Coronavirus Vaccine Trial Opens in US With First Doses

Zachary Stieber
By Zachary Stieber
March 16, 2020US News
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Coronavirus Vaccine Trial Opens in US With First Doses
Pharmacist Michael Witte (L) gives Neal Browning (R) a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16, 2020. (Ted S. Warren/AP Photo)

The first patients in a coronavirus vaccine trial in the United States received doses on Monday about two weeks after recruitment for the study started.

Scientists at the Kaiser Permanente Washington Research Institute in Seattle jabbed Jennifer Haller, a 43-year-old mother of two who lives in Seattle, as several other volunteers waited in line.

“We all feel so helpless. This is an amazing opportunity for me to do something,”  Haller said.

After the injection, she left the exam room with a big smile: “I’m feeling great.”

The injections marked the beginning of a series of studies in people needed to prove whether the shots are safe and could work. Even if the research goes well, a vaccine wouldn’t be available for widespread use for 12 to 18 months, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci
Director of the National Institute of Allergy and Infectious Diseases Anthony Fauci, answers a question during a press conference about the coronavirus as Vice President Mike Pence (L), Centers for Medicare and Medicaid Services Administrator Seema Verma (2nd L), and Health and Human Services Secretary Alex Azar (R) look on, at the White House in Washington on March 2, 2020. (Charlotte Cuthbertson/The Epoch Times)

In a statement Monday, he said that finding a safe and effective vaccine to block the SARS-CoV-2 virus, which started in China last year, “is an urgent health priority.”

The new trial launched in record time, Fauci said, calling it “an important first step toward achieving that goal.”

There are no vaccines for the new virus at this time. No proven treatments exist either, though a slew of drugs have shown effectiveness in some settings and are being tested by researchers.

The trial in Seattle is testing a vaccine called mRNA-1273 developed by National Institute of Allergy and Infectious Diseases scientists in collaboration with Moderna, a Massachusetts-based company.The vaccine uses a genetic platform called messenger RNA to direct the body’s cells to express a virus protein that it is hoped will elicit a robust immune response.

The vaccine doesn’t contain the coronavirus itself.

“We don’t know whether this vaccine will induce an immune response, or whether it will be safe. That’s why we’re doing a trial,” said Dr. Lisa Jackson, a senior Kaiser investigator who’s leading the study. “It’s not at the stage where it would be possible or prudent to give it to the general population.”

syringe
A syringe containing the first shot given in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, rests on a table at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16, 2020. (Ted S. Warren/AP Photo)

The vaccine has shown promise in animal models. The trial is the first to examine it in humans, the agency said. Prior studies on vaccines for related coronaviruses, such as SARS and MERS, contributed to the quick start of a trial.

The 45 participants, aged 18 to 55, will receive two doses of the vaccine via injection in the arm approximately 28 days apart. They’ll be examined at intervals across a year after the second shot.

Researchers are still recruiting people. Those who are interested can visit this website.

“This work is critical to national efforts to respond to the threat of this emerging virus,” Jackson said.

Jackson described her team’s mood was “subdued” after working around the clock to prepare for the start of the trial but called the short timeline, around two months, in getting a vaccine to trial unprecedented.

If the vaccine proves effective in the phase one trial, a much wider population will be tested in a phase two trial.

Dr. Lisa Jackson
Dr. Lisa Jackson, a senior investigator at the Kaiser Permanente Washington Health Research Institute, works in her office in Seattle on March 15, 2020. (Ted S. Warren/AP Photo)

Other vaccines are in the pipeline. Dozens of research groups around the world are racing to create a vaccine against COVID-19. Another candidate, made by Inovio Pharmaceuticals, is expected to begin its own safety study—in the United States, China, and South Korea—next month.

Because vaccines are given to millions of healthy people, it takes time to test them in large enough numbers to spot an uncommon side effect, cautioned Dr. Nelson Michael of the Walter Reed Army Institute of Research, which is developing a different vaccine candidate. “The science can go very quickly but, first, do no harm, right?” he told reporters last week.

The Seattle experiment got underway days after the World Health Organization declared the new virus outbreak a pandemic because of its rapid global spread, infecting more than 169,000 people and killing more than 6,500.

COVID-19 has upended the world’s social and economic fabric since the first case emerged in the Chinese city of Wuhan late last year, with regions shuttering schools and businesses, restricting travel, canceling entertainment and sporting events, and encouraging people to stay away from each other.

The Associated Press contributed to this report.

From The Epoch Times

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