“Shared expectations lead to predictability.”
141. Public trust in vaccines is a major problem.
Q. Will 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?
- 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.
- 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.
