Source: Scientific American
Late-stage clinical trials of the first two coronavirus vaccine candidates in the U.S. plan to recruit 60,000 Americans
Dr. Eric Coe jumped at the chance to help test a COVID-19 vaccine.
At his urging, so did his girlfriend, his son and his daughter-in-law. All received shots last week at a clinical research site in central Florida.
“My main purpose in doing this was so I could spend more time with my family and grandchildren,” Coe said, noting that he’s seen them only outside and from a distance since March.
“There’s a lot less risk to getting the vaccine than contracting the virus,” said Coe, 74, a retired cardiologist. “The worst thing that can happen is if I get the placebo.”
The Coes’ eagerness to offer up their bodies to science reflects the widespread public interest in participating in the pivotal, late-stage clinical trials of the first two COVID vaccine candidates in the United States.
Those trials began rolling out July 27. During the next two months, vaccine makers hope to recruit 60,000 Americans to roll up their sleeves to test the two vaccines, one made by Pfizer and BioNTech, a German company, and the other by biotech startup Moderna. While small tests earlier this year showed the preventives were safe and led to participants developing antibodies against the virus, the final phase 3 testing is designed to prove whether the vaccine reduces the risk of infection.
Amid a pandemic that in the U.S. has caused roughly 5 million infections and nearly 160,000 deaths while decimating the economy, the vaccine trials have drawn far more interest than is typical for a clinical trial, organizers said.
Also, the test sites pay volunteers as much as $2,000 for completing the two-year study.
“We have no shortage of volunteers and we have thousands of people interested in participating,” said Dr. Ella Grach, CEO of M3-Wake Research of Raleigh, North Carolina, which is conducting vaccine trials at six sites.
Paul Evans, president of Velocity Clinical Research in Durham, North Carolina, said his company plans to recruit more than 10,000 volunteers in seven states to test COVID vaccines. At least four of Velocity’s sites – in Ohio, California and Oregon – have already started injecting volunteers with the Moderna vaccine.
“It’s been phenomenal,” he said. Patient recruitment is one of the biggest challenges to running trials, but this time patients have been eager to sign up.
“I’ve been working in this business for 30 years,” said Evans. “Outside of a COVID study, you might have to reach out to four or five, up to 10 people to find [one person] who is suitable.”
Other vaccine candidates are being tested abroad and more tests will be launched in the U.S. later this year.
People 18 and older are eligible to participate in the trials, and Moderna and Pfizer are pushing to include high-risk individuals such as health workers, the elderly and people with chronic conditions such as diabetes and asthma. Organizers are also seeking to enroll Blacks and Hispanics, groups hit hard by the virus.
The vaccine makers have contracted with dozens of clinical research sites across the country. About 15 have started inoculating, and it will likely take until September for all volunteers to get their first shot. The participants will get a booster shot about a month later. They are asked to keep an electronic diary to record any symptoms. Because the virus is widespread across the country, the studies are expected to be able to note differences between infection rates in those who got the vaccine and those who received a placebo.
Government health experts say they hope to know if the vaccines are working by this fall. If the trials are successful, it would likely take until early next year before a vaccine could gain federal approval to start widespread distribution.
To determine effectiveness, half of the trial participants will receive the vaccine and half a placebo.
Coe, of Leesburg, Florida, said that several hours after getting his shot on Saturday he developed chills and was tired, symptoms that lasted until Sunday afternoon. “I’m virtually certain that I did not get a placebo because normal saline would not do that,” he said. His daughter-in-law, Lisa Coe, 46, said she did not have any reaction other than soreness at the injection site.
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