How Does A Vaccine Trial Work?

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What’s the hold up?

Essentially, you can speed up the vaccine development process to respond to a pandemic, but you don’t want to speed it up so much that you allow a bad vaccine to enter the market, explained Dr. Greg Poland, director of the Mayo Clinic’s Vaccine Research Group.

“The process of developing, testing and licensing a vaccine for widespread population use is designed to be slow, deliberative, peer-reviewed, reflective, evidence-based, so that we don’t make mistakes,” Poland said.

Going too fast could lead to a vaccine that’s not effective or, worse, can cause serious health problems, Poland said.

Typically, clinical trials take 10 to 15 years and a billion dollars to complete, Poland said.

Vaccine trials come in three phases, said Dr. Wilbur Chen, an adult infectious disease expert at the University of Maryland’s Center for Vaccine Development and Global Health:

  • Phase I trials test whether the vaccine is safe, and usually last about six months.
  • Phase II trials examine how well the vaccine works in creating an immune response within volunteers, and last up to a year.
  • Phase III trials track the effectiveness of the vaccine in preventing infection in people who are being exposed to the pathogen. This phase could take three years or more, and depends on the virus remaining active long enough for participants to be exposed to it.

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