More Covid-19 FAQs

  “Shared expectations lead to predictability.” 

  1. Disinfecting a room or interior space

Q:  How does one disinfect interior areas?

A: There are several situations where an interior space needs to be disinfected.  Among these are:

  • School and university classrooms and common areas;
  • After someone completes a 14-day quarantine;
  • At home after an infected person recovers from COVID;
  • After a group of people meet in a facility such as church for an activity or meeting.

The CDC provides the following guidance for cleaning and disinfecting a school, an office, or just a room, hallway, bathroom and other interior space:

  1. In advance, limit the spaces the individual of group will use.  This will limit the areas later needing to be disinfected.
  2. Wear gloves to protect your hands, and ensure good ventilation
  3. Wash with soap and water then wipe dry all tables, chairs, shelves flat surfaces and “high touch” areas including door knobs, handles. light switches, toilets, faucets and sinks.  Washing removes quantities of virus. dirt, and any debris.
  4. Go back and apply a disinfectant such as Lysol to all surfaces.  Spray application is better than wiping.  Leave the surfaces moist and let them air dry.  (If a disinfectant is not available, use a dilute bleach solution – 5 tablespoons or 1/3 cup of bleach containing between 5.25% – 8.25% sodium hypochlorite added to 1 gallon of water.  On light switches, outlets and electronic devices, gently wipe – do not spray.
  5. Once disinfected, the space may be used again immediately.
  6. Note: If a space has not been occupied by anyone for 7 or more days after use, it does not then need to be disinfected.

 

  1. Vaccine safety – past and present examples  

Q: Why do we have to wait so long for a vaccine to be tested for safety?

A: It is natural to want an effective vaccine to be deployed as soon as possible – “Why wait for perfection while so many people are dying each day?”  A case study of a past problem illustrates the morality of scientifically determining a vaccine is safe.

In early 1976, hundreds of soldiers at Fort Dix contracted a new virus that many said resembled the one that killed at least 50 million people during the 1918 pandemic.  President Gerald Ford decided not to wait for the World Health Organization to develop its annual influenza vaccine.  It was an election year, and he wanted to develop a specific vaccine early to address this new threat.  In March, he publicly announced he was requesting $135 million to provide every person with a vaccine to prevent this impending crisis of what became known as “the swine flu.”  That fall, celebrities lined up to become vaccinated.  But as it turned out, the swine flu never made it out of Fort Dix.  Only one soldier become a fatality.  Also, it turned out the flu wasn’t a virulent as first suspected, and it soon died out naturally.   Of the 45 million who were vaccinated, 450 people became afflicted with a permanently paralyzing disease called Guillian-Barre syndrome.  More than 30 died.  By December, the vaccination program was stopped.  Many attribute this failure as causing the continuing reluctance by many to become vaccinated.

The Astra-Zeneca test vaccine Phase 3 clinical trial was recently suspended when one participant in England developed a rare inflammation of the spinal cord called a transverse myelitis.  This resembled a more common complication of COVID-19 – inflammation of various organs in the body.  Tests have been done to determine of the vaccine might be the cause by creating an over-reaction of her immune system.  Apparently not because it was reported last Saturday that the clinical trial for this trial vaccine has been resumed.

One has to bear in mind the average time to develop a safe and effective vaccine for past diseases has averaged 4 years.  There certainly are possible risks involved when less than this time is allowed for valid scientific evaluation.

 

  1. Large gatherings prove to encourage the spread of COVID – Sturgis, SD

          Q: How come we don’t hear about the outcomes of large group gatherings?

A: The IZA Institute of Labor Economics, based in Bonn, Germany, is a large collective of international scientists and              economists.  Four authors from this group undertook a study of the contagion of coronavirus during the motorcycle Rally in Sturgis, South Dakota, between August 7 and 16.  Nearly 462,182 people attended this rally.  Using anonymous cell phone data, local health and CDC data, the study estimated that 267,000 COVID-19 cases throughout the nation could be attributed to the rally.  The cell phone data indicated the highest number of attendees were from South Dakota, Arizona, California, and 4 other states.  Complex calculations were made to identify the increase in cases in the home counties of those attending two weeks after their return.  From these estimates, further calculations were made based on a 2020 study by Kniesner and Sullivan estimating the average cost of a single COVID-19 patient to be $46,000.  The estimated overall cost of this super spreader event was greater than $12.2 billion.

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  1. Some COVID-19 patients have long-term consequences after recovery   

            Q: Are people are now recovering more easily from COVID?

            A:  It is true that many therapeutics are now available to more effectively treat COVID patients.  But this “novel” coronavirus continues to reveal new characteristics.  From as many as 40% of the patients who are infected being asymptomatic – showing no symptoms – to as many as 8% of Connecticut COVID cases resulting in death, a new phenomena are emerging.  Nationally, many of those who recover from the disease are finding a variety of near-chronic, long term symptoms and conditions remain.  A newly formed patient advocacy group in Great Britain is called “LongCovidSOS.”  King’s College scientists have developed a symptom tracker used by this group.  As many as 10% of recovered patients remain unwell after 3 weeks, and 5% remain sick for months.  Conditions include breathlessness, memory loss, extreme fatigue, headaches, brain fog. muscle pain and swollen joints.  And most recently, many healthy athletes who recover are now finding they have heart damage that may be long-lasting.  A common term used for this group is “long haulers.”  While it is known that for many people the severity of these conditions become less severe over time, studies are underway to identify if any eventually do not disappear, and what might be the various underlying causes.  This creates public ambivalence on addressing the seriousness of COVID-19.  Many deny the need for masks because it doesn’t appear to them to be an important disease.  Others are finding the fear, anxiety, and depression are at least as debilitating as the physical fragilities themselves.

 

  1. Science v. politics: HHS officials ask Fauci to downplay COVID in children.

          Q: Is Anthony Fauci still on the Coronavirus Task Force?

A:  The Coronavirus Task Force no longer meets regularly, and president Trump has turned to a different physician, Scott Atlas, MD, for medical guidance (detailed earlier in FAQ #110).  Dr. Fauci has been at the National Institute of Health (NIH) as the director of the National Institute of Allergy and Infectious Diseases since 1984.  He has served with distinction and is internationally recognized for his past success dealing with other infectious diseases including HIV and Ebola.  He continues to speak out on the science of coronavirus-19

Paul Alexander is a political appointee to the DHHS hired to help the Trump administration on the science of the pandemic.  He formerly was an assistant professor of health research at McMaster University in Canada.  An article was published last week by the American publishing company Politico. After obtaining multiple e-mails from Alexander that directed Dr. Fauci to restrict giving press briefings, Politico stated Alexander continues “to have an issue with kids and university students getting tested repeatedly.”  He stated he “vehemently” disagrees with Dr, Fauci on this.  He directed Dr. Fauci to include the following talking points “There is ‘zero’ risk for kids to get COVID, kids should not wear masks, and testing asymptomatic people makes no logical sense.”  “There is no data, none, zero across the entire world that shows children especially young children, spread this disease to other children, pr to adults, or to their teachers.  None. And if it did occur, the risk is essentially zero.”   Obviously, these are the White House talking points.

Dr. Fauci replied when he learned of this pressure to modify his comments, stating, “No one tells me what I can say and cannot say.  I speak on scientific evidence.  Last week, president Trump at a rally openly stated his position on opening all schools right now because children are immune and they will be safe.  Dr. Fauci replied soon after directly refuting this claim by stating the need to judge the level of community infection before deciding to open school – that, indeed, children are not immune.  Many fear retributions against Dr. Fauci from his direct contradiction of the administration’s message.  The National Institutes of Health lies within the DHHS.

It is interesting to note that Joe Biden, the democratic nominee for president, has publicly stated that if he is elected president, he would ask Dr. Fauci to serve as his spokesman for all things coronavirus – that he has already asked him and Dr. Fauci has agreed to this role.

More Covid-19 FAQs

  “Shared expectations lead to predictability.”

Comment: From the start, this column has focused on the science of epidemiology – the study of the coronavirus-19 virus and its resulting disease, COVID-19.  Scientific research and preventive programs have been our focus.  It is now increasingly difficult to separate this science from political influences.  This conflict will probably increase as the upcoming elections approach.

  

  1. Draft priorities developed for groups to receive vaccines when approved.

            Q:  Has the scientific group finished its proposed recommendations for who gets an approved vaccine first, and in what order others will be vaccinated?

  1. (The outline of this activity was previously discussed in FAQ #94.)  The National Academies of Sciences, Engineering, and Medicine has released a draft proposal for distributing a coronavirus-19 vaccine in the US. The proposal states the vaccine would be distributed in four phases as additional doses are manufactured and become available
  • Priority 1: Healthcare workers, the elderly and those with underlying health conditions. It is estimated this would cover about 15% of the population.
  • Priority 2: Essential workers, teachers, people in homeless shelters, people in prisons, jails and detention centers, and older adults not included in Phase 1. This would include up to 75% of the population in phases 1 and 2.
  • Priority 3: Young adults, children, and workers in industries essential to the functioning of society who are at risk of exposure to the virus. About 90% of the public would be included at the end of Phase 3.
  • Priority 4: All others not included in the prior three phases.

This proposal was submitted to the CDC and the Department of Health and Human Services.  A period for public comment was quickly announced: between Tuesday, September 1, and Friday, September 4, or for just 4 days!  The CDC will decide on the final prioritization by the end of October.  

  1. The CDC is authorized to manage a program to postpone evictions

            Q: Under what authority is the CDC acting to eliminate evictions?

A: On September 1, president Trump signed an executive order giving the CDC this role under its broad authority to establish quarantines.   The objective is to prevent people who have or may have COVID-19 from becoming homeless and thus unable to be quarantined.   While not usually thought of as a regulatory agency, the CDC is now publishing draft regulations in the Federal Register.  Individuals who are anticipating being evicted can then make application to the CDC, and if they are approved, be free of eviction during the pandemic.  It is not clear how this application and approval process will be implemented, and what penalties might exist for the CDC to impose on landlords and lending institutions that evict people anyway.  House speaker Nancy Pelosi and senate minority leader Chuck Schumer have jointly stated there are now over 40 million Americans who are at risk of eviction.  This could lead to a lot of applications!

In addition to providing exemption from being evicted, this order provides financial assistance to property owners as well as tenants.  The White House stated this assistance will be from the CARES Act passed by Congress earlier this year, as well as other government agencies such as the Treasury, and Housing and Urban Development.

There are caveats, however.  First, this order is open to all tenants and owners, not just those covered by the previous CARES Act who needed to be living in federally subsidized housing or homeowners with federally backed mortgages.  To qualify, a single applicant must show they earn less than $99,000 a year (or, if a married couple, less than $198,000).  Many other people will now be left out – including immigrants without a Social Security Number, and high earners who may have lost their jobs.  Applicants must also show they have made active efforts to seek government assistance to make rental payments, and demonstrate how they would become homeless or have to move into crowded housing if evicted.  It is unclear how managing the details of this complex application/approval process will deflect the CDC from its primary missions of research and disease prevention. It is also unclear how long approvals will take for each applicant. 

  1. CDC directive to states – submit plans to distribute vaccines by October 1

Is it true that states have to immediately plan for vaccine distribution?

A: The CDC, reportedly directed by the White House, has written the 50 states and 5 large cities asking them to submit plans to the CDC to provide vaccinations to the public beginning as early as November.  Each state has to identify where these vaccinations will be offered, and the logistics for receiving, storage, and inventory control of the doses they will receive.  Also required is identifying the workers in each of the 16 identified areas of critical infrastructure who will need to be trained.  One of the possible trial vaccines currently being developed has to be shipped and stored at minus 70° Celsius (- 90° Fahrenheit) requiring dry ice.  A second is required to be kept at minus 20°C (- 4° F).

A separate 3-page document lists assumptions to be considered in each state’s plan.  This includes identifying the individual vaccination providers who will each need to sign a separate agreement form.

  1. Public’s unwillingness to immediately get a new “untested” vaccine   

            Q: I don’t want to get a new vaccine if it hasn’t been thoroughly tested.  How do other people feel about this?

            A:  On September 4, a USA Today/Suffolk poll of 1,000 voters was published.  It shows that if a vaccine was introduced “fueled by mistrust of the Trump administration’s push to speed up its development,” 33%, or less than half of the population is ready to be vaccinated.  David Solmon is a professor at the School of Public Health at John Hopkins Medical Center.  He stated, “If you have 330 million doses of a vaccine and nobody wants it, it accomplishes nothing. You probably need between 70% and 80% of the population to get control of COVID.”

Laurie Garrett is a Pulitzer Prize winning science writer.  She is well known for her landmark book The Coming Pandemic.  Her work and opinions are frequently cited in the popular press.  On September 3, Laurie, speaking on behalf of science, strongly stated, “In its mad sprint to Election Day, the White House has ordered government agencies to execute their public health duties at breakneck speed that defy credulity.”  She continued, “I can no longer recommend that anyone retain faith in any public health pronouncements issued by government agencies.”  News media reports of scientists’ criticism of politics directing the efforts are clearly playing a part of this change in public perception.

The most likely vaccines for initial approval are being developed by three pharmaceutical companies.  Each of these companies has stated they will not request authorization until all the scientific protocols have been completed.  Their concern about long-term public distrust over the early release assures these commitments are firm.  This will frustrate any proposed public vaccinations until December, at the earliest. 

  1. Trump pivots on coronavirus strategic planning.

Q:   What’s with this shift in national strategy over control of the coronavirus-19?

A:  Over the past few weeks, actions have surfaced that that national strategy for mitigating coronavirus is shifting away from the science of epidemiology.  (Issues previously discussed in FAQ #102). The recommendation for self-isolating or quarantines when traveling from a state or country with a high COVID-19 case load has been removed.  The need for testing of people who have been in contact with someone testing positive has now been eliminated.  On September 2, Politico published an article that tied these to a broader shift in national strategy.  The White House has brought on a new coronavirus medical advisor, Scott Atlas, MD.  He is a neuroradiologist trained in X-Ray, CAT Scans and MRI imaging of the brain and spine.  He is not a specialist in public health, epidemiology or infectious diseases.  The recommendations he is expounding are being picked up and implemented by president Trump.  This includes not wearing masks, putting aside the trace, test and quarantine public health model; minimizing testing of the public and opening all the schools.  In other words, expanding the number of people who will be infected    His medical recommendations are focused on building immunity in the population by letting those infected people who recover build public immunity in this way.  He does not use the term herd immunity (previously discussed in FAQ #84), but the process he is advocating is the same.  Scientists have reflected this approach if carried out would result in an estimated 2,000,000 deaths in this country, and take years to achieve.  Dr. Atlas has stated he wants to protect the elderly and those who are at-risk.  But, with asymptomatic patients making contact with family members, the elderly and those with health-risk co-morbidity, it will be nearly impossible to protect these groups.

More Covid-19 FAQs

  “Shared expectations lead to predictability.”

101. Positive update: reported new cases and deaths decrease

Q:  Is progress being made in controlling COVID-19?

A: Reuters News Service documented that the number of reported new cases of COVID-19 last week in the United States fell by 17%.  This was the fifth straight week of declining reported cases.  The number of deaths also continues to decline with the 6,700 deaths reported last week being 9% lower than the previous 7 days.  Even then, the United States still has the worst outbreak globally with about a quarter of all cases in the world.

An Associated Press report published August 26 quoted experts identifying the most critical factor leading to the decline in reported cases has been the increased wearing of masks.  Monica Gandhi, MD an infectious disease expert at the University of California credits the public’s growing understanding of how the virus spreads.

This reporting also cited a reduced level of testing as part of this reduction.  Jonathan Quick, MD, who heads the pandemic response for the Rockefeller Foundation stated, “We’re grossly under-testing in some of the places that are still having high caseloads.”  He singled out Georgia, Mississippi, North Dakota and Texas. The state with the greatest increase in new cases last week (a 50% increase) was South Dakota,  Infections have been increasing there since the annual motorcycle rally in Sturgis, which saw more than 100,000 people from August 7 to 16.  It is also worthy of note that even though the number of new reported cases in America has recently declined, the current 43,000 new cases per day is far higher than the average of 34,000 daily cases during last spring. 

  1. Negative update: CDC guidance impacting on the control COVID-19.

Q: Is the number of tests reaching the goal of 4 million tests per day?

A: Two CDC guidelines were recently modified, which impact on controlling new COVID-19 infections.  The first was concerning quarantine restrictions for all international travelers and for domestic travel from states with high levels of COVID-19 cases.  Previous guidelines called for travelers into the country from abroad to be quarantined for 14 days.  The same previous guidelines are to be self-imposed by people traveling between states from an area with a high concentration of cases.  Last week, those guidelines were revised by eliminating quarantines for asymptomatic people who might be carrying the virus.   By contrast, this revision does provide detailed guidance – to follow state and local requirements, not traveling if you feel sick, even detailed protective steps to take when pumping gasoline.  But the issue of asymptomatic patients infecting healthy people is now ignored.

A second set of revisions have more potential for increasing the spread of the disease.  Throughout this pandemic, everyone has been guided to get tested if they have been in contact with a person who has tested positive.  Last week, these guidelines were rewritten to recommend that only people who show symptoms need to be tested.  If followed, this guidance will dramatically reduce the number of people being tested.  It would also disable the classic public health program of tracing, testing and isolation.  Identifying people who were in contact with any infected person before they can spread the disease would not be possible.  And ultimately, the disease will rapidly become more prevalent.  The New York Times reported, “Two federal health officials have said the shift came as a directive to the CDC from higher ups at the White House and the Department of Health and Human Services.”  Similarly, the Washington Post reported that the change “was directed by the White House’s coronavirus task force.”  This corresponds to the president’s frequent claim that increased testing results in a greater number of cases.  Many have faulted that reasoning by suggesting if we stopped offering pregnancy tests, we would have fewer babies being born.

Connecticut has joined with New York and New Jersey for collaborative COVID planning.  All three governors have stated they will not follow these recommendations and will continue to expand testing and tracing.  In fact, Reuters News Service has reported that, “a majority (33) of U.S. states have rejected the new Trump administration COVID-19 testing guidance in an extraordinary rebuke of the nation’s top agency for disease prevention.”  Many of the other states reported they have not yet decided if they would comply.  “This is the states almost all-out rebelling against the new guidelines,” said Michael Mina, assistant professor of epidemiology at the Harvard School of Public Health.  Reuters continued by stating, “Public health experts said a rupture of this magnitude with the CDC may be unprecedented and shows a deepening distrust of the Trump administration and its response to the pandemic.”  

  1. Abbott’s new “BinaxNOW COVID-19” $5 rapid test authorized

Q:  When will we have a rapid turnaround test available?

A: Abbott Laboratories has already launched six different COVID-19 tests that have received Emergency Use Authorization (EUA) by the FDA.  Last week, the FDA granted an EUA for the latest Abbott antigen test referred to as BinaxNOW COVID-19.  It simply exists as a card, about the size of a credit card, on which a nasal sample swabbed by a health care professional is deposited.  If the person is positive, within 15 minutes a colored stripe appears.  A negative finding can then be paired using a provided application allowing the person to show the negative results on their cell phone as a “digital health pass.”.  The EUA was granted on data from initial studies provided by Abbott.  These data showed that positive readings were shown for 97,1% of the 35 people who had the disease, and negative readings were shown for 98,5% of the 67 people who were not actually infected.  If continued data collected under the EUA confirms these findings, a more accurate and reliable test will confirm this as a vitally important test.  Each test costs about $5.00.  It is now designed for “point of care” use (not yet for home use) because the sample has to be taken by a trained heath care provider wearing PPE.  Abbott is now planning to have 20 million test cards shipped for use during September and 50 million tests during October.

 

  1. Vaccines in other countries  

Q: How well advanced is vaccine development in other countries?

A:  The Russian approval of its COVID-19 vaccine has already been reported in this column.  Apparently, their approval bypassed the traditional third phase of testing, which would have demonstrated its safety and effectiveness.  Last week, it was reported by Russian Deputy Prime Minister Tatiana Goliikova that Russia is preparing to approve a second vaccine in September or October.  Western experts have been skeptical, warning that until all internationally approved testing and regulatory steps have been taken, no vaccine should be released for public use.  Now it has been learned that the People’s Republic of China has apparently been deploying its own vaccine since July.  While its vaccine is still experimental and undergoing trials, it is being used for over a month to immunize health care personnel and border guards.

The Washington Post’s columnist Michael Gerson noted that “vaccine nationalism” creates chaos and provides “bad medicine.”  He cites that a robust 20-year-old in a town devoid of infection could be a priority for vaccination in one country while a physician in another country with severe case loads would not be eligible for vaccination there.  He also cited that increasing infections in some countries can present a direct threat to other countries that have effectively eliminated the disease.  Covid-29 does not recognize national boundaries.

105.  FDA warns against hand sanitizer packaging.

Q:   I’ve heard about some hand sanitizer having flavoring added.  Is his true?

A:  Thursday last week, the Food and Drug Administration warned against some hand sanitizer products being packaged to look like food or drinks.  Several products have appeared on the market that look like beer cans, children’s food pouches, water bottles. Juice bottles and even vodka bottles.  Some products have cartoons on them that appeal to children.  Some do have added food flavors like chocolate or raspberry.  FDA Commissioner Stephan Hann said in a statement, “These products could confuse consumers into accidently ingesting a potentially deadly product.”   Ethyl alcohol in high concentration can be toxic.  And some hand sanitizers are still being sold that use methanol, a highly toxic substance.

Covid19 Frequently Asked Questions

  “Shared expectations lead to predictability.”

 96. Children may be “silent spreaders” of coronavirus-19

            Q:  Is the report I read true that children might be more infectious than sick adults?

            A: Cells in many organs of the body exude a particular enzyme (angiotensin-converting enzyme 2) referred to as “ACE2”). This enzyme serves many different important functions.  In the epidemiology of cofonavirsu-19, it responds to the spikes on the individual virions to permit it to cross the membrane entering into a healthy cell.  It is inside healthy cells that this virus replicates into thousands of new virions that later exit that cell to infect other healthy cells.  In studying children, the current scientific hypothesis has been that children are less likely to get sick with COVID-19 because they have reduced ACE2 available thus reducing the expansion of an infection.

A recent study conducted by the Massachusetts General Hospital was published this month in the Journal of Pediatrics.  The study confirmed this hypothesis, but went a step further.  Researchers studied 192 children ages 0-22.  Of this group, 49 (26%) tested positive as having the virus.  Another 18 (9%) had late onset of symptoms.  The study then found that symptomatic and asymptomatic children who were infected also had a significantly higher levels of virus in their airways than hospitalized adults in intensive care units.  Lael Yonker, MD, lead author of the study, stated, “I was not expecting the viral load to be so big.  You think of a hospital and all of the precautions taken to treat severely ill adults, but the viral loads of these hospitalized patients are significantly lower than a ‘healthy child’ who is walking around with a high (coronavirus-19) viral load.”

The risk of contagion is greater with a high viral load.  Findings from nose and throat swabs and blood samples from this study carry implications for the reopening of schools, daycare centers and other places with a high density populations of children.  “Kids are not immune from this infection, and their symptoms don’t correlate with exposure and infection,” says Alessio Fasano, MD, one of the authors of this study.  “During this COVID-19 pandemic, we have mainly screened symptomatic patients, so we have reached the erroneous conclusion that the vast majority of people infected are adults.  However, our results show that kids are not protected against this virus.  We should not discount children as potential spreaders for this virus.”  Silent spreaders! 

  1. Early FDA approvals before scientific analysis is completed.

            Q: Are Emergency Use Authorities (EUAs) by the FDA being given out too early?

            A: Last week, president Trump accused the FDA chief Stephen Hann of bureaucratic delays in approving treatments and vaccines while they are being studied.  The president’s chief of staff Mark Meadows stated, “The president is about cutting red tape.”  In a published newspaper report, “Trump aides have been banking on…  an ‘October surprise’ that could help the president make up ground in the polls.”

On Sunday, August 23, president Trump announced an Emergency Use Authority had been granted by the FDA for the use of convalescent plasma.  This was announced as a “breakthrough” and was reported to reduce COVID-19 deaths by over 30%.   However, the Mayo Clinic study, yet to be published, stated in an observational study that some groups of patients showed a 3% reduction of fatality rates, and for other groups up to 5%.  Formal studies were being planned to identify the point in a course of treatment this has a greater effectiveness, and what role a single or more than one dose might play.  It is now felt that a formal study won’t now be possible.  Few volunteers will volunteer because they know they can get this as an approved therapy.  It is significant to note that the chief scientist for the FDA, Denise Hinton, noted “Convalescent plasma should not be considered a new standard of care for COVID-19 patients.”

In separate recent political announcements, it is now anticipated that an “approved” vaccine will be announced soon during the presidential campaign.  This contradicts the anticipated completion of the current clinical trials until at least January 2021.  These trials will define a safe and effective vaccine.  With the increasing presence of political influence over science, Peter Marks, director of the FDA Center for Biologics Evaluation and Research announced he has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective.  Peter Marks has an essential role in approving vaccines.  If a vaccine is authorized for an untested vaccine, and it turns out to be unsafe, or if it doesn’t provide immunity beyond a few weeks, the credibility of the FDA and the NIH could be permanently destroyed. 

  1. Recommendations for voting during this pandemic..

            Q:  What concise recommendations exist for voting this year?

A: The Secretary of state for Connecticut has a website that is very useful for all Connecticut voters. Using this website, you can find out right now if you are registered to vote.   Later, you can check there to verify that your absentee ballot has been received by your Town Clerk – hence you won’t have to vote in person.

Another excellent resource for information is NBC.newsPlanYourVote.

Finally, the CDC has published recommendations for visiting polling places.  In addition to the usual guidelines (masks, social distancing, etc.), the following is offered:

  • Fill out a sample ballot at home to spend less time at the voting booth;
  • Bring in your own black pen to use, if allowed.
  • Bring your own stylus or similar object if touchscreen machines are used.
  • Do not disinfect any electrical devices at the voting place – it can damage them.

Rising costs for treating COVID-19 patients 

Q. Will it cost more for hospital care once donated medications are stopped?

            A:  As there was initially a rapid increase in hospitalized patients, many pharmaceutical companies developed drugs.  To gain formal approval, companies produced large quantities of these and donated them to hospitals.  This allowed studies to advance more rapidly leading to licensing authority for future sales.  IllumiCare is a health data firm that recently completed a study.  This study identifies where many patients will soon find themselves financially.  Remdesivir, once offered patients at no cost is now charged at $3,120 per treatment course ($2,340 for Medicare patients).  Tocilizumad, a drug for treating arthritis, when in hospital care of COVID patients, its use jumped 29% during July compared to June.  The cost per patient is now $2,200.  The most frequently prescribed drug for COVID-19 patients is an anti-coagulant called enoxaparin.  It was given to 50% of COVID patients last month at a cost of $322 each.  The steroid dexamethasone costs $8.78.  The study did recognize some areas of cost savings – fewer patients now require ventilators, reducing the costs of painkillers and sedatives that would otherwise have been used.  Also, the average length of stay is becoming less over time.  

  1. Testing capacity is abundant, but falling short of effectiveness.

Q:   With all the testing capability available, why isn’t the number of cases less?

A:  Reuters News Service recently published an article surveying 16 testing facilities run by commercial, state, hospital and academic labs.  It also analyzed several state and city procurement plans.  The roadblock was identified is that laboratories are locked into separate and unique proprietary supply chains.  Just a few companies dominate the market with laboratory equipment that require their separate chemical kits, small plastic parts, plates and pipettes that only they sell.  “The vendors are in an impossible situation right now where they can’t say yes to everyone,” said Geoffrey Baird who runs the medical lab at the University of Washington.  The US processes about 800,000 diagnostic tests daily, but scientists estimate that from 6-8 million tests are required per day to effectively combat the high number of infections now present.  Congress has earmarked $11 billion to support testing, but current planning at the national level shows the core issues of supply chain problems have not been addressed.  With several competing propriety tests currently in use, and more on the way, It will be nearly impossible to officially select one as “the winner” and enact the Defense Production Act to manufacture the needed supplies in sufficient quantity to meet the demand.  Those not selected would certainly not accept the loss of their investments.  To invoke the Defense Production Act to require all manufacturers to produce their individual supplies required would require the government to establish the quotas normally defined by the free market place   Gary Kobinger, a Canadian researcher best known for his work on Ebola, argues that all diagnostics should be done on an open platform”  This is not where testing for coronavirus-19 started.   Solving this problem will not be easy.

More Covid-19 Frequently Asked Questions

  “Shared expectations lead to predictability.” 

  1. Recent concerns refuted about coronavirus-19 in food and packaging

            Q:  I heard there are reports of food being sold that is contaminated with coronavirus-19.  Is this true?

            A: Officials in two cities in China recently reported they had found traces of the coronavirus in imported chicken wings from Brazil and on outer packaging of frozen Ecuadorian shrimps.  This raised fears that contaminated food shipments might cause new outbreaks.  The World Health Organization countered the scare these reports created.  Mike Ryan, head of emergency programs at the WHO stated at a meeting in Geneva, “People should not fear food or food packaging or processing or delivery of food.”  WHO epidemiologist Maria Van Kerkhove said China had tested hundreds of thousands of packages and “found very, very few proving positive for the virus.”  Brazil’s Agriculture Minister and Ecuador’s production minister Ivan Ontanda, defended their countries’ ability to safely produce and package food items.

Finally, it is important to remember the earlier CDC guidance that heat quickly kills the coronavirus-19 virus.  Cooking food eliminates the threat.  Also, that while the virus can live on frozen surfaces for years, once thawed the virus can be quickly removed by cleaning packaging surfaces, and will not survive at room temperatures beyond 4 days.

  1. Trials underway in Australia using horse plasma for treatment.

            Q: What’s new about convalescent plasma injections to treat COVID patients?

            A: Scientists at the biotech company Immunova in Australia on July 29, announced they have been working on a COVID-19 treatment using a unique process.  With 175,000 confirmed cases in that nation, Immunova discovered that horses quickly react when the coronavirus-29 protein is injected into their blood stream.  The horses’ bodies quickly release a substantial quantity of antibodies to neutralize that virus protein.  Blood is drawn from the horse and the plasma is removed with the remaining blood being returned to the horse.  The plasma is purified before being made into a serum which has the neutralizing power between 30 and 100 times greater than plasma found in recovered human patients.  If further laboratory study demonstrates positive results, a formal clinical trial will begin using 242 COVID patients who have moderate to severe symptoms.  These trials will determine if this could be an approved effective treatment for the disease.

Fernando Goldbaum, the scientific director of Immunova, expressed optimism about the effectiveness of the serum.  It is expected the serum will lower the ability of the virus to replicate itself inside human cells.  It is also possible that this therapeutic could help prevent the virus from even entering cells allowing it to reproduce.  One can speculate that the horse exposed to coronavirus-19 rapidly develops a strong enough response to prevent it from infecting others.  As a result, they aren’t identified in the chain of spreading the disease. Perhaps horses aren’t the only non-human animals to react this way. 

  1. The SalivaDirect test receives EUA approval.

            Q:  I heard about a new test developed by Yale University.  What is this?

A: SalivaDirect, as its name implies, requires a saliva sample instead of a naso-pharyngeal (nose/throat) specimen taken by a swab.  On August 15, the FDA granted Yale School of Public Health an Emergency Use Authorization (EUA).  But this approval was for a protocol, not for a kit.  The protocol was developed to address three barriers to the current testing system:

  • People can deposit their own saliva in a small container instead of requiring PPE by those taking the sample thus decreasing the risk of infecting others, and many people now refrain from getting tested because of the discomfort.
  • It doesn’t require laboratory extraction of the nucleic acid from specimens.
  • The test can be conducted using a variety of different laboratory equipment and different reagents. This helps overcome supply chain shortages and can be used by many different laboratories with existing equipment.

The Yale School of Public Health is authorized to review applications from eligible certified clinical laboratories and approve their use of this protocol.  In turn, all approved laboratories will be supervised by, and send investigative data to Yale.  Among other data, the effectiveness of tests being performed (including false negatives and false positives), will be reported by Yale back to the FDA.  Each laboratory can process several panels of 90 specimens at a time, and results for each panel will be available in just 3 hours.

This project was developed in part with a grant from the National Basketball Association.  The protocol is currently being used for daily testing of NBA players.  Yale is supporting development of “point of care” test kits using this protocol for remote use at test sites.  The cost for SalivaDirect is “significantly lower” than for the swab testing currently being in use.

  1. Planning for eventual COVID-19 vaccine distribution 

            Q: Do we know yet who will get the first vaccine doses that become available?

            A:  Once a vaccine becomes approved, not everyone will be able to get theirs doses right away.  It might take a year or more before enough doses are available for everyone.  Decisions are now underway to establish an approved priority for distribution.  US public health officials on July 24 charged a group of independent scientists and people dealing with medical ethics to determine this priority ranking.  The group will develop guidelines for the CDC to create a plan for sequential distribution of any approved vaccine.

At its initial meeting, National Institute of Health director Francis Collins, MD charged the committee to consider the needs of individuals who are at the highest risk of complications of COVID-19.  Additionally, the list should consider the consequences of the disease, the needs of healthcare workers, the military, essential workers, and places in the country where the virus is most active.  Also, those in the category 3 clinical trials who were given a placebo and are not now immunized should be considered.

It is expected that the results will be controversial, as everyone will want the first doses that are available.  Transparency will be important.  The first draft report by this group is due by the end of August, and will be made open for public comment.  The CDC final report is expected to be released by the end of September.

  1. Bits and Pieces

          Q:   What’s new about this pandemic?

A:  Several items of updates on COVID-19

  • Jorge Akopov, director of Tecpar, a technology institute in Brazil has signed a cooperation agreement with Russia to produce their newly approved vaccine for distribution in Brazil and other Latin American countries.
  • Alessandro Sette of the La Jolla Institute for Immunology in California reported that studies show the T cells created by the coronavirus that causes the common cold, if present in a COVID-19 patient helps limit its severity.
  • The University of Sidney, in the Southern Hemisphere’s winter flu season reports that the usual seasonal flu has hit record lows. This is due to the practice of social distancing and the wearing cloth face coverings.
  • The FDA has authorized a trial of a drug NeuroRX on COVID-19 hospitalized patients to test its effectiveness in preventing respiratory failure. Trials of this therapeutic, also known as aviptadil, will begin on or about September 1.

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

  1. FDA effectiveness standard for vaccine approval

Q:  Can we expect that by Election Day, November 3, that we’ll have a vaccine and this COVID pandemic will be over?

A:  Not at all!   Many – perhaps most – people expect a rapid end to the disease when a vaccine is approved and made available.  This is the hope of politicians who want this to be true, and is fed by the frustrations of many who are confused and socially driven to resume close social contacts with other people.  This widely shared expectation, which is not based on medical technology and science can only lead to unpredicted outcomes and frustration.

A scientific consideration guiding vaccine development was recently announced.  The FDA will review data from the Phase 3 clinical trials just now underway, and grant an Emergency Use Authorization (EUA) if any trial vaccine is safe and effective.  Effectiveness is defined as giving immunity to at least 50%.of the number of infected people in the control group.  For example, if 3,000 people are enrolled in the trial, 1,500 people will be given the vaccine.  The other 1,500 – the control group – will be given a harmless injection.  It is now expected that in two months, data will be compared.   If 200 people in the control group test positive, then up to 100 of the 1,500 who received the vaccine can contract the disease from others and the trial vaccine will be authorized for distribution.  As a result, people who then receive the authorized vaccine can only be assured that they will have a 50% lowered chance of catching COVID-19 from future social contacts.  Yes, they can still become infected.  Of course, it is hoped that the trials will show a higher degree of effectiveness.  Either way, it will be important when a trial vaccine is approved that everyone be informed of the level of proven effectiveness to guide their personal expectations

There are four major vaccines now being tested.  For any vaccine receiving a EUA, its Phase 3 trial will have to continue into the future.  The general population receiving the vaccine will not have a control group to make additional scientific comparisons.  Over time, if the continuing trial finds immunity is short-lived and the approved vaccine might only provide protection for a limited time, it will probably be allowed to continue.  Partial protection is better than none.  But it has to be understood from the start that social distancing, wearing face masks, washing hands frequently, and testing, tracing and quarantines will still be required after being vaccinated.  The expectation must be that the vaccine can reduce but not eliminate future infections and contracting the disease..

It is interesting to note that Russia is currently moving more rapidly than the United States through the standard scientific process.  Its goal is to become the first nation in the world to approve a vaccine.  By not following the scientific models for vaccine development, Russia may soon be approving a vaccine that is not only ineffective but may also be unsafe.  Many scientists have compared this to the late 1950s when the US and the USSR were racing to be the first to put a man in space.  “Sputnik” revisited.

  1. International study for advanced care of COVID-19 critical patients

Q: What’s new in developing therapies to treat COVID-19 patients?

A:  In 1989, a group of clinical professionals and scientists in advanced life support techniques formed a group that would share knowledge on best practices to mechanically provide oxygen to failing organ system.   One of their many developments over the years has been the creation of a machine used in an ICU to replace the functions of damaged lung tissue to oxygenate blood for circulation to the body.  This process is called ExtraCorporeal Membrane Oxygenation (ECMO) and has been used in ICUs to assist COVID-19 patients in respiratory distress.

There is no ECMO manual for ICU staff to follow with this leading-edge technology for COVID-19 patients.  A new consortium has been formed to organize studies to reach this goal.  The study is a multi-centered international research and sharing effort focusing on COVID-19 patients admitted to an ICU using a ECMO device.  Participants include hospitals in Asia, Australia, New Zealand, Europe, and now the US.

Hartford Healthcare System has now joined this study.  This will include Hartford Hospital, and 6 other Connecticut hospitals in their network.  Other participating centers are in the Midwest and West Coast, but the Hartford Healthcare System is the only group in the northeast currently participating.  The procedures and therapies developed to compensate for temporarily disabled lungs will add to the growing list of advanced techniques to further reduce the fatality rate of Covid-19,

  1. COVID-19 during Flu season

Q:  How bad will it be when the influenza season hits during the pandemic?

A:  There has been speculation predicting increasing difficulties when the coming seasonal flu arrives.  Everyone is urged to get their flu shots when they become available starting in September and October.  This coming season, there will be two high dose vaccines for people over age 65.  This coming year, manufacturers plan to provide at least 194 million doses, which is greater than the 175 million available last year.

The problem anticipated during this next flu season is differentiating between COVID-19 and seasonal flu types A and B.  In anticipation of this, CDC has developed a new test that can differentiate between the two.  Even then, patients arriving at hospitals for care will have symptoms that are similar to each.  These patients must be treated with full PPE and isolation until test results prove it is not COVID.  Another possibility that will be studied is how to treat a person that might become simultaneously infected with both seasonal influenza and COVID-19.

The one positive factor is that protection against both COVID-19 and seasonal flu are the same.  Staying home, social distancing and wearing of cloth face coverings when outside and constant hand washing and use of hand sanitizer reduce both infections.  For people already practicing these measures, fewer people will have the flu this year than previously.

  1. Effectiveness of face masks identified   
  2. What is the evidence that wearing cloth face coverings work? 
  3. A. In an editorial published in the July14 Journal of the American Medical Association (JAMA), the latest science was reported affirming that cloth face coverings are a critical way to reduce the spread of infection within a community.  With asymptomatic patients increasingly prevalent in communities, even people who have no awareness they are spreading the virus can prevent their virus-filled exhaled air significantly spreading beyond the mask.  Two case studies were cited.  One reported in JAMA showed that in a Boston hospital system, universal masking policies reduced the transmission of coronavirus-19.  In the other, reported in the CDC Morbidity and Mortality Weekly Report that masks worn by two Missouri hair stylists infected with COVID-19 prevented their passing the virus over several days to their 139 customers.

The effectiveness of using masks increases when increasing numbers of people adopt their use.  Optimal effect is reached when the practice is universal.  During April 7-9, the CDC conducted a survey of 503 adults.  A follow up survey was conducted later during May 11-13.  The number of people who use masks when outside the home went from 62% to 76% during that month.  White non-Hispanic adults from 54% to 75%, Black, non-Hispanic adults from 74% to 82%, and Hispanic/Latino adults from 76% to 77%.  The largest regional increase was in the Northeast from 77% to 87%.  Next was the Midwest region from 44% to 74%.

 

  1. Psychiatric disorders among newly discovered aftereffects of COVID-19

Q:   What else is being learned about the aftereffects for COVID survivors?

A:  A study conducted at the San Raffaele Hospital in Milan was published last week in the scientific journal Brain, Behavior and Immunity.  It found that more than half of the 402 patients monitored after being treated for COVID-19 experienced at least one of the following psychiatric disorders: post-traumatic stress (PDSD), anxiety, insomnia, depression and obsessive-compulsive symptoms.  The study found that women in particular suffered the most from anxiety and depression despite the lower severity of their infection.  “We hypothesize that this may be due to the different functioning of the immune system,” said Professor Benedetti, Group Leader of the Research Unit at the hospital.

Earlier, scientists had warned of an increasing awareness of coronavirus-related brain damage in recovered COVID-19 patients.  The psychiatric consequences of this disease can be caused by the immune responses to the virus and by psychological stress factors such as stigma, social isolation and fears about infecting others, this study reported.

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

76.Impatience over vaccinations

Q:  Is it true that once vaccinations are approved, we can return to normal?

A:  The public clearly expects vaccinations to be the one definitive answer to containing COVID-19 as a wide-spread infectious disease. Caution must be taken to avoid the expectation that vaccine approval will quickly lead to the final resolution of this pandemic.  The previous push to open up the economy resulted in an explosion of the number of infected people.  Care must now be taken that once a vaccine is approved, the public cannot feel that with immunity, it’s really safe to go back to normal times.

First, consider this broad issue: should a trial vaccine in another country be approved, that other country will want to vaccinate its own citizens first before making it available in the U.S.  Many nations have entered into a pact to share their approved vaccines with other nations in the pact.  The White House has refused to enter into this agreement!

The phase 3 clinical trials for the four U.S. trial vaccines are just now starting.  The White House has repeatedly stated that approval of any of trial vaccine could be in October.  This would limit the clinical trials to demonstrating immunity for at most, 6 weeks.  If the FDA grants emergency use authorization (EUA) for any these vaccines by mid-September, it may not provide immunity for very long.  The antibodies developed by the disease itself often has shown a limited time of protection.  Many have been reinfected after recovery.   Vaccination may later demonstrate a short time of prevention from contracting COVID.

Then there is the delay caused by the need to produce and package a vaccine after it gains approval.  The proposed vaccines in clinical trials are now being produced for distribution before approval.  Pfizer BioNTech based in Connecticut, has been given a contract for nearly $2B to immediately start production of 1 million doses in 2020, with another 500 million in 2021.  So even if their trial vaccine is approved in October, it may take 15 months from now before 600 million doses would become available.

There will next be the need for a plan deciding who receives the initially limited available doses.  Would it be hospital staff first, or essential business workers?  Would it be EMS providers, or nursing home staff and patients?  Might it be government workers including fire and police, or school teachers and their students?  No reports have been found that the federal government or any state is currently addressing this issue.  How long would the general public have to wait before their time came as supplies grow in the years ahead?

Another consideration: if the immunity from a single dose is found to be inadequate, a two-dose regimen might be required.  Perhaps even a third!  The first priority would be giving additional doses to those who already have received the first.  This would require waiting into 2022 or beyond before everyone can receive the vaccination

 

  1. Crisis standard of medical care in Texas

Q: Are all hospitals able to provide adequate medical care to COVID-19 patients?

A:  The issue of not being able to provide standard medical care for patients was previously identified.  The American Medical Association has approved, when needed, the process to shift to the “crisis standard of medical care,”  This became a reality this past week in Starr County, Texas (population 64,700).  Eloy Vera, the county judge (chief executive officers in Texas are called judges) reported that the only hospital in that county was so overrun by COVID-19 patients that they have invoked the crisis standard of care.  Jose Vasquez, MD of the Starr County Health Authority announced on July 21 that the Starr County Memorial Hospital is establishing an ethics committee.  This group will define a triage system to decide how best to allocate limited resources  He stated, “For all those patients who most certainly do not have any hope of improving, we believe that they are going to be better taken care of within their own family in the love of their own home, rather than thousands of miles away, dying alone in a hospital room,”   After making this announcement, Starr County was hit hard by hurricane Hannah!

The implications of this provides added difficulties.  Do they discharge a patient already receiving care to make room for one who is deemed “more survivable?”  If not, with all beds full, what is done with new “survivable patients” who can’t be admitted?  What are the implications for the family members who are without PPE and other protective measures?  What are the legal liabilities for not first considering erecting tents or other temporary care facilities and added staff?  What are the emotional impacts from “sending sick patients home to die?”  Much will be learned from this initial use of the “crisis standard of care.”

 

  1. CDC revised guidance for opening schools

Q:  The president sent the CDC guidelines back for revision.  Where are they?

A:  After increasing public demands for more specific guidance on opening schools, the White House last week released a revision of the previously proposed guidance.  It is remembered that a few weeks earlier, a revised copy of initial guidelines was sent back by the White House as being “too tough, impractical and expensive.”  No promised revised copy was ever issued by the CDC. The current revision, released just last week, is reported to have been written by the White House staff, even though it was released under the letterhead of the CDC.  The initial guidelines issued months ago started with checklists.  The first considerations were several conditions leading to the decision not to open the school.  Planning steps were then identified to define how opening schools can best be realized.  In the currently released guidance, there was no discussion about any need to close a school.  This conforms to Trump’s demands for all school buildings to open.

Other variations from the initial guidance also reflect the president’s current demands for opening schools.  The specific reference for keeping students 6 feet apart has now been dropped.  The statement is made that a school “may consider” closing (not “must,” or “should”) “if there is substantial, uncontrolled transmission” of the virus.  CDC customarily offers objective criteria for its guidelines, such as community testing shows an infection rate above 1% – this kind of guidance is now absent.  When asked what situations would meet the definition of “uncontrolled transmission,” Robert Redfield MD, director of CDC named the “hot spots” that exists in 33 states.”  The Washington Post reported, “This mixed messaging was another indication of how health officials at the CDC have been squeezed between Trump’s demand for a normal school year and an out-of-control virus.”

 

  1. Prevalence of COVID-19 greater than reported  

Q:  Is the reporting of COVID-19 cases accurate? 

A:  The CDC on July 21 issued a report that the actual number of infected people is many times greater that the number reported.  The number of actual cases in Connecticut (population 3,563,100 is now reported to be actually between 6 to 11 times greater than the number reported up until April 1. This means that the reported 3,128 cases could represent between 18,800 and 34,400 actual cases.  One major reason for this was before April 1 only positive test results were reported to the CDC.  Testing was not as wide- spread at first, and “presumed cases” from review of medical records identifying COVID-like symptoms and other indicators were not used.  As presumed cases were added and other steps taken, a persistent problem continues to this day:  Infected people who are asymptomatic are spreaders of the virus.  Many never get tested, and are not treated.  These actual patients have to record of their infection.  It is reported that as many as 30% of infected patients are asymptomatic.  This is the major reason for wearing a cloth face covering when in public.  These masks protect everyone else from becoming infected by people who have no idea they are actually infectious and spreading the disease.

 

  1. Younger people now getting COVID-19

           Q: What’s this I hear about younger people getting this disease?

A: Teens and younger adults are increasingly contracting COVID-19.  In a sample study, people in Connecticut between the ages of 20-29 at first represented only 12.5% or all cases.  More recently in July, that nearly doubled to 23%.  Connecticut deputy state epidemiologist Lynn Sosa, MD attributes much of this to “Kids are socializing because that’s what kids do.”  With schools closing early in the pandemic, socialization in schools was not possible.  But with the warmer weather and outdoor recreation more of a possibility, the temptation for this becomes great.  Also, with a sense of a return to normal as the state opens up, the feeling of shedding restraints can be overwhelming.  Finally, it is well reported that younger people have a greater sense of invulnerability, immortality, and willingness to take risks.  “They need to realize that they are not immune to COVID,” Dr. Sosa stated.  Awareness of this issue calls for greater public education and mitigation efforts for local high schools and especially colleges and universities as they open up.  The cultural impulses and expectations for socialization in the young can be quite powerful!

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

  1. Air fresheners to clear coronavirus

Q:  Could we use air fresheners in our meeting house to help make indoor group meetings safer?

A:  Air fresheners are often called room deodorizers.  Their primary function is to mask any unpleasant or offensive odors that might be present.  None of the commercially available air fresheners disinfects or destroys bacteria or virus particles that may be suspended in the ambient air.  Using air fresheners in the meeting house would also be contrary to our policy protecting congregants who are sensitive to perfumes or personal colognes worn by others.

There are also small plug-in air cleaners available.  These pass air through small filters that screens out soot, dust and other particulates.  The individual coronavirus-19 virions are sub-microscopic and will easily pass through these filters.  In addition, the amount of air filtered is very small compared to the large volume in our meeting house rooms.

Coronavirus-19 infects people when the virus in sufficient concentration is inhaled into the respiratory system of a healthy individual.  This is why wearing cloth face coverings is an effective practice by reducing the concentration of coronavirus virions appearing in the space close to an infectious person.  There are other effective ways to reduce the concentration of virus in indoor room air:

  • The least costly way would be to send room air outside replacing it with fresh, in-flowing air. Opening windows is one tactic that could help.  Putting an outward-facing window fan in each open window would greatly improve the result.  In winter, evaluation on the degrees of heat loss in our meeting house would have to be evaluated if a room ventilation system doesn’t already add fresh incoming air to be warmed before it blows into interior spaces.
  • In hospitals, ventilation systems use High-Efficiency Particulate Air (HEPA) filters before air is returned to the interior. HEPA filters are commercially available for many mechanical ventilation systems. Airflow would be more restricted when using HEPA filters.  The rate of air exchange would have to be evaluated in our meeting house to ensure adequate protection.
  • Another system used in health care facilities is exposure of air taken from interior space to ultraviolet light, killing the virus before returning the air. These systems are probably too expensive for us but still could be evaluated.
  • Finally, any ceiling fans, if used, provide a very short-term benefit. These would only stir up the room air lowering the concentration of virus particles near the people, but slowly raising this concentration to critical levels throughout the room.

 

  1. Prolonged medical problems after recovery from COVID-19

Q: Once a person recovers from COVOID-19, are there any lasting effects?

A:  Continuing research is showing new problems that infected people may have after they recover. Previously identified post-recovery issues included heart damage, lung damage, strokes, and other neurological issues.  On June 27, it was reported that another type of problem has emerged.  Anthony Fauci, MD, identified a series of neurological conditions.  Dr. Fauci Identified these as “brain fog, fatigue, and difficulty in concentrating.”  He continued, “So, this is something we need to seriously look at because it may very well be a post-viral syndrome associated with COVID-19.”  Work is continuing to identify the precise causes of this syndrome.  Currently the focus is on small proteins called cytokines which cross the blood barrier and interact directly with brain cells.  Post-viral or chronic fatigue is more commonly observed in women than in men.   It affects patients of all ages, but appears to be more pronounced with older people and people with underlying health conditions.  One positive aspect currently under study is it appears for many people to resolve itself with slow improvement over time.

 

  1. Sleepaway camp CDC investigation a warning for when schools open.

Q:  What problems were discovered when sleepaway camps opened?

A:  The CDC on July 31, released a report on its Morbidity and Mortality Weekly Report studying the experience at the YMCA Camp High Harbour, a sleepaway camp in Georgia, warning that this illustrates what might happen when schools will soon open.  The overnight camp adhered to the measures identified in Georgia’s Executive Order guiding camp operations.  It also followed most of the CDC published guidelines.  This included documentation of a valid negative COVID-19 test taken within t2 days by each person coming to camp.   It opened its doors on June 21 with 597 Georgia residents attending.  Two days later, one teenage staff member felt ill and left the camp.  He later tested positive for COVID-19.  On June 24, staff began sending other campers home.  On June 27, just under one week after opening, the camp closed.

The Georgia Department of Health began a follow-up testing program and eventually reached 344 (58%) of the attendees who live in Georgia.

  • Of the people tested, 260 (76%) tested positive.
  • Among the 136 cases whose symptoms were recorded, 36 (26%) reported no symptoms. They were asymptomatic.
  • The percentage of children testing positive diminished by age group;
    • Of the group that were aged 6-10 years – 51% tested positive;
    • Of those aged 11-17 years – 44% tested positive;
    • Of those aged 18-21 years – 33% were positive.

The camp had not followed some of the CDC guidelines.  Staff were required to wear cloth face coverings but not the children, and doors and windows were not opened to permit air-replacement ventilation.  Also, children were often engaged in singing and boisterous cheering.  The conclusion of this study was stated, “These findings demonstrate that COVID-19 spread efficiency in a youth-centric overnight setting, resulting in high attack rates among persons of all age groups, despite efforts by camp officials to implement most of the recommended strategies to prevent transmission.”

  1. Herd immunity 

Q:  What is herd immunity? 

A:  Many infectious diseases give immunity for those who have recovered.  This protection prevents the person from becoming reinfected.  The more of these recovered patients in a community or nation, the fewer the number of susceptible people who remain to get the disease.  Most epidemiologists calculate that when 60% of a population has recovered from such an infectious disease, the possibility of the remaining susceptible people would be so low that that disease would die out and no longer represent a threat.  This threshold is identified as “herd immunity.”

In Connecticut, 60% of the current population would be 2,138,000 people needing to get such an infectious disease to reach herd immunity.  To achieve this additional number of confirmed cases could be calculated on a recent 10-day average of new cases at 9.14 per day.  This would require 23,390 days (64 years) before herd immunity could be reached.  Obviously, this cannot be a goal for Connecticut to conquer this pandemic.  Some nations started out this way, including the United Kingdom and Sweden.  After closer examination, no one is now proceeding this way.

And, remember that there is early suspicion that immunity for recovered COVID-19 patients may be temporary.  If so, herd immunity might never be possible.

 

  1. COVID “saliva testing” for more rapid results.

Q:   Why do we still have COVID testing that takes a week or more to get results?

A:  Still missing is a national program for COVID-19 testing. Each state competes to identify their preferred platform from the multiple tests that have been authorized.  Many of these involve throat swabs that have to be sent to a laboratory which are all becoming overwhelmed with increased volumes.  This delays prompt reporting of the results. An ideal option would be a self-contained testing system giving prompt results by not using swabs which many people feel are uncomfortable and irritating.

One such test is now being evaluated in Australia.  It has the advantage of allowing the patient to more comfortably provide the test sample by spitting into a container.  Health workers don’t have to wear personal protective equipment to administer the test, Other tests are being developed that allow the saliva sample to be tested outside of a laboratory by offering an at-home testing kit.  Evaluation of this method is still underway.  In one small unpublished test, the saliva test was found to identify as false negatives nearly a fourth of those tested who actually have the infection.  This suggests the concentration of the virus in saliva may not be as high as found by swabbing the nose and throat.  This current effort illustrates the dynamic research underway to find better test methods.  If authority is finally granted for such a test even with many false negatives, it would allow rapid, daily identification of individuals who test positive in groups such as school students and staff. This would reduce the number of swab tests for all the others who tested negative.

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

  1. Testing problems continue unresolved

Q:  Why are people in states with high caseloads not able to promptly get tests?

A:  With increased number of cases being identified, the public is requesting tests in ever expanding numbers.  Without an organized national testing program, supplies for many of these tests are hard to locate and expensive for states to purchase.  In addition, the lack of national coordination has placed excessive demand on large laboratories that do the testing.  This presents an overwhelming number of tests for some laboratories to manage resulting in long delays – up to 7 to 10 days – for results to be returned.  Finally, under the false but stated assumption that more testing results in increased number of cases, the president has been promising to close down several large testing sites the federal government has promised.  All these issues could be resolved by developing a national testing policy – but that seems unlikely for the time being.

  1. Circulatory system effects

Q: If coronavirus-19 affects the respiratory system, how come so many younger COVID-19 patients are having strokes?

A:  Initially, this infectious virus was referred as the novel coronavirus-9.  It was identified as within the coronavirus family (spherical with multiple spikes protruding resembling a crown-like object).  Bur there was little known about how this virus affects the human body compared to and contrasted from other corona viruses – such as the ones that cause the common cold.  Studies and evaluations would be needed to identify its unique or novel characteristics.  It was recognized early that a common manifestation of the COVID-19 disease was difficulty breathing.  It was spread to others through exhaled and inhaled respirations.   Later studies of how COVID-19 affected children found a significant number of cases where inflammation of body organs was found.  Another finding in younger adults was an infrequent but significant number of patients suffering strokes caused by blood clots.  The immediate impact of this added knowledge was to consider and later approve for treatment the steroid dexamethasone that reduces inflammation, and of blood thinners such as Heparin.    Investigators have now been drawn to examine more closely how the coronavirus-19 affects other organs and systems.

Earlier studies in April at Mount Sinai Hospital reported finding blood thickening and clotting in some patient organs.  A more thorough examination by autopsies of COVID-19 patients has recently been concluded at the Department of Pathology, New York University at Langone Medical Center.  Amy Rapkiewicz, M.D. chairman of the Pathology Department stated that clotting “was dramatic because though we might have expected to find it in the lungs, we found it in almost every organ that we looked at.”  Autopsies also revealed large bone marrow cells called megakaryocytes that are common in bone and lung tissues were located throughout the body in multiple different organs.  “Notably in the heart, megakaryocytes produce something called platelets that are intimately involved in blood clotting,” Rapkiewicz stated,

From these findings, it is speculated that many who have recovered from COVID-19 may have hidden organ damage.  Examples include kidney and liver damage, and a host of other conditions.  There is much more yet to be learned about this novel coronavirus!

  1. EMS resources stressed

Q:  How are ambulance resources holding up with increasing COVID caseloads?

A:  Ambulances have always been paired with the transportation of the sick and injured to a hospital.  In 1968, the national Emergency Medical Services (EMS) program was established.  EMT training, vehicle design and equipment on ambulances were all standardized nation-wide. For over a decade, with the wide acceptance of defined medical care being performed at the scene by paramedics, there have been proposals to allow paramedics to practice their skills in the field without transporting the patient to a hospital.  An example would be at a school clinic.  But this remains an aspiration for many.  Current funding of all EMS services depends heavily on the patient being transported.  Even in a municipal service, EMS is able to bill health insurance companies.  However, they do not reimburse for calls unless the patient is moved in the ambulance.  Thus, the major impact on EMS during this pandemic is financial.  If the community is overwhelmed with COVID-19 calls, the call volume can increase.  However, if the hospital and medical officials decide to request that no CPR and transport be given to all patients who are found to be  in cardiac arrest at the scene, that EMS response takes time away from other calls, and later cannot be billed.  Likewise, if the ambulance must wait in the hospital parking lot for 4, 6, or in one case 10 hours before the patient can be brought into the emergency department, there is no billing allowed for that waiting time.  If EMTs contract COVI-19 while on duty, any overtime paid for others to cover their shifts cannot be billed.  To counter all this, there is one offsetting resource available.  FEMA has the ability to mobilize ambulances from outside the disaster area to travel to the areas where added EMS resources are needed.  But even then, as this pandemic disaster widens to cover more of the nation, this pooling of shared resources becomes more difficult.

  1. Classic epidemiology: science and politics  
  2. Why is it so hard for people to follow proven recommendations of public health experts? 
  3. A. Epidemiology is the science of managing contagious diseases.  Standard strategies have evolved to control such threats.  A basic strategy to control an epidemic is “test-trace-isolate-and-treat” those affected. Accurate testing can locate infected people.  For each person testing positive, they can be asked to identify who they have recently been in contact. These new contacts are then located and tested for the disease.  All who test positive are then quarantined or isolated to prevent them from coming into contact with others.  Each recently tracked person is tested.  If their test is positive, they are asked to identify other contacts and over time, the chain of continued infections can be stopped.  This strategy has evolved into an accepted policy for managing infectious diseases.

This series of FAQ has been focused on the science of managing coronavirus-19.  But it appears that politically, it is increasingly important to reopen the economy and ignore the science.   the current situation may be better illuminated by trying to understand what is behind the political discussions overtaking this issue:

In a new book “The Imposters” written by Steve Benner, many examples are cited with explanations showing that the Republican Party has been turning away from developing policies based on expertise, analysis and research.  Policies that could result in debates leading to compromise.  This shift began long before Trump ran for the office of the president.   As far back as May 2009, GOP leaders were concerned after losing back-to-back election cycles.  “The House GOP conference chairman (who was Mike Pence) advised his colleagues to start getting rid of legislative staff – aides responsible for writing and scrutinizing policy proposals, giving the party its capacity to govern – and start hiring aides who would focus exclusively on the media.”   “Kentucky’s Mitch McConnell was often candid about how he approached his responsibility.  …the GOP senator settled on a strategy of maximal partisanship, demanding total Republican opposition to Democratic proposals” (p.7).  Trump entered office with his own unique deficits of leadership, but has been supported and enabled by the newly-refocused Republican Party.  Each of the chapters in his book focuses on one of eight different policy issue being managed including health care, immigration policy and climate change. It is well researched and annotated.  This book, perhaps can serve to better understand why so many people in the country appear to be unable to understand and sensibly react to the many rational policy options being discussed.   The full title of the book is “The Imposters. How Republicans Quit Governing and Seized American Politics”.

  1. Confusion reigns

           Q: I’m confused.  Should I send by 4th grader to school?

A: Everyone is confused!  The lack of a national pandemic policy focused on reducing the infection rate using standardized mitigation steps creates a confusing situation for the public.  As a result, Americans are divided and state and local leaders are creating conflicting strategies to contain the surging COVID-19 cases.  In Georgia, the governor Brian Kemp sued Atlanta’s mayor to prevent her from mandating masks.  Medical professionals are angry over all this because more than 1,200 of them, 161 being nurses have already died from this disease.  Many people say they won’t wear masks because it violates their freedom.  The Trump administration is demanding that all schools fully open this fall – or he will cut their federal funding.  Educators and many local officials are objecting because of the risk – to the students, staff and older people living back home.  Thirty of California’s 58 counties are on the state’s watch list and their schools may remain closed.  The CDC was ordered to revise their reopening school guidelines to make them less restrictive.  Now the CDC has decided (or has been ordered) not to provide their revised standards to the public.  Anger and angst are the expected result of all this chaos!

Frequently Asked Questions about COVID-19

“Shared expectations lead to predictability.”

66. FDA actions to ensure a safe and effective vaccine
Q: Is it possible that a test vaccine could be approved for political reasons without the clinical trials being completed?
A: On June 30, the US Food and Drug Administration stressed the importance of science over politics by announcing it has taken action for the “timely development of safe and effective vaccines to prevent COVID-19.” Significant federal funding has already been approved for some companies to begin manufacturing large quantities of their test vaccines and prepare individual doses in syringes ready for use. It has been reported that Phase 3 clinical trials for several candidate vaccines are just now beginning. To evaluate if a trial vaccine is unsafe, for example by creating a significant number of adverse conditions such as blood clots resulting in strokes, a “double-blind” administration of the vaccine is conducted Half the group is injected with the trial vaccine, while the other half is given a harmless injection such as a saline solution. None of the participants knows which is actually being administered. The subjects then return to their usual routines. They are frequently evaluated for the presence of antibodies, side effects and for COVID symptoms. At the end of the trial, the data from each group is compared. If the trial vaccine created antibodies and there were no symptoms, this could prove the trial vaccine was effective. If the group with the vaccine developed symptoms, it could prove the trial vaccine was not effective. If the vaccinated group developed unusual side effects, the conclusion could be reached it was unsafe. This process usually takes at least two months for the immunity to be proven, and for adverse findings to develop. And, of course if immunity is temporary, lasting only a few month, more study time would be needed to learn this.
This action taken by the FDA appears to make it clear that approval of any trial vaccine will not occur before the clinical trials have had the chance to prove safety and effectiveness. Peter Marks, MD, PhD, director of the FDA’s Center of Biologics Evaluation and Research stated, “Right now, neither the FDA nor the scientific community can predict how quickly data will be generated from vaccine clinical trials. …But make no mistake, the FDA will only approve and make available a COVID-19 vaccine if we determine it meets the high standards that people have come to expect of the agency.”
67. Coronavirus-19 during a hurricane
Q: If we are hit by a hurricane, how do we continue to control the spread of this pandemic?
A: In May, the Federal Emergency Management Agency (FEMA) published a 22-page manual, “COVID-19 Pandemic Operational Guidance for the 2020 Hurricane Season.” This is focused on guiding state and local operations. Its purpose is to offer advance description of anticipated challenges to disaster operations posed by COVID-19, outline how FEMA plans to adapt its response and recovery operations, and to allow state and local officials to plan in advance.
FEMA separates all disaster planning into phases based on when activity is required. In this case, planning guidance is separated into response – while a hurricane disaster is underway, and recovery – restoring normal routines after the event is over.
FEMA has a well-established system layering their operations through its national center, 10 regional offices and multiple joint field offices. These guideline states that FEMA will continue to provide resources to hurricane affected areas when requested. Once the national COVID-19 national emergency declaration was issued on March 15, FEMA activated its national coordination efforts, and authorized $100 million in grants to states to allow them to prepare emergency responses to the pandemic. The newly issued hurricane guidelines are included in the required preparation activities supported by that action.
Specific topics are identified, and considerations are outlined for state and local response plans that must now include:
• Capability available to respond with reduced staffing;
• Continuity of essential functions with no interruptions;
• Ability to stabilize communications between groups and agencies;
• Ability to protect personnel that must be deployed to the field;
• Provided for adequate medical grade personal protective equipment (PPE);
• Hospitals to have evacuation plans for patients, staff and medical equipment;
• Plans exist for the medically appropriate evacuation/sheltering of high-risk patients;
During recovery, many considerations for “mass care” that would require advanced planning are identified and discussed, including:
• “Non-congregate sheltering” of displaced people – providing social distancing and isolation such as the use of hotel rooms and dormitories.
• Special needs addressed for people with disabilities or medical needs such as dialysis;
• Availability of isolation or quarantine areas in remaining congregate shelters;
• Medical supplies, PPE, and individualized pre-packaged food services for citizens, staff and volunteers.
It is comforting to note that in Connecticut, especially in the region around Hartford, this planning is underway and goals are being reached. It remains to be confirmed that FEMA supplies and support will meet demands. That assumption is challenged by past problems of offering testing supplies and PPE for “routine” (non-hurricane) pandemic operations.
68. A recent discovery about T cells and immunity
Q: What’s this I hear about a different way the body defends itself against an infection that doesn’t involve antibodies?
A: All research developing a vaccine has been focused on the development of an agent that can cause people to develop antibodies to combat coronavirus-19 without actually infecting them. The virus is pictured as a spherical object with many spikes. It is these spikes that react in contact with human cells allowing it to be drawn inside the cell where it reproduces thousands of copies of itself and moves on to infect other cells. Antibodies are generated that interrupt the spikes’ ability to penetrate new host cells. A recent study, not yet published for peer-review, has identified another mechanism the body uses to fight this disease. There are two specific types of white blood cells. These are named “T cells” and “B cells.” In a complex way, these interact to stop the ability of the virus to replicate itself once inside a host cell. Early findings indicate that T cells have a longer “memory” of the coronavirus than antibodies. If proven to be true, vaccines using this different approach could prove to offer immunity over greater periods of time. More research is indicated, especially because it’s possible that some antibodies may actually enhance the process of a virus entering host cells making the disease actually more infectious. The more we learn, it seems, the more we find there’s a lot more to be learned!
69. New 15-minute COVID-19 test approved
Q: Is there any improvement in rapid turn-around testing for COVID-29?
A: Early in July, the Becton Dickenson & Co. was awarded an emergency use authorization (EUA) for a hand-held “BD Veritor Plus System” testing device which can deliver results in 15 minutes. The device is authorized to be used in health care settings, and does not require sending samples to a laboratory for evaluation. This and other similar devices still under development will shorten the time spent in lines waiting to take a test. They also provide information earlier to permit better contact tracing and isolation of newly infected patients. As with all COVID-19 testing, questions of accuracy have been a problem. In clinical studies leading up to its approval, the new unit reaches up to 84% accuracy finding true positive cases, and 100% finding true negative results. In other words, as stated by the FDA, “there is a higher chance of false negatives, so negative results do not rule out infection.” “The results may also require another diagnostic test “prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative.”
70. More on the “crisis standard of care”
Q: Are there hospitals that continue to have more patients than can be managed?
A: It has been reported that in the US, 5 months into the pandemic, there have been 1,000 medical and health workers who have died from COVID-19. The impact on the availability of remaining workers, and their comfort continuing to work in EMS and in hospitals cannot be underestimated.
Also, in Texas, it is now reported that tents are being set up outside several hospital emergency departments. Not to treat patients, but for ambulances to offload so they can return to service other patients. In these tents, patients are waiting often more than 4 hours, before a physician is available to see them.