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    May 15, 2020
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Business Insight Coronavirus; Lesson 4-Vaccines We all want it gone; we just no longer have patience to see the numbers growing and we cannot do anything about it. If we got to the Moon fifty years ago, why can't we stop the virus? The answers aren't as simple as they are complex. Getting ready for the Moon was a long-term planned action, with consistent progress, scientists and engineers working together, and the goal was an obvious target. There were setbacks and challenges but the goal was always the same and clear. Coronavirus is new. We know so little about it that focusing on a clear goal is impossible. We try to save people's lives as a priority. It is hard. We try to save the healthcare system before it collapses. We try to protect healthcare providers and first responders and we're not always as successful. We also attempt to try other medications, already existing, and develop the new ones to treat the COVID-19 cases. Some work, but are not safe, and some are still tested. done on HUMANS, like you. Not in the lab tube. Testing vaccines is actually much more difficult than new medications. The risk for patients is much higher than new medicines. And the pool of patients is much larger. If some little details of safety are missed, people may die, short-term and long-term. And those who are testing it must be really brave volunteering their participation for exposure with unknown consequences. Our country just granted funds of almost 500 million to a company that never succeeded in developing a new drug or vaccine. I listened carefully to the meeting that led to that decision. I heard the leader of that company committing to bringing the vaccine by the fall, in several months. This is how it was granted the funds. And finally, we need vaccines. They do not exist and we need to develop them. We could not even think of it until the genome model of the virus was made public by Chinese scientists earlier this year. And some impatient individuals want a vaccine by the summer or fall of this year. We hear the voices of our leaders pushing on the timing and approving only the answers promising an immediate vaccine release. Please, listen to me: it is impossible. Like every clinical research drug, vaccines must go through the processes of evaluation in phases of clinical research. We cannot skip anything. Phase 1 is trying the drug/ However, hardly anybody paid attention to vaccine on a small group of individuals who agree to receive various doses of it to verify the toxicity level. Phase 2 is working with groups of 200-300 patients, continuing safety verification but also efficacy, which is how well the product is working. And here is the trick: the only way to verify if except that I will not trust the development the vaccine is working is to actually expose the patient to the virus. We need 200 patients, 50% of whom will receive placebo and the other 50% a real vaccine, and we need to expose them to the virus in a very equal way, observing and verifying whether and how well they respond. Finally, in phase 3, we will test 1000+ patients, extending the inclusions criteria to many groups of people and watching for safety events, like reactions long-term. Testing of new drugs or vaccines is the details of what was added at the very end: the company will bring in the vaccine in several months, will bring it to phase 2 development. Re-read the above. This does not mean we WILL have a safe vaccine by the fall. It actually means nothing to me until we get phase 3 results. Which might or might not happen as the company has never conducted any studies beyond phase 2. 1 am sure our leaders do not understand that. I am also sure they do not comprehend the concept of safety in drug/ vaccine development. Clinical research is about safety and science. I cannot find the same idea in the current discussions about COVID-19 vaccine. And it worries me more than the virus itself. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net Business Insight Coronavirus; Lesson 4-Vaccines We all want it gone; we just no longer have patience to see the numbers growing and we cannot do anything about it. If we got to the Moon fifty years ago, why can't we stop the virus? The answers aren't as simple as they are complex. Getting ready for the Moon was a long-term planned action, with consistent progress, scientists and engineers working together, and the goal was an obvious target. There were setbacks and challenges but the goal was always the same and clear. Coronavirus is new. We know so little about it that focusing on a clear goal is impossible. We try to save people's lives as a priority. It is hard. We try to save the healthcare system before it collapses. We try to protect healthcare providers and first responders and we're not always as successful. We also attempt to try other medications, already existing, and develop the new ones to treat the COVID-19 cases. Some work, but are not safe, and some are still tested. done on HUMANS, like you. Not in the lab tube. Testing vaccines is actually much more difficult than new medications. The risk for patients is much higher than new medicines. And the pool of patients is much larger. If some little details of safety are missed, people may die, short-term and long-term. And those who are testing it must be really brave volunteering their participation for exposure with unknown consequences. Our country just granted funds of almost 500 million to a company that never succeeded in developing a new drug or vaccine. I listened carefully to the meeting that led to that decision. I heard the leader of that company committing to bringing the vaccine by the fall, in several months. This is how it was granted the funds. And finally, we need vaccines. They do not exist and we need to develop them. We could not even think of it until the genome model of the virus was made public by Chinese scientists earlier this year. And some impatient individuals want a vaccine by the summer or fall of this year. We hear the voices of our leaders pushing on the timing and approving only the answers promising an immediate vaccine release. Please, listen to me: it is impossible. Like every clinical research drug, vaccines must go through the processes of evaluation in phases of clinical research. We cannot skip anything. Phase 1 is trying the drug/ However, hardly anybody paid attention to vaccine on a small group of individuals who agree to receive various doses of it to verify the toxicity level. Phase 2 is working with groups of 200-300 patients, continuing safety verification but also efficacy, which is how well the product is working. And here is the trick: the only way to verify if except that I will not trust the development the vaccine is working is to actually expose the patient to the virus. We need 200 patients, 50% of whom will receive placebo and the other 50% a real vaccine, and we need to expose them to the virus in a very equal way, observing and verifying whether and how well they respond. Finally, in phase 3, we will test 1000+ patients, extending the inclusions criteria to many groups of people and watching for safety events, like reactions long-term. Testing of new drugs or vaccines is the details of what was added at the very end: the company will bring in the vaccine in several months, will bring it to phase 2 development. Re-read the above. This does not mean we WILL have a safe vaccine by the fall. It actually means nothing to me until we get phase 3 results. Which might or might not happen as the company has never conducted any studies beyond phase 2. 1 am sure our leaders do not understand that. I am also sure they do not comprehend the concept of safety in drug/ vaccine development. Clinical research is about safety and science. I cannot find the same idea in the current discussions about COVID-19 vaccine. And it worries me more than the virus itself. Michael Bukhalo, MD Arlington Dermatology 5301 Keystone Court Rolling Meadows, IL 60008 Tel. 847 392 5440 | www.arlingtondermatology.net