Last week as the nation watched COVID-19 infections climb for the third time in 2020, two pharmaceutical companies paused their clinical trials — one for a potential vaccine, another for a possible treatment.
News first broke on Oct. 12 that Janssen, a subsidiary of Johnson & Johnson, would be pausing its vaccine research due to an “unexplained illness” in one of its volunteers. The next day, pharmaceutical giant Eli Lilly announced that it would stop enrolling new patients in its antibody treatment study, at the recommendation of an independent data safety monitoring board.
Both Janssen and Eli Lilly have enlisted research groups in New Orleans, one of the U.S. cities hit hardest by the COVID-19 pandemic in the first surge of infections in the spring. However, medical experts say residents volunteering for these studies should not worry.
“These holds, they’ve been portrayed as a bad thing. I look at them as a good thing,” said Dr. Anna Durbin, a professor of international health at Johns Hopkins Bloomberg School of Public Health. “This is the way that things are supposed to work in a clinical trial.”
Durbin is also one of the principal investigators for another COVID-19 vaccine trial by Astrazeneca, which in September paused its study because one of its volunteers in the United Kingdom developed transverse myelitis, a neurological condition characterized by inflammation of the spinal cord. That study has been deemed safe enough to resume in the U.K. The company is waiting for a decision by the Food and Drug Administration to restart in the United States.
Durbin explained that pauses in vaccine trials are quite common.
“I do a lot of vaccines. When we’re doing our protocol, we build in what we call pausing rules, so if something happens, it automatically triggers a pause,” Durbin said.
It’s noteworthy that the vaccine studies and Eli Lilly’s treatment trial have all been paused in phase 3. According to Durbin, by the third phase of a clinical trial scientists have generally figured out the appropriate dosage to give to volunteers and are looking to see just how effective the vaccine is. Most common complications would have been detected by previous steps that use between hundreds and thousands of volunteers. In phase 3, investigators involve tens of thousands of volunteers. In fact Janssen, which had not begun its recruitment in New Orleans when the halt was announced, is planning to enroll 60,000 individuals in the latest stage world wide.
“Part of what you want to understand in a clinical trial is how does this impact people of different race ethnicities [and] how does it impact people of different ages,” former Louisiana Secretary of Public Health and current CEO of LSU Health Care Services Dr. Rebekah Gee explained.
Gee believes that along with the impact that COVID-19 had on the Crescent City in the spring, the promise of a multi-ethnic group of volunteers has brought these trials to New Orleans.
“New Orleans is a very diverse place that represents people from many different places and ethnicities, and so it is a very good place for a company who wants to have a clinical trial involving many different groups of people,” she said.
Both Gee and Durbin called the speed at which COVID-19 vaccines are being developed “unprecedented.” This is due in part to efforts by the international public health community, particularly the Coalition for Epidemic Preparedness Innovations (CEPI) that began before the COVID-19 pandemic, following the outbreaks of SARS COV-1 in 2003 and MERS in 2012.
“There was an effort to say, ‘If we’re in the middle of an epidemic, it cannot take us 20 years to get a vaccine,’” Durbin said.
In 2017, CEPI encouraged funding for different research groups to create technology for vaccine research that would allow investigators to input antigens — the element of a vaccine that causes an immune response — into specific platforms and quickly create potential vaccines.
“The amount of innovation that’s happened in a short period of time is extraordinary,” Gee said.
But it’s President Donald Trump’s portrayal of that speed that’s led to distrust in the vaccine development process, she added.
“Unfortunately, terms like ‘warp speed’ have been really undermining of public trust,” Gee said, referring to ‘Operation Warp Speed,’ the government’s effort to develop a COVID-19 vaccine as soon as possible. “No person in U.S. history has undermined vaccines more than this U.S. president.”
In recent months President Trump has claimed that the vaccine will be ready by Election Day.
The percentage of Americans who said that they would get a vaccine if it were available today has dropped from 72 percent to 51 percent, according to the Pew Research Center.
“When you have someone saying, ‘We’re gonna have a vaccine by the end of October,’ that does not instill confidence because we know that we will not have sufficient data.” Durbin said. “And I will say if somebody tells me, ‘this vaccine is ready to go you should be vaccinated on November 2nd,’ I would not be vaccinated because I know that there has not been due diligence in the review of that process.”
On Sept. 8, the nine pharmaceutical companies that are developing potential vaccines for COVID-19 signed a pledge to adhere to “high ethical standards and sound scientific principles,” and to “always make the safety and well-being of vaccinated individuals our top priority.”
The Department of Health and Human Services website now says it expects a vaccine in January 2021. However, both Gee and Durbin said a vaccine is more likely to be delivered by mid-year.
These pauses in clinical trials are a reminder that some things are worth the wait.
“For those of us that want the vaccine quickly, I think it reminds us that the timeline that we may want may not be the timeline that the science will provide” Gee said. “Frankly the public doesn’t want speed. We want safe.”
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