As senior vice president, head of chemistry and co-founder of Lynk Pharmaceuticals, alumnus Michael Vazquez, ’80, has expert insight regarding the current race for COVID-19 treatments and vaccines. For his career’s work doing research that has led to commercial anti-HIV products and autoimmune treatments, he received the NIU Alumni Association’s (NIUAA) Alumni Achievement in the Sciences award in March. The NIUAA recently asked Vazquez to discuss what goes into discovering and developing treatments and vaccines for novel viruses.
NIUAA: In your experience, is the 12–18-month timeline for a vaccine realistic?
Vazquez: Based on what I have read and in my own experience working in big pharmaceutical companies, I do believe 12–18 months for a vaccine is possible. However, this is a very aggressive timeline, and it will require a massive, coordinated effort. I think the actual identification of a viable vaccine can be relatively fast. It is running clinical trials to ensure safety and efficacy, and also putting the vaccine into production, that can take some time. What I hope for is that, once vaccine candidates are identified, a coordinated effort among major pharmaceutical companies will accelerate production and clinical testing. Then, I hope there will be a coordinated effort to get early and possibly limited supplies to people with the highest risk of infection. Of course, I want to point out that most people recover on their own from COVID-19, so just reducing the severity and/or length of the illness through treatments may be all that is needed for now.
NIUAA: What is entailed in getting a new medication or vaccine approved?
Vazquez: Investigative compounds are typically given to a small number of healthy volunteers starting at a low dose and they slowly increase the dose to ensure they do no harm. This is called Phase 1 and is done to determine the safety and tolerability of a drug candidate. For example, are there any rashes at the injection site, allergic reactions, serious side effects, etc., at the doses that may be required to treat the virus? This is followed by a Phase 2 study, where select patients are now treated and efficacy is assessed using doses determined to be safe in the Phase 1 study. If Phase 2 is successful, then one or more larger Phase 3 studies are initiated in the target patient population, essentially anyone who might benefit from the new drug. In total, it often takes anywhere from 6–10 years to get a new drug approved.
To shorten the timeline to 18 months means that a lot of these steps need to be done in parallel at great cost, tremendous effort and with a high likelihood of failure, which is why we need multiple vaccine and/or drug candidates to be evaluated simultaneously. There are a couple of opportunities to shorten the development time. One is to use patients in the Phase 1 study, for example, but while some of these patients may benefit, others may not if the dose is too low to have any effect. There is also a significant risk that the treatment could compromise the patients’ health and increase their risk of a negative outcome. Another time-saving opportunity that is highly likely to be used with COVID-19 treatments is that the FDA can allow what is called “compassionate use” of an exploratory (unapproved) compound in life-threatening situations when no other treatment is available. This is typically used after Phase 2 studies have been completed and we know the candidate is safe and works in at least some patients.
NIUAA: How do the medical and pharmaceutical communities work together to find answers?
Vazquez: The medical and pharmaceutical communities are inextricably linked. Pharmaceutical companies cannot deliver new medicines without the medical community, and the medical community is always seeking new treatments for their patients. Large networks of scientists and medical personnel already exist. There are strong bonds within these groups and a common desire to develop new treatments for human diseases, so marshaling these resources to defeat the virus requires nothing more than a shift in focus.
Regulators at the FDA will also play a key role in ensuring safety yet allowing for the rapid development of new treatments for COVID-19. I would be remiss if I did not also mention the role academic and government labs play, doing the basic research into how the virus infects cells and biochemical pathways within the virus that may be good targets for drug intervention.
NIUAA: What encourages you about vaccine and treatment news today?
Vazquez: Large portions of the medical, pharmaceutical and academic communities have shifted their focus and pulled together to identify treatments. This is very encouraging, as this is a tremendous amount of resources devoted to the effort. As I mentioned above, I don’t think for now we need a cure for COVID-19, we just need to lessen its severity. In that respect, I believe we will find some of our existing medicines may be helpful. There is a lot of news about existing drugs, like remdesivir. I am hopeful they will help.