Post-Covid 19 Chronic Anxiety syndrome

-“Doctor….I’m not feeling well. Losing my temper. Can’t sleep…So much anxiety- what’s going on?”

Celia X. is a proficient and dedicated nurse of a major Fort Lauderdale hospital who had consulted us for resilient Migraine Headaches many years ago but then chose another practitioner, closer to her residence in Broward County. As she has been a loyal reader and fan of this web page, she called us a few days ago to congratulate us for the publication of our new book. From the start she started “spilling he beans’ and confessed to us that, even though she has been spared the worst ravages of this terrible pandemic at the personal. labor, financial and social levels, she was still not feeling right. Her live-in migraines and depression worsened with the arrival of a new boarding buddy: Anxiety.

We told her that, in a major or minor degree, it is a common situation for almost all of us and that she should not despair. Slowly but surely we will al come out of this protracted, insufferable, cruel Social Isolation that has wrecked the Mental Health of millions of humans across the World. We counseled her to deal with one little problem at a time and not overburden her daytime with too many objectives at work and home, like she had finely done before the pandemic struck us. We also encouraged her to continue chatting about these issues with family, friends, counsellors, etc., because the mere act of “bringing it out into the open” will bring her some balsamic relief and give her new perspectives by analyzing their input. She told us that after just chatting with us for a few minutes, she was already feeling a little bit better. As the French psychologist Jacques Lacan said:

“Dans tout acte manqué, il y a un discours réussi.”

(In every failed act, there is a successful address)

Note. This reproduction of Claude Monet’s Camille Monet on a park bench was taken from Wikimedia Commons.

https://commons.wikimedia.org/wiki/File:WLA_metmuseum_Camille_Monet_on_a_Garden_Bench_by_Claude_Monet.jpg

Here is an excerpt of our book Emotional Frustration – the Hushed Plague where we discuss it:

“Once the lockdown is levied, many of the once thriving small businesses that used to predominantly employ women will be gone. And there will be hardly any credit for entrepreneurial initiatives as the banks will be reluctant to lend. Not only did women hold most of the jobs of Education and Health Care —the hardest hit economic sectors—but they were also furloughed in greater numbers than men…

A large proportion of them are single parents of the Latino and Black Minority groups. These disadvantaged single women, lacking adequate social/family support, rely on their children’s school services for their care, instruction, and meals. If they cannot take their kids to school, they will not be able to resume their former duties.

The same chronic anxieties pervading the workplaces may foster a creeping loss of libido and eroticism in many blue collars’ bedrooms. On the other hand, women with a “hot” privileged spot in the upcoming New World Order will be less amenable to passivity, demanding equal rights inside and outside the bedroom. Moreover, after months of this pandemic and its Social Isolation, our nerves are so frayed that we are seeing in our offices a rising number of patients sick with a depression associated with high anxiety—the Post Covid 19 Chronic Anxiety syndrome.

Has my world become dangerous? Will I keep my job? Will I find a partner?

Can I safely touch this person? Did I clean my groceries carefully enough?”

We will address specific issues of this critical clinical condition for different age, ethnic and socio-economic groups in our upcoming Wellness articles and Podcasting . Stay tuned for much more.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

We got the Pfizer-BioNtech booster shot!

Dear readers and fellow bloggers;

Good morning. Yesterday, my son Gian Luca and myself got the third dose of the Pfizer-BioNtech vaccine in the brand new Walgreens store located in Calle Ocho and Eight Avenue of Miami. 

In this picture you can see how a lovely technician called Elleny (very beautiful but too shy to allow us to take a simple screenshot of hers) administers the so-called booster shot of that vaccine.

Thank you very much for taking care off us with great diligence and patience for this important step.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Are booster shots for COVID 19 vaccines necessary right now?

Rationing of Health Care Resources is that miserable member of the Public Health family that is always pushed to the kiddies’ table in the bacchanal feast of American Health Care delivery , never to be mentioned in the polite conversation of its policymakers, physicians, wonks, etc. Le Sans Nom. Unlike the United Kingdom, where the criteria for use of scarce resources like kidney dialysis are way up front and totally assumed, in the USA we tend to tiptoe around this issue in a hypocritical, yet popular dance. We discussed this issue at length in our Columbia University Doctoral thesis.

Note. This reproduction of John Raphael Smith‘s picture of Edward Jenner, the English inventor of the modern vaccination techniques, was taken from Wikimedia Commons.

https://commons.wikimedia.org/wiki/File:Edward_Jenner.jpg

On September 20, 2021, Ariana Eunjung Chua and Meryl Kornfeld wrote in the Washington Post that: “Kristen Solana Walkinshaw, a physician on the coronavirus triage committee at Providence Alaska Medical Center in Anchorage, found her team making one of the most agonizing decisions of their careers…Four patients needed continuous kidney dialysis, her colleague explained, but only two could be made available. How should I choose?”

The recent surge of the Delta variant affecting the scandalously high number of unvaccinated people that need immediate hospitalizations in the USA, has made the issue of the booster shots for the mRNA vaccines for Covid 19 much more relevant. Boosting might be eventually necessary in the general population that has already gotten the two-dosages of the mRNA mediated -vaccines due to the waning immune responses and the potential inefficacy of vaccines against newly surging variants.

On September 17, 2021, a scientific panel of the Food and Drug Administration (FDA) recommended that the booster shots for the Pfizer-BioNtech vaccine (Moderna has not yet submitted all the needed documentation) should be given to persons older than 65 years old, the immunocompromised and those with direct exposure to sever cases of SARS-CoV-2 infection only. The rest has to keep waiting. After Dr, Fauci publicly announced that there might be a need for a third booster shot , imprudently kowtowing to the undiplomatic move by the Biden administration to start offering them after September 20, this issue turned vitriolically political. How can Father-Knows-Best-Joe, who claimed in is campaign rallies that he would always follow science once he was in government, dared to put his chariot of convenience in front of the Faulkerian horse of tasking? Did you start lying, Papa Joe?

On September 13, 2021, an article in the Financial Times reported that: “two top scientists who recently announced their retirement form the US drug watchdog  have criticised the policy of giving most people Covid 19-booster vaccinations, just days before the Biden administration plans to start doing so. Philip Krause and Marion Gruber, who resigned from the Drug and Food Administration two weeks ago, are among the authors of a scathing critique of widespread booster shots…”

Those two scientists joined a large group of colleagues that, in an Overview article of The Lancet on September 13, 2021, to make the point that the available scientific data so far does not justify the use of booster shots, except in special circumstances. They propose to use the available resources to boost the public vaccination drive for millions of people in the USA and elsewhere that have yet not had their first shot. They show their open disgust at the maladroit move of politicians to soil their turf.

In a personal level, let us confess that after being fully vaccinated with the Pfizer-BioNtech vaccine since February, we will take advantage of that opportunity due to our age. Our immunity might still be good and not a cause of concern….We follow Social Distancing guidelines…Mmm… However….

En tout cas.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Crying Alone in the Bathroom as a coping mechanism in the Pandemic

-“Doctor…Why didn’t we insist that he should get the vaccine—feel so guilty.”

Maria X. is a brave and tenacious middle-aged homemaker with a loving husband and two gorgeous teenagers, having worked tirelessly since they immigrated to the USA from Cuba in that infamous Mariel exodus. Since they arrived in South Florida, we have been good friends and they even visited our medical office several times.

Her husband, very confused by the false mantra of the social media liars and anti-vaccination wackos decided that they should all wait until the mRNA vaccines got the final expert approval to do the only know way to avoid disease: get vaccinated. They did observe the basic rules of Social Distancing and wore the needed mask. However, all those precautions were for naught as one of his store customers got infected with the dangerous Delta variant in early July and passed it on to him.

Yesterday I garnered enough courage to visit him in the Intensive Care Unit where he has been hospitalized for a week already, with plenty of machines whirring away. Heavily sedated, he could open his eyes to welcome me when the nurse told him. Deeply distraught, I went to the waiting area where his loving family had been keeping vigil day and night, praying to God Almighty and expecting a miracle. When his children saw me approaching, they raced to embrace me and cry in my arms.

After forty years of continuous and varied medical practice, I believed that there would be few things that could shake me to the very bone. I was wrong. That did. I tried to talk them out of their despair and re-assure them that there was still hope. Pushing away at an almost irrepressible desire to cry together, I did what most of us, physicians, have doing during this terrible ordeal. Stiffen my upper lip and carry on. After talking a few minutes with Maria in a discreet corner, I invented an excuse and promised them that I would return. I skedaddled down the hallway to the nearest bathroom.

I cloistered myself in the loo and slumped on a covered toiled seat. I welled up in earnest.

Note. This reproduction of Rembrandt’s Weeping Woman was taken from Wikimedia Commons. https://commons.wikimedia.org/wiki/File:Rembrandt_A_Weeping_Woman.jpg

Ever since the sanitary facilities were invented in the nineteenth century, they have been used as a clandestine hiding place by women. But now men are catching up fast. The following text is an excerpt of my upcoming book Emotional Frustration – the hushed plague.

—”Doctor…I hide in the bathroom—so my children can’t hear me cry.”

Susan X. is a nice, intelligent, and hard-working mother of a small child who must shoulder the entire burden of her household all alone, even though she was diagnosed with Multiple Sclerosis. Her husband works as a salesman and has had a chronic back problem since he was injured in a previous stint as a truck driver.

Her family cannot help her economically but her mother pitches in occasionally. Oftentimes she puts her child to bed, finishes her household duties and, before her husband arrives for a late supper, locks herself in the bathroom to well up at ease. It is a simple ritual that gives her emotional relief. Crying alone in the bathroom.

The tried-and-true escape valve for women in angst. Like our mother Gladys did.

Modern women, who are employed full-time in demanding jobs, usually must return home to complete the house chores with little or no help from their live-in partners; to make matters worse they might not have the support offered by close family members or friends. In our hyper-connected age, where most of the rooms at home are taken over by the obnoxiously-pinging squatting devices, they must retrench to the bathroom—their “panic room” to do an exorcism of sorts.

Welling up, they slump on the floor and hug the cold toilet with passion.

Isn’t it sad that they had to anoint a disposal unit as a default confidante?”

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Anger Displacement as a coping mechanism in the Pandemic

The following text is an excerpt of our upcoming book Emotional Frustration- the hushed plague.

—”Doctor…when I get home, I can’t help lashing out at the kids—so bad.”

Verschiebung. This German term can be translated as “shift” or “move.” It was used by Sigmund Freud to describe a psychological defense mechanism; it entails the shifting or displacement of an aggressive emotion from an important person or object into other ones that are less relevant and often lame. [i] Our patient had many situations of Emotional Frustration in her blue-collar job with her despotic boss and his unreasonable demands but, being a single Mom, she hid her anger towards him and the system, fearful of losing her job in tough  times. Often, she scolded her children a little bit too much for just some obnoxious but inconsequential pranks.

This unconscious defense mechanism is an expression of what Freud dubbed as the mortido—our basic aggressive drive. There are three main mechanisms:

  1. Displacement of object
  2. Displacement of attribution
  3. Bodily displacements.

Unfortunately, as we slowly come out of our forced Social Distancing and we interact much more with other human beings, we are loaded up with stress and, as a natural consequence, we will have a shorter fuse, easily snapping away. We will have a hard time containing ourselves, even with an act of mea culpa [ii], if we allow our emotions to get the best of ourselves in the mad frenzy for survival.

Note. This reproduction of Un episodio de la Fiebre amarilla en Buenos Aires, the great painting from our fellow Uruguayan artist Juan Manuel Blanes, was taken from Wikimedia Commons. Even though it is shockingly gory to watch, it does convey the message that there are many dangerous things that we can bring home and affect our families’ well-being – the virus is just the most lethal.

https://commons.wikimedia.org/wiki/File:Juan_Manuel_Blanes_-_Un_episodio_de_la_fiebre_amarilla_en_Buenos_Aires.png

One of the most disregarded aspects of the Social Isolation that we have all been enduring for almost one year already is its serious emotional toll on us. Like the young women and men that went into isolation in a Florentine villa in the Decameron, those coming out of seclusion will not be the same ones that went in. There will be multiple changes in our societies, especially for labor opportunities. The economic analysts are already predicting that, besides the contraction of consumer spending due to loss of jobs, there will be a two-speed labor market.

On one hand there will be persons that can work at a distance, with little physical contact. But on the other hand, there will be those that will be dangerously exposed to contagion. This will bring a generalized angry mood in the street like we have never witnessed before. No longer will we be able to take for granted the barista’s familiarity when we arrive at our Starbucks; she might be too worried about being infected while mulling about her son’s day care. After her shift is over, she might be too stressed out to hang out with her girlfriends. A self-sustaining vicious circle.

Stay distant. Stay safe. Stay beautiful.

References

[i] Sigmund Freud, New Introductory letters on Psychoanalysis, George Allen and Unwin, London, January 1940,

[ii] This term in the Latin language refers to the ancient act of contrition of Christians in front of the Holy Cross when they beat up their chests while they publicly assumed responsibility for their sins or faults.

What do you think? Please tell us.

Don’t leave me alone.

 

 

Sexual Pleasure as a coping mechanism in the Pandemic

During the incredibly lengthy and tragic Pnndemic that we have been suffering from the worldwide Covid-19 infection, we have oftentimes discussed, in public and personal spheres, whether our sex life has improved or not due to the close proximity. The results are mixed, as many long-term happy couples have enjoyed it, while others with “less than friendly attitudes” toward each other have definitely hated it.

The fact that both members of a couple had to spend more time together at home has certainly frayed the nerves of all genders, as it always good to have “a little respite.” Now that the economy is slowly picking up in the USA, after the quasi-massive vaccination of almost 50% of the population and the corresponding lifting of the restrictive measures in public, many employees and professionals are reluctant to go back to the offices with the 9 to 5 presence. But others are only too happy to do it.

Of course the natural reaction is to ascribe this “enthusiasm to go back to the office” to Men, who were always looking for any kind of excuses to play “two-timing.” Even though there are not yet any reliable social and psychological studies about the changing dynamics of our (true) sexual lifestyles, there are some good indicators. One of them is that Women seem to be almost as enthusiastic to “hit the road again” to re-connect with friends, work buddies, etc., and pourquoi pas, a hidden flame.

One of the most radical aspects of the Pandemic’s aftermath is that Women, who have been bearing the brunt of keeping their homes functional under extreme duress, may no longer accept the same sex they used to. We discussed this in our new book Emotional Frustration-the hushed plague. We hereby present two excerpts from different sections of that upcoming book.

—”Doctor…Never had so many fab orgasms—not going back to same old.”

Wanda X. is a lovely middle-aged entrepreneur that had the misfortune of being surprised by the “staying at home” order in a business trip to a distant state. Fortunately, she had an old friend from college that gladly welcomed her to bunk. Unlike her, she was single and childless, which gave her a lot more sexual leeway.

One of the little perks of her friend’s lifestyle is to unabashedly recur to the use of a vibrator when she felt the irrepressible urge to satisfy her sexual desire. Reluctant at first, Wanda X. eventually relented, after a month of seclusion. Slowly she learnt how to handle it and at the same time learn more about her sexuality. When she would be finally able to return to her home, she is planning to sit down for a serious discussion with her partner. She will tell him that she is tired  of her culturally assigned role of a passive giver of love and that she wants the urgent addition of the role of active demander of love. Clear as a spring brook can be.

Note. This reproduction of Toulouse Lautrec’s Dans le lit- Le Baiser was taken from Wikimedia Commons.

https://commons.wikimedia.org/wiki/File:Toulouse_Lautrec_In_bed_the_kiss.jpg

The same chronic anxieties pervading the workplaces may foster a creeping loss of libido and eroticism in many blue collars’ bedrooms. On the other hand, women with a “hot” privileged spot in the upcoming New World Order will be less amenable to passivity, demanding equal rights inside and outside the bedroom. Moreover, after months of this pandemic and its Social Isolation, our nerves are so frayed that we are seeing in our offices a rising number of patients sick with a depression associated with high anxiety—the Post Covid 19 Anxiety Syndrome.

Note. This reproduction of Gustave Courbet’s Les amants was taken form Wikimedia Commons.

https://commons.wikimedia.org/wiki/File:Courbet-Amants-Lyon.jpg

Has my world become dangerous? Will I keep my job? Will I find a partner? 

 Can I safely touch this person? Did I clean my groceries carefully enough?

We are just beginning to see (and experience) a radical re-engineering of erotic relationships.

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Alcohol Abuse as a coping mechanism in the Pandemic

Did the Social Isolation during the Pandemic increase the use and abuse of Alcohol in the USA?

In a recent article of the Journal of the American Medical Association (JAMA) Rita Rubin stated that the generalized decision to keep the liquor stores open in the USA during the worst period of the pandemic (wrongly considered as “essential businesses”) had the unintended but grave effect of increasing its use and abuse by many segments of our society. She said: “…the immediate effects of alcohol abuse patterns have been increases in alcohol-related emergencies such as alcohol withdrawal, withdrawal-related suicides, methanol toxicity, and alcohol-related motor vehicle crashes.”

Moreover, the abuse of Alcohol might have worsened the clinical symptoms of the patients infected with Covid-19 because the virus impairs the normal immune defenses of the Respiratory System. an effect that the medical personnel treating the 1918 Influenza pandemic had already observed.

Note. This reproduction of Edouard Manet’s Un bar Aux Folies Bergères was taken from Wikimedia Commons.  

By Édouard Manet – Un bar aux Folies-Bergère d'E. Manet (Fondation Vuitton, Paris), CC BY 2.0, https://commons.wikimedia.org/w/index.php?curid=83676367

If women often have borne the greatest brunt of the social and economic consequences of the dire Social Isolation and changes in the work/study parameters of their homes, did they abuse it too? We do not have yet a much needed segmentation of the data in a published paper, but we guess they did. As the dynamics of Alcohol Abuse in Women is different, we would like to present an excerpt of our upcoming book Emotional frustration- the hushed plague, to start the discussion. Here it is:

—”Doctor…Got to have a shot before I go to bed…Can’t sleep if I don’t!”

Carol X. is a divorced middle-aged mother of three that looks much older than her chronological age due to her chronic abuse of alcohol and smoking. Paradoxically she kicked her husband out of their house due to heavy drinking but his bottle—a callous counsellor of sorts—stayed behind in a cupboard’s top shelf. Like for many women, it started as a self-medication for her resilient depression and insomnia, furtively used at home, without nosy witnesses; slowly she became hooked on that habit, even after having Detox and joining Alcoholic Anonymous.[i]

A study [ii] by the National Institute of Alcohol and Drug Abuse shows that 60% of US women have at least one drink a year; 13% of the latter group have more than seven drinks per week. This level is above the “Dietary Guidelines for Americans” [iii], issued by the Health and Health Services Department.  Women’s bodies have less water than men’s ones, which makes it harder for them to disperse the toxic by-products in brain, liver, digestive tract, and kidneys. Even with small intakes, they are at a higher risk for car accidents and abuse.[iv]  Even though it is illegal in all states, underage women engage in it, especially in American colleges.[v] Alcohol temporarily blunts all the sensory input to the brain, which brings an illusory sense of relief; it enables the onset of the first superficial phase of the sleep process, but it decreases the duration of the REM phase. [vi]

References

[i] https://www.aa.org/

[ii] https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-facts-and-statistics

[iii] https://health.gov/dietaryguidelines/

[iv] National Institute on Alcohol Abuse and Alcoholism, Video presentation “Alcohol and the Female Brain”, presented by NIAAA Director Dr. George F. Koob, January 9, 2018.

https://www.niaaa.nih.gov/alcohol-and-female-brain-presented-by-NIAAA-director-george-koob

[v] “Are women more vulnerable to alcohol effects?” National Institute on Alcohol Abuse and Alcoholism, No. 46, December 1999. https://pubs.niaaa.nih.gov/publications/aa46.htm

[vi] Soon-Yeob Park, Mi-Kyyeong Oh, Bum-Soon Lee, “The effects of Alcohol on Quality of Sleep”, Korean Journal of Family Medicine 2015 Nov; 36(6): 294-299

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

 

 

 

Longer lasting Immunity against Covid-19 from mRNA vaccines

A successful humoral response to any modern vaccination entails the creation of a high affinity and durable antibody response that will protect individuals for many years. For all those of us who have received the mRNA-platform vaccines—the Pfizer BioNtech or the Moderna brands—the question is: “How long will our protection really last?”

In an accelerated article preview—mechanism through which a paper of high public interest gets prioritized —of the prestigious journal Nature, Jackson S. Turner et al., from the Washington University School of Medicine, addressed this issue. They studied the induction of Antibody Secreting Plasmablasts (PBs) and Germinal Centre (GC) B cells by the two available messenger RNA-based vaccines at present.

They said: “we conducted an observational study of 41 healthy adults (8 with history of confirmed SARS-CoV-2 infection) who received the Pfizer-BioNtech vaccine…Blood samples were collected at baseline and at weeks 3 (pre-boost), 4,5,7 and 15 after the first immunization. FNAs of the draining axillary lymph nodes were collected form 14 participants (none with history of SARS-CoV-9 infection) at weeks 3 (pre-boost), 4, 5, 7 and 15 after the first immunization.” Do the mRNA-based vaccines induce significant antigen-specific PB and GC B cell responses?

They found that one week after the booster immunization, this vaccine induced a strong IgG-dominated antibody response in blood and that there were strong binding GC-B cell responses and PB responses in the lymph nodes’ aspirates from the 14 participants. These responses were initially detected after the first immunization, and they rose significantly after the second dosage. Compared to the humoral response to the seasonal flu-virus vaccination, these responses were higher in magnitude.

The authors said: “the persistence of S-binding Gc B cells and PBs in draining lymph nodes is a positive indicator of induction of long-lived plasma cell responses. Future studies will be needed to examine whether mRNA-vaccination induces a robust-S-specific long-lived plasma cell compartment in the bone marrow.” The authors admit that these are just preliminary studies that need much stronger scientific follow-ups. If the mRNA-based vaccines induce strong GC reactions, they will become critical tools in the fight against a pandemic that is still producing dangerous virus variants. Moreover, the rise of vaccine hesitancy in the USA and other nations, has to be remedied by increased delivery of good information to the public by the often “isolated, haughty scientists.”

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Just a good vaccine will not magically fix the pandemic

Today, December 10th, an experts’ commission on vaccines from the Food and Drug administration (FDA) is reviewing the scientific data of the Pfizer-BioNtech vaccine candidate to eventually determine whether it is safe and effective against the COV-Sars 2 virus that has been producing this terrible pandemic we have been suffering for almost a year. As expected, we are all very hopeful that they will approve it.

In a recent paper in Health Affairs, A. David Paltiel—nominated by President-elect Joe Biden to join a group of experts to advise him on the pandemic’ cure—et al. warn us that there are other factors that will determine the vaccines’ effectiveness. They said that: “Using a mathematical simulation of vaccination, we find that factors related to implementation will contribute more to the success of vaccination programs than a vaccine’s efficacy as determined in clinical trials. The benefits of a vaccine will decline substantially in the event of manufacturing or deployment delays, significant vaccine hesitancy, or greater epidemic severity.”

In a June 2020 paper, the FDA stated that there are two pillars of vaccine efficacy:

  1. Ability to cut the viral transmission. The capacity of the virus to jump from an infected person to a healthy one and provoke the disease.
  2. Disease-modifying effects. The capacity to slow the progression of the clinical symptoms and to hasten the recovery process to save scant resources.

A good vaccine will have direct effects—preventing the spread of the virus—and indirect effects—reducing the infectivity of affected individuals. The FDA determined that there should be a transmission endpoint and a disease-modification endpoint. “Regardless of how a manufacturer defined their efficacy endpoint, the FDA also established a minimum efficacy threshold, specifying a primary efficacy endpoint point estimate of at least 50% to ensure—in FDA’s view—that a widely deployed COVID-19 vaccine is effective.” The determination of that relatively low efficacy—common in vaccines against influenza, a much less contagious and deadly disease—baffled many scientists, used to much higher FDA demands for vaccines. However, the terrible human, social and economic consequences of this pandemic might have exerted a deciding influence on the experts, desperate for a good cure.

In order to rigorously evaluate the efficacy of a vaccine, the experts must not only determine their usefulness to cut the transmission of the virus but also its beneficial effects to stop the progression of the disease in already infected individuals. Moreover the vaccine efficacy against the virus is just one of many factors at play.

These authors used mathematical models because they “asked how vaccine-related changes in susceptibility to infection, progression of disease, and severity of illness might translate into population outcomes of interest such as cumulative infections, hospitalizations and deaths. We explored how those downstream outcomes might vary in the face of alternative operational assumptions (e.g. the pace of scale-up and the degree of public acceptance) and changes in the epidemiological context.” The researchers used three different scenarios, based on the Rt reproduction number:

  1. Rt of 1.5, which represents the strict adherence to preventive measures.
  2. Rt of 2.1, which represents greater risk due to the winter weather and greater indoor activity.
  3. Rt of 1.8, which represents a baseline.

The Rt is the ratio of the infected and the potential victim of transmission; an Rt of 2.I means that for each infected individual, he/she will infect two other individuals.

The researchers utilized the Susceptibility-Exposed-Infectious-Recovered (SEIR) model, which considers the disease progression as “a sequence of transitions among a finite number of health states (or compartments)” First they divided the “infected” compartment into four well defined sub-compartments like this:

  1. Asymptomatic
  2. Mild (outpatient)
  3. Severe (hospitalized)
  4. Critical (hospitalized in an ICU)

Second, they account for the vaccination by creating a parallel set of compartments:

  1. Susceptible unvaccinated
  2. Susceptible vaccinated
  3. Exposure
  4. Infection
  5. Recovery
  6. Death

They studied three types of vaccines:

  1. Preventive vaccine. It decreases the likelihood of infection in a healthy person
  2. Disease modifying vaccine. It improves the health outcomes in infected persons.
  3. Composite vaccine. It combines the attributes of both types of vaccines.

For both types of vaccines they set the efficacy rate at 50% for both components; they examined ranges of 25 to 75% in sensitivity analyses. The time needed to reach effectiveness were considered to be:

  1. Fourteen days for fast acting, single dose
  2. Thirty days in the base case in two-dose vaccines with partial immunity after the first dose.
  3. Forty-two days for a two dose-vaccine with no efficacy after the first dose.

The effectiveness of a vaccine deployment drive does not only depend on the quality of the product per se but also on two implementation variables: pace and coverage. The researchers said: “In a population of 100,000 and at a baseline Rt of 1.8, the model projects 61,112 infections and 2755 cumulative deaths over the course of 6 months without a vaccine. Introducing preventive, disease-modifying and composite vaccines at baseline efficacy levels would result in 42,583, 39,767 and 1,199 cumulative infections and 1,896, 1318 and 1199 cumulative deaths, respectively.”

They found that a 50% effective disease modifying vaccine would have a greater impact on hospital admissions, clinical morbidity, and mortality than a 50% effective preventive vaccine. The impact of both vaccines would be similar in the worst epidemics but the disease modifying vaccine would have a bigger benefit in less grave epidemics. The 50% effective composite vaccine would have the best impact.

The researchers found that the potential benefit of any vaccine is highly dependent on the number of circulating virus at the time of its introduction in a community. When the viral spread, measured by the Rt factor, is relatively low, a vaccine with relatively low efficacy—for example 25%—has greater benefits on the morbidity and mortality rates that a much effective vaccine—for example 75%—introduced when the viral spread is relatively high. Where a vaccine lands, has consequences.

This study buttresses the opinions of many health care experts who are warning the public at large that only an effective vaccination drive with a good product will not magically erase the human, social and economic consequences of the pandemic. We must still continue to use the Social Distancing guidelines for many months to come.

Note. On December 10, the experts’ panel of the FDA recommended the Pfizer BioNtech vaccine for human use. On December 14, the first American citizen, an Intensive Care nurse in a Long Island hospital, was the first patient to get vaccinated. On December 17, the FDA panel will review the results of the Moderna vaccine. Let’s pray for the best!

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.

Emergency Use authorizations for Covid-19 vaccine candidates

We are all extremely tired of the devastating health, economic and psychological consequences of the Covid-19 pandemic produced by the SARS-CoV2 virus. For the past few months, several scientific groups have been actively working in the design and preparation of vaccine candidates that will be both safe and efficacious. Recently we got very auspicious news from the Pfizer-BioNtech vaccine we had already discussed in a previous article.

On November 19, an article in The New York Times informed us that: “the drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19…The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines such as measles.”

Buoyed by these highly encouraging results, the companies are already talking about getting an emergency approval with the corresponding regulatory authorities. We have already discussed in another article how the deep public distrust of vaccination could undermine the generalized acceptance and eventual efficacy of a vaccine to cut the transmission chain of the virus in public and private spaces. A big challenge.

Do we have any recent scientific experience about provisional authorizations? Yes. In a comment published in The Lancet, Maxwell J. Smith et al.—after discussing the dubious validity of the Russian and Chinese vaccines that have not met the stringent regulatory controls of the Phase III clinical trials—said: “So why have the actions of Russia and China drawn such criticism? And how can other national regulatory authorities ensure that future emergency use authorizations for Covid-19 vaccines are issued in a way that is scientifically and ethically sound? Experience for emergency use authorizations for investigational Ebola virus vaccines in Guinea and Democratic of the Congo (DRC) can elucidate key lessons that can guide ethical emergency use authorizations for Covid-19 vaccines.”

In 2016, the regulatory authorities of Guinea granted a temporary authorization for an expanded access to the recombinant vesicular stomatitis virus (rVsV) vaccine that expresses the glycoprotein of Zaire Ebola Virus (ZEBOV) which induced and immunogenic response in the affected patients. Using a World Health Organization (WHO) protocol for scientific research ethics, the vaccine was approved for the individuals exposed to the Ebola-infected patients in a national vaccination drive. In the beginning of 2017, two other Ebola vaccines that were in Phase III of clinical  trials, but that were not yet licensed, were also approved for expanded access. In 2019 the Food and Drug Administration (FDA) approved these vaccines and in 2020 the European Commission followed suit, approving their medical use.

The authors state that there are two major differences in the regulatory requirements for the emergency approval of the Ebola and Covid-19 vaccines. First of all, the emergency authorization of the Ebola vaccines was done in an extremely transparent way. “The 2013-2016 outbreaks of Ebola virus disease in West Africa prompted WHO to develop an Emergency Use Assessment and Listing (EUAL) procedure to expedite the availability of vaccines.” This was meant as a guiding manual to engage the public discussion with representative institutions, media influencers and the general public about the unavoidable trade-offs in times of extreme social danger. Would the Guinean public be willing to accept “a little bit certainty” regarding the safety parameters for the concrete possibility of accessing a life-saving tool for millions of them, including children?  These authors stated that: “it is unclear whether these Covid-19 vaccines meet WHO manufacturing quality norms and standards, including whether the benefits outweigh the foreseeable risks.”

The second key difference is the disgusting chauvinism that “has infected” the larger public discussion of the many vaccine candidates, with most developed nations with the critical capacity to conduct clinical trials and to mass manufacture the product, fighting to be “the first one” to get the product to their citizenry and insisting of having early access to a vaccine before giving it to other less endowed countries. This resembles a “war with other means” and History has taught us that the first casualty in any kind of war is always the same: Truth. This geopolitical tug of war will compromise the access of poor citizens to the vaccines, with risks for us all. Moreover, can we really trust any product if we suspect that there are dark political interests behind its emergency use authorization? Talk of fear of The Deep State

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.