Phase III trial launch reached with unprecedented speed, no compromises, NIH leaders say
With a shot administered to a volunteer in Savannah, Georgia, late-stage testing of an experimental vaccine to protect against COVID-19 began this morning, with hopes for results that could see an effective preventive tool against the disease by the end of the year.
The launch of the randomized placebo-controlled on-the-ground trial, which seeks to enroll 30,000 adults at 89 sites across the United States, reflects the unprecedented dispatch of a collaborative government effort that began to take form in early January within hours of China’s publication of the genetic sequencing of the novel coronavirus that was beginning to spread rapidly in Wuhan. Marking the fastest progression in the United States of an investigational vaccine candidate from laboratory to population setting testing, the start of the trial marks “a truly historic event,” Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases said this morning. With National Institutes of Health Director Dr. Francis Collins, he emphasized that speed did not come at the cost of safety or science.
The phase III trial follows earlier small-scale trial results showing that the candidate prompted an immune response among those to whom it was administered and without significant side effects, was safe. Some volunteers in the earlier trial experienced pain at the injection site, mild fever and muscle aches.
The performance of the vaccine candidate, developed in a collaboration between NIAID and the Cambridge, Massachusetts-based Moderna, Inc. will be tested among volunteers against that of a saline solution, with hopes for signs that the candidate offers protection against SARS-CoV-2, the virus that causes COVID-19 by November or December. Results indicating that the investigational product offers protection to at least 60% of those receiving it, compared to those receiving the placebo will provide grounds to move forward, with plans to distribute “hundreds of millions of doses” of vaccine. While that won’t be enough to vaccinate every American, distribution would begin with a focus on populations including Black Americans, Latinx, and older people and those with exacerbating health problems, facing the greatest risks of infection and illness, Dr. Collins said. Sites across the country were selected for their high incidence of COVID-19 transmission. A greater degree of effectiveness is hoped for, Dr. Fauci said, citing the protection offered by the measles vaccine to 97 to 98% of those receiving it.
Based on early, small scale results, volunteers will receive two doses of the vaccine, about four weeks apart. A worldwide campaign to distribute a one-dose vaccine would be easier, Dr. Collins noted, adding, “but we want something that really works.” In addition to the effectiveness of the two doses in preventing COVID-19 illness, researchers also will seek to evaluate the potential effectiveness of one dose, and, in the event of limited protection, if it reduces incidence of severe disease or death as a result of the disease.
Enrollment for the trial is continuing and Dr. Collins urged potential volunteers for this, and future COVID-19 vaccine trials to fill out a form at the Coronavirus Prevention Network Volunteer Screening Registry.
Expedition of the Moderna vaccine was facilitated through the federal multi-agency “Operation Warp Speed,” which is also working to bring three more candidates, including from a collaboration between Oxford University and AstraZeneca, from Johnson & Johnson to large scale trials.