“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
- 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.”
- 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.”
- 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.
- 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!
