- A COVID-19 vaccine could be produced in record time, but that still won't be fast enough to to solve our current pandemic.
- What could: treatments.
- Developers all over the world are working on repurposing old drugs and creating new ones to treat COVID-19, and some could be ready by April this year.
- The reason treatments might be available so much sooner than a vaccine has to do with safety.
- We spoke with a couple researchers - one developing a treatment and one developing a vaccine - about their timelines.
- Visit Business Insider's homepage for more stories.
Following is a transcript for the video.
Narrator: A COVID-19 vaccine will take at least a year to get approved, which may sound like a long time, but it would actually be record-breaking. New vaccines usually take between 10 and 15 years to get to market, but a year still won't be fast enough to hold off any upcoming outbreaks. What potentially will are treatments. A treatment helps people who are already sick, while a vaccine prevents a disease in healthy people. And that's the main reason a vaccine is going to take so long. As of March 26, there were over 120 different developers pursuing three different approaches to curing COVID-19: repurposed drugs, new antibody treatments, and vaccines.
Maria Elena Bottazzi: Vaccines, unfortunately, since we know it's given to healthy people, you really have to be very careful what you give because, one, you want to make sure it's super safe, that you're not going to cause something bad by just giving the vaccine. More importantly is that when you then get the infection, that the vaccine is good to tackle the infection, but it's not going to make the reaction so severe.
Narrator: Vaccines are designed to trigger an immune response without actually causing an infection. By taking a weakened, inactive, or partial virus and introducing it to your system, it can start producing the right antibodies to fight it. Antibodies are created naturally by your body, but it takes time - weeks, sometimes months - to produce one just the right shape to fit, and therefore fight, a virus your body hasn't seen before. For some people facing the COVID-19 pandemic, that's too long to wait. The infection can spread rapidly in the lungs, causing lasting damage or even kill a person before the body produces enough antibodies. A vaccine allows your body to go through this process without the risk and sets it up with memory cells that will recognize the pathogen if it ever comes back, getting rid of it before you even know it's there. But vaccines have extra-long clinical trial phases because it can take weeks or months for a participant to develop immunity. Researchers then have to wait several more months to see if they get sick, since it would be unethical to expose them to the virus intentionally. And because vaccines are meant to prevent, it's more difficult to get one approved for compassionate use.
Bottazzi: Like when you're already so sick that you are gonna die, you'll try anything and everything, right? And so the FDA gives you permission to sometimes try nontraditional drugs because, you know, you're already pretty much, you know, almost dead, right?
Narrator: Dr. Maria Elena Bottazzi leads a team at Baylor College of Medicine that's working on a COVID-19 vaccine. Two, in fact. They're using old research, a vaccine candidate from SARS-1 that they developed a decade ago. It's been frozen and constantly monitored ever since interest and funding ran out. The virus that causes SARS and the virus that causes COVID-19 share about 70% to 80% of their genetic makeup, making this vaccine a good jumping-off point. As it stands, the original vaccine could offer limited protection against COVID-19, but it could also accelerate the development of a more effective vaccine.
Bottazzi: It's a rapid switch strategy, where you start doing some studies with the current SARS. You build evidence of safety by bringing that molecule to the clinic fast. You may then stop there and not pursue it, meaning not pursue it for licensure, but by then we will have the other one, and you can rapidly bridge it in and switch it in. And then you continue the studies with the other one that is more specific.
Narrator: But even with this head start, their vaccine still won't be widely available for at least 12 months. After it's developed, the vaccine will move into safety and toxicity testing, followed by a clinical trial, then FDA approval. And this is the case for all 40-plus vaccines currently in development. It's unlikely any of them will be finished and approved in time to affect this pandemic, but they could stop future outbreaks. Even the leading front-runner for a vaccine, a candidate developed by Moderna that's already in human trials after unconventionally bypassing animal testing, is still looking at one year or longer for commercial release. It would be a rare example of a vaccine being approved for compassionate use, but it is worth noting that the company is looking into emergency use of the experimental vaccine, specifically for aid workers, by fall of this year. Besides taking too long, vaccines don't work as well in people who are elderly or immunocompromised, two groups that are at high risk of dying from COVID-19. Antibody treatments get around that. These treatments follow a similar path to vaccines to widespread use, but instead of setting your body up to make antibodies itself, this treatment injects premade antibodies into your system.
Sarah Ives: They can be administered to people who are infected, and they'll start clearing the virus, and they'll clear the infection within a matter of hours. They will actually help people recover faster as well as reduce the mortality rate.
Narrator: They can be used preventatively, but they don't last as long as vaccines do, so they're primarily used as treatments. But in this outbreak, medical professionals could benefit from a preventative antibody treatment.
Ives: So, antibodies usually take a while too, but we're doing something that is extremely rapid, and that's because we've already let nature do half of the work for us.
Narrator: Sarah Ives and other scientists at Distributed Bio are working on a monoclonal antibody based on one that is already able to neutralize a SARS infection.
Ives: Because these people have already created these antibodies in their bodies, and we are just taking those resources, because people have already studied them, already published their sequences, and we're cutting out months to years of the drug-development process.
Narrator: Once the team identifies the new antibodies that fit the COVID-19 virus the tightest, it still has to go through the same trials a vaccine does, but a shorter version. The team hopes to have a drug available for widespread use by early fall of this year. And they're just one of more than 20 developers hoping to create a successful antibody treatment. Finally, repurposed drugs could be available as early as April. Those are drugs that the FDA or another regulator has already approved to treat other diseases and that could work for COVID-19. Repurposed drugs don't need to go through as much testing as experimental ones, which makes a great case for compassionate use, and could already exist in large quantities. The World Health Organization has started global trials on the four treatments that look the most promising, three repurposed treatments alongside one experimental drug, but there's no guarantee that any will work. One of these treatments, a drug combo used to treat HIV, already failed in a small Chinese study. But the WHO believes a larger trial with potentially thousands of participants in dozens of countries is warranted. The study is unusual, forgoing the traditional double-blind method, which opens the study up to the possibility of placebo effects. But it also means they can move faster and get answers, and hopefully a cure, as soon as possible. As of March 24, the FDA had approved the use of convalescent plasma as an investigational treatment on a limited basis. It involves taking blood plasma from a person who's recovered from COVID-19, testing it for antibodies, and injecting the plasma or a derivative of it into someone who's sick. It's worked in the past, but not on every disease, so it's not certain if it will be safe or effective for COVID-19, which is why, outside of clinical trials, it's only being approved for use in patients with serious or life-threatening infections. Even if it is proven to work, convalescent plasma isn't scalable. The treatment requires large amounts of donated blood from recovered patients, and each donation can be given to only a handful of sick patients. So there's no way to manufacture or distribute it as widely as needed for a pandemic. These timelines are a best-case scenario, where nothing goes wrong. For both treatments and vaccines, there's the potential they won't be approved by the FDA for safety or efficacy reasons. And even if they do get through the approval stage, there's still the issue of making sure there's enough to go around.
Bottazzi: So, there's three layers of issues, right? So, there's the money issues, that you don't have enough, and, to be quite honest, never enough. Scalability and suitability, right? You know, so, the logistical piece of not only making it, but delivering it and distributing it. And, you know, how often do you make them? Where do you store them? Who's gonna buy them?
Ives: We are going to need significant financial and government support so that we can scale up these antibodies and manufacture them at a high enough capacity to be delivered to hundreds and hundreds of thousands of people.
Narrator: Both treatments and vaccines are valuable and necessary for fighting COVID-19. But the bottom line is that we likely won't see any way to medically treat or prevent this disease for weeks. All of the developers are working on fairly parallel timelines, simultaneously trying to make long-term and short-term solutions available to the global public. And the rest of us can help by staying home.
Ives: Social distancing and self-quarantine are the only measures that we can take right now to mitigate the spread of this virus. But when we have a medicine, it will allow people to go back to work. And even if the virus does start to come back in waves, it will still reduce the burden on the healthcare system as well as our economy.
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