Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

141. Public trust in vaccines is a major problem.

        QWill an approved COVID-19 vaccine be safe once it’s approved?

        A:  Many people have said they will not take an approved COVID-19 vaccine, because it may not be safe.  When a COVID-19 vaccine is approved for use in the US and is available to people in Connecticut, it will have been judged safe by an independent, non-political board of experts.  After being given to 15,000 to 20,000 people in a double-blind Phase 3 trial, any individual adverse effects to those people will have been studied and the causes determined by the board of experts.  Their findings should be made public, and open for review by everyone to determine the safety risks.  After the Phase 3 clinical trial leads to an Emergency Use Authorization (EUA) and the vaccine is made available to the public, that vaccine should be much safer than continuing to be exposed to the coronavirus-19.  Anyone making a decision to not take the vaccine should first learn the details of the findings of safety in the Phase 3 trials.

142. Effectiveness of an approved vaccine, along with when and where it will be offered,  have important considerations.

        Q: When a vaccine is available, when and where will it be offered and should I get it?

        A:  The State of Connecticut has submitted its 77-page distribution plan for any FDA-approved COVID-19 vaccines.  Several considerations should be understood:

  • A return for a second shot may be required.
  • The vaccines currently being developed are only for adults.
  • No children will be vaccinated in this round of vaccinations. It may take a year or more before a vaccine for children will be available.
  • At least one vaccine under development requires very cold (dry ice) storage from manufacture to shipping to storage at the vaccination facility until it is administered. If this is a requirement of any approved vaccine, logistics will have to provide for this kind of storage that may eliminate many local pharmacies, doctor’s offices and outpatient clinics from providing the shots.
  • The Connecticut distribution plan identifies “critical populations” as the first to be given the initially available vaccinations. This includes:
    • Essential workers (medical and non-medical) dealing with potential and actual COVID-19 patients.
    • People at increased risk of severe illness from COVID-19, including those with underlying medical conditions and people over 65 years of age.
  • People not in the first priority critical population group will have to wait until sufficient vaccine doses become available later.
  • After receiving the vaccination, it may take up to two weeks for it to generate immunity. Any immediate feeling of safety cannot be justified.
  • Depending on the identified effectiveness of the approved vaccine, there will remain a degree of risk for still contracting COVID-19 when vaccinated. If the phase 3 trial was found to be 80% effective, then one must assume that 1 out of every 4 vaccinated people (20%) will not become immune and could contract the disease.  Wearing masks and social distancing for everyone will remain a requirement.

One question not yet been raised is if a second or third vaccine is later approved, can it be taken after someone has already taken a previous one?  What if a subsequent vaccine is found to be more effective?

  1. Herd immunity becomes an unrecognized reality

          Q:  Why is Trump holding many large rallies with people without masks packed together?

          A:  On a CNN talk show this last Sunday, White House chief of staff Mark Meadows stated, “We are not going to control the pandemic.”  When asked why the White House wasn’t going to rein in the disease, Meadows said, “Because it is a contagious virus just like the flu.”   He further stated the White House is now focused on getting effective vaccines and therapeutics to market.  The rapid number of political rallies being held with thousands of attendees close together and most not wearing masks coincide with the reduction in testing, the surge in the daily number of new cases, and an accelerating number of deaths in the US.  All these demonstrate the integrated policies of the administration that refute recognized public health policies to mitigate against the spread of COVID-19.   Five members of vice president Pence’s staff have now tested positive repeating the previous situation in which even within the White House, control of the spread of the virus among its staff is not a priority.  It is clear that “herd immunity” is actually the current policy now being followed by the administration.  This follows the recommendations of Scott Atlas, MD, currently the de facto White House medical advisor. “Herd immunity” is seen by all infectious disease experts and epidemiologists as unethical and a flawed strategy that will not accomplish its stated goal of stopping the disease.  It is significant that the Trump administration has not labeled their policy with its rightful name.  But its component parts are all there.

If this strategy is followed, it is estimated by the University of Washington Institute for Health Metrics and Evaluation that by December 31 of this year, as many as 318,000 deaths will have occurred.  Even then, this would be less than 20 percent of the anticipated number of deaths required to achieve herd immunity – 4 more deaths for each one who will have died by January 1.  And that assumes that after recovery, all infectious patients will achieve long term permanent immunity, which is highly questionable.

  1. Reinfections reported for patients who had COVID-19 and survived.

          Q: Can patients who have had COVID-19 and recovered get it again?

          A: There has not been much attention given to the issue of reinfection, but it is known that someone who has recovered from the disease can get it again.  In the journal The Lancet, scientists have confirmed a reinfection of a patient in Nevada.  To the question can you get the disease twice?  “The short answer is ‘yes,’” said Soumya Swaminathan, chief scientist of the World Health Organization.  A couple of dozen cases so far have been reported globally.  While this occurrence is rare, the implications could be profound.  The Lancet points out that many infected people may have been asymptomatic and a reinfection would not have been recognized as a second encounter.  Genetic testing of the coronavirus-19 that caused each the initial and the second infection has shown significant differences.  Viruses are known to mutate to remain infectious.  Immunity generated by the body and introduced by vaccinations would be ineffective if the virus mutates to a different form that doesn’t respond as before.  We all get common colds caused by a virus, but either the resulting immunity fades over time, or the virus mutates resulting in repeated colds being caught again and again.  Each year, a new flu shot is required because comprehensive immunity is not permanently carried by either having a single shot or by a catching the disease.

  145. Remdesivir is approved by the FDA even though the WHO says it has no positive effects on COVID-19 patients.

          Q. What is the current status of Remdesivir in treating COVID patients?

          A:  Remdesivir had previously received Emergency Use Authorization (EUA) in May to treat hospitalized patients of COVID-19.  It was initially found that it reduces hospital stays by 5 days.  The EUA allowed continued use of the drug on hospitalized patients to further study its effects.  Last week, just before the final presidential debate, the FDA awarded the drug formal approval.  It is the first and only drug approved for this disease in the US.  This in spite of the fact that the World Health Organization study of Remdesivir involving 11,000 patients in 30 different countries found that death rates after 28 days, the need for ventilators, and the number of days spent in the hospital were not statistically affected by the use of Remdesivir.  The WHO study has not yet been published in a peer-review journal, and Gilead, the manufacturer of Remdesivir is challenging the WHO study.  The cost of the Remdesivir, which will be sold under the brand name Veklury, will be $3,120 for a 5-day course of treatment.  Additional costs to the patient will include charges by the hospital and medical staff for administering the drug.

Frequently Asked Questions About COVID-19

  “Shared expectations lead to predictability.”

  136. Increased infections with coronavirus-19 is encouraged by Trump.

          Q.Where is Trump getting his information that herd immunity is the right strategy?

          A:  Increasingly, president Trump has been holding rallies and giving speeches that refer to wearing masks as a personal decision, social distancing is optional, and that we need to “open up the economy” and that “schools must open up.”  The concept of herd immunity has been previously discussed in this column[1]  Scott Atlas, MD is now informally the White House medical authority who advocates letting everyone become infected with COVID-19 as a way to build population or herd immunity.

The American Institute for Economic Research is located in Great Barrington, Massachusetts.  The stated mission of this Libertarian think-tank includes, “educating Americans on the value of personal freedom, free enterprise, property rights, and limited government.”  The Media Bias/Fact Check group states “They often publish factual information that uses loaded words (wording that attempts to influence an audience by using appeal to emotion or stereotypes to favor conservative causes.”  While many academics participate in the Institute, it is an independent 501c(3) organization maintained by donations.  On October 4, 2020, this Institute signed a declaration that appears to have been adopted as the current national policy of the White House!  It advocates that people at low risk of death from COVID infection should individually decide if they will immediately resume their normal pre-pandemic living habits by working away from home, socializing in bars and restaurants, and gathering in large numbers at sports and cultural events (and Trump rallies!).  The goal is to contract COVID-19.  No binding government rules should prevent this.  It is presumed that most of these people won’t die, and this would build up population immunity.  If the elderly and those at risk are protected, the nationwide spread of COVID-19 would create herd immunity reducing future case loads.

Institute representatives call this “focused protection.”  They are against mandatory “stay at home orders” and other governmental mandates such as wearing masks and maintaining social distancing.  They advocate that the focus should instead be on “shielding” those at risk.  Individuals, based on their own perception of risk of dying from COVID-19, should personally choose the risks, activities and restrictions they prefer.  On October 5, the day after the declaration was signed, three Institute representatives from Oxford University, Stanford University and Harvard University met with Alex Azar, US Secretary of Health and Human Services and the new White House medical advisor Scott Atlas MD.  Secretary Azar, at this meeting stated, “we heard strong reinforcement of the Trump administration’s strategy of aggressively protecting the vulnerable while opening schools and the workplace.”  It is quite apparent that Trump has adopted the Great Barrington Declaration as the new national strategy for his combatting COVID-19.

  1. Public health officials and medical professionals declare the Great Barrington Declaration an ethical nightmare

          Q: What do scientists feel about the Great Barrington Declaration?

          A:  Medical and public health officials are opposed to this approach to COVID-19:

  • “Never in the history of public health has herd immunity been used as a strategy for responding to an outbreak, let alone a pandemic,” World Health Organization Director General Tedros Ghebreyesus said this week. “It is scientifically and ethically problematic.”
  • Natalie Dean, a University of Florida biostatistician said, “It just presumes that with this level of control you can really wall off people who are at high risk.” Society doesn’t neatly separate itself into risk groups.  We’ve seen outbreaks that began in younger people move on to infect older ones. How do we isolate and protect the poor, and the socially scattered people with pre-existing health conditions?
  • To achieve a minimum 60% of the population contracting COVID-19 to reach natural herd immunity, the resulting number of US deaths would exceed 2,000,000 people – ten times the number who have already died from the disease in the US.
  • Joshua Michaud, PhD, associate director of Global Health Policy at the Kaiser Family Foundation stated, “It remains unclear that COVID-19 confers immunity from reinfection. You may never be able to reach that magic ‘herd immunity’ threshold at all if people can be re-infected.”  Reinfected patients are now being reported.
  • A group of 80 researchers and epidemiologists reported in a letter published in the Lancet – a peer-reviewed medical journal – warning that  “herd immunity approaches  are a dangerous fallacy unsupported by scientific evidence.” They also noted that “protecting our economies is inextricably tied to controlling COVID-19.”
  • An alliance of 14 public health organizations known as the Big Cities Health Coalition issued a statement calling the Great Barrington Declaration “a political statement” that is “NOT based in science and would “haphazardly and unnecessarily sacrifice lives.” Further, “It preys on a frustrated populace.  Instead of selling false hope that will predictably backfire, we must focus on how to manage this pandemic in a safe, responsible and equitable way.”

No matter how the forthcoming elections turn out, the Great Barrington Declaration has sown many seeds of false expectations that will lead to unpredictable outcomes before returning to proven public health measures that can effectively overcome this pandemic.

  1. New research: coronavirus-19 can remain virulent for 28 days on cell phones and hard surfaces

          Q:  Is there any new research on how long coronavirus-19 stays alive on surfaces?

          A: The Australian national science agency CSIRO conducted a recent study that found the virus remains viable – able to infect people if picked up and taken near the mouth, nose or eyes – for up to 28 days.  This includes on cell phones, especially the glass on touch screens.  Sharing a cell phone with others can thus be an easy mode of transmission.  This is a longer time interval than found in earlier studies.  The results were published in the peer-reviewed Virology Journal.  “It really reinforces the importance of washing hands and sanitizing where possible and certainly wiping down surfaces that may be in contact with the virus,” said the study’s lead researcher, Shane Riddell.  To clean cell phones, use a cloth moistened with a disinfectant rather than a spray.  Otherwise, moisture might penetrate by the keys and openings to short out and damage the interior electronics.

  1. The Phase 3 trial of a vaccine by Johnson and Johnson is paused.

          Q: Under Trump’s “Warp Speed” vaccine development, will vaccines be safe?

          A: There is a wide-spread perception that the first vaccines to be available may not be safe.  Many people may not want to receive it.[2]  As a result, the FDA and vaccine developers are being careful to demonstrate that all vaccines will be safe.  Johnson and Johnson announced last week that it was pausing its Phase 3 trials to allow an independent board to review data on one patient who developed an unexplained illness.  During this pause, no additional patients will be given trial vaccines while those already in the trial will continue to have the effects of their vaccinations studied.  Under the guidelines of the FDA, the board review on this one case will be submitted for FDA approval before the trial can reopen.  Johnson and Johnson said such pauses are normal in large trials.

140. Essential nursing staff caring for COVID-19 patients are under stress.  

          Q. Is anyone looking at the long-term impact of stress on health care workers?

          A: One of the significant causes of stress on nursing staff in hospitals, long-term care facilities, clinics and other areas of congregant living is the persistent lack of personal protective equipment (PPE).   This and the emotional stress of the constant and intense issues of tending to overwhelming numbers of critically ill patients are leading to significant burn out and psychological distress.  On October 9, which was World Mental Health Day. the International Council of Nurses (ICN) also cited that many nurses face abuse and discrimination outside of work.  Howard Catton, RN, a British nurse who is the ICN’s chief executive, reported that roughly a quarter of its national nursing associations in the greater than ICN’s 130 countries participated in a recent survey.  More than 70% of those surveyed cited they have been subject to discrimination or abuse.  Many who are considered essential workers say they have been unable to find child care to allow them to work.  Others have cited fear of exposing their own families to COVID-19 at home, and some have been threatened with discrimination by landlords refusing to renew their leases.  But paramount among the stresses cited by Catton, “We still continue to see problems with the supplies of personal protective equipment.”  These are factors to consider if a “herd immunity” strategy is followed.  Added stress could result in a shortage of nursing staff just as the number of seriously ill patients expands and overwhelm the health care system.

[1] See FAQ #84, 3102, and #120

[2] See FAQ #109

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.”

 131. The conflict continues: science v. politics

          Q:  Is the CDC still unable to stay focused on the science of communicable disease?

          A: The controversial conflicts continue:

  • Politics over science: The CDC created a sweeping order in September requiring all passengers and employees to wear masks on all forms of public and commercial transportation in the United States. This included airplanes, buses, subways, taxis, shuttles, tourist conveyances and limousines.  This order was supported by Alex Azar, the US Secretary of Health and Human Services.  But the White House Coronavirus Task Force led by vice president Mike Pence refused to even discuss this order and blocked it from being released.  If it had been released, it would have been one of the toughest federal mandates to date controlling the expanding numbers of COVID-19 cases. An unnamed “task force official” said this kind of requirement should be left up to the individual states to decide.  “Local and state officials need to determine the best approach for their response efforts depending on how the coronavirus is impacting their area.”  The CDC director, Robert R Redfield, MD, who oversaw the order’s drafting, recently stated he thinks masks are the most powerful weapon we have to confront COVID-19, and we all need to embrace masks and set the example for each other.”  But this order was never released.
  • Science over politics I: William H, Foege, MD is perhaps one of the leading epidemiologists of our times.  In 1976, he devised the global strategy that led to the total eradication of the disfiguring and often fatal infectious disease – smallpox.  He served as the director of the CDC between 1977 and 1983.  Under his leadership, CDC grew to become a world leader in research and prevention of communicable diseases.  On September 23 of this year, Dr. Foege sent a personal letter to Robert Redfield, MD, the current director of CDC.  This letter was later released to the public.  He opened, “The first thing would be to face the truth.  You and I both know that.”  “This (pandemic response) will go down as a colossal failure of the public health system of the country.  The biggest challenge in a century and we let the country down,” “The public health texts of the future will use this as a lesson on how not to handle an infectious disease pandemic.”   “In 6 months, they have caused CDC to go from gold to tarnished brass.”  He went on to chide Dr. Redfield for allowing this damage to continue by acquiescing and letting political influence to occur.  He challenged Dr. Redfield’s legacy, encouraging him to apologize to the scientists and staff in the agency and to stop allowing politics to intervene.  He told him that by telling truth to the people at CDC, he will probably be fired, but he will be able to hold his head high from the bad headlines that will last only for a few weeks.
  • Science over politics II: The New England Journal of Medicine, a prestigious peer-reviewed medical journal, became the third scientific journal to editorialize against the way the White House has mismanaged the response to coronavirus-19.  Its editorial entitled “Dying in a leadership vacuum” stated, “They have taken a crisis and turned it into a tragedy.”  When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent.”  The other two scientific journals on record include The Lancet that published an editorial in May asking that a president be elected that “understands that public health should not be guided by partisan politics.”   Scientific American published a more direct editorial endorsing Joe Biden for president because of the failures of the Trump administration.
  1. Scientists study possible coronavirus-19 mutation

          Q: Many viral diseases mutate over time.  Has this happened to coronavirus-19?

          A: In Patagonia, a far-flung region of Chile in South America, a second wave of COVID-19 has broken out that appears to be significantly more contagious than experienced earlier.  Marcelo Navarrate, MD, of the University of Magallalanes stated that researchers have detected “structural changes” in the spikes of the coronavirus-19 virus.  These changes indicate the virus has mutated.  Research is underway to explore this correlation.  The Magallanes region in Chile is a remote glacier-strewn wilderness dotted with small towns.  Hospitals are nearing capacity with patients being evacuated to the capital, Santiago.  This finding corresponds to a preliminary study in Houston, Texas that found that during its second wave, a more contagious strain has dominated.  Scientists say the mutations may make the virus more contagious but do not necessarily make it more deadly, nor do they necessarily inhibit the effectiveness of a potential vaccine.  More research is underway.

133. Debora Birx MD cites the cause of currently increased COVID infections                                                                            Q. Dr. Birx of the White House Coronavirus Task Force spoke in Connecticut. What was her message?

          A: Deborah Birx, MD, spoke in Hartford last Thursday.  She has served on the White House Coronavirus Task Force as its response coordinator.  She has been excluded from recent influence in that group’s discussion since president Trump decided to limit the role of science in developing federal policies.  Dr. Birx came to this position after working decades to advance research on HIV/AIDS vaccines.  She informed her audience, “The kind of spread we’re seeing now is very different from the spread experienced in May and April.”  The spread in the Northeast “is not coming from classrooms or workplaces, but rather social gatherings indoors and outdoors when masks and distance protocols are not followed.”  She stressed it is important to be “socially engaged but physically distant” when around friends or family who do not live in the same household.  Especially with the holiday gatherings being planned now, it has to be recognized that masks should become part of “everyday life.”  She said it should be assumed that everyone nearby, even if you have known them for a long time, may now be infected and contagious even it they don’t appear or feel ill.  Vin Gupta MD, from the Institute for Health Metrics and Evaluation at the University of Washington stated recently that as many as 80% of the people who are spreading coronavirus-19 and infecting other people look completely healthy.  Half of these people spreading the disease are asymptomatic, and the rest are “pre-symptomatic” – shedding the virus during the few days before they become sick.

134. Russia has approved its first COVID-19 medication for sale in pharmacies                                                                          Q. Is Russia further along in its COVID research than we are?

          A:  Russia’s pharmaceutical company “R-Pharm” has announced that starting this week, a COVID-19 prescription medication “coronavir” can be picked up at local pharmacies.  This is an antiviral drug for outpatient treatment of mild to moderate COVID-19.  This is in the same family of Russian drugs as another antiviral drug (“Avifavir”) rolled out last May for use in hospitals.  Both medications are based on favipiravir, which was developed in Japan in 2014 for use with the common flu.  Coronavir’s Phase III trial was comparatively small, involving only 168 COVID-19 patients.  One report stated, “R-Pharm’s announcement is another sign Russia is pushing hard to take a global lead in the race against the virus.  It is already exporting its COVID-19 tests and has clinched several international deals for supplies of its Sputnik-V vaccine,”       

  1. Bits and pieces…

          Q: What else is new?

          Answer:

  • Pine-Sol is approved as a disinfectant for coronavirus-19. The Environmental Protection Agency (EPA) has been testing and listing approved disinfecting agents to protect surfaces on which the coronavirus-19 may collect.  All the identified products appear in a category they call “List N,” and are identified by their chemical composition.  This makes it difficult for homeowners and small groups to find a product by its trade name.  Recently, the commonly available product, Pine Sol, was approved, and notices went out by the EPA notifying the public of its use giving its common name as it appears on retail store shelves.
  • The pharmaceutical company, Eli Lilly, put out a press release stating it was seeking emergency use authorization (EUA) for its experimental antibody treatment currently undergoing limited trials. This therapeutic works similar to the Regeneron’s REGN-COV2 administered to president Trump after his admission to Waller Reed hospital.  In this highly competitive market, some officials have stated this EUA request is too early.  The trials have just begun and have involved only 268 people of whom 112 received the drug.  Early results show some success, but more data is needed.  The Regeneron’s drug is also not approved for an EUA, but it did capture the headlines because it was granted “compassionate use” for Trump.
  • A study published last week in the journal Clinical Infectious Diseases, Omar Hasan, MD, from the University of British Columbia reported, “When our body fights the new coronavirus in our lungs, it also starts to fight its own proteins that keep our blood from clotting.” That protein has been identified as phospholipids.    Knowing what may be causing the excessive blood clotting in severe COVID-19 patients may help to find ways to prevent this in the future.

 

Frequently Asked Questions about COVID-19 — October 6, 2020

  “Shared expectations lead to predictability.”

  1. After President Trump was diagnosed with COVID-19, he was given the Regeneron antiviral cocktail along with Remdesivir and Dexamethasone

          Q:  What is this “Regeneron antiviral cocktail” given president Trump last Friday?

          A: Regeneron Pharmaceuticals, Inc., based in Tarrytown, NY, has been conducting a seamless Phase 1/2/3 trial of its investigational antibody cocktail (REGN-COV2) with non-hospitalized patients.  Two types of antibodies are derived from serum taken from recovered COVID-19 patients.  Each is then processed and concentrated to increase their effectiveness.  These are then mixed together, making this pharmaceutical a “cocktail.”  The first antibody type attacks the spikes on the coronavirus making it more difficult for the virus to penetrate into a healthy cell where it can replicate itself.  The second antibody type allows the healthy cell with a coronavirus virion inside to remain healthy.  Normally, a cell with a virion replicating inside, dies once the replicated coronavirus virions exit to find new hosts.  These current trials are preliminary to Regeneron later applying for authority to conduct expanded clinical trials.  To date, there has been descriptive analysis of the first 275 people participating in this current trial.  It has been a double-blind study where half the group is given the drug, the other a placebo.  “We are extremely gratified to see that Regeneron’s REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-9 patients,” said George D. Yancopoulos, MD. PhD, president and chief scientific officer at Regeneron.

As widely publicized, president Trump was taken by helicopter last Friday to The Walter Reed National Military Medical Center in Bethesda, Maryland.  After he arrived, the medical team caring for him wanted to administer REGN-COV2.  But this “investigational pharmaceutical” is not authorized to be given to patients outside the clinical trials.  However, the physicians at Walter Reed agreed that this drug was the most appropriate one available for Trump.  On their request,  the FDA granted “compassionate use” to administer this. Compassionate use, or more formally known as “extended care,” is reserved for a pharmaceutical to be used for a patient with a serious or immediate life-threatening condition to gain access to an investigational medical product for treatment.  He was given a maximum dose (8 grams) of REGN-COV2 on Friday.

Later, president Trump began a five-day regimen of Remdesivir[1], an anti-viral medication authorized for use only by seriously ill patients.   Even later, Dexamethasone[2] was prescribed.  This is a medicine also authorized for use only on seriously ill patients.  It suppresses the immune system.  A patient’s overreacting immune system with too many antibodies can cause inflammation in the lungs and other organs.  Dexamethasone reduces the patient’s immune system to abate this inflammation.  If used on less seriously ill patients, a reduced immune system could actually increase the viral load.  Based on the information available about Trump’s care, many physician experts have publicly questioned how recovered Trump really is.  Sean Conley, D.O., the White House physician, repeatedly has cited that he is “doing great.” But Dr. Conley has also avoided questions about Trump’s lung scans, the date of his last negative coronavirus test, and clinical findings.  This questioning of the treating physician’s judgement will only escalate after it was announced Monday, mid-afternoon, that Trump will soon be discharged!

  1. COVID-19 cases among young adults are rising.

          Q: Is it true that an increasing number of younger people are getting COVID-19?

          A: The CDC conducted a study on the impact of young adults returning to attend college.  Between August 2 and September 5, weekly cases of COVID-19 rose an average of 55.1%.  The Northeast region recorded a 144% increase while Midwest cases rose 123.4%.  This increase was not limited to people attending college, as non-college students were also included in this study.

In a separate study published in last Tuesday’s CDC Morbidity and Mortality Report, researchers reported a rapid rise of COVID-19 cases two weeks after a North Carolina university opened its campus to students.  Between August 3 and August 25, the university reported 670 laboratory-confirmed cases.  Preliminary findings show that student gatherings and congregate living contributed to this spread.  On August 19, classes moved online and the school began to reduce the density of on-campus housing.  Results show a decrease in reported cases.  No deaths were reported in this second study.

128. Moderna COVID-19 vaccine shows positive results in its clinical trials.

Q. What’s happening with the scientific findings of vaccine clinical trials? 

          A: Results from an early safety study of Moderna’s “MRNA.O” coronavirus candidate vaccine showed that it produced virus-neutralizing antibodies in older adults to the same level as in younger adults.  It also produced side effects compatible with the current, long-term, wide-spread seasonal flu shots.  The study was published in the New England Journal of Medicine.  It offers an improved picture of the vaccine’s safety in older adults who have risk of severe complications of COVID-19.  “The findings are reassuring because immunity tends to weaken with age,” stated Evan Anderson MD, lead researcher of the Emory University (Atlanta) study. The early study was an extension of Moderna’s Phase 1 safety trial, conducted for individuals aged 18-55.  This more recent study tested two doses of Moderna’s vaccine – 25 micrograms and 100 micrograms – in 40 adults aged 56 to 70, and another group over age 70.  Side effects, which included headache, fatigue, body aches, chills and injection site pain, were deemed mild to moderate.  Two cases, however, resulted in more severe reactions.  One developed a grade 3 fever (over 101.9 degrees Fahrenheit).  The other developed a short period of severe fatigue.  These appeared soon after the injections, and resolved quickly.  “This is similar to what a lot of older adults are going to experience with a high dose influenza vaccine,” Dr. Anderson said.   Moderna is continuing with its phase 3 clinical trial with the higher dose of this vaccine.  This phase 3 study is the last step before its findings can be reviewed for emergency use authorization allowing it to be released to the public.

129. Can Vitamin D  reduce the impact of COVID-19?

Q. I saw on TV that president Trump was given Vitamin D at the hospital. Does this help? 

          A:  Recent research has shown that Vitamin D can reduce the risk of COVID-19 infection by 54%.  It can also cut in half the risk of fatal consequences of this disease.  This new research was led by Michael Holick, MD of Boston University School of Medicine.  It claims that adequate vitamin D levels is linked to a significantly decreased level of inflammatory markers and higher levels of immune cells.  “Because vitamin D deficiency and insufficiency is so widespread in children and adults in the U.S. and worldwide, especially in the winter months, it is prudent for everyone to take a vitamin supplement to reduce the risk of being infected and having complications from COVID-19,” he said.

130. China vaccination program continues. 

          Q: We heard that China had begun its vaccination program months ago.  Is it continuing?

          A:  China has developed four different experimental COVID-19 vaccines.  Two were developed by the state-backed China National Biotec Group (CNBG): one by Sinovac Biotech.  These three are all in Phase 3 trials.  A fourth trial vaccine developed by Can Sino Biologics was approved last June to be used by the Chinese Military.

Zheng Zhongwei, an official of the National Health Commission, stated China launched its emergency program in July[3] after communicating with the WHO in late June.  Mariangela Sim, MD, assistant director-general of WHO stated that countries have autonomy to issue their own emergency use authorizations for any health product following their national laws and regulations.  WHO chief scientist Soumya Swaminathan said earlier that emergency use authorization for coronavirus vaccine is a “temporary solution” and that a long-term solution lay in completion of Phase 3 trials.

China has been reluctant to release any information about its clinical trials.  Working in isolation of other national efforts, China has avoided collaboration to share knowledge and technical information.  Many have assumed China is taking a  competitive stance.  If China immunizes its population before any other country, this would give it an immense strategic advantage diplomatically, economically, and militarily.  The assumption can be made that by stating that WHO indirectly approved this effort rather than by its own national authorization, China can avoid direct responsibility should the vaccines prove unsafe or ineffective.

[1] See FAQ #24 & #33

[2] See FAQ #52

[3]  See FAQ #62 & #104

Frequently Asked Questions About COVID-19 — 9/30/2020

  “Shared expectations lead to predictability.” 

  1. State of Connecticut v. UUS:E guidelines

   Q:  The state of Connecticut plans to allow indoor religious services for up to 200 people starting October 8.  Why is UUS:E not going along?

   A: Governor Lamont has announced that Connecticut is planning to open up to a Phase 3 level later next week “contingent upon coronavirus metrics remaining low.”  But the risks are many.  On Sunday, the Hartford Courant front page headline stated “After quiet summer, cases climbing”

On May 14, the UUA published guidance about church gatherings.  The Policy Board adopted the June 9 recommendation of the Emergency Preparedness Task Force to hold all meetings outdoors.  Only staff would be allowed access to the offices and inside spaces for routine functions and the holding of Sunday services by Zoom.  Later, on August 13, the task force met, and the Policy Board reviewed a recommendation that for the Holiday Fair, a small number of people could briefly meet inside to support the sale of items purchased online.  Even then, special procedures would be required including enhanced inside air exchange and proper disinfection at the end of each day.

In its guidelines, one of the UUA principles about opening of church facilities is, “an abiding care and concern for the most vulnerable, inside and outside our congregation.”  Another is “affirmation that good science coupled with our UU values must be the basis on which we make decisions.”

These guidelines recommend that “congregations plan for ongoing virtual gathering and operations through May 2021.”  New UUA guidelines will probably be distributed before that date.  On September 24, the Emergency Planning Task Force met and agreed that the building should remain closed to gatherings.

“It’s better to be patient than to be a patient!” 

  1. Evaluating if one should receive any newly authorized vaccine

   Q: Should I take the vaccine when one is approved and available?

   A: The two questions to ask are “is it safe?” and “is it effective?”   It is possible and likely that any immediate safety risks will have been identified in the abbreviated Phase 3 clinical trials.  The risk of any adverse effects later has to be weighed against the benefits from taking the vaccine.  The effectiveness of the vaccine can be learned if the results of the trials are made known.  If the effectiveness reaches 50%, which is the minimum level for authorization, at least half the people being vaccinated will be protected.  This means up to 50% are still at risk of being infected after being vaccinated.  They would remain able to spread the disease to others.  If the trials produce 90% effectiveness, the risk will be far less for contracting or spreading COVID-19.   For those not being vaccinated right away, it is important to consider it will be many months until those who do take the vaccine can receive it.  On the date the announced vaccine has been approved, one cannot assume it is safe to “go back to normal.”   Wearing of masks and keeping social distancing will probably be required for years to come.

  1. New dashboard will track COVID-19 in schools
  2. How many public-school children have been infected by coronavirus-19?

   A: There has been no system to collect data on the prevalence of COVID-19 in K-12 schools in the country.  Recently, the national School Superintendents Association based in Virginia announced the creation of a dashboard that will provide this information.  As of September 23, public, private and charter schools in 47 states providing both in person and on-line education for about 200,000 students have reported.  This data shows that there were 230 COVID-19 cases per 100,000 students, and 490 cases per 100,000 staff members.  These early findings indicate the infection rates among school children and staff may well be below the average community infection rates in their communities.  This data may reflect some unreliability because it is not yet a full representation of all schools. But as new participants participate in the expanding dashboard, the results will be watched with interest.  The current news media reporting makes it difficult to make comparisons between communities or states.  In some jurisdictions, one student testing positive can cause a cohort group of 12 students to quarantine for two weeks, while in another jurisdiction, an entire school may close and shift everyone to remote learning.  This dashboard will begin to produce reliable information that will make future decisions more uniform and effective.

  1. CDC Guidelines for celebrating fall holidays
  2. My large family wants to gather at my aunt’s house for Halloween.. What’s the risk?

   A:  On September 21, the CDC revised its guidance for celebrating Halloween as well as Thanksgiving.   The following guidance is offered:

For Halloween, do not use a costume mask to replace a cloth face covering.  Instead, create a decorated cloth face covering with a Halloween theme.

Consider the following low risk activities:

Carving pumpkins outside with friends and neighbors, holding a virtual costume contest, watching Halloween movies with people you live with, and holding a scavenger hunt at your own home to find hidden treats.

Activities with moderate risk could include organizing a neighborhood trick or treat activity where goodie bags are put outside where pre-identified participants can take one without ringing doorbells, holding a socially distant costume parade, visiting outdoor pumpkin patches, and viewing a Halloween movie outdoors.

Avoid higher risk activities including ringing doorbells for traditional trick-or-treating, holding “trunk-or-treating” where goodies are handed out, attending crowded indoor costume parties, and going to an indoor haunted house.

For Thanksgiving gatherings, consider the following variables:

  • The risk increases with higher COVID-19 community caseload and spread where the gathering is planned, as well as where people will be coming from.
  • The risk is reduced if the event location is outdoors. “Outdoors” implies good ventilation with air currents dispersing any aerosoled virus. A fully enclosed tent in a backyard should not be considered “outdoors.”
  • The longer the duration of the event, the greater the risk.
  • The number of people affects the risk. Larger groups equal greater risk.
  • Prior to coming actions can affect risk. People coming from areas with high community caseloads should consider limiting outside contacts 14 days in advance,
  • Mitigation steps at the event will reduce risk – wearing cloth face coverings, social distancing at least 6 feet apart, washing hands and using a hand sanitizer.

Food preparation should be done by a limited number of people, all wearing masks.  Disposable plates and utensils will help reduce risk.  Avoid buffet style service where utensils are shared by everyone – one person serving individuals would be a lot safer.

  1. Clinical trials starting for a new single dose vaccine.

   Q: Are all the vaccines under development going to require two doses weeks apart?

   A:  Last week, the fourth vaccine to enter phase 3 clinical trials was announced.  This vaccine is being developed by Johnson and Johnson, and will require only one dose.  The testing will include 60,000 participants, twice the number in the other three clinical trials.

Paul Stoffels, chief scientific officer of Johnson and Johnson predicted the phase 3 trial may produce enough data to make the decision by the end of the year to seek approval.  He went on to say that this would then cause one billion doses being manufactured in 2021.  Unlike two of the other vaccines under development, this vaccine can be stored in a refrigerator for up to 3 months.  The others that must be kept frozen or stored at ultracold temperatures complicated the logistics of distribution.

Vaccine development is highly competitive.  The financial rewards will be great for success.  This latest Johnson and Johnson entry has yet to announce what the costs would be for receiving one dose if it is approved.  Scientifically, can someone who earlier received a different vaccine be safely vaccinated with this product?  If multiple vaccines are allowed, how will scientists continue to separately evaluate each vaccine when two or more vaccinations are taken?.  Without a national pandemic plan in place, these questions and others will have to be resolved as they appear.

Frequently Asked Questions about COVID-19

  “Shared expectations lead to predictability.” 

  1. Risk of dining out

          Q:  What are the risks of dining out??

A: The CDC has released a study showing that in a group of patients, twice as many who tested positive for Covid-19 had eaten at a restaurant during the previous two weeks.  The study included 341 patients from 11 different states.  Of this group, 160 tested negative, and 154 tested positive.  71% of those who tested positive declared they did wear cloth face coverings when out in public.  The whole group was questioned by investigators about other activities including shopping, gym attendance, going to bars and salons, or working in offices.  There was no statistical difference between those who tested negative and those who were positive.  But in restaurants, the chance of getting a viral infection practically doubled.  Among the possible reasons cited were that in restaurants, you cannot eat and drink and keep a mask on.  In bars and coffee shops, one can remove masks for shorter periods of time than for eating a whole meal.  Social distancing and poor ventilation were also cited.  Further study is indicated to verify these findings with a larger group, differentiate between indoor and outdoor dining.

 

The CDC on September 6, identified four levels of risk for eating out:

  • Lowest Risk – drive-through, delivery, take-out and curb-side service.
  • More Risk – on-site dining with outdoor seating 6 feet or more apart.
  • Even more Risk – Indoor seating with tables at least 6 feet apart.
  • Highest Risk – Outdoor and indoor seating with tables closer than 6 feet apart.
  1. COVID-19 death toll projected to rise dramatically

          Q: What does the future look like with increasing COVID-19 deaths?

A: The University of Washington’s Health Institute frequently revises its predictions on the spread of the COVID-19 infections, hospitalizations and deaths. “We expect the daily death rate because of seasonality and declining vigilance of the public to reach nearly 3,000 a day in December.”  This means the total deaths in the US would reach 410,000 by January.  This projection means the number of deaths to date – 7 months – will more than double in less than 4 more months.

118. Description of variables for those under age 21 who died from COVID-19     

          Q: What are the variables among children who die from COVID-19?

A: A recent CDC study reported in its Morbidity and Mortality Weekly Review showed that black and Hispanic children have a higher death rate than the rest of the US population.  The study looked at data from 47 of the 50 states between February 12 through July 31.  During this period, there were 121 deaths of children under the age of 21.   Of this group, 73% were minorities, even though minorities in this age group represent only 41% of the population.

Data was presented by age group for all 121 children who died:

  • Children under age 1 were 10%,
  • Between ages 1 to 9 years 20% and
  • Between 10 to 20 years was 70%

Of all deaths of children in the study, 63% were male.  Those who had at least one prior medical condition accounted for 75% of the deaths.  The remaining 25% were healthy.

The CDC recently reported that the number of children with COVID-19 is now steadily rising over time..

119. Trial launched for therapeutic drug fostamatinib (Trade name Tavalisse)  

            Q. What’s new on the research for medications to treat COVID-19?

           A:  Fostamatinib (Tavalisse) is a medication manufactured by Rigel Pharmaceuticals, Inc. in San Francisco.  It is used to treat a rare blood autoimmune disease in which the body’s immune system destroys healthy platelets leading to easy bruising or bleeding.  It is suspected that the same process in that disease for which Tavalisse is already approved may be present in severely ill COVID-19 patients.  On September 17, the National Institutes of Health (NIH) approved a Phase 2 trial of Tavalisse on 60 critical COVID-19 patients.  Half the group will be administered Tavalisse twice daily for 14 days, the other half will be given placebos or harmless pills.  For the following 60 days, the results will be recorded leading to an evaluation of its safety and degree of effectiveness.  The value of research by pharmaceutical companies is shown by the Rigel stock jumping 91% once the announcement of this phase 2 trial was announced.

  1. Science v. politics: Mixed messages – from testing/tracing to herd immunity back to promised vaccine availability and beyond.

          Q: Why is everything so confusing about coronavirus responses?

A:  Two factors appear to be at play here.  For one, there is confusion by leaders and the public over the difference between public health and personal health.  The other is the preponderance of mixed messages.

Public health is based on steps each person takes to protect the public – the entire population.  Personal health is based on what one should do to protect their own health.  For example, wearing a mask protects others in the population from becoming infected by anyone who is asymptomatic.  Vaccinations are developed to reduce the number of people in the public from becoming infected.  Some people today say they will not wear a mask or get vaccinated by saying “If I get sick, that’s a risk I will take.”   While this is a responsible action for someone to decide on their own personal health, it is an irresponsible decision for the many other people in the public who would then become ill and might die.

Mixed messages cause confusion.  Confusion results in conflicting expectations. Differing expectations can cause one group of people to disagree with others who don’t share the same view.  Expectations not shared with others creates unpredictability.  From the beginning, Trump’s directing each state to develop its own responses to COVID-19 has created confusion and competition.  The president’s shifting to the goal of opening the economy resulted in different leaders demonstrating behavior that is against public health principles.  Even in Connecticut, Governor Lamont has recently been confronted at public events by demonstrators loudly demanding that masks must not be required in public.  Some legislators are demanding the state capitol be opened to the public for hearings and face-to-face meetings. Different and opposing expectations lead to confusion.

Recently, guidance came from the CDC stating that people who have been in contact with someone who tested positive do not need to be tested.[1]  The origin of this apparently was encouraged by a new White House medical advisor, Scott Atlas[2].  It is now reported that Dr. Atlas was a commentator on Fox News espousing “herd immunity,”[3] and president Trump was impressed and asked him to come to the White House.  The result is we are now implementing without any reporting a program of herd immunity (letting as many as 70% of the population get the disease to build immunity to stop its spread).  Politicians at the US Department of Health and Human Services (DHHS) actually wrote the guidelines for no testing, and posted it on the CDC Website over the objections of the CDC scientists.  Paul Alexander, a political appointee at DHHS stated that children have near total immunity from COVID and should attend schools.[4]  Last week, news reports broke that this was clearly a move toward herd immunity.  Scientists calculated this new effort would take several years, and 230 million people would become infected.  It would result in up to 6 million deaths within the US.   Paul Alexander was then terminated and the person who hired him is now on leave.  It appeared that this attempt to subvert the science by placing political influence within the agency had been stopped.  The NIH and CDC has continued to contradict the White House on estimates for the date for release of a vaccine.[5]

This past Sunday, the New York Times broke the news that the Secretary of DHHS, Alex M. Azar, has now prohibited the nation’s health agencies – including the FDA, NIH, and CDC – from “signing any new rules concerning the nation’s foods, medicines, medical devises and other products including vaccines.”   Peter Laurie, former associate commissioner of the FDA called this “a power grab.”  More mixed messages and unpredictability are now certain.  All this validates the axiom, “Shared expectations lead to predictability.”

[1] See previous FAQ #102

[2] FAQ #110

[3] FAQ #84

[4] FAQ #115

[5] FAQ #43  #44  #109

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.

.

  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.