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