Category Archives: COVID19

COVID-19 UPDATE: Masks, social distancing much more important than cleaning surfaces.

Today’s update from the Johns Hopkins Center for Health Security:

An editorial published in Nature discusses the need to shift focus away from surface decontamination as a mechanism to reduce SARS-CoV-2 transmission risk. Multiple studies have found that transmission of SARS-CoV-2 via contaminated surfaces, or fomites, is relatively rare compared to respiratory transmission via droplets or aerosols. Despite the evidence supporting respiratory exposure as the overwhelming driver of community transmission, numerous public health entities, including the WHO and US CDC, continue to emphasize the importance of surface decontamination, which can cause confusion among the public regarding transmission risk and appropriate protective measures. Notably, surface decontamination efforts, while highly visible and easy to recognize, are costly and likely not effective means of reducing transmission risk. The editorial calls for increased focus on improving ventilation and air filtration capacity to reduce respiratory exposure. Additionally, proper physical distancing and face mask use remain key tools in mitigating exposure and transmission risk for individuals.

The key to reducing the risk of symptomatic infection, especially moderate to severe illness and death appears to be vaccination.

While vaccination clearly reduces the risk of severe illness and death, we do not yet know whether or how much vaccination reduces the risk of carrying and transmitting the virus. So even after vaccination, an asymptomatic or minimally symptomatic person can still transmit the disease to others.

50-60% of viral transmission appears to be from asymptomatic individuals. So wearing a mask, social distancing, and avoiding unventilated crowded indoor spaces remains extremely important.

DOUBLE MASKING IS MORE EFFECTIVE THAN SINGLE MASKS.

A TRIPLE LAYER MASK OF TIGHTLY WOVEN FABRIC IS MORE EFFECTIVE THAN a SINGLE OR DOUBLE LAYER MASK.

N95 MASKS ARE MOST EFFECTIVE BUT THEY MUST FIT THE FACE WITH A TIGHT, SNUG FIT. 

TO IMRPOVE THE BARRIER FUNCTION OF MASKS WEAR A SNUG FABRIC MASK OVER A SURGICAL MASK OR OVER AN N-95. THIS WILL PROTECT BOTH THE WEARER AND THOSE AROUND THE WEARER. The fabric mask over a surgical or N-95 mask provides two mechanisms of protection. It adds an extra layer and it provides for a tighter fit of the underlying mask.

Doctors and nurses in hospitals and clinics often wear a surgical mask over an N-95. 

Face shields do not protect you or those around you from infection. Face shields and goggles (more so) likely decrease the risk of infection transmitted from aerosols that hit your eyes but do nothing for the most important mechanism of spread, breathing aerosols or droplets into your nose. Aerosols spread around a face shield into your nose. 

Think about smelling the pleasant odors of food cooking in a kitchen. Face shields will not block those aerosolized food vapors from entering your nose, but tightly fitting masks will do it to some degree.

SARS-CoV-2 virus is at least 10 times more lethal than an “average” case of influenza. Newer circulating variants have mutations that have probably increased the mortality rate.

SARS-CoV-2 is at least 10 times more easily transmitted compared to most respiratory viruses. Newer circulating variants have definitely increased ease of transmission by at least 30%. As a result, herd immunity will likely require 85-90% vaccination of a given population.

10 times 10 equals 100 TIMES MORE SERIOUS.

In addition, compared to other respiratory viruses, this virus will more frequently cause long lasting or even permanent damage and disability involving one or more organs (heart, lung, kidney, brain). Long-COVID can occur following minimally symptomatic illness and even after asymptomatic illness.

This virus is unique in that TRANSMISSION OCCURS MOST FREQUENTLY FROM ASSYMPTOMATIC INDIVIDUALS.

This occurs for two reasons.

1. Unlike most other respiratory viruses, there is a long time from the onset of when a person becomes infectious to when they become symptomatic. (an average of 5 days)

2. Some individuals never develop symptoms but are still highly infectious for up to 2 weeks.

Restaurants, bars, churches, meeting rooms, cafeterias, parties in closed spaces are situations for SUPERSPREADER EVENTS. An this includes SUPER BOWL PARTIES.

Studies in hospitals show that transmission to health care workers occurs most frequently in the cafeteria and in meeting rooms, not at the bedside where providers are wearing PPE.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels. Supplement with Vitamin D3 to get your levels above 30 ng/ml. (read this Open Letter)
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

Autoimmunity: Another reason why VACCINE is safer than INFECTION.

There is growing evidence that self-attacking ‘autoantibodies’ could be the key to understanding some of the worst cases of COVID-19.

This might explain why lung damage and other organ damage sometimes continues to worsen AFTER the body seems to have cleared the SARS-CoV-2 virus. And it could explain why some individuals fail to mount an adequate immune response early in the disease.

With respect to the later, in September 2020 researchers at the Rockefeller University reported that > 10% of 987 patients with severe COVID-19 infection had antibodies that blocked type 1 interferon molecules, an essential part of the innate immune system.

Other researchers have screened patients with varying severity of COVID-19 and found higher prevalence of autoantibodies against the immune system in infected individuals compared to uninfected controls.

Yet another study found that some infected individuals had autoantibodies against proteins in their blood vessels, heart and brain.

Many patients with severe COVID suffer from life threatening blood clots. Phospholipids play a major role in controlling blood clotting. 52% of 172 people hospitalzied with COVID 19 were found to have anti-phospholipid antibodies.

Annexin A2 is a human protein that protects the integrity of small blood vessels in the lung. Researchers have found a significantly higher average level of anti-annexin A2 antibodies in people who died of COVID-19 compared to patients with less severe illness.

So far it is unclear whether the virus caused these antibodies or whether these unlucky individuals had higher than normal amounts of auto-antibodies prior to infection.

A paper published in the immunology literature just yesterday might shed some light on this issue as well as on the topic of LONG COVID.

We sought to determine whether immune reactivity occurs between anti-SARS-CoV-2 protein antibodies and human tissue antigens, and whether molecular mimicry between COVID-19 viral proteins and human tissues could be the cause.

In other words, they tested antibodies against the SARS-CoV-2 virus to see whether they reacted against various kinds of human tissue. Here is what they found.

We found that SARS-CoV-2 antibodies had reactions with 28 out of 55 tissue antigens, representing a diversity of tissue groups that included barrier proteins, gastrointestinal, thyroid and neural tissues, and more.

This extensive immune cross-reactivity between SARS-CoV-2 antibodies and different antigen groups may play a role in the multi-system disease process of COVID-19, influence the severity of the disease, precipitate the onset of autoimmunity in susceptible subgroups, and potentially exacerbate autoimmunity in subjects that have pre-existing autoimmune diseases.

You can read the full study here: https://www.frontiersin.org/articles/10.3389/fimmu.2020.617089/full

Cross reactivity between antibodies against COVID-19 virus and human tissue was found for every major organ system in the human body.

The concept of “molecular mimicry” has been well described in auto-immunity for many years. This occurs when a portion of a foreign protein (on for example a virus or bacterium) is identical to a portion of a protein found in human tissue. When the immune system responds to invasion by a virus or bacteria it creates antibodies to various proteins on the invader. But in so doing the anti-bodies can react against human tissue that shares a small common string of amino acids (referred to as an epitope).

A famous example of molecular mimicry occurs with Rheumatic Heart Disease in which antibodies against the bacteria responsible for Strep Throat cross react with heart tissue causing destruction of heart valve tissue and a resultant leaky heart valve. In this situation cross reaction can also occur with tissue in joints resulting in arthritis, another hallmark of rheumatic fever. These were serious complications of Strep Throat before Penicillin became widely available.

So far we know that sicker COVID-19 patients demonstrate antibodies against multiple types of human tissue.

We also know that antibodies that react against various portions of the virus can also react against human tissue.

Finally we know that multi-organ failure is an inflammatory response wherein the immune system, rather than the virus, causes organ failure.

It would be a reasonable conclusion that auto-immunity can acutely contribute to cytokine and bradykinin storm.

It would also be a reasonable conclusion that auto-immunity contributes to LONG COVID.

So why would that make an mRNA vaccine safer?

The mRNA vaccine results in antibodies against one part of the virus (one epitope, the spike protein).

But infection results in antibodies against MULTIPLE PARTS OF THE VIRUS (multiple epitopes). Because multiple antigens or epitopes are involved in the immune response to infection, it increases the probability that cross reaction with multiple human tissues can result.

From an autoimmune perspective, the mRNA vaccine is much safer.

Obviously, given the fact that over 400,000 deaths have resulted in the US from this infection and no deaths have been attributed to the vaccine, the vaccine appears to be much safer than infection. Both the Pfizer and Moderna vaccine have decreased the risk of symptomatic infection by 95%. Severe symptomatic infection can lead to death. Even asymptomatic infection can cause LONG COVID. The risk-benefit analysis overwhelmingly favors the vaccine.

For a deeper dive into auto-immunity and COVID-19 here are a few more references:

High frequency of cerebrospinal fluid autoantibodies in COVID-19 patients with neurological symptoms

Autoantibodies against type I IFNs in patients with life-threatening COVID-

Diverse functional autoantibodies in patients with COVID-19

Prothrombotic autoantibodies in serum from patients hospitalized with COVID-19

 Association between anti-interferon-alpha autoantibodies and COVID-19 in systemic lupus erythematosus

Autoantibodies related to systemic autoimmune rheumatic diseases in severely ill patients with COVID-19

 IgM autoantibodies recognizing ACE2 are associated with severe COVID-19

Is the association between IgG anti‐cardiolipin autoantibodies and COVID‐19 severity related to the lung injury or to the SARS‐CoV‐2 infection?

Do cross-reactive antibodies cause neuropathology in COVID-19?

Immunoserologic detection and diagnostic relevance of cross-reactive autoantibodies in coronavirus disease 2019 patients

Anticardiolipin IgG Autoantibody Level Is an Independent Risk Factor for COVID‐19 Severity

Rheumatic manifestations of COVID-19: a systematic review and meta-analysis

The immunology of multisystem inflammatory syndrome in children with COVID-19

Clinical, Serological, and Histopathological Similarities Between Severe COVID-19 and Acute Exacerbation of Connective Tissue Disease-Associated 

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels. Supplement with Vitamin D3 to get your levels above 30 ng/ml. (read this Open Letter)
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

Vitamin D for All, the time is right

On Dec 7, 2020 a group of more than 100 scientists signed a letter recommending that governmental agencies and major medical organizations endorse their recommendation for universal Vitamin D supplementation at adequate doses in order to decrease the risk of COVID-19 infection and death.

https://vitamindforall.org/letter.html

The letter cites multiple converging sources of data from several studies that should no longer be ignored.

To all governments, public health officials, doctors, and healthcare workers,
[Residents of the USA: Text “VitaminDforAll” to 50409 to send this to your state’s governor.]
Research shows low vitamin D levels almost certainly promote COVID-19 infections, hospitalizations, and deaths. Given its safety, we call for immediate widespread increased vitamin D intakes .
Vitamin D modulates thousands of genes and many aspects of immune function, both innate and adaptive. The scientific evidence shows that:
● Higher vitamin D blood levels are associated with lower rates of SARS-CoV-2 infection.
● Higher D levels are associated with lower risk of a severe case (hospitalization, ICU, or death).
● Intervention studies (including RCTs) indicate that vitamin D can be a very effective treatment.
● Many papers reveal several biological mechanisms by which vitamin D influences COVID-19.
● Causal inference modelling, Hill’s criteria, the intervention studies & the biological mechanisms indicate that vitamin D’s influence on COVID-19 is very likely causal , not just correlation.

I have previously discussed the relationship between low Vitamin D levels and COVID-19 infection.

https://practical-evolutionary-health.com/2020/05/02/covid-19-link-to-vitamin-d-status-should-doctors-prescribe-sunshine/

Since that post several more studies have been published strengthening the evidence that low levels of Vitamin D are not only ASSOCIATED with increased risk of infection, severe illness and death from COVID-19, but that this relationship is CAUSATIVE.

80% of patients requiring ICU care for COVID-19 infection have low vitamin D levels (25-OH Vitamin D levels less than 30 ng/ml)

“The data strongly suggests that vitamin D is the safest, easiest, and most important anti-pandemic measure the world is failing to prioritize,” says Karl Pfleger, Ph.D., biotech investor, former Google data scientist, and one of the organizers of VitaminDforAll.org.

More than 80 percent of COVID-19 patients are deficient in Vitamin D, studies show.

But how much vitamin D should an adult take and in what form?

As discussed in the letter, 3875 IU (97 micrograms) of Vitamin D3 daily is required for 97.5% of adults to reach a level of 20 ng/ml. 6200 IU (155 mcg) are required for 97.5% of adults to reach a level of 30 ng/ml. These doses far exceed the RDA (minimum daily requirement) necessary to prevent rickets.

On a sunny day, not too far from the equator, adult humans are capable of generating 10,000 units of vitamin D per day from the interaction of sunlight with skin. Human studies have demonstrated NO TOXICITY with daily supplementation of 10,000 units Vitamin D3 per day. Because of the risks of skin cancer, common use of sun block, distance from the equator, and a decrease in the ability of humans to make vitamin D from sunlight as we age, too many people have chronically low levels.

Vitamin D is a fat soluble vitamin. On a given daily dose it takes about 3 months to reach a steady state (stable tissue levels).

The point of that open letter and similar letters which have been published in major medical journals is the following. There exists today enough data to support universal supplementation with safe doses of Vitamin D3, well above the RDA, in order to decrease the risk of COVID-19 infection, risk of severe illness, and risk of death with the infection. Any further delay, waiting for more data is senseless. The risk benefit calculation based on present data is a “no-brainer”.

My wife and I have been supplementing with 4000 IU per day. Fauci is reported to be taking 6000 IU per day. We take it with food in order to maximize absorption. Our levels have been measured. Our levels are >30 ng/ml, <40 ng/ml on this dose. These are protective levels.

The amount of supplementation necessary to achieve these levels varies from person to person, season to season, and varies with distance from the equator. Some individuals will require less, some more to achieve levels above 30 ng/ml. But adults can safely take the daily amount recommended in VitaminDforall, http://HTML version.

The suggested protocol for those not already receiving the recommended intake is 10,000 IU (250mcg) daily for 2-3 weeks (or until achieving 30ng/ml if undergoing testing), followed by taking 2000-4000 IU daily thereafter.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels. Supplement with Vitamin D3 to get your levels above 30 ng/ml. (read this Open Letter)
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

UK variant, Ro and herd immunity

The new SARS-CoV-2 variant first appearing in southern England has a transmission advantage of 0.4 to 0.7 points higher in reproduction number, also known as R0, compared to the initial strain, British researchers found.

From the study itself:

There is a consensus among all analyses that the VOC has a substantial
transmission advantage, with the estimated difference in reproduction numbers between VOC and non-VOC ranging between 0.4 and 0.7, and the ratio of reproduction numbers varying between 1.4 and 1.8.

The researchers published their findings on the school’s website. VOC means “variant of concern”.

In other words, this new variant has an Ro which is 1.4 to 1.8 times higher than the previously circulating predominant strain.

CDC has concluded that based on genetic studies (discussed in a previous post) and reactivity to antibodies found in the blood of vaccinated individuals it appears unlikely to impact COVID-19 vaccine effectiveness. This conclusion has been reached by multiple immunologists who did those studies. (See https://practical-evolutionary-health.com/2020/12/31/new-uk-sars-cov-2-variant-we-see-no-evidence-that-the-reported-mutations-would-substantially-increase-reinfection-risk-or-decrease-vaccine-efficacy/)

So what is the reproduction number? Ro is the average number of individuals infected by one person. A Ro of 2 means that every infected person on average infects 2 other people.

When a critical proportion of a population becomes immune, called the herd immunity threshold (HIT), the disease no longer spreads exponentially in the population. The disease reaches an endemic steady state. It neither grows nor declines exponentially.

From Wikipedia:

This threshold can be calculated from the effective reproduction number Re, which is obtained by taking the product of the basic reproduction numberR0, the average number of new infections caused by each case in an entirely susceptible population that is homogeneous, or well-mixed, meaning each individual can come into contact with every other susceptible individual in the population,[and S, the proportion of the population who are susceptible to infection, and setting this product to be equal to 1:

Ro X S = 1

S can be rewritten as (1 − p), where p is the proportion of the population that is immune so that p + S equals one. Then, the equation can be rearranged to place p by itself as follows:

Ro x (1-p) = 1, 1-p = 1/Ro, so {\displaystyle p_{c}=1-{\frac {1}{R_{0}}}.}

When the effective reproduction number Re of a contagious disease is reduced to and sustained below 1 new individual per infection, the number of cases occurring in the population gradually decreases until the disease has been eliminated.

An assumption in these calculations is that populations are homogeneous, or well-mixed, meaning that every individual comes into contact with every other individual, when in reality populations are better described as social networks as individuals tend to cluster together, remaining in relatively close contact with a limited number of other individuals. In these networks, transmission only occurs between those who are geographically or physically close to one another. The shape and size of a network is likely to alter a disease’s HIT, making incidence either more or less common

But transmission is not just affected by the characteristics of the virus, it is also affected by the behavior of the population in which the virus is observed. So it is complicated. As stated by the authors of the transmission study.

We note that these estimates of transmission advantage apply to a period
where high levels of social distancing were in place in England; extrapolation to other
transmission contexts therefore requires caution.

So if social distancing is relaxed, fewer people wear masks, more people congregate, then this variant could have a much higher Ro.

Ro for measles is 12-18 rendering HIT at 92-95%

Ro for SARS CoV-1 (2002-2004 pandemic) was estimated at 2-5 rendering HIT 50-80%

Ro for SARS CoV-2 (COVID-19) has been estimated at 2.5-4 giving and HIT of 60-75%.

This is not the first variant to demonstrate increased transmission. A new variant emerged in February of 2020 called D614G which had a higher Ro compared to the previously circulating predominant strain. Such strains with higher transmission rates eventually become the predominant strain circulating in a population.

So just as more people suffer from pandemic fatigue and drop their guard we have a more easily transmitted virus. Now is not the time to loosen up on precautions.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

New UK SARS CoV-2 variant: “we see no evidence that the reported mutations would substantially increase reinfection risk or decrease vaccine efficacy.”

We must all be thankful for the immunologists who continue to stay on top of the pandemic. They have our backs.

Recent tweets posted by reliable experts who have evaluated the mutations in the B.1.1.7 strain.

We used our database of 579 COVID patient samples to evaluate immune evasion the UK variant (B.1.1.7). Overall takeaway is reassuring: we see no evidence that the reported mutations would substantially increase reinfection risk or decrease vaccine efficacy. (1/n)

Here is some data from the lab of Winn Haynes. @hayneswa

I would prefer this in a manuscript, but given the time of year and that I’m tired, I’ll just tweet the data regarding the UK #COVID19 variant: PRNT50 values from COVID patients for SARS2 WT WA1 vs a mutant that contains N501Y (among other spike mutations).

What does this mean?

In the words of Prof Akiko Iwasaki

As RT above, @TheMenacheryLab has shown functionally that the N501Y mutation in the RBD does not evade existing antibodies’ ability to block replication. (8/n)

Eric Topol:

The good news is that it is not anticipated the current vaccines, which rely on inducing neutralizing antibodies to the spike protein, will be affected by B.1.1.7 or N501Y

If you want to keep up on these issues I suggest you follow Akiko Iwasaki on twitter.

Prof. Akiko Iwasaki

@VirusesImmunity

Bottom line:

The vaccines should work for this new variant despite the mutations.

There is no evidence that the new strain is more lethal (time will tell).

It is probable that the new strain is more easily transmitted (greater affinity for the ACE2 receptor and recent epidemiologic data)

Masks, social distancing, hand washing will continue to work.

Improved ventilation (in-door settings) remains important.

If you want to visit and celebrate, DO IT OUTDOORS with masks and distancing.

Humans need social interaction, this can be done safely without ignoring hygiene recommendations. Socialize and exercise safely outside.

Super-spreader events (such as Whitehouse holiday parties) should be avoided.

Religious services should be held outdoors with precautions. Tents with distancing and masks work!

If you are sick isolate.

Remember, individuals are most infectious before symptoms develop and for the first 5 days after symptom onset. So even though you feel well, you could be a spreader.

Everyone is vulnerable.

Young previously healthy teens and adults are dying and suffering Long-Covid with significant chronic illness.

If you are obese, overweight, pre-diabetic, or have diabetes, now would be a good time to go low-carb with an anti-inflammatory diet. The benefits occur immediately even before or without weight loss.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Happy New Year

Doctor Bob

COVID 19 Immune Response, How does it fail?

Dr. Akiko Iwasaki, an immunologist at Yale, has led an amazing research team from the start of this pandemic, analyzing the immune response of patients sick with COVID 19. She has co-authored a review of the immune response to be published in the January edition of Scientific American.

Iwasaki A, Wong P.  The immune havoc of COVID-19.  Scientific American, January 2021, 35-41.

Here is the link.

http://The Immune Havoc of COVID-19 – Scientific American

Before reading that article, a good place for a lay person to start would be her 8 minute youtube video, Immunology 101.

After watching that video and reading the Scientific American article, if you want a deeper dive into some of her team’s research, watch this video (28 minutes).

The Scientific American article discusses many of the unique characteristics of SARS CoV-2 compared to two previous corona viruses SARS CoV-1 and MERS. SARS CoV-2 which causes the illness called COVID-19, evades the human immune system in many ways. Those who become seriously ill, requiring ICU care, seem to suffer a time lag in their immune response compared to those who suffer less severe illness. In addition, the T-cell response in sicker patients is subdued and inadequate to clear the virus. Finally, a hyper-inflammatory response is present in most who succumb to the illness. Dr. Iwasaki discusses how the Cytokine storm of COVID-19 differs significantly from that seen with other viral infections and likely includes a new phenomenon referred to as a Bradykinin Storm which involves another major component of the immune system. There may even be an auto-immune component to this disease in some or many patients.

Early in the pandemic, physicians did detect elevated cytokines in patients, but the amount of these proteins and the subsequent inflammatory state they evoked differed from that of a classic cytokine storm.

We observed high levels of IL-5 and IL-17,cytokines not classically associated with antiviral immune activity. Instead these cytokines initiate a seemingly misguided
response—one better suited for infections by parasites and fungi.
We have yet to understand whether this response causes damage
to tissue or just diverts resources the body needs to fight the virus.

In the second video linked above Dr. Iwasaki describes how men and women demonstrate different immune responses with a higher fatality rate observed among men.

Much has been learned but much remains to be discovered as this pandemic continues to unfold.

There are a few clear facts emerging from multiple studies and observations.

Masks and social distancing work. Masks protect both the wearer and those around the wearer.

Most transmission occurs by droplets and aerosol (emitted from the nose and mouth).

Six feet of distancing is helpful but does not guarantee protection. Cases of transmission in restaurants via air flow from HVAC units have been described in which the infected person transmitting disease is far removed from the people becoming infected. (aerosol spread). Droplets and aerosol studies have demonstrated that coughing and sneezing can project infectious particles up to 26 feet.

The most dangerous circumstances for transmission include indoor confined spaces, with multiple people interacting for long periods of time (restaurants, bars, meeting rooms, parties, social gatherings).

Ventilation and air turnover are important factors.

This virus is unique in that higher viral loads and transmissibility occur BEFORE ONSET OF SYMPTOMS, rendering this virus more dangerous than previous pandemics. This can occur in patients who later develop symptoms or in people who carry the virus without ever developing any symptoms.

Some estimate that as much as 50% of transmission occurs from people exhibiting no symptoms.

Finally, “herd immunity” for infectious disease has never been achieved by reaching a critical number of infected people. “Herd immunity” has only been achieved in the past with vaccination programs. Herd immunity does not mean that disease transmission ceases, it means that transmission rates are very low.

What is herd immunity?

When most of a population is immune to an infectious disease, this provides indirect protection—or herd immunity (also called herd protection)—to those who are not immune to the disease.

For example, if 80% of a population is immune to a virus, four out of every five people who encounter someone with the disease won’t get sick (and won’t spread the disease any further). In this way, the spread of infectious diseases is kept under control. Depending how contagious an infection is, usually 50% to 90% of a population needs immunity to achieve herd immunity.

Most experts estimate that vaccination of at least 70% of the population will be required to reach some degree of herd immunity for COVID-19.

Here is a 2 minute discussion of herd immunity from Johns Hopkins before the Pfizer-BioNtech and Moderna vaccines were given Emergency Use Authorization by the FDA.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

New COVID strain in UK: Is it more dangerous?

A new strain of the SARS-CoV-2 virus has been identified in an area of the UK. The media are reporting on this as a new, more easily transmitted or more virulent strain.

Hold on!

There are theoretical concerns that some of the many mutations identified in this virus might make it more contagious and/or cause more severe illness. But this has not been confirmed by clinical data. The case rate in this part of UK is accelerating, leading to more restrictive social measures, but it is not clear whether this is related to human behavior, virus mutations, or a combination of both.

Caution would be prudent.

Here is the link to the posted report.

Preliminary genomic characterisation of an emergent SARS-CoV-2 lineage in the UK defined by a novel set of spike mutations

This report appears on the website:

SARS-CoV-2 coronavirusnCoV-2019 Genomic Epidemiology

This strain is of concern for several reasons.

It presents an unusually high number of mutations.

One of these mutations increases the virus’s affinity to the human ACE2 receptor.

Another mutation has been linked to evasion from the human immune system.

This strain accounts for an increasing proportion of cases in parts of England.

The number of cases of this strain is growing, and the number of regions reporting this strain are growing.

This combination of facts should be a red flag and the authors of the post state:

The rapid growth of this lineage indicates the need for enhanced genomic and epidemiological surveillance worldwide and laboratory investigations of antigenicity and infectivity.

In other words, it needs to be studied and tracked to see if it is significantly more contagious and what impact it has on the pandemic (spread of spread, intensity of illness, morbidity-mortality).

The authors speculate on the possible causes for this large a number of mutations in a single strain. They suggest that the administration of antibody therapy to immune deficient-depressed chronically infected patients could create conditions of evolutionary pressure for rapid and diverse mutation. If that theory is correct, given that there is no data demonstrating reduced mortality rates with this form of treatment, we may be creating a problem with an unproven therapeutic intervention (iatrogenesis).

Convalescent plasma is often given when patient viral loads are high, and Kemp et al. (2020) report that intra-patient virus genetic diversity increased after plasma treatment was given.

Hmmmmmmmmmmmmmm!

Stay tuned for updates.

Also, please read my post from 12/18/20 on the Pfizer-BionTech vaccine. I have made a few minor corrections and clarifications since the original post.

Covid 19 Vaccine: Statistics, Safety, Efficacy, What is a Confidence Interval? | Practical Evolutionary Health (practical-evolutionary-health.com)

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

Covid 19 Vaccine: Statistics, Safety, Efficacy, What is a Confidence Interval?

This week began the saga of vaccine implementation for the mRNA vaccine developed by the Pfizer-BioNtech partnership. The New England Journal of Medicine published a peer-reviewed article reporting the data from the RCT (Randomized Controlled Trial) and an Editorial appeared on the same day in the NEJM. You can view both here:

http://Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

http://SARS-COV-2 Vaccination — An Ounce (Actually, Much Less) of Prevention

If you go to the first link you can click on a link to a 3 minute video that summarizes the results. The video is informative and succinct.

Here is the most important table in the peer-reviewed article:

Age > 55 includes >=65 and >=75, Age >= 65 includes age >=75. If age>= 75 were not listed separately, all age groups would have statistical significance. This is why overall number of infections in the vaccine group is 8 but the total of the four age groups is 9. One of the 3 infections in age >55 was 65 or older. Got it?

Look at the third column labeled “Surveillance Time”. The first number in this column is described under the caption as “total time in 1000 person-years for the given endpoint..” So multiply by 1000 and you get a number that represents “person years” of observation. This is an odd number but a reasonable way to present information. The trial data covers a period of 6 months starting from when the first patient was vaccinated. The median duration of observation was 2 months after vaccination with the second dose. (50% of patients had been vaccinated for more than 2 months and 50% of patients less than 2 months)

The number in parentheses gives the number of people in each category of age, sex, race/ethnic group, country.

Notice that as we descend through the age groups from youngest to oldest, the number of participants decreases significantly in >= 65 and >=75 years old.

Now go to the last column labeled “Vaccine Efficacy, %”. The first number is the overall efficacy for that age group. But how confident are we about that efficacy % for each age group? The numbers in the parentheses represents a range or “confidence interval” which is determined statistically. This range is determined by the number of people in each (age) group and by the difference between the placebo and drug treatment outcome in that age group.

Note that the confidence interval widens as you go down from younger to older age groups. That is primarily because the number of people represented by the groups age >=65 and >= 75 are much smaller than the first two age groups.

For the age group > 65, the efficacy is reported at 94.7%. But that is an average number that shows that compared to the placebo group, the symptomatic infection rate in the vaccinated group was 94.7% lower. For the age group between >=65, there were 19 cases of symptomatic infection in the placebo group and only 1 in the vaccine group. 1/19 equals 0.0526. 1 minus 0.0526 equals 0.947 or 94.7% (rounding).

What is a 95% confidence interval?

The 95% confidence interval is the the range over which we are 95% confident the “true” value falls within. In other words, for age >=65 there is a 95% probability that the true vaccine efficacy falls somewhere between 66.7% and 99.9%. As more people age >=65 are entered into the trial, the confidence interval will get narrower for that age group provided the difference between the placebo and vaccine group remains the same. If the difference between placebo and vaccine groups increases AND the number of people in this age group increases, the confidence interval will shrink further.

This is a fantastic result!

But now look at the confidence interval for age >=75. It is -13.1-100. A minus number is in the range. That means we do not have enough people in the study age 75 or older to reach a “statistically significant” conclusion. There were only 774 folks who received the vaccine and 785 people who received the placebo in this age group. 5 in the placebo group got sick, 1 in the vaccine group got sick. This difference shows a “trend” but does not reach “statistical significance”. We need more data for this group.

But again, do not lose heart. Based on this data, which includes efficacy and safety overall, I recommend that my 92 year old mother-in-law receive the vaccine as soon as it is available.

What is “statistical significance”?

Simply stated, a result is “statistically significant” in a drug trial if the probability that the difference between the placebo group and the drug group occurred by accident (or by chance) is less than or equal to 5%. Or to put it another way, the probability that the difference between placebo and drug did not occur by chance but rather represents a true difference in outcome is 95% or greater. 5% is the standard cutoff point in medical trials. This is usually reported as a “p value”. If a p value is less than or equal to 0.05 the difference is considered statistically significant.

“Clinical significance” is another issue. For example, a drug might only decrease relative risk of an event by 5%, but the result could be “statistically significant”.

In the case of this vaccine, the clinical significance is outstanding.

Here is another important chart.

Protection begins at day 14 after first dose

This chart demonstrates that 14 days after the first dose of vaccine protection from symptomatic infection begins. The blue line shows infections in the placebo group, the red line is the vaccine group. They diverge at day 14. Thereafter the divergence increases. This makes sense. It is consistent with our understanding of how the immune system works. This time course is very reassuring.

Now let us look at side effects.

These are the usual side effects expected with any vaccine. Symptoms such as fever, malaise, local reaction at the injection site, muscle aches are all to be expected. This profile is a little worse than the flu vaccine, but less compared to the shingles vaccine.

So far 2 episodes of anaphylaxis have occurred in the US and in UK with the vaccine rollout. (millions of doses already given) This can happen with any vaccine, that is why 15 minutes of observation following vaccination is part of the protocol and the vaccine should only be administered in a location that has epinephrine available to treat a severe allergic reaction.

This vaccine time sequence is historically unprecedented. This was made possible by a combination of advances in science and incredible action on the part of the public and private sectors in response to a global crisis. Prior to this, the shortest time to develop an effective vaccine was 4.5 years (measles mumps, and that was done by Maurice Hilleman with the help of a few lab assistants, more about Maurice in my next post).

I received my first dose of the vaccine today (as a member of hospital medical staff). I was directed to a CDC website to register as a vaccine recipient. The CDC will send me periodic questions on side effects which I will answer. If everyone participates in this program more data will become available on safety and efficacy. So please participate when you get the vaccine (vsafe.cdc.gov).

Many questions remain. Here is a quote from the NEJM editorial:

  1. Will unexpected safety issues arise when the number grows to millions and possibly billions of people?
  2. Will side effects emerge with longer follow-up?
  3. Implementing a vaccine that requires two doses is challenging. What happens to the inevitable large number of recipients who miss their second dose?
  4. How long will the vaccine remain effective?
  5. Does the vaccine prevent asymptomatic disease and limit transmission?
  6. And what about the groups of people who were not represented in this trial, such as children, pregnant women, and immunocompromised patients of various sorts?

The logistic challenges of manufacturing and delivering a vaccine remain daunting. This vaccine, in particular, requires storage at −70°C, a factor that may limit its deployment in some areas. Nevertheless, the remarkable level of safety and efficacy the vaccine has demonstrated thus far make this a problem that we should welcome solving. What appears to be a dramatic success for vaccination holds the promise of saving uncounted lives and giving us a pathway out of what has been a global disaster.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

LONG COVID, WHAT IS IT?

I recently read an outstanding review of the topic “LONG COVID”. This has been defined in various ways. It can include persistent symptoms and/or organ damage following apparent “recovery” from the illness. There is no agreed upon definition. Our understanding is evolving. Time will tell how long symptoms can persist. It is clear that persistent symptoms and/or organ damage can occur even after minor illness or subsequent to asymptomatic positive PCR.

Full report can be found HERE

The following are EXCERPTS from the full report. References provided in the full report:

It has become clear in more recent months that an increasing number of individuals have been afflicted with persisting symptoms following a SARS-CoV-2 infection. Of these individuals, who have been referred to as “long-haulers” or as having “long COVID,” many did not initially experience a severe case of COVID-19, but rather had mild symptoms or were asymptomatic (Marshall, 2020)

According to Harvard Health, COVID-19 “long-haulers” include two groups of people affected by the virus (Komaroff, 2020):

· Those who experience some permanent damage to their lungs, heart, kidneys, or brain that may affect their ability to function.

· Those who continue to experience debilitating symptoms despite no detectable damage to these organs.

A team from the United Kingdom estimated that roughly 10% of individuals who have had COVID-19 experience prolonged symptoms (Greenhalgh et al., 2020). A guidance published on September 7, 2020 by Public Health England indicated that roughly 10% of “mild” COVID-19 cases who were not admitted to the hospital reported symptoms lasting more than four weeks (Public Health England, 2020).

Examples of some of the symptoms reported include:

· Prolonged low-grade fevers that do not respond to standard fever-reducing medications

· Neurological manifestations, such as memory loss and changes in the ability to recall words in a primary or secondary language

· Exercise-induced fatigue from walking around the block that led to a relapse of symptoms

· Symptoms in the central and peripheral nervous systems, gastrointestinal symptoms, skin problems, cardiovascular system occurrences

Some of the more commonly reported symptoms of long-COVID include: fatigue, cough, dyspnea, loss of taste and smell, muscle weakness, muscle and joint pain, headache, confusion, conjunctivitis, chest pain, decreased mobility and falls (Marshall, 2020; Paice et al., 2020).

On November 10th, 2020, the CDC updated its report entitled, “LongTerm Effects of COVID-19” (Centers for Disease Control and Prevention, 2020) to include the following information on long COVID: The most commonly reported long-term symptoms include:

· Fatigue

· Shortness of breath

· Cough

· Joint pain

· Chest pain

Other reported long-term symptoms include:

· Difficulty with thinking and concentration (sometimes referred to as “brain fog”)

· Depression

· Muscle pain

· Headache

· Intermittent fever

· Fast-beating or pounding heart (also known as heart palpitations)

More serious long-term complications appear to be less common but have been reported. These have been noted to affect different organ systems in the body. These include:

· Cardiovascular: inflammation of the heart muscle (in a German study 70% of patients had evidence of this, 80% of those patients had not been hospitalized)

· Respiratory: lung function abnormalities

· Renal: acute kidney injury

· Dermatologic: rash, hair loss

· Neurological: smell and taste problems, sleep issues, difficulty with concentration, memory problems

· Psychiatric: depression, anxiety, changes in mood

An organized study from Italy assessed the prevalence and types of persistent symptoms observed in 143 individuals after they were discharged from the hospital (Carfì et al., 2020)

The mean age of participants was 56.5 years old, with a range from 19 to 84 years of age, and 37% were female. The mean length of hospital stay was 13.5 days, and while in the hospital, 15% had received non-invasive ventilation, and 5% of the participants had received mechanical ventilation. The assessment described in the report occurred a mean 60.3 days after the onset of the first COVID-19 symptoms, and 12.6% were completely free of any virus related symptoms. The researchers reported that at a mean evaluation time of 60.3 days following COVID-19 symptom onset, 32% of the participants still had one to two symptoms, while 55% were still experiencing three or more symptoms.

The concept of chronic fatigue syndrome has been observed in individuals following infection with both viral and non-viral micro-organisms (Hickie et al., 2006). A study describing survivors of a SARS outbreak in Hong Kong stated that 40% had chronic-fatigue problems after three years and 27% met the criteria for chronic fatigue syndrome. The fatigue, also called postexertional malaise, results from a severe multi-organ crash following even light activities like a short walk. Similar effects have been reported after other large disease outbreaks (Hickie et al., 2006)

In summary, because the COVID-19 pandemic commenced only months ago, rather than years ago, the relatively long-term sequelae of COVID-19 are unknown; however, it seems that not unlike prior coronavirus outbreaks, COVID-19 has yielded reduced pulmonary and physical function, compromised quality of life and emotional distress. Unfortunately, prior outbreaks – including the SARS-CoV-1 epidemic — suggest that these associated effects can last for years (Marshall, 2020).

Challenges for people experiencing longer term effects from COVID19 can include:

· Widespread perception that people either die, get admitted to hospital, or recover after two weeks; however, it is clear that some individuals experience ongoing, or long COVID.

· Long COVID is a multisystem disease; thus, the symptoms vary significantly among the individuals with persisting effects from COVID19.

· It is unknown why some experience a prolonged recovery while others do not.

· Many individuals with mild or asymptomatic COVID-19 cases experience long-term COVID-19, but oftentimes, they were never initially tested for a SARS-CoV-2 infection, and therefore have not been flagged for a positive test result.

· There is a lack of consensus on diagnostic criteria for long COVID.

· Lack of guidance for reaching a working diagnosis and code for clinical datasets.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob

COVID-19 update: Vaccines, Drugs, Good News and Bad News.

This week has brought good news and bad news.

First the good news, preliminary data on two vaccines (from Pfizer and Moderna) show 95% efficacy. Today Pfizer applied to the FDA for EUA (Emergency Use Authorization) for their mRNA VACCINE. Both vaccines use an approach never used before. The vaccines both involve injecting messenger RNA (mRNA) which enters human cells where the cell machinery produces a sequence of amino acids which reside on the spike protein of the SARS-COV-2 virus. The immune system then responds to that portion or the virus protein. Both vaccines reduced the rate of moderate to severe illness by about 95% compared to the placebo group. No study subjects were younger than 18. We do not yet know the age distribution or underlying medical condition profile of the vaccine and placebo recipients.

Data are being released to the medical community for review. Hopefully there will be a broad representation of our population in the study groups.

If approved for Emergency Use Pfizer estimates that about 40 million doses could be produced by year’s end. That would cover 20 million people (each person receives a series of two shots).

Cautions:

  1. So far safety looks good, but rare complications will not be known for a long time.
  2. Safety and efficacy in folks younger than 18 not known.
  3. The Pfizer vaccine requires very cold storage which is not available in pharmacies, doctor’s offices and clinics. Distribution logistics will be complicated and will require storage in hospitals or other facilities that have minus 70 degree F capability.
  4. We do not know if the vaccine reduces death rate with infection, that will not be known for at least a year or two.
  5. We do not know how long immunity will last.
  6. It will take more than a year to ramp up production and administer the vaccine to adequate numbers of people to achieve herd immunity.
  7. Even after large numbers of people are vaccinated, masks, social distancing and hand washing will remain important parts of protecting the public.
  8. If availability of a vaccine causes people to be less adherent to behavioral guidelines, the net effect could be greater illness and death rather than less protection.

You can listen to an interview with vaccine specialist Dr. Paul Offit here:

http://For COVID-19 Vaccines, ACIP Will Be a Critical Gatekeeper

A transcipt is also available at that site.

The interview describes how the vaccine trials were designed and discusses the independent groups of scientists and doctors who review data on vaccines. The important roles of the DSMB (Data Safety Monitoring Board) and ACIP (Advisory Committee on Immunization Practices) are discussed. Many areas are covered. They include problems with previous vaccines, realistic expectations about production and distribution, the many kinds of vaccines still under various stages of study, the process of EUA and the differences between EUA and FDA final approval.

There’s a DSMB for each of these phase 3 trials, which is a multidisciplinary group,
including people who are experienced with clinical trials, biostatisticians, bioethicists,
immunologists, vaccinologists, and virologists. You have this big crew, they’re reviewing the blinded data, and they have a pre-programmed time of review. Also, they have stopping rules that are defined ahead of time for both futility and for overwhelming efficacy.

Drugs for Covid:

Dexamethasone, an anti-inflammatory steroid, has been demonstrated to reduce death rates in very sick patients.

The study, published in The New England Journal of Medicine in July, found the drug cut mortality by a third among severely ill COVID-19 patients who were on ventilators, and by a fifth for patients receiving supplemental oxygen. It was found not to have any benefits for patients with mild illness, and there was some evidence of potential harm.

So far, no other drugs have been shown to reduce risk of death. Remdesivir at best reduces duration of illness.

But today a combination drug (Baricitinib plus Remdesivir), was granted an EUA by the FDA. Like Remdesivir, the combination reduced length of illness. In the case of the combination, the duration of illness was reduced by only ONE DAY which is less than the reduction previously reported with Remdesivir alone (3 days). This discrepancy has not been explained and it concerns me. Why would an effective drug combination produce less reduction in duration of illness than one of the drugs used alone? Hmmmmmmmmmmmm

But more importantly:

The odds of a patient dying or being ventilated at day 29 was lower in the combination group compared with those taking placebo + remdesivir, the press release said without providing specific data. For all of these endpoints, the effects were statistically significant.”

Data on the actual reduction in risk of death has not yet been released for scientific review.

Remember EUA was previously granted for Hydroxychloroquine, then revoked when larger controlled studies showed no benefit and possible harm. Likewise, use of convalescent plasma from recovered COVID patients was granted EUA but the data so far do not support its use.

So we have very hopeful preliminary data on 2 vaccines and we have dexamethasone and a new combination drug reported to reduce mortality in very sick patients. The data on dexamethasone is convincing. All we have on the combination treatment is a press release so far.

Now the bad news.

Hospitalization rates and infection rates are at record highs.

One out of five hospitals this week in the US anticipate a critical staffing shortage of health care workers within a week.

Last week I heard an interview with an ICU doctor in Billings Montana. The ICU COVID-19 cases were so great in number that in order to meet the demand the hospital did the following:

  1. Converted single bed ICU rooms to doubles
  2. Converted the cardiac care unit to a COVID ICU
  3. Converted recovery room beds to ICU beds
  4. Converted ER beds to ICU beds.

All of those ICU beds were full. The doctor said if the growth in cases did not slow down they would be left with “difficult choices”. Read that as triage. Patients most likely to survive get critical care, those less likely get comfort measures. Meanwhile non-COVID patients who need critical care may not get the level of service they need.

Doctors and nurses across the country are suffering burnout. Many have become infected. Some have died. The American Nurses Association report over 1200 nurses have died from COVID-19 in the US.

In a survey of hospital nurses conducted last week 80% reported inadequate PPE.

Interviews with nurses reveal that some patients dying of COVID do not believe they have the disease. There is a cult of Trump followers who believe his dangerous lies, misinformation and conspiracy theories. Despite death staring them in the face, some still refuse to believe the virus is real. Amazing.

So it will get worse before it gets better.

Next post will discuss “Long Covid”.

In the context of the COVID 19 pandemic I will close with the usual summary.

  1. Avoid alcohol consumption (alcohol wreaks havoc with your immunity)
  2. Get plenty of sleep (without adequate sleep your immune system does not work well )
  3. Follow good sleep habits
  4. Exercise, especially out of doors in a green space, supports the immune system
  5. Get some sunshine and make sure you have adequate Vitamin D levels.
  6. Eat an anti-inflammatory diet rich in micronutrients.
  7. Practice stress reduction like meditation and yoga which improves the immune system
  8. Eliminate sugar-added foods and beverages from your diet. These increase inflammation, cause metabolic dysfunction, and suppress immunity.
  9. Eliminate refined-inflammatory “vegetable oils” from your diet, instead eat healthy fat.
  10. Clean up your home environment and minimize your family’s exposure to environmental toxins by following recommendations at EWG.org with regards to household products, personal care products, and organic foods. (https://www.ewg.org/)

THIS WEBSITE PROVIDES INFORMATION FOR EDUCATIONAL PURPOSES ONLY. CONSULT YOUR HEALTH CARE PROVIDER FOR MEDICAL ADVICE.

Eat clean, drink filtered water, love, laugh, exercise outdoors in a greenspace, get some morning sunlight, block the blue light before bed, engage in meaningful work, find a sense of purpose, spend time with those you love, AND sleep well tonight.

Doctor Bob