Vaccines are useful even when there is a treatment for a disease, contrary to claim by Lee Merritt in The New American video

A video of an interview, published by The New American on 15 January 2021, featured Lee Merritt, an orthopedic surgeon and former president of the American Association of Physicians and Surgeons (AAPS). The AAPS has previously published misinformation about vaccines and COVID-19.

During the interview, Merritt made several claims regarding COVID-19 vaccines and treatment, some of which were debunked in the past. The original video and its copies received more than 21,000 interactions on social media platforms including Facebook, Twitter, and Reddit, according to social media listening tool Buzzsumo.

Below, this review explains how several of Merritt’s claims are inaccurate, misleading, the result of flawed reasoning and/or unsupported by scientific evidence.

Claim 1 (Flawed reasoning):

“Why do we have vaccines? We have vaccines because we didn’t have treatment for smallpox and it was a very deadly disease that made sense to have a vaccine. We didn’t have treatment for polio initially, so [it] made sense to have a vaccine but this? Even without doing anything, this disease has a 99.991[%] chance of survival.”

This line of reasoning is misleading. The purpose of vaccines is to prevent a disease entirely and so avert the risks associated with the disease. While it is important to have an effective treatment, treatments cannot prevent a disease. And the principle that preventing a disease is always better than curing it is actually a key concept of modern medical care around the world.

Furthermore, vaccines help to build herd immunity in a population. This prevents the spread of an infectious disease in the community, thereby protecting individuals who are vulnerable to severe illness and are at a greater risk of dying from the disease, like those with chronic illnesses and the elderly. Treatments cannot build herd immunity.

While vaccines are commonly associated with unpleasant side effects, such as fever, headache, and fatigue, these effects are milder and short-lived compared to the risks that a person runs with developing a natural infection. For instance, in the case of COVID-19, some survivors find themselves having to cope with persistent health problems that interfere with daily life.

Overall, the benefits of vaccines outweigh their risks. Given that a safer alternative to acquiring immunity exists, suggesting that natural infection remains a viable option for people to take, as Merritt did, risks causing more harm to the community than is necessary.

Merritt’s claim that COVID-19 has a survival rate of 99.991% is false. For COVID-19, the overall infection fatality ratio (IFR), or the proportion of people who die from the infection, has proved difficult to calculate, given that multiple variables in a population, such as the quality of healthcare and age, can influence the IFR. But a meta-analysis of IFR estimates from different countries conducted by Meyerowitz-Katz and Merone reported an overall IFR for all ages at between 0.53 to 0.82%^[1].

Claim 2 (Inaccurate and Unsupported):

“it’s really not a vaccine, but whatever this thing is […] the Pfizer vaccine, this Moderna vaccine, this RNA thing – it doesn’t prevent transmission by their own admission, okay?”

Merritt appeared to echo an earlier claim made by David Martin, which was covered in an earlier review by Health Feedback.

It is false to claim that the COVID-19 RNA vaccines aren’t vaccines. By examining the definitions of a vaccine by the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and the World Health Organization (WHO), it is clear that the RNA vaccines are indeed vaccines.

The CDC defines the term “vaccine” as:

“A product that stimulates a person’s immune system to produce immunity to a specific disease, protecting the person from that disease.“

The FDA explains how vaccines work:

“Vaccines work by mimicking the infectious bacteria or viruses that cause disease. Vaccination stimulates the body’s immune system to build up defenses against the infectious bacteria or virus (organism) without causing the disease. The parts of the infectious organism that the immune system recognizes are foreign to the body and are called antigens. Vaccination exposes the body to these antigens.

Some vaccines contain weakened versions of a bacteria or virus, other vaccines contain only part of the bacteria or virus. Some vaccines contain only the genetic material for a specific protein and direct the body to produce a small amount of that protein. The body’s immune system reacts defensively once it detects this protein.

After vaccination, the immune system is prepared to respond quickly and forcefully when the body encounters the real disease-causing organism.”

And the WHO explains how vaccines work:

“Vaccination is a simple, safe, and effective way of protecting people against harmful diseases, before they come into contact with them. It uses your body’s natural defenses to build resistance to specific infections and makes your immune system stronger.

Vaccines train your immune system to create antibodies, just as it does when it’s exposed to a disease. However, because vaccines contain only killed or weakened forms of germs like viruses or bacteria, they do not cause the disease or put you at risk of its complications.“

The two COVID-19 vaccines that were approved for emergency use by the FDA, one co-developed by Pfizer and BioNTech and the other by Moderna, meet the requirement for a vaccine to prevent disease. Therefore, both are vaccines according to the definitions outlined by the CDC and FDA. Preliminary data from clinical trials indicate that both vaccines have more than 94% efficacy in preventing COVID-19 in vaccinated individuals. Clinical trials are still underway, so estimates of each vaccine’s efficacy may change.

Whether the Moderna and Pfizer-BioNTech COVID-19 vaccines can prevent transmission is still unclear. Work is underway to establish this, but scientists think it is likely for these vaccines to reduce transmission to some degree.

In this Quartz article, Matthew Woodruff, an immunologist at Emory University, said, “I can’t imagine how the vaccine would prevent symptomatic infection at the efficacies that [companies] reported and have no impact on transmission.”

Akiko Iwasaki, an immunologist and professor at Yale School of Medicine, told the New York Times, “My feeling is that once you develop some form of immunity with the vaccine, your ability to get infected will also go down […] Even if you’re infected, the level of virus that you replicate in your nose should be reduced.”

Samuel Scarpino, director of the Emergent Epidemics Lab and assistant professor at Northeastern University, told Wired, “We don’t have any reason to think the Pfizer and Moderna vaccines won’t block transmission. It’s just not what has actually been measured, and something we aren’t likely to find out until we either start mass vaccination and/or they release more detailed information on the study locations—and epidemiologists start looking for effects of herd immunity.”

As John Moore, a virologist and professor at Weill Cornell Medicine, said to the New York Times, “The more you reduce viral load, the less likely you are to be transmissible”. But he added that “all of these are things where data trumps theory, and we need the data”.

Claim 3 (Unsupported):

“Not only is hydroxychloroquine and chloroquine good for treatment, it’s good for prevention”

The claim that hydroxychloroquine and a closely related compound named chloroquine are effective against COVID-19 has been repeated often during the pandemic. However, scientific evidence provided by large-scale, randomized controlled clinical trials showed that these drugs don’t provide any meaningful benefit to patients, in terms of mortality and length of hospital stay, as earlier reviews by Health Feedback (here and here) explained.

The U.S. National Institutes of Health (NIH) conducted clinical trials on adults hospitalized with COVID-19 across 34 hospitals nationwide. A press release by the NIH stated that the “interim results showed the drug neither caused harm nor improved patient outcomes. The trial had enrolled 479 of the expected 510 patients”. The researchers’ findings were published in JAMA^[2].

The U.K.’s RECOVERY trial compared the outcomes for 1,542 patients treated with hydroxychloroquine and those of 3,132 patients who were given usual care only. A statement by the trial’s chief investigators after a review of the data reported that they found no significant improvement in 28-day mortality and “no evidence of beneficial effects on hospital stay duration or other outcomes”.

The investigators concluded that “These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalised with COVID-19.” Their findings were published in the New England Journal of Medicine^[3].

The WHO’s Solidarity trial, which enrolled more than 11,000 adults across 405 hospitals in 30 different countries (among whom 954 were assigned to hydroxychloroquine treatment) also found no significant improvement in the mortality of hospitalized COVID-19 patients treated with hydroxychloroquine, when compared to standard of care. The findings were published in the New England Journal of Medicine^[4].

Nor has hydroxychloroquine shown itself to be effective at preventing COVID-19. A randomized clinical trial that included more than 100 healthcare workers found that hydroxychloroquine didn’t significantly reduce the incidence of COVID-19 in the workers^[5]. Another randomized clinical trial in more than 1,000 healthcare workers likewise found that hydroxychloroquine treatment didn’t reduce the incidence of COVID-19^[6].

Overall, high-quality scientific evidence contradicts Merritt’s claim that hydroxychloroquine is “good” for treatment and prevention.

Claim 4 (Unsupported and Misleading):

“There’s a very small percentage of people that are in the ICU or dying. Who are those people? [T]he Indonesians […] looked and they found out that […] the biggest, biggest thing is what your vitamin D level was. If it was above 30, your chance of being in the ICU was less than four percent of sick people in the hospital […] So [the] biggest thing people can do is get their vitamin D level up”

Merritt didn’t cite the title of the actual study she referred to nor did she mention the names of its authors, making it difficult for viewers to verify her claim.

However, the paper described by her bears a strong resemblance to this one, which was at one point uploaded to SSRN, a repository for research preprints. Preprints are studies that have not been peer-reviewed or published in a scientific journal. (Note that the preprint is no longer available on SSRN.)

However, a group of researchers from Indonesia pointed out several anomalies about the preprint and its authors, published in a letter to the British Journal of Nutrition^[7]:

“[W]e assessed the preprint manuscript for validity and found several issues: (1) the authors did not mention specifically the name of the hospitals (or the number of hospitals) and how they obtained the confidential data for their manuscript (similar to the Surgisphere incident). At the time this paper was written, there were only two cases of confirmed COVID-19 (both survived) in Sukamara Regency, where the Sukamara’s Regional Public Hospital is located. Currently, the hospital is not a regional referral centre for COVID-19 care. None of the authors is affiliated to the Ministry of Health/other governmental hospitals, and they did not acknowledge any of them. (2) The name of the ethical/institutional review board was not mentioned, and there is no ethical clearance for the study. (3) Vitamin D is not routinely checked in Indonesia; the data collection method was retrospective, which is suspicious. Finally, we called the COVID-19 administration for Sukamara’s Regional Public Hospital, which is allegedly affiliated with the authors. Upon confirmation, the administrator told us that no authors’ names that we mentioned worked in this hospital.”

It is unclear if Merritt was aware of these issues with the preprint. However, the anomalies detected in the paper, described above, indicate that the reliability of its findings are in question. At any rate, using a single preprint to claim that vitamin D insufficiency causes a higher COVID-19 mortality rate is misleading.

The role of vitamin D levels in preventing COVID-19 and severe disease is still being investigated by scientists. Vitamin D is important for health. It is involved in the absorption of calcium and is therefore critical for maintaining healthy bones and teeth. Vitamin D deficiency can lead to a loss of bone density, which in turn contributes to a disease called osteoporosis and an increased risk of fractures.

There are also indications that vitamin D can influence our body’s immune response to infection^[8]. And as explained in this earlier review by Health Feedback, several studies reported a correlation between vitamin D deficiency and an increased risk of developing COVID-19 or severe COVID-19.

Overall, there are grounds for investigating whether vitamin D levels influence the risk of infection and severe disease. However, such work is still in progress and it remains unclear whether the lack of vitamin D causes a higher risk of infection or severe disease.

For example, the correlation that researchers observed in these studies could also be explained by the fact that people with certain chronic illnesses like cancer, are more likely to have vitamin D deficiency to begin with. And scientific evidence shows that patients with certain chronic illnesses are more likely to develop severe COVID-19.

As of January 2021, the World Health Organization and the U.S. National Institutes of Health have not issued a recommendation for vitamin D supplementation to treat or prevent COVID-19.

However, vitamin D deficiency is common. A review article published in the European Journal of Clinical Nutrition reported that the estimated prevalence of vitamin D deficiency stands at 24% in the U.S., 37% in Canada, and 40% in Europe, while more than 20% of the population in India, Tunisia, Pakistan, and Afghanistan are affected^[9].

Therefore, despite the lack of conclusive evidence about the benefit of vitamin D in preventing COVID-19, some health authorities recommend that people take vitamin D supplements to avoid negative health effects due to deficiency. However, people should also be careful not to overdose on vitamin D supplements. Excessively high vitamin D levels over a prolonged period can potentially damage the bones, kidneys, and heart.

Claim 5 (Unsupported):

“I believed early on in February that this was a biologically manipulated bioweapon”

The origins of the virus that causes COVID-19, named SARS-CoV-2, is still unknown. The presence of a laboratory studying viruses in the initial epicenter of the pandemic in Wuhan, China, led to multiple speculations, like Merritt’s, that the virus was a product of that laboratory.

However, there is no evidence to support the speculations that the virus was “biologically manipulated”. Some individuals claimed to have evidence showing that the virus was genetically engineered, however, a closer examination of the purported evidence in these cases proved that these were the results of shoddy methodology and unsubstantiated assertions, as documented in reviews by Health Feedback.

Indeed, the available evidence favors the hypothesis that the virus occurred naturally. For example, experts who studied the genetic features of the virus didn’t detect signs of genetic engineering. In addition, researchers discovered coronaviruses similar to SARS-CoV-2 that were isolated from wild animals, as reported in this news article by Nature from November 2020.

Alice Latinne, an evolutionary biologist at the Wildlife Conservation Society Vietnam in Hanoi, told Nature that these “discoveries are exciting because they confirm that viruses closely related to SARS-CoV-2 are relatively common in Rhinolophus bats, and even in bats found outside China”.

Referring to these viruses collected from wildlife and stored in laboratories to be analyzed later, as is typical of zoonotic disease surveillance programs, Aaron Irving, a virologist and assistant professor at Zhejiang University in Haining, China, added that “The findings also suggest that other as-yet undiscovered SARS-CoV-2 relatives could be stored in lab freezers”.

These findings indicate that wild animals are likely to be a reservoir for SARS-CoV-2 and/or its closest ancestor. On top of this, about 60% of emerging infectious diseases reported worldwide are zoonotic diseases, according to the World Health Organization (WHO). Zoonotic diseases are caused by the transmission of disease-causing organisms from animals or insects to humans.

Experts have also considered the “lab escape” theory, which would not necessarily involve a genetically engineered virus. This theory is viewed with skepticism (see this Insight article by Health Feedback for a detailed explanation). One reason for this is that the theory is supported largely by circumstantial evidence and is unsupported by genomic analyses and publicly available information. However, viruses have escaped from laboratories and caused infections before, as this Vox article reported.

Overall, while one cannot rule out an accidental lab leak as the actual source of the outbreak as there is no evidence for or against that theory, the weight of scientific evidence and prior probability rather point towards a zoonotic infection by a naturally occurring virus. Merritt’s belief that the virus was engineered is unsubstantiated and contradicted by the evidence.

Claim 6 (Misleading and Unsupported):

“There have been four different vaccines and three different animal studies [in] cats and ferrets […] They started after SARS [and] after MERS, they tried it in ferrets and something else. And what happened is all the animals died […] but they didn’t die of the vaccine. What they died from was called immune enhancement or […] antibody dependent enhancement. They call it ADE now. […] Here’s what happens: […] when they challenge those cats with SARS, what happened is instead of killing the virus, […] the virus came into the cat’s body like a Trojan horse unseen by the cat’s own immune system”

Merritt repeated the claim that COVID-19 vaccines will lead to more severe COVID-19 due to a process called antibody-dependent enhancement (ADE). This claim was previously reviewed by Health Feedback; scientists found that the claim was unsupported by evidence.

ADE occurs when antibodies are unable to neutralize a virus’ infectivity, but instead enhance a virus’ ability to infect cells. The potential danger posed by ADE is one that scientists developing vaccines are mindful of.

This is due to previous experiences with vaccine candidates for other coronaviruses, such as the virus SARS-CoV-1, which causes severe acute respiratory syndrome, as well as coronaviruses that infect animals. In the case of the former, researchers developed a vaccine candidate for SARS-CoV-1 using inactivated (“killed”) virus, which was tested in mice. They observed that vaccinated mice showed more severe lung disease upon infection with live virus^[10]. In the case of the latter, cats that were vaccinated with a recombinant virus vaccine survived for a shorter period of time compared to unvaccinated cats^[11].

A vaccine candidate against the respiratory syncytial virus (RSV) also failed human clinical trials, as it caused more severe illness in vaccinated people^[12].

The lessons learned from the past led researchers to be cautious about COVID-19 vaccines. As such, the vaccines authorized for emergency use by the FDA are carefully monitored for ADE and other severe side effects.

Indeed, clinical trials so far haven’t shown any indication that ADE occurs in people who received the COVID-19 vaccines. In Health Feedback’s previous review, Sanjay Mishra, a staff scientist and project coordinator at Vanderbilt University Medical Center who is also working in the COVID-19 and Cancer Consortium, pointed out, “The major vaccine candidates that have so far progressed in the large-scale Phase 3 trials, such as the ones by Moderna, Pfizer, and AstraZeneca, have all ruled out any serious safety concerns”.

Walter Orenstein, a professor at Emory University’s School of Medicine and associate director of the Emory Vaccine Center, also agreed: “Vaccine-enhanced disease is theoretically possible with SARS-CoV-2 vaccines, but it has not been seen as of yet in the clinical trials reported.”

REFERENCES

• 1 – Meyerowitz-Katz and Merone. (2020) A systematic review and meta-analysis of published research data on COVID-19 infection fatality rates. International Journal of Infectious Diseases.
• 2 – Self et al. (2020) Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial. JAMA.
• 3 – The RECOVERY Collaborative Group. (2020) Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19. New England Journal of Medicine.
• 4 – WHO Solidarity Trial Consortium. (2020) Repurposed Antiviral Drugs for Covid-19 — Interim WHO Solidarity Trial Results. New England Journal of Medicine.
• 5 – Abella et al. (2020) Efficacy and Safety of Hydroxychloroquine vs Placebo for Pre-exposure SARS-CoV-2 Prophylaxis Among Health Care Workers: A Randomized Clinical Trial. JAMA Internal Medicine.
• 6 – Rajasingham et al. (2020) Hydroxychloroquine as Pre-exposure Prophylaxis for Coronavirus Disease 2019 (COVID-19) in Healthcare Workers: A Randomized Trial. Clinical Infectious Diseases.
• 7 – Henrina et al. (2020) COVID-19 and misinformation: how an infodemic fuelled the prominence of vitamin D. British Journal of Nutrition.
• 8 – Aranow C. (2011) Vitamin D and the Immune System. Journal of Investigative Medicine.
• 9 – Amrein et al. (2020) Vitamin D deficiency 2.0: an update on the current status worldwide. European Journal of Clinical Nutrition.
• 10 – Bolles et al. (2011) A Double-Inactivated Severe Acute Respiratory Syndrome Coronavirus Vaccine Provides Incomplete Protection in Mice and Induces Increased Eosinophilic Proinflammatory Pulmonary Response upon Challenge. Journal of Virology.
• 11 – Vennema et al. (1990) Early death after feline infectious peritonitis virus challenge due to recombinant vaccinia virus immunization. Journal of Virology.
• 12 – Kim et al. (1969) Respiratory Syncytial Virus Disease in Infants Despite Prior Administration of Antigenic Inactivated Vaccine. American Journal of Epidemiology.