Connecticut Bioscience Companies Tackle COVID-19
The coronavirus has caused dual crises, but many actions underway by industry and academic researchers indicate that the upheaval in our healthcare system and economy will soon begin to recede.
First, in a very short time biomedical researchers have learned a great deal about the nature and workings of the coronavirus and the disease it causes, COVID-19.
The virus is often described as the “novel” coronavirus, but this indicates only that it is a new variant in the well-known class of coronaviruses.
The coronavirus we’re fighting is something more familiar than mystery.
Efforts to educate the public about how to mitigate transmission of COVID-19 appear to be working.
This includes actions like social distancing and frequent hand washing, but also the more recent finding that the amount of exposure to the virus is critically important to how severe the disease will be.
Greater exposure, such as through coughing and sneezing, seems to translate into more serious symptoms, versus lesser exposure giving rise to milder symptoms.
This knowledge has helped improve the protocols for persons more at risk for greater exposure, such as healthcare workers.
Second, efforts to combat the virus itself are advancing with uncommon speed and on many fronts. There are more than 75 COVID-19 treatment efforts afoot.
This includes 40 vaccine candidates, including programs by Connecticut Bioscience Growth Council members Pfizer and Johnson & Johnson. Three COVID-19 vaccine candidates are in phase one of their clinical trials.
It’s important to bear in mind that vaccines work by exposing our bodies to something that resembles the pathogen we’re hoping to eradicate. Such exposure alerts the immune system to recognize the pathogen, attack it and kill it.
Creating something that resembles a pathogenic virus enough to trigger the immune system to sense the actual disease-causing virus, without itself causing disease, is complicated to say the least.
Like all FDA approved medicines, vaccines must be tested through three stages of clinical trials that can begin only after preclinical laboratory studies assessing preliminary efficacy, toxicity, pharmacokinetic and safety information have been completed.
Phase I clinical trials then test the medicine in a very small number of volunteers for safety.
Phase II tests the medicine in a larger, but still modestly sized, group for both safety and efficacy (i.e., is the medicine safe and does it work?).
Phase III involves a large number of subjects to further gauge safety and efficacy, especially to see what, if any, side effects occur when a wider population is tested. This phase alone, at a minimum, takes six to 18 months.
As intricate, costly and time-consuming as vaccine R&D is, manufacturing an approved vaccine, in vast quantities, is itself an enormously complicated task.
To this end, Johnson & Johnson has committed to opening a new vaccine manufacturing plant in the U.S., and to scale up capacity in other parts of the world, in order to make one billion doses of a COVID-19 vaccine globally on a not-for-profit basis.
Research and Development
Since vaccines are a medium-to-long-term solution, it’s gratifying to see how many treatment R&D projects are in the works (i.e., efforts to treat, versus prevent, COVID-19 disease).
Testing, for example, is underway of two anti-malarial drugs for effect on COVID-19. Bioscience Growth Council member Alexion is testing its game-changing rare disease drug, Soliris, on COVID-19.
Other companies are working to see if their antiviral medications will combat the coronavirus.
Gilead, for example, is testing its Remdesivir, used to treat Ebola, against Covid-19; Abbvie is testing Kaletra, an HIV medication.
Still other companies are working to find and develop anti-bodies to infuse into COVID-19 patients to fight off the disease.
Ironically, it appears that some COVID-19 patients’ immune systems overreact to the disease.
To combat this aspect of the COVID-19 disease profile, several companies are testing their anti-inflammatory drugs for use on these patients. For example, Sanofi and Roche are testing their arthritis drugs for use against COVID-19.
Finally, it is heartening to learn how many companies are contributing, in so many creative ways, to assist public health efforts related to the coronavirus.
For example, in response to the economic hardship faced by many during this public health emergency, council member Eli Lilly is working to ensure insulin affordability.
Another council member, Medtronic, is sharing the design specifications for its Puritan Bennett 560 ventilator to aid rapid manufacturing of ventilators.
For more information, contact CBIA’s Paul Pescatello (860.244.1938) | @CTBio
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