The race to a COVID-19 vaccine; what the developing process looks like
SPOKANE, Wash.– We’re witnessing history with this COVID-19 vaccine.
No vaccine has ever been developed this fast; one was made for Ebola in about four years.
But, medical experts at the University of Washington said this historic timeline is not taking away from the safety of these COVID-19 vaccines.
Usually scientists would wait for one phase of a clinical trial to finish, then analyze that data before moving onto the next phase.
That urgency is now ramped up, so once a company meets safety criteria after one phase, they just move straight to the next.
“There’s more of an overlap then sequential and that’s helped to cut down the timeline,” Dr. Deborah Fuller of UW Medicine said.
All of the safety protocols are still being met.
Vaccines go through a pre-clinical trial phase where they test the vaccine on mice and other animals, and then it’s onto those clinical trials.
Phase 1 uses about 40-50 healthy adults ranging from 18-55 years old.
The goal is to figure out how safe the vaccine is and best dosage for it.
Phase 2 involves 1,000-2,000 people. This phase is when you test the vaccine on different demographics, like older people who are more at risk.
Then there’s phase 3, which is almost near the finish line.
Anywhere from 30,000 to 60,000 people are needed for that phase at multiple different sites across the world.
The goal in that phase is simple: figure out how effective the vaccine is.
That’s what Moderna and Pfizer are doing right now in their phase 3 trials.
“You’re gonna be immunizing some people with vaccine and you’re gonna give placebo to other people,” Dr. Fuller said. “You’re gonna compare those two groups of people to determine if your vaccine is helping to prevent infection.”
You may hear of someone involved in these trials getting sick, but several different things can be a factor there. If a volunteer in a clinical trial throws up or even has a heart attack, then that trial has to be paused and investigated.
Often times, the sickness is unrelated to the actual vaccine, and more so just an adverse event that happens to people.
So, once the sickness and all factors are investigated, an entire panel then decides if the vaccine was the cause or not and eventually decides when that trial can resume.
Phase 4 is when you’d see the vaccine go out to a small group of people.
The first round of vaccines we see will be used to slow the spread and likely go to first responders and specific communities first.
But, that won’t be effective for everyone, and that’s why scientists at UW Medicine are working on a second vaccine to come out 6-12 months after the first.
The hope is for that “second generation vaccine” to be more accessible and effective than the first.
“Really improve on what these first vaccines are able to offer, fill gaps that they’re maybe not able to fill,” Dr. Fuller said.
The main goal is to make sure that vaccine can help older people.
“When it gets in the body, it copies itself multiple times,” Dr. Fuller said. “When it does that, it’s able to produce more vaccine protein, and more vaccine protein translates into stronger immune responses.”
Fuller’s team is working closely on that vaccine, and she said it should work in less doses and also live in room temperature longer, so it can be distributed more widely. That vaccine is still in pre-clinical trial phase with hopes of entering phase 1 soon.
We’re also starting to learn about some specific plans from these companies making the vaccine.
Moderna just announced it’s going to charge less than $40 per dose for most customers.
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