Covid-19: The Lifecycle of a Vaccine Explained

The world is being consumed by news of COVID-19 cases spreading like wildfire, with hundreds of thousands already dead and millions infected around the globe.

The disease has become so serious that it’s reached the level of “global pandemic”, with no signs of it slowing down anytime soon.

That is likely because there is no vaccine to prevent it or medications effective at doing more than slowing it down fractionally. Given the virulence and wide spread of COVID-19, experts are agreeing that the only thing to reverse its effects is to come up with a vaccine to block—and hopefully eradicate—the virus, as well as protect our bodies against it.

“So when’s that vaccine going to come out?” you’re probably asking. “How long do we have to wait until we’ve got it in our hands?”

Well, that’s a more complex question than you might realize. The process of discovering, testing, and spreading a vaccine around a single country—much less the world—is extremely comprehensive.

Below, we’ll get into what the lengthy process looks like, and what you can expect even once a proper COVID-19 vaccine is discovered.

The Lifecycle of a Vaccine

Before we get into the complex vaccine creation, testing, and approval process, you need to understand something important: a vaccine is a preventative measure.

As the International Federation of Pharmaceutical Manufacturers & Associations [1] explains:

“Vaccines are primarily intended for use in healthy individuals as a preventive measure. They are complex biological products which are developed to prevent:

• Infections by current or emerging infectious disease agents (pathogens such as viruses, bacteria, and parasites).

• Infections against diseases where classical medicinal products don’t work any longer (e.g. against antibiotic resistant bacteria).”

Vaccines aren’t like medications, and they’re not given to treat diseases in people who are ill. Instead, they’re given to healthy people to prevent disease and infection.

The IFPMA gives a pretty simple and easy-to-understand breakdown of the process to approve a vaccine:

Drug Discovery – In this initial stage, there are up to 100 candidates tested over the course of 2-5 years. This includes finding a potential vaccine, optimizing it, and profiling those who it works on—all in the end goal of narrowing it down to a short list of potentially effective vaccines.

Pre-Clinical – In this second stage, only around 20 candidates are included, and it lasts for around 2 years as the various vaccines are tested. The researchers analyze immunogenicity, short-term toxicology, and the safety of the vaccine. The formulation itself is also analyzed, as well as the potential to scale up production to manufacture enough for all the people requiring the vaccine. In vitro and in vivo tests are conducted and the information collected in order to analyze for future human trials.

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Clinical Development – On to the third stage, which lasts anywhere from 5-10 years and is broken down into three sub-stages:

• Phase 1 Vaccine Studies, which lasts 2 years with 10 candidates. This works with a group of between 20 and 80 participants to analyze the vaccine for its efficacy and safety, determining safe dosage range, and identifying side effects. Testing begins with adults, and slowly the age of test subjects is stepped down until it is proven safe for children.

• Phase 2 Vaccine Trials, which lasts 2-3 years with only 5 candidates. These candidates are studied more closely to determine the best proposed doses, method of delivery, and immunization schedule. Larger groups of up to several hundred participants will be used to determine the vaccine’s effect on a wider demographic.

• Phase 3 Vaccine Trials, which lasts 5-10 years but works with just one candidate. Typically, anywhere from three to tens of thousands of participants will be involved in this phase, giving researchers a chance to assess efficacy and safety of the vaccine on a very large group of people—including those who the vaccine are specifically targeting.

At this stage, research has (ideally) pinpointed the vaccine that will be the most effective and safest.

Approval -- For the drug to go into widespread use, it must first be approved. In the US, it’s the FDA’s Center for Biologics Evaluation and Research [2] that handles the approval process, which will take up to 2 years. Even after licensing and approval, however, the FDA will monitor the vaccine’s production and testing processes.

Phase IV – Once the drug has been approved, it’s time to disperse it to the entire country (and the world, if it has gone through the globalized clinical development process). This phase is life-long, but it involves regular monitoring of the long-term safety of the vaccine. If updates are required, the vaccine undergoes further clinical development. Ultimately, the vaccine is a product that will save lives and prevent disease (as per its research).

And this is just the process for getting the vaccine approved in the United States—to get it approved around the world will take far longer and require far more effort. However, given the virulence and spread of COVID-19, the global scientific community appears to be working together to achieve the end goal of a viable vaccine far more effectively than in the past.

With the global pandemic, authorities are stating that potential vaccines will be pushed through the development and approval process at an accelerated pace. While this could give us a vaccine to counteract the spread of COVID-19 more quickly, there is also the risk that the end product has been insufficiently evaluated or is based on less-than-thorough research.

Over the next few years—which, as you’ve seen above, is how long a vaccine takes to be properly developed—we will be witnessing how authorities try to find the balance between fast-producing a vaccine but making certain it is safe and effective.

Resources:

[1] https://www.ifpma.org/wp-content/uploads/2019/07/IFPMA-ComplexJourney-2019_FINAL.pdf

[2] https://www.cdc.gov/vaccines/basics/test-approve.html

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