JACKSON — News about the dozens of COVID-19 vaccine trials can seem removed from the coronavirus outbreak in Teton County, vague science experiments with no bearing on local life.
But for Dr. Marty Trott, an otolaryngologist at St. John’s Health, the trials are in fact reality because he is a participant in one.
“I’ve always felt a sort of responsibility to the community in general and society at large to support clinical trials,” Trott said. “I’ve been involved in other trials even when I was in medical school.”
Trott is part of a trial for a Pfizer vaccine, which like many other vaccines, is a two-step process. Recipients receive the first shot, then a second one 21 days later. Along the way and for months afterward, blood draws show what level of antibodies patients have. Half the participants are given a placebo and the other half the vaccine.
Trott doesn’t know what he was given, but he thinks it was the vaccine. He had a localized reaction at the injection point, which is often a sign of an actual vaccine, not a placebo.
The Pfizer vaccine Trott is involved in testing is in Phase III. For any medication or vaccine, trials go through a series of steps. With a small number of participants, Phase I determines if something is safe and produces some level of immune system response.
Phase II is a larger version of that same concept, but is still relatively small. If a vaccine or drug is found to be both safe and effective in the first two phases, it enters Phase III, in which thousands of people are recruited and efficacy is tested on a wide scale.
As a doctor and member of the scientific community, Trott wanted to further the research and development of a vaccine.
Most trials want someone to be in a city where the work is actually taking place, in part so participants can be tested for COVID-19 if they start feeling ill after being administered the vaccine.
The runners of the Pfizer trial in Denver were happy to have him join because St. John’s has the testing capacity should Trott start to feel sick.
Another Jacksonite, philanthropist and former nurse Ann Lurie, found herself able to participate in a different trial because she splits time between Jackson and Chicago, where research is underway.
“I just felt like I wanted to make a contribution to this in some tangible way,” Lurie said.
She is part of the Moderna trial, which is also at Phase III.
Vaccines in the Moderna and Pfizer trials both employ a relatively new technology, called messenger RNA. At its most basic, RNA is genetic code that triggers cells into some form of action. Messenger RNA tells cells to produce certain types of protein, and it is part of the creation of antibodies.
During a viral infection, cells respond to parts of a virus’ genetic code with antibody production, but a messenger RNA vaccine stimulates that kind of immune reaction without exposing the body to the full virus.
“They don’t have to worry about completely making a new virus. They’ll just make one little part of the virus,” said Dr. Ken Cornell, a Boise State University professor of biochemistry and vaccine development. “They’ll focus on making a part of the virus that you need to get an immune response to.”
Many vaccines use actual viral material to stimulate that immune response. By using messenger RNA, researchers don’t have to subject patients to the entire virus (meaning you can’t get COVID-19 from it), and they can mass produce the vaccine, because the genetic material is easy to replicate.
“It’s very easy to assemble large, large, large amounts of it,” Cornell said. “You can just synthesize it in a machine in the lab.”
Scalability is a huge benefit. The federal government has given drug companies billions of dollars for vaccine research in return for millions of doses. Both Moderna (nearly $1 billion) and Pfizer ($1.9 billion) have received federal money, according to The New York Times’ vaccine tracker.
Some manufacturers expect they could conclude Phase III trials in the next month or November, which Cornell sees as an indication that vaccines could be available in January or February for limited use. Production and distribution capacity are the two biggest factors in how quickly vaccines will be available for widespread use, and the ability to produce the hundreds of millions of necessary doses to protect just Americans will likely take longer.
Cornell said health care workers and high-risk populations are likely to be in that midwinter first round of distribution, meaning many people may not be able to be vaccinated until spring or summer.
Centers for Disease Control and Prevention Director Robert Redfield told the Senate Health, Education, Labor and Pensions Committee last week that it would be “late second quarter, early third quarter” before the vaccines were widely available.
Compounding the Herculean endeavor of simply distributing millions of doses of vaccines, most of which need to be kept at subzero temperatures, is a growing sense of mistrust about a COVID-19 vaccine.
Estimates of herd immunity are anywhere from 50% to 80%, at least, so that many people would either need natural exposure or vaccination to stop the virus.
However, a Pew Research study conducted in early September found that 51% of Americans say they would “probably or definitely” get a COVID-19 vaccine, a 21-point drop from May.
One worry is that the vaccine development process is being rushed, since most vaccines take five to 10 years to go from idea to distribution. The idea of producing one in less than a year may give the impression that the process was pushed along.
Trott said he trusts the scientific community to vet the results of each trial and approve vaccines accordingly. Cornell, the Boise State professor, took a similar stance and said rapid vaccine development is not abnormal.
“There is plenty of precedent for putting out a vaccine quickly,” he said. “We have an annual influenza vaccine. The choices for this year’s vaccine weren’t made five years ago; they started last year.
“So there’s industrial machinery already in place to produce an influenza vaccine every year.”
For those opposed to such a vaccine, Lurie said she hopes to ease their worries.
“I think the way to change that is obviously by educating the people who might not want to take it, just saying things that will alleviate — at least to some extent — their fear of it,” she said.