First human COVID-19 vaccine test needs 30,000 to roll up sleeves
However, tensions between Moderna, U.S. scientists indicate rivals have knives out
CAMBRIDGE, Mass. (WKBT) — HELP WANTED: 30,000 volunteers to be subjects in the final trial stage for the first COVID-19 vaccine tested in the United States.
The early-stage testing in the U.S. showed that the potential vaccine revved up the subjects’ immune systems the way scientists had hoped.
The vaccine, a joint effort of the National Institutes of Health and Moderna Inc. in Cambridge, is one of nearly two dozen possible COVID-19 vaccines in various stages of human testing around the world.
The first U.S. study was small, involving just 45 people, according to results the NIH and Moderna released Tuesday in the New England Journal of Medicine.
The initial testing protocol involved three doses of the vaccine in groups of 15 volunteers ages 18-55. They got two shots 28 days apart.
Researchers found that more than half experienced brief, flu-like reactions to the shots such as fatigue, headache, chills, muscle aches or pain at the injection site, according to the researchers’ report in the journal.
Those reactions were more likely after the second dose and in people who were given the higher of three doses, according to the report.
Moderna’s pathway toward the vaccine has hit a few potholes, according to an exclusive Reuters report last week.
The company has jousted with government scientists, delayed delivering trial protocols and resisted experts’ advice on how to run the study, three sources familiar with the vaccine project told Reuters.
Those tiffs contributed to a delay of more than two weeks in launching Moderna’s vaccine trial, which now is expected late this month.
Moderna “could be on schedule if they were more cooperative,” Reuters quoted one source as saying.
The squabbles raised concerns about the young biotech firm’s inexperience and lack of staff and expertise to conduct the most critical phase of trials, for which it is seeking 30,000 volunteers.
More established drug makers, such as AstraZeneca Plc and Johnson & Johnson, that are working on other leading vaccine candidates have not had such problems, Reuters reported. The NIH and the Food and Drug Administration also are working with those other companies.
Moderna denied missteps but acknowledged “differences of opinion” with experts involved in the unprecedented effort to deliver on the Trump administration’s “Warp Speed” pledge to find a vaccine within months. It usually takes about 10 years to develop a vaccine, and many endeavors ultimately fail.
Moderna also insisted that it has an experienced research team that includes people who have run many large-scale trials.
The Associated Press contributed to this report.
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