“Shared expectations lead to predictability.”
- FDA effectiveness standard for vaccine approval
Q: Can we expect that by Election Day, November 3, that we’ll have a vaccine and this COVID pandemic will be over?
A: Not at all! Many – perhaps most – people expect a rapid end to the disease when a vaccine is approved and made available. This is the hope of politicians who want this to be true, and is fed by the frustrations of many who are confused and socially driven to resume close social contacts with other people. This widely shared expectation, which is not based on medical technology and science can only lead to unpredicted outcomes and frustration.
A scientific consideration guiding vaccine development was recently announced. The FDA will review data from the Phase 3 clinical trials just now underway, and grant an Emergency Use Authorization (EUA) if any trial vaccine is safe and effective. Effectiveness is defined as giving immunity to at least 50%.of the number of infected people in the control group. For example, if 3,000 people are enrolled in the trial, 1,500 people will be given the vaccine. The other 1,500 – the control group – will be given a harmless injection. It is now expected that in two months, data will be compared. If 200 people in the control group test positive, then up to 100 of the 1,500 who received the vaccine can contract the disease from others and the trial vaccine will be authorized for distribution. As a result, people who then receive the authorized vaccine can only be assured that they will have a 50% lowered chance of catching COVID-19 from future social contacts. Yes, they can still become infected. Of course, it is hoped that the trials will show a higher degree of effectiveness. Either way, it will be important when a trial vaccine is approved that everyone be informed of the level of proven effectiveness to guide their personal expectations
There are four major vaccines now being tested. For any vaccine receiving a EUA, its Phase 3 trial will have to continue into the future. The general population receiving the vaccine will not have a control group to make additional scientific comparisons. Over time, if the continuing trial finds immunity is short-lived and the approved vaccine might only provide protection for a limited time, it will probably be allowed to continue. Partial protection is better than none. But it has to be understood from the start that social distancing, wearing face masks, washing hands frequently, and testing, tracing and quarantines will still be required after being vaccinated. The expectation must be that the vaccine can reduce but not eliminate future infections and contracting the disease..
It is interesting to note that Russia is currently moving more rapidly than the United States through the standard scientific process. Its goal is to become the first nation in the world to approve a vaccine. By not following the scientific models for vaccine development, Russia may soon be approving a vaccine that is not only ineffective but may also be unsafe. Many scientists have compared this to the late 1950s when the US and the USSR were racing to be the first to put a man in space. “Sputnik” revisited.
- International study for advanced care of COVID-19 critical patients
Q: What’s new in developing therapies to treat COVID-19 patients?
A: In 1989, a group of clinical professionals and scientists in advanced life support techniques formed a group that would share knowledge on best practices to mechanically provide oxygen to failing organ system. One of their many developments over the years has been the creation of a machine used in an ICU to replace the functions of damaged lung tissue to oxygenate blood for circulation to the body. This process is called ExtraCorporeal Membrane Oxygenation (ECMO) and has been used in ICUs to assist COVID-19 patients in respiratory distress.
There is no ECMO manual for ICU staff to follow with this leading-edge technology for COVID-19 patients. A new consortium has been formed to organize studies to reach this goal. The study is a multi-centered international research and sharing effort focusing on COVID-19 patients admitted to an ICU using a ECMO device. Participants include hospitals in Asia, Australia, New Zealand, Europe, and now the US.
Hartford Healthcare System has now joined this study. This will include Hartford Hospital, and 6 other Connecticut hospitals in their network. Other participating centers are in the Midwest and West Coast, but the Hartford Healthcare System is the only group in the northeast currently participating. The procedures and therapies developed to compensate for temporarily disabled lungs will add to the growing list of advanced techniques to further reduce the fatality rate of Covid-19,
- COVID-19 during Flu season
Q: How bad will it be when the influenza season hits during the pandemic?
A: There has been speculation predicting increasing difficulties when the coming seasonal flu arrives. Everyone is urged to get their flu shots when they become available starting in September and October. This coming season, there will be two high dose vaccines for people over age 65. This coming year, manufacturers plan to provide at least 194 million doses, which is greater than the 175 million available last year.
The problem anticipated during this next flu season is differentiating between COVID-19 and seasonal flu types A and B. In anticipation of this, CDC has developed a new test that can differentiate between the two. Even then, patients arriving at hospitals for care will have symptoms that are similar to each. These patients must be treated with full PPE and isolation until test results prove it is not COVID. Another possibility that will be studied is how to treat a person that might become simultaneously infected with both seasonal influenza and COVID-19.
The one positive factor is that protection against both COVID-19 and seasonal flu are the same. Staying home, social distancing and wearing of cloth face coverings when outside and constant hand washing and use of hand sanitizer reduce both infections. For people already practicing these measures, fewer people will have the flu this year than previously.
- Effectiveness of face masks identified
- What is the evidence that wearing cloth face coverings work?
- A. In an editorial published in the July14 Journal of the American Medical Association (JAMA), the latest science was reported affirming that cloth face coverings are a critical way to reduce the spread of infection within a community. With asymptomatic patients increasingly prevalent in communities, even people who have no awareness they are spreading the virus can prevent their virus-filled exhaled air significantly spreading beyond the mask. Two case studies were cited. One reported in JAMA showed that in a Boston hospital system, universal masking policies reduced the transmission of coronavirus-19. In the other, reported in the CDC Morbidity and Mortality Weekly Report that masks worn by two Missouri hair stylists infected with COVID-19 prevented their passing the virus over several days to their 139 customers.
The effectiveness of using masks increases when increasing numbers of people adopt their use. Optimal effect is reached when the practice is universal. During April 7-9, the CDC conducted a survey of 503 adults. A follow up survey was conducted later during May 11-13. The number of people who use masks when outside the home went from 62% to 76% during that month. White non-Hispanic adults from 54% to 75%, Black, non-Hispanic adults from 74% to 82%, and Hispanic/Latino adults from 76% to 77%. The largest regional increase was in the Northeast from 77% to 87%. Next was the Midwest region from 44% to 74%.
- Psychiatric disorders among newly discovered aftereffects of COVID-19
Q: What else is being learned about the aftereffects for COVID survivors?
A: A study conducted at the San Raffaele Hospital in Milan was published last week in the scientific journal Brain, Behavior and Immunity. It found that more than half of the 402 patients monitored after being treated for COVID-19 experienced at least one of the following psychiatric disorders: post-traumatic stress (PDSD), anxiety, insomnia, depression and obsessive-compulsive symptoms. The study found that women in particular suffered the most from anxiety and depression despite the lower severity of their infection. “We hypothesize that this may be due to the different functioning of the immune system,” said Professor Benedetti, Group Leader of the Research Unit at the hospital.
Earlier, scientists had warned of an increasing awareness of coronavirus-related brain damage in recovered COVID-19 patients. The psychiatric consequences of this disease can be caused by the immune responses to the virus and by psychological stress factors such as stigma, social isolation and fears about infecting others, this study reported.
