I may not have mentioned it here but I’ve been working in the pharmaceutical industry for over 30 years. In that time I’ve worked in biotech companies, companies that make sterile drugs, and some that make vaccines. Lately, as you might imagine, things are quite busy. I’m not working on a COVID-19 related project, but one look in my LinkedIn Feed shows me that so many people are. Every day there are new stories of what’s being done – new research, promising therapies, and collaboration between companies that normally compete that is so inspiring.
A week or so ago I noticed that many people in my social media feed were feeling worried and hopeless – that what we’re experiencing now might just be how it is forever. While I have no “inside information” to share, I started sharing what I’m seeing in my feed. There’s so much happening and it gives me great hope. I’m going to share a few stories and details here and I hope they give you some hope as well.
I see three big areas which are hugely promising: Diagnostics, Treatments, and Vaccines.
Diagnostics seem to be the furthest along right now and it’s a good thing. The more people we can test more quickly, the better we can understand how this virus is progressing, and how big our challenges are ahead. A test that tells us whether they’re infected is good, but there is also research being done on antibody tests. These will tell if a person has antibodies to COVID-19. This can tell us if that person has been exposed and already has had an immune response. This second one is good as if we build up an immunity after one infection then this shows who could possibly go out. That is, provided that a test for the virus actually is negative. (They could have an immune response and be infected – literally fighting it off at the time of testing.). The pathway from discovery to availability is short as the big needs in getting it moving are to demonstrate that the test is effective (no false negatives or positives), and that there is large scale production capacity. Without the production capacity, the best test will do us no good. Here are some developments on this front.
The next front I see promising news on is treatment. An effective treatment, could be antiviral (killing the virus), relieving symptoms so that the patient can survive long enough to fight the virus, or immune boosting. The pathway for this is a little longer. The US Food and Drug Administration and other regulatory bodies like this have strict requirements. The biggest two are that we must demonstrate that a drug is both safe and effective. It must do what we say it will do and it should not harm or kill people as it does it. The means for proving both of these are clinical trials. These are experiments done on increasingly large groups of people in a controlled manner. Some receive the treatment, some receive a placebo, and detailed data is gathered. Did anyone have negative reactions? What were they? How many were there? Did they get better when we gave them the treatment? At the end of the trials, the data is reviewed and if the drug is approved then commercial production can begin. Of course this requires that a facility be available and ready to produce this and that the process and equipment used to produce this new drug has been thoroughly tested.
So as you might imagine, this has a bit longer timeline. It takes time to set up and run the study, gather enough data to be statistically significant, and of course to ready a facility and its people for production. And that assumes that the trials went as hoped.
But before you get discouraged, there is a bit of positive news on this front. Just as you or I might think to try aspirin for knee pain after it worked for shoulder pain, people are looking at existing approved drugs with a similar, albeit more technical eye. This is called “off label drug use” and without approval it is not acceptable. However, with appropriate clinical trials new uses can be added for existing drugs. And in this case, there’s already a great deal of data about the safety of the drug for humans. So the trial focuses more on ensuring that the existing drug is effective for the new use. This makes for a somewhat shorter timeline.
Vaccines are the most exciting option as they provide immunity without exposure. With effort, vaccines can even be used to eradicate diseases. This has already been done for smallpox and is nearly done with polio. However, a new vaccine needs to go through full clinical trials after it’s been developed. At the same time, the process must be scaled up from the lab scale to clinical scale to commercial scale. In some cases this can take years. However, because many companies had already started development of a SARS vaccine (SARS is a similar coronavirus to COVID-19), much of that work can be leveraged. Still, clinical trials must happen before it can be widely rolled out.
Any of these solutions also requires a facility be ready to produce it. Some companies do have production capacity, but others may need to design, build, and then test a new facility along with the new process as well. All of this will take time, however, I can say with confidence, having been through many of those processes, that if there’s enough of a driver and the money is there (as it seems to be for this pandemic), there’s a lot of room for accelerating this process. In my experience on projects like that, for example, while many work long hours, it is very rare to maintain more than a 5 day single shift operation. If a promising vaccine were, for example, to need to be produced and the building wasn’t ready, construction could go much more rapidly than usual – and the resources would be motivated to get it done.
Finally, some are looking at stimulating immune systems with the use of plasma containing antibodies against the virus. This has shown some promise and clinical trials for this are already underway in several countries.
Over the past several days I’ve been posting all of the links I can provide on the subject to my social media feed and I will share some of them with you here now. Do recognize that many of these are not confirmed. They are leads toward possible solutions. The clinical testing process is where we find out just how effective it is. There’s a lot in the pipeline, though, from lots of smart people in lots of companies so I am hopeful that we’ll see progress soon.
Abbot has developed a test that can give a result in five minutes. It’s already being deployed including in Detroit.
Mylan in India has developed a “Made in India” diagnostic kit
QIAGEN from the Netherlands has begun shipping their test kits to the US thanks to a new FDA policy.
Spartan Bioscience from Ottawa, Canada has developed a mobile test kit
Lots of different groups – even from outside the industry are chipping in. Health Canada is asking the Cannabis industry to get involved since they also have analytical labs who are used to doing testing.
Experiments in Monash University show that an antiparasitic drug Ivermectin eliminates SARS-CoV-2 in cells in 48 hours.
Gilead’s antiviral Remdesivir is showing promise and they’ve administered it to over 1,700 people. They are stepping up production in response to this.
CytoDyn is cleared to begin Phase 2 clinical trials for their drug for mild to moderate COVID-19 infections
Sanofi Pasteur is starting clinical trials using their Rheumatoid Arthritis drug, Kevzara, for severe COVID-19. They hope the same anti-inflammatory properties that make it good for arthritis will help with COVID-19 related inflammation.
One team at the University of BC has found a drug that blocks the virus in engineered tissues. This means cells grown outside the body. Of course this still has to go through a great deal of testing including clinical trials but it does hold promise.
Genentech’s drug Actemra is being looked at to treat COVID-19 related pneumonia.
Though there’s not so much supportive data on the usefulness of hydroxychloroquine, many trials are starting. Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries
And if you’d like more discussion on how these drugs might get to market faster, have a look at this: Clinical Trials for Coronavirus Drugs May Take Only Months.
I have the most hope for vaccines as these have the potential to stop the disease before it starts. The path to a vaccine is longer than the other drugs, but the payoff is bigger. With a successful vaccine, it is possible to completely eradicate diseases as I said. Though the path takes years, generally speaking, many are saying between our previous research and the fact that we’re working together so hard for a vaccine, we could do it faster. Here is an article on the subject: Developing a vaccine takes 10 years. Sanofi seeks to do so within 18 months. Here is some of the news I’m seeing:
First off, for my friends in India. There are early indications that you may be in better shape than many of us. Some are saying that being vaccinated with the BCG vaccine (for Tuberculosis) reduces fatality rates. There’s an article in the New York Times on that and another article here with even more data and analysis.
One recently-developed vaccine has been shown to generate enough antibodies to fight off the virus. So far it has only been tested in animals so this may come a little later.
Sanofi Pasteur and Translate Bio are collaborating on an mRNA-based vaccine.
There’s more about what Sanofi Pasteur is doing here. They have two vaccine candidates that I know of, but one of the most important things I saw in that press release is this: “[If] we can develop a safe and effective vaccine, the global pharmaceutical industry has the capacity to make and deliver it. My company alone has the established capacity and infrastructure to make up to 600 million doses in two existing facilities based in New York and Pennsylvania, without compromising the supply of vaccines for other illnesses, including influenza. Other companies have similar capacity. A vaccine will only be effective if we can make and distribute adequate supply.”
In Canada, a company called Medicago based out of Quebec City is poised to start a clinical trial for their vaccine in July or August thanks to a partnership with the Canadian Government.
Pfizer and BioNTech are working together on a vaccine of their own.
Glaxo Smithkline has offered to collaborate with other companies by sharing their adjuvant technology with other companies. Adjuvants are ingredients that are added to a vaccine that makes them generate a stronger and more effective immune response. They’ve already started collaboration with several companies to work toward solutions.
This pandemic is definitely very serious. It has already killed nearly 100,000 people. But there is hope. People in my industry are working hard to find solutions. Meanwhile, people doing essential services from healthcare workers to grocery store workers to cleaners and more are now some of the most important people for keeping us safe. And in the absence of a vaccine or treatment, we have to protect them. And that means respecting your local quarantines, curfews, and lockdowns. Better still, exceed their requirements if you can. The virus isn’t spreading, we are spreading the virus so the less unnecessary contact we have with strangers the better.
Be safe and take care. As I get more good news I will continue to share it with you.