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Researchers need volunteers to test the COVID-19 vaccine. Would $1,100 convince you to get it?

Ethical challenges abound in the race to develop a new vaccine and the human testing that is required.

SHARE Researchers need volunteers to test the COVID-19 vaccine. Would $1,100 convince you to get it?

Ambulance workers move a man on a stretcher from the Life Care Center in Kirkland, Wash. into an ambulance, Friday, March 6, 2020. The facility is the epicenter of the outbreak of the the COVID-19 coronavirus in Washington state.

Ted S. Warren, Associated Press

SALT LAKE CITY — Sarah King was willing to get the flu for $3,000, but she wants a raise when it comes to the novel coronavirus.

The mother of three in St. Louis, Missouri, was among volunteers who let researchers put the flu virus in their nostrils and then monitor them for 10 days in November. The research was designed to study how the immune system responds to the viral invader.

While King, 44, didn’t wind up getting sick, she is one of the “unsung heroes of public health” whose willingness to participate in research enables a new vaccine or drug to come to the market, according to Dr. Kawsar Talaat, an assistant professor at the Bloomberg School of Public Health at Johns Hopkins University and a specialist in vaccines and infectious diseases. “The whole world really owes the vaccine volunteers a debt for stepping up and saying this is something I can do,” Talaat said.

A few hundred heroes will soon be needed to test vaccines for the novel coronavirus. But the first trial in the U.S., which is now recruiting volunteers, doesn’t pay as well as the flu: just $1,100 — $100 for each of 11 visits. (But it includes free parking in downtown Seattle, if that’s an inducement.)

Recruitment for the trial is opening as researchers worldwide race to be the first to bring a vaccine to market to help calm fears about the spread of COVID-19, the disease which first appeared in late 2019 in Wuhan, China. Some say they have already developed one, including the Boston-based biotechnology company Moderna, which announced in February that it had developed a vaccine in conjunction with the National Institute of Allergy and Infectious Diseases, just 42 days after China published the genetic code of the novel coronavirus.

The first human trial for Moderna’s vaccine is already listed on clinicaltrials.gov, the federal compendium of planned, ongoing and completed drug research. And the Kaiser Permanente Washington Health Research Institute, where the trials will take place, has a website where people can take a survey if they are interested in participating.

The researchers are seeking 45 men and nonpregnant women between the ages of 18 and 55 for the study.

Potential participants must be in good health and agree to use birth control or practice abstinence a month before and two months after the last vaccination they receive. They also must not have any tattoos on their upper arms that might prevent researchers from observing reactions at the site of the injection, among other restrictions.

Here’s what is known about the upcoming trial and the ethical standards that govern such research.

Who wants to be a lab rat?

President Donald Trump has called for speed in the development of a vaccine, but it typically takes from 15 to 25 years before a vaccine can be developed and thoroughly vetted, according to Dr. Paul Offit, a Philadelphia pediatrician specializing in infectious diseases and an expert on vaccines, immunology and virology. 

Offit, the co-inventor of a rotavirus vaccine, said “you can actually do more harm than good” with a vaccine if it isn’t thoroughly tested. 

The U.S. requires three phases of human testing once the Food and Drug Administration gives its OK. Phase 1 involves between 20 and 80 adults who are closely monitored for adverse reactions. In some trials researchers may attempt to infect volunteers with the pathogen after they are vaccinated, according to the “The History of Vaccines” website run by the College of Physicians of Philadelphia. The goal of Phase 1 trials is to establish the safety of the drug and assess the participants’ immune response.

While Phase 1 generally involves healthy participants, Phase 2 expands to several hundred people, some of whom may be at greater risk of developing the disease. (In the case of the coronavirus, this would include seniors and people with health conditions that make it more likely that their symptoms be more virulent.)

Phase 3 tests the drug or vaccine in thousands of people.

Offit, who believes that fear about COVID-19 is overblown in the U.S., said he expects that researchers won’t find it difficult to get volunteers for the human trials, given the widespread concern about its spread in the U.S. When polio vaccine trials began in 1954, parents enrolled more than 1.8 million children.

For the coronavirus, researchers could find a willing pool of applicants in Washington state, where 13 people have died. They might also hear from members of a small group of people who earn a living by participating in paid clinical trials. Traveling from study to study, or living in a city with lots of ongoing medical research, they call themselves “guinea pigs” or “lab rats.”

King said there was a professional “guinea pig” in her flu study at St. Louis University. And writing for The Atlantic, Cari Romm noted, “For professional guinea pigs, Phase 1 trials are almost always where the money is.”

Ethical concerns

Compensation for studies is among the issues that medical ethicists debate about clinical trials. While many people argue that research volunteers should be compensated for their time, discomfort and assumption of risks, others note that payment may make the poor disproportionately willing to participate in studies. Talaat, at Johns Hopkins, said ethicists and researchers generally agree that money should not be “an undue inducement to participate.”

Another is the exclusion of pregnant women in research.  

While pregnant women are not banned from taking part in drug research, they are considered a “vulnerable class” and typically excluded. A review of 558 clinical trials sponsored by pharmaceutical companies found that 95% did not accept pregnant women, according to a report by a task force that advocates expanding research on pregnant women.

Supporters of expanded research say the exclusion is unfair to pregnant women and new mothers, who need evidence-based information about the risks that drugs present to their babies. And writing for STAT, Carleigh Krubiner, Ruth Faden and Dr. Ruth Karron argue that such research is especially important when it comes to COVID-19, because the family of coronaviruses appears to result in greater mortality among pregnant women and adverse outcomes with the pregnancies.

“Development of coronavirus vaccines that pregnant women aren’t able to use would be not only a tragedy but a grave injustice,” Krubiner, Faden and Karron wrote.

For its part, the FDA has urged greater inclusion when it comes to clinical trials. “Researchers should test medical products in all groups of people to help ensure medical products are safe and effective in everyone who will use them. That’s why diversity in clinical trials is essential,” the FDA said in a statement calling more participation.

The FDA acknowledged, however, that some people may hesitate to participate in research because of “historical mistreatment” of human subjects as in the Tuskegee Study, which began in 1932 and continued for 40 years. And while fatalities and complications are rare, they do occur and are required to be reported on Clinicaltrials.gov.

But Talaat noted that clinical trials, especially Phase 1, undergo scrutiny by an ethical review board before the FDA gives the go-ahead, and volunteers give consent after being informed of all benefits and risks to participating. “We’ve come a long, long way from the earliest days of vaccine trials, the earliest being James Phipps being given cowpox to protect him against smallpox without his consent.”

Maybe next year

In the recent Ebola outbreak in West Africa, the seemingly rapid emergence of a vaccine made it appear that it had been developed in response to the outbreak. In fact, Offit said, Phase 1 and 2 testing had already been done. “When the outbreak occurred, the vaccine was rolling off the shelves because they’d been working on it for 20 years,” he said.

So even though The Wall Street Journal called the production of Moderna’s vaccine “stunningly fast,” don’t plan to roll up your sleeve this year, even if recruitment is easy and the clinical trials go well, said Offit, the author of “Vaccines and Your Child,” among other books.

It’s possible it could be ready next year, but safety is more important than speed, he said. “Twenty children have died of flu this year, just since Jan. 1. I know we’re scared of COVID-19 and there’s every reason to be scared of flu also, but COVID-19 has killed no children. So you want to make sure you’re not doing more harm than good. That’s the job of the FDA; to make sure that these are tested as extensively as possible, for a virus that, for the most part, is not going to kill you.

“We fear this virus more than is reasonable. We’ve got this notion that it’s uniquely capable of killing you, and I just don’t think that’s true,” Offit said.

People who are interested in volunteering for the Moderna trial can register their interest here. But you’ll probably want to live in Seattle, or at least visit regularly. Participation requires one visit for screening, two visits for vaccinations (28 days apart) and eight follow-up visits.

Even though a vaccine trial is much different than being infected with live flu, King, in St. Louis, said she probably wouldn’t do it. She enjoyed participating in the flu study, not only because she didn’t get it, but because she got to spend 10 days in relative quiet and peace, with a private room and catered meals. She chatted each day with her family on FaceTime, and brought work, books and knitting.

“By day 10, I was like, how am I going to live on the outside?” she said. 

King said she’s not up for the back-and-forth of getting vaccines for COVID-19 and follow-up visits, even if the trial was close to her city.

But then she reconsidered. “Maybe for a crazy amount of money to make it worth the risk.”