The Clinical Trial Process for a COVID-19 Vaccine

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It’s hard to wrap one’s mind around the coronavirus (COVID-19) outbreak and what it means for society. There’s a lot we don’t know and this is the first time we’ve had to deal with a global pandemic of this magnitude. In addition, the situation is changing rapidly from hour to hour, and there’s a mix of misinformation and fact floating around the internet. (For information on how to protect yourself, your loved ones, and your community, please rely on information from the CDC.)

 

One of the biggest questions and areas of confusion is: when will there be a vaccine? Since clinical trials happen to be one of our areas of expertise, we wanted to take a minute to provide an overview of the process a new vaccine would have to go through before being available to the public, and why that process is so important.

 

The process of testing and approving a new treatment or vaccine is a complex one, and for good reason. There need to be safeguards in place to confirm that a treatment or vaccine is effective and safe before using it on the general public. That’s particularly true with a vaccine, since a vaccine is used on healthy people and the last thing anyone wants to do is make healthy people sick.

 

As a result, even though some companies are already announcing promising progress on developing potential vaccines, the process of producing a usable coronavirus vaccine will take at least 12 to 18 months, and even that timeframe is considered extremely aggressive. Let’s look at why.

 

Note: We are talking about the clinical trial process for a vaccine, which would prevent healthy people from contracting COVID-19. There are also treatments for COVID-19, which need to be researched and trialed as well, but those trials are run on people who currently have the virus. We are not discussing those trials in this post, but hope to do so in a future post.

 

Current Phase: Research and Discovery

Right now companies and labs around the world are working to identify and develop potential vaccine candidates and test them on animals to determine whether they’re promising and safe enough for human trials. Once the vaccine has been proven to be successful and safe in animal testing, the FDA will approve it for human clinical trials. Some companies are already pushing to skip animal testing to accelerate the timeline to get to release, but many researchers are concerned about the risks of skipping this crucial step.

 

Phase 1

The first phase of the human clinical trial will involve giving the potential vaccine to a small group of healthy people (fewer than 100) and then monitoring those people for a few months for effectiveness and side effects. This will help researchers understand the effect of the vaccine on the human body and whether there are harmful side effects that outweigh the benefits of the vaccine.

 

Phase 2

Once the vaccine passes the first phase, it will be approved for phase 2, which will involve a larger group of patients monitored over a longer period of time. Phase 2 clinical trials usually involve hundreds of patients and can take up to two years. Due to the immediate nature of the pandemic and the fact that the vaccine is meant for the general population (and not a very specific subset of the population that could take a long time to recruit) this phase could be completed much faster than the normal timeframe.

 

Phase 3

Once the vaccine candidate is proven successful in the phase 2 trial, it will be approved for phase 3, in which the vaccine will be given to thousands of patients to gauge varying effectiveness and safety with different subsets of the population. This will help ensure that the vaccine is truly effective for everyone and not just healthy and young members of the population.

 

Approval and Release

Finally, the FDA will review the results of the clinical trials and approve the vaccine for the public. Then the company behind the vaccine can mass-produce the vaccine for public use. The vaccine creator will still be required to run phase 4 trials after release to look for additional side effects and understand the long term effects of the vaccine once it’s out on the market. And at any time the vaccine can be taken off the market if necessary.

 

Even with an immediate global need, unlimited funding (it will take billions to shepherd vaccine candidates through the testing and approvals process), and collaboration from dozens of companies and governments, it will still take over a year before any vaccine will be available to combat COVID-19.

 

What We Can Do Now

In the meantime, we as a society need to listen to our health professionals as they provide us with the best possible advice in this rapidly evolving situation. Our goal as a people needs to be to manage the spread to prevent our healthcare systems from being overwhelmed and supporting each other as the situation develops.

 

We’re working with our customers at major academic medical centers to brainstorm how our artificial intelligence platform can support their research teams as they develop their understanding of and response to COVID-19. It’s part of our commitment to helping researchers harness the power of their data to improve healthcare and change the world.

 

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