Administration officials, like Dr. Anthony Fauci, had predicted it would take 12 to 18 months. On Sunday, President Trump said he thought it would be ready by the end of 2020.
“We think we’ll have a vaccine by the end of this year and we’re pushing very hard,” President Trump said in Fox News town hall.
So, how close are we? Good Question.
Right now, more than 100 companies and research institutions are working on a COVID-19 vaccine.
Some have already begun clinical trials on small groups of humans, while others are still in the pre-clinical development.
The Mayo Clinic has “three or four” different COVID-19 vaccines in the works, according to Dr. Richard Kennedy, co-director of Mayo Clinic’s Vaccine Research Group.
“We’re in the very early stages, mostly pre-clinical development, testing in the lab, testing in some animal models,” Dr. Kennedy said. “We’re a ways away from clinical trials right now.”
There are at least three different types of vaccines, according to Dr. Marc Jenkins, director of the Center for Immunology at the University of Minnesota. One is to kill a virus and use the dead virus as a vaccine. A second is to grow it until it loses its ability to cause disease and then allow the immune system to recognize it. A third to take part of the virus and use that as the vaccine.
“The ones we have in trials right now are mostly nucleic acids or vector vaccines,” said Dr. Kennedy. “Those got a head start because they were originally developed for SARS or MERS.”
Those would include the Moderna vaccine trial in Seattle and the Oxford University vaccine trial.
“Every type of vaccine has its own advantages and disadvantages and, right now, we don’t know which type will work,” Dr. Kennedy said.
Getting a vaccine to market generally takes, on average, ten years. It begins with academic research followed by pre-clinical development. Then comes animals trials and three phases human trials. Phase 1 usually begins with 30 to 50 people, Phase 2 with hundreds of people and Phase 3 with thousands of people. All the way along, researchers are testing whether it’s safe and effective.
“At that point, if we’ve got enough data collected, we can move into actually getting approval from the FDA to license and manufacture and mass-produce it and make it available to the public,” said Dr. Kennedy.
Each of those steps can normally take years, but COVID-19 is different.
“One big difference is there’s a world-wide push,” said Dr. Kennedy. “Everyone wants to see a vaccine.”
Dr. Jensen said it is possible to fast-track the human trials to a within a year.
“The more subjects in trial, the more chances to find a rare, side effect,” Dr. Jensen said. “But, when an epidemic is on-going there will be enough infections in a control group so you don’t have to do as many people to determine efficacy.”
Last week, the White House announced it would begin “Operation Warp Speed” to ramp up production of some potential vaccines before they’re proven to work.
Dr. Kennedy believes the 12 month to 18 month timeline is “pretty optimistic,” partly because many clinical trials of vaccines fail.
“Once we get that data, we’ll be in a better position to say if that’s realistic or not,” he said. “I think we’ll get a vaccine, it’ll just take some time.”
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