effective in controlling the spread due to high transmissibility.” They also stated that “During an emergency, it should be expected that implementation of some NPIs, such as travel restrictions and quarantine, might be pursued for social or political purposes by political leaders, rather than pursued because of public health evidence.”

For a virus who clinical manifestation ranges from asymptomatic or mildly symptomatic to fatal, the percent of reported COVID-19 hospitalizations and deaths that were due to COVID-19 versus with COVID-19 should be separated out, i.e. when a patient was hospitalized or died due to another cause after testing positive for COVID-19.

One audit of death data in Alameda County, CA, found that 25% of COVID-19 deaths reported were not due to COVID. Most concerning, the CDC has not reported accurate data on COVID-19 deaths in young people. A review of the WONDER database for Underlying Cause of Death (UCod) and Multiple Cause of Death (MCoD) through December 2021 indicates that the vast majority of reported pediatric COVID-19 deaths were in children with other serious conditions.

Knowing that general health is important to fight off infections, and with obesity as a major risk-factor, why did the CDC and state health officials not encourage healthier eating and more exercise, instead of closing both outdoor and indoor recreational spaces? 

The infection fatality rate (IFR) is the risk that an infected person will die from a  disease. Since not all infected persons are diagnosed, it is different from the case fatality rate (CFR), which is the risk of dying among those that have been diagnosed with the disease. The latter changes over time depending on the amount of testing done. During the beginning of the pandemic, public health officials and scientists conflated these two basic epidemiological concepts. 

1. To accurately estimate an IFR, it is necessary to have accurate cause-of-death data but the CDC reports included deaths with an incidental COVID-19 infection. Why did the CDC consistently provide inaccurate IFR estimates? 
2. The IFR is often given as a single number, even though there can be more than a thousandfold difference in IFR depending on age. Since different states and countries can have very different age structures, combined IFRs cannot be compared between different geographical regions. In light of this, why did scientists and the media continuously emphasize a single national number?

Why did policy makers assume that Chinese reports about initial disease spread, released in December 2019, were accurate?

With limited knowledge and weak or no evidence about efficacy of existing drugs against COVID-19, physicians had to make treatment decisions in the absence of complete knowledge. This information void led to many controversies and disagreements among doctors, between patients and their doctors, and between the public and health authorities as to best practices for treating COVID-19. Even as post-vaccination infections mounted in the summer of 2021, trials to evaluate existing medications with unresolved potential for efficacy were not accelerated and some, even today, remain incomplete. 

At times, individual doctors and hospitals were left without solid guidance as to how to treat COVID-19 patients at various stages of illness. Who was responsible for assembling and updating best practice clinical guidelines? The CDC, NIH, FDA, the American Medical Association, the American College of Physicians, or leading academic hospitals? Who, if anybody, stepped up to the plate to support floundering front line doctors? 

[this is a BIG assumption. Many doctors used their education and experience to develop their own solutions. But the big guns pushed them down and in some cases pushed them out of medicine. Natal doctor with 100% success rate.]

By mid-2022, 95% of Americans had a prior COVID-19 infection,

The CDC’s definition of an underlying health condition that exacerbates risk for severe disease is extremely broad, including mental health conditions, pregnancy, and being a former or current smoker.  

InApril 2022, at a cost of $530 per treatment course, the Federal Government purchased 20 million courses of Paxlovid from Pfizer, at a total cost of around $10 billion. How did the US government assess the need for this drug, given that most older high-risk Amerians had already been vaccinated or recovered from the disease by then? Was this investment cost effective? 

Trials conducted in populations with high immunity, through vaccination or prior infection, such as the Fluticasone ACTIV-6 trial, are going to yield very different results than trials conducted in immune naive populations.

In 2020, some physicians promoted early outpatient hydroxychloroquine treatment for mild to medium severe COVID-19 to prevent hospitalization and subsequent mortality.

Because of the controversy and repeated warnings from the CDC, NIH and FDA on the dangers of taking ivermectin, physicians were hesitant to prescribe it and pharmacies were hesitant to dispense it. However, ivermectin is a useful and safe drug to treat diseases and conditions such as ascariasis, head lice, lymphatic filariasis, river blindness, scabies, strongyloidiasis, and trichuriasis. Were Americans denied appropriate use of ivermectin for these conditions because of controversies surrounding ivermectin for COVID-19? Were side effects of ivermectin of COVID-19 exaggerated by some media outlets and some health providers?

<spelling> current benefit wasis based on

<spelling> Why unvaccianted

Vaccines were developed and approved in record time. What contributed to this remarkable accomplishment? 

1. There were early indications that prior infection provided significant protection against reinfection and even more robust protection against future severe disease. Why, in all age groups and demographics, did the FDA and the CDC assume that the benefits of two doses of vaccine in previously infected people would exceed the potential risks of vaccine adverse reactions?
2. For previously infected people, why were no randomized trials done with sufficient sample size, and thus power, to assess vaccine efficacy against severe disease? Without evidence from such a trial, why were previously infected individuals told to get vaccinated? 

The Pfizer randomized trial showed 95% efficacy against symptomatic COVID-19 infection, the trial’s primary endpoint. The Moderna randomized trial showed 94% efficacy against symptomatic COVID-19 infection, that trial’s primary endpoint. The Johnson & Johnson randomized trial showed 67% efficacy against moderate or severe COVID-19 infection, the trial’s primary endpoint, and 67% efficacy against any symptomatic infection, a secondary endpoint. 

Despite roughly 37,000, 28,000 and 40,000 participants, respectively, only 5% of patients were in the >75 age group, the group at highest risk for a severe outcome due to age. Thus, none of the Pfizer, Moderna or the Johnson & Johnson trials were sufficiently powered to evaluate efficacy against hospitalization and death and none could determine efficacy against transmission. 

While the trial designs allowed rapid deployment to the public, the limitations in  knowledge they produced– particularly about absolute risk reduction for hospitalization and death, vaccine adverse reactions, and about the fact that trials did not study whether vaccines limited transmission – were not clearly conveyed to the public. 

What led some states, such as Florida and Texas, to reject the CDC guidelines and instead prioritize by age? 

People who have recovered from COVID-19 infection already have excellent immunity. Why were they given the same vaccine priority as those without immunity? How many people died unnecessarily because those with natural immunity got the vaccine before susceptible older Americans with high mortality risk? 

How many older people died because of this pause?

[how many people got sick? Why were only deaths considered in this report?]

A vaccine scientist with expertise in the early evaluation of safety data objected publicly to pausing the J&J vaccine for older Americans (Dr. Martin Kulldorff, who was on the faculty of Harvard Medical School and is one of the authors of this document). After voicing his concerns, he was fired from the CDC working group on COVID-19 vaccine safety. Who made that decision? Will such terminations affect willingness of other public health scientists to voice their views when those views are contrary to the views of the CDC?

In April/May 2021, Israel reported an increased risk of myocarditis after the Pfizer vaccine, predominantly in young males after dose 2, putting the risk at somewhere between 1/3000 to 1/6000 for males 16-24. (And from the report in science.Org this could be 25 times higher than the normal background rate)

The randomized controlled vaccine trials did not evaluate the ability of the vaccines to reduce or prevent transmission.

In 2021, without supporting evidence, the CDC claimed that the COVID-19 vaccines “can keep you from getting and spreading the virus that causes COVID-19.”  Was this messaging deliberate or an honest mistake by the CDC?

When the public learns that CDC is making inaccurate claims about COVID-19 vaccines, how does that affect the trust in the benefits of this and other vaccines?  How does this affect trust in our public health agencies?

Why did it take so long to correct this information? Were CDC officials with knowledge of the shortcomings of the vaccine afraid to speak against official CDC views? 

In 2021, universities, hospitals, governments and private employers started requiring proof of vaccination, often firing those who would not or could not comply. The vaccine mandates included people who had infection-acquired immunity, despite substantial evidence of robust immunity in recovered persons, even those who had mild or asymptomatic infections. Furthermore, the vaccine trials did not assess the ability of the vaccine to reduce transmission. 

1. Why were mandates pursued without carve-outs for those with immunity due to prior infection? Why were people fired, destroying careers and reducing healthcare capacity? 
2. Why were there mandates for low-risk working age employees and students?
3. What was the intent of the vaccine mandates? If it was to prevent transmission, why was it not made clear that we did not yet know whether or not the vaccines prevented transmission? 
4. Why did many organizations continue with mandates through summer and fall of 2021, despite data demonstrating both waning efficacy of symptomatic infection and reduced long term ability to curb viral spread?

Pfizer included 16-17 year old adolescents as part of its adult trial. For both Pfizer and Moderna vaccines, separate randomized trials were subsequently conducted for 12-15 and 12-17 year olds respectively, for 5-11 year olds and for children between 6 months and 5 years old. The pediatric trials were small and participants were followed for fewer than 4 months. The Pfizer and Moderna trials were not powered to detect vaccine efficacy against severe disease, nor rare but serious adverse events. There was no assessment of the impacts of the vaccine on viral acquisition or transmission. It thus was impossible to perform a reliable risk benefit analysis for this very low risk population. 

Pfizer failed to demonstrate significant efficacy against symptomatic infection (page 53 of the FDA submission) after either 2 or 3 doses of vaccine in either the 6 month to 2 year olds or in 2-5 year olds.

Since excess risk of myocarditis after mRNA vaccines is well established for young men, why was it considered “anti-vaccine” to discuss this adverse reaction to the vaccine, when such evaluations and discussions have been considered “pro vaccine” for other vaccines, such as intussusception after rotavirus vaccines and febrile seizures after measles containing vaccines? 

In the summer of 2021, studies showed that vaccine induced immunity was rapidly decreasing. In a study from Qatar, vaccine effectiveness against infection went to 0% after 20-24 weeks. This led to the introduction of booster shots in late 2021. Rather than using randomized trials, boosters were evaluated using observational data, which are confounded because people who choose to get a booster dose will likely have different health status, behaviors, and/or attitudes towards vaccination than those who do not choose to boost.

1. Early information about waning vaccine efficacy came from countries such as Israel and Qatar. Why did the United States not collect its own data on this in a timely manner?
2. Why did the FDA approve boosters without randomized trials to evaluate the efficacy and safety of COVID-19 booster vaccines? In particular, why were there no randomized booster trials in people under 65, for whom there was no longer an emergency?
3. Using a database of 4.7 million people, an Israeli study failed to identify any benefit of Pfizer booster doses against hospitalization in people <40. Why were boosters recommended for those under 50 without accompanying data showing efficacy?

[where the boosters tested?]

An independent analysis anticipated that for every one COVID-19 hospitalization prevented in previously uninfected young adults <30, there would be more than 18 serious adverse events, including 1.7 to 3.0 booster-associated myocarditis cases in males, and 1,373 to 3,234 cases of grade ≥3 reactogenicity (defined as interfering with daily activities).

A Danish household transmission study[6] found no difference in secondary transmission rates in boosted vs vaccinated vs unvaccinated people.

“When the Secretary determines that a threat or condition constitutes a present or credible risk of a future public health emergency, the Secretary may issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures to diseases, threats and conditions identified in the declaration.”

To prevent COVID-19 spread, it is important to test hospital and nursing home staff and visitors so they do not infect frail elderly high-risk individuals.

Positive tests forced children to miss school and adults to miss work without evidence of these strategies effectively decreasing community transmission or benefiting the health of the community.

antigen tests remain particularly inaccurate at detecting infection in the absence of symptoms.

Testing and contact tracing is important for containing many infectious diseases, such as sexually transmitted diseases, but it is ultimately futile for reducing the spread of respiratory diseases such as influenza or SARS-CoV2 that have an infectious period during an asymptomatic or mildly symptomatic phase. Furthermore, by the time COVID-19 tests were widely available, the disease was widespread across the globe, as already demonstrated in April of 2020, and not amenable to eradication by quarantine. Also, COVID-19 can infect multiple species of animals, making it even more unlikely it could ever be eradicated, even if it had been possible to quarantine all infected humans (which it was not). In 2021, for example, surveillance studies showed that SARS-CoV-2 was present in white tailed deer. 

Why no spending on better ventilation in schools instead of school closures?

1. Why did the CDC require testing for international air travel, but not for domestic? 
2. Why did the CDC require testing for international arrivals by air, but not by land or sea? 
3. In 2015, the CDC evaluated effectiveness of border entry screening during the SARS1 and H1N1 influenza outbreaks, and concluded that both were heavily resource intensive, unlikely to be successful in preventing entry of disease, and should not be used. Why did the CDC not follow its 2015 conclusions? 

Home testing has been an effective strategy to enable rapid results when people want to know if they can safely visit an older relative. The medical profession has a long history of resisting home testing, evidenced by resistance to home pregnancy tests for women, which were not available until 1977 despite being developed in the 1920s. Similar resistance delayed the introduction of home HIV tests. 

Nucleic acid amplification tests, such as polymerase chain reaction (PCR) tests, are used to detect the presence of SARS-CoV-2 genetic material in individual samples. However, a positive result does not indicate the presence of live virus or an ability of a positive person to transmit the virus to others. 

In July, 2020, CDC published its first study on mask efficacy against COVID-19. In this study, two hairstylists tested positive for SARS-CoV2 yet did not infect any of their patrons. The authors concluded that the lack of transmission was due to consistent adherence to masking on the part of the hairstylists. However, viral loads were not tested, and in an early study of household transmission, the secondary attack rate was only 19%.  Therefore, regardless of masking, there was a low probability of spread and, despite the positive test, it is possible that viral levels were too low to be infectious.  Furthermore, this study consisted of a sample size of two and no control group.  Why was this report considered strong evidence of mask effectiveness?

Few RCTs have evaluated the effectiveness of cloth masks. The results from the first concluded that “cloth masks should not be recommended for health care workers”. If they are not effective for hospital staff, why were they recommended for the public?

In 

January 2021, the CDC published a study from Wood County, Wisconsin, which found lower transmission rates in schools, where masks were commonly used, compared to the community at large. Despite the lack of a comparative unmasked control group, why did the CDC and the Secretary of Education use this study as evidence that masks are effective? Schools in Norway that did not mask students <12 also saw similarly low transmission levels during the same time period.  Was the possibility that children transmit less frequently than adults, rather than mask mandates, considered as an explanation to why schools had relatively low transmission rates?

In May 2022, another Duke University study evaluated whether schools with or without mask mandates had a higher proportion of secondary (school acquired) versus primary (community acquired) COVID infections. The classification of primary versus secondary transmission was conducted by school health staff.  Masked school districts, however, did not generally consider masked students to be potential contacts during tracing because of CDC guidelines which stated that “the close contact definition excludes students who were between 3 to 6 feet of an infected student if both the infected student and the exposed student(s) correctly and consistently wore well-fitting masks the entire time.” This would lead to in-school transmission cases in districts with mask mandates being overlooked by contact tracers and incorrectly considered community transmission, giving falsely low rates of secondary transmission in districts with mask requirements. Despite its obvious and serious methodological flaws, why did the NIH promote this study, claiming that mandatory masking in schools reduced COVID-19 cases? 

An Italian study published in March 2021, found that masking is a barrier to speech recognition, hearing, and communication, and that masks impede children’s ability to decode facial expressions, dampening children’s perceived trustworthiness of faces. Why was this not considered when implementing mask mandates in children?

Mask wearing may cause physiological harm, including breathing difficulties, headaches, dermatitis, and general discomfort which may have several negative downstream effects, including reduced time and intensity of exercise, additional sick days, reduced learning capacity, and increased anxiety. Were these factors considered when implementing mask mandates?

[The CDC guidelines are suggestions. They aren’t enforceable unless a government decides to enforce them. Different American states acted in different ways. And in a democracy, the government is an agent of the people. Why did governments turn on their people?]