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Where is the Coronavirus Vaccine: Clinical Trials Explained

March 16, 2020

Scientists around the world are trying to find a way to stop the novel coronavirus, the virus behind the COVID-19 pandemic. Some groups are making progress with their research but reaching clinical trials takes time. The process is slow because it can be difficult to find what you’re looking for and it’s slow because there are several hoops scientists must jump through before they can offer vaccines or treatments to the public. Here is a short primer as to why it may take at least a year for a COVID-19 vaccine.

Why are clinical trials necessary?

Clinical trials are vital to help ensure new treatments and vaccines are safe for humans. They also tell doctors how much of the product to prescribe and when, what side effects to expect, and which patients will likely benefit the most. Many drugs and treatments reach clinical trials, but never reach the public because they don’t work or they are harmful. This process prevents something coming to market that is not helpful or can be harmful.

Clinical trials aren’t just for new treatments. They are also used to expand use of previously approved drugs or therapies. For example, in mid-2019 the Food and Drug Administration (FDA) approved the drug pembrolizumab (Keytruda) to treat a drug some cases of head and neck cancer. However, pembrolizumab has been on the market since 2014, when it was approved for treating melanoma and some types of lung cancer, among others.

Clinical trials for vaccines

As with any other type of medication, vaccines must be rigorously tested before they are available. Not only do researchers need to know if the vaccines work and for whom, they have to ensure the vaccines don’t make things worse. Because you introduce the virus, either weakened or inactive, you run the risk of complications. A study for an HIV vaccine in 2011 failed because researchers found that it may actually have increased the risk of HIV infection among some people.

A vaccine doesn’t contain the virus only. There are other components that help make the vaccine more effective and keep it stable. Each component must work together. While one alone may be harmless, it may not work well with another component. This is another part of testing.

Clinical trial phases

After completing laboratory studies (called pre-clinical studies), required applications and getting approval, researchers can start the clinical trial process. They closely follow patients as they take the medications and data collection can take years before there is enough information to back up the dosages and uses.

Phase I

Phase I clinical trials usually include a small group of healthy volunteers, although if the medication or vaccine is for a terminal illness, the trials may include patients. The aim to ensure the medication or treatment is safe and that it reaches or affects the targeted area. The researchers also look to see if it is having the desired effect.

Phase II

If the Phase I trial is successful, the product moves to Phase II. Here, the researchers divide a larger group of people into groups that will receive the drug or treatment and one who gets a placebo (non-medical treatment). There may be other groups as well. The goal is to get more evidence that the drug or treatment works and to learn about side effects, dosing issues, and more.

Phase III

Phase III trials are the last hurdle in the initial research phase. The researchers divide much larger groups of actual patients, usually in the thousands, into groups, one of which will get the treatment. Others may get a placebo or other already proven treatments to compare. The researchers want to confirm they have the right dosing levels, the drug or treatment is effective, any side effects, and any other pertinent information.

Don’t get discouraged

It does take a long time from drug or vaccine ideas to reality, but the FDA does allow for emergency status. According to the FDA website, there are three options for urgent situations:

  • Fast Track is a process designed to facilitate the development and advance the review of drugs that treat serious conditions, and fill an unmet medical need, based on promising animal or human data. Fast tracking can get important new drugs to the patient earlier. The drug company must request the Fast Track process.
  • Breakthrough Therapy designation expedites the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. A drug with Breakthrough Therapy designation is also eligible for the Fast Track process. The drug company must request a Breakthrough Therapy designation.
  • Priority Review means that FDA aims to take action on an application within six months, compared to 10 months under standard review. A Priority Review designation directs attention and resources to evaluate drugs that would significantly improve the treatment, diagnosis, or prevention of serious conditions.

 

Preventing infection today

Since there is no vaccine for COVID-19 yet, the only way to help slow down the spread is through human behavior:

  • Stay home unless for essential activities
  • Practice social distancing (staying far away from others if you must go out)
  • Wash your hands while out and when getting home
  • Disinfect all common surfaces, such as doorknobs, shopping cart handles, etc.

Updated at 3 pm EST: First human trial for coronavirus vaccine begins Monday in the US

Learn more about infection prevention here.

Learn more about Sepsis and COVID-19 here.

And you can learn more about clinical research versus medical treatment at the FDA website.

Related reading:

COVID-19 Infection Prevention: Soap and Water or Hand Sanitizer?

COVID-19, the Coronavirus, Now a Pandemic