By Greg Barnes
Matt Irving didn’t think much about his participation in a new clinical trial for a coronavirus vaccine until someone mentioned it on social media and people started thanking him.
“I just didn’t think it was a big deal,” the Fayetteville resident said.
But deep down, Irving knows that his involvement in the clinical trials could play a small part in helping to put an end to the nightmare of death and disease caused by COVID-19. An end to wearing masks and social distancing. An end to shuttered businesses and high unemployment. An end to a virus that has taken over the world.
“I feel like I can be part of the solution,” he said.
Irving is one of more than 300 adults who are participating in a Moderna vaccine trial in Fayetteville. The biotechnology company is among the leaders in the race to develop a safe and effective vaccine. It plans to enroll 30,000 people ages 18 or over across the country in the third phase of its trial in the coming weeks.
Irving and thousands of others who have volunteered for one of dozens of clinical trials throughout the country hold the key to whether a vaccine — and potentially a return to normalcy — will be approved by the Federal Drug Administration in the coming months.
Unwittingly, however, Irving and the other participants have been indirectly drawn into the political fray.
Last week, President Donald Trump suggested that a vaccine could be made available by the Nov. 3 election.
“We are going to have a vaccine very soon, maybe even before a very special date,” Trump said during a Labor Day media briefing. “You know what date I’m talking about.”
Science, not politics
Trump’s comments have drawn the ire of leading scientists around the country who say the president is putting politics over science, safety and common sense in the race for a vaccine. It’s a race the Trump administration has dubbed “Operation Warp Speed.”
Among those scientists is Holden Thorp, a chemist from Fayetteville, editor-in-chief of the Science Family of Journals and a former chancellor of the UNC university system.
Thorp has written blistering editorials in Science magazine critical of Trump and Stephen Hahn, director of the Federal Drug Administration. Thorp points out the missteps the Trump administration has already made in the fight against the coronavirus, including Trump’s early endorsement of hydroxychloroquine as a cure for the virus. Hahn had granted emergency use authorization for hydroxychloroquine before further studies proved it wasn’t effective in preventing COVID-19.
“Premature approval of a vaccine in the United States (or anywhere) could be a disastrous replay of the hydroxychloroquine fiasco but with much higher stakes,” Thorp wrote in an August editorial. “Approval of a vaccine that is harmful or isn’t effective could be leveraged by political forces that already propagate vaccine fears.”
In an interview Sept. 4 with NC Health News, Thorp said he is encouraged by the Moderna trials, as well as others around the country and the world. But Thorp said he doesn’t believe a vaccine will be approved before the election. The earliest, he said, might be December.
Like other scientists, Thorp abhors the president’s efforts to politicize the pandemic.
“Trump’s goal is confusion,” Thorp said. “He’s trying to sow confusion about this and so far he’s been partly successful and it’s going to take everything we have in journalism and in scientific leadership to try to get the right information to people.”
Irving, the man participating in the clinical trials in Fayetteville, doesn’t see himself as a political pawn. He just wants to help discover a safe and effective vaccine as quickly as possible.
“I do not take any medical advice from any politician,” Irving said.
On Tuesday, Moderna and eight other pharmaceutical companies signed a letter jointly pledging to “stand with science” and not rush for a vaccine’s approval before it has been proven safe and effective.
The Fayetteville trials
Irving works as a billing analyst for Cape Fear Valley Health System, a partner in the Moderna trials in Fayetteville along with the Carolina Institute for Clinical Health and Wake Research of Raleigh, which is overseeing trials across the country.
Irving, 43, said part of the reason he is participating in the trials is that he considers himself high risk for contracting COVID-19. He often takes his mother for kidney dialysis, where people sit in close quarters for hours. He said his husband works at Cape Fear Valley Medical Center, where coronavirus patients are being treated.
Judith Borger is a Cape Fear Valley doctor and the principal investigator of the clinical trials in Fayetteville. Borger said the trials are being conducted so successfully that the Fayetteville clinic has been approved for up to 200 more participants.
Participants are screened to ensure that they don’t suffer from disqualifying health conditions or other factors. Those who do qualify are administered the vaccine shortly after the screening and again three to four weeks later.
The fact that it takes up to four weeks to get the second shot is one reason Thorp and other scientists don’t believe a vaccine will be ready for approval before the election.
On Sept. 3, Borger said Moderna had enlisted 18,500 vaccine participants throughout the country, a long way from the 30,000 it hopes to enroll. Borger also said that only 21 percent of the participants are minorities. The company, like the others conducting trials, is striving for 25 percent minority participation. Borger said all of the companies are having trouble enrolling Blacks, Latinos and other ethnic groups.
“We want to make sure that the vaccine is safe and effective for as diverse of a population as possible,” Borger said. “That’s why they chose sites all over the country.”
But if participants are still being enrolled and it takes a month between vaccine injections, Thorp and others say, it is highly unlikely that a Phase 3 trial can be completed and a vaccine approved before December, at the earliest.
Even then, Thorp said, the vaccine would likely first be given to people who are at greatest risk of being infected by the coronavirus.
“Those of us who can work from home who are relatively young and don’t have underlying conditions, we should be late in the process,” Thorp said. “Health care workers should be at the beginning and other people who are at risk. And so, yeah, that’s gonna take, I would say, at least the first two quarters of ‘21.
“To me, that’s exciting that a year from now we might be doing most of the things that we used to do. But for some people, that’s an awfully long time, and understand that there has to be an orderly process for doing all this.”
Thorp pointed to a discussion draft by the National Academies of Science, Engineering and Medicine called “A framework for equitable allocation of the vaccine for the novel coronavirus.” The Centers for Disease Control and Prevention and the National Institutes of Health commissioned the national academies to develop the report. A draft was made public Sept. 1.
“Despite the worldwide effort to develop safe and effective vaccines against COVID-19 and ramp up production capacity, it is inevitable that initial vaccine supply will be limited,” the national academies says on its website. “Therefore, policymakers must develop plans to ensure the equitable allocation of limited doses until there is sufficient global supply.”
If and when a vaccine is approved, it is not known how long it will provide protection and there is no guarantee that it will be completely effective, scientists say. That raises the specter that SARS-CoV-2, the virus that causes COVID-19, could be here to stay.
Want to join the trials?
At the Fayetteville clinical trials, Borger said none of the participants has had any adverse reaction to the vaccine, other than expected swelling at the injection site and mild flu-like systems.
Irving said he became fatigued for about 48 hours after his initial vaccine injection and for about 24 hours after the second one. Like all of the participants, Irving doesn’t know if he got the vaccine or a placebo. He praised the clinic for being organized and thorough.
“I just felt confident even when I went in there and talked to everybody,” he said. “They were informative, educational. They follow up very timely with you. It felt like just going to a regular doctor’s visit pretty much.”
Borger said time is running out, but people can still sign up for the trial, which remains in particular need of minorities and people at high risk of contracting the virus. Participants are paid about $1,900 over the course of the two-year study, Borger said.
Among the trial requirements are to keep an e-journal to record reactions to the injections over time. Anyone interested in enrolling can visit here: https://www.ci-cr.com/studies_list/covid-19/?cid=COVIDStudiesWeb. Trials are also being conducted in Raleigh: https://www.pmg-research.com/studies/facility/raleigh/covid-19-investigational-vaccine-study/About the companies
Moderna, in partnership with Swiss drugmaker Lonaz, is among three U.S. pharmaceutical companies that have reached Phase 3 of the trials. Pfizer and AstraZeneca are the others. Moderna was the first to reach Phase 3, the final phase before a decision on approval could be reached. In June, the FDA said a coronavirus vaccine would have to protect at least 50 percent of vaccinated people to be considered safe and effective.
While the Moderna and Pfizer trials have been moving along, last week, AstraZeneca halted its testing when a participant had a suspected adverse reaction. Researchers were trying to determine whether the reaction was caused by the vaccine or was coincidental before deciding whether the trials should resume.
Moderna has also partnered with the National Institutes of Health on its vaccine, which relies on a piece of genetic material called messenger RNA, or mRNA, a technology that hasn’t been used in any approved vaccines to date, according to LiveScience.
“Traditional vaccines are made up of weakened or inactive viruses, or proteins of those viruses, to trigger an immune response; mRNA vaccines, on the other hand, are made up of genetic material that teaches cells to build these viral proteins themselves (in this case, the coronavirus’ spike protein),” LiveScience reports. “Both traditional and mRNA vaccines trigger an immune response in the body such that if a person is naturally exposed to the virus, the body can quickly recognize and fight it. “
Pfizer, which has partnered with German biotechnology company BioNTech, is also developing a vaccine that uses messenger RNA to prompt the immune system to recognize the coronavirus.
The federal government awarded Moderna $955 million for development of the vaccine, and on Aug. 11 awarded up to $1.5 billion more for the manufacture and timely delivery of 100 million doses.
In August, Pfizer and BioNTech were awarded a $1.95 billion federal contract to produce 100 million doses of their vaccine by the end of the year.
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