Coronavirus vaccine shows early promise after ‘positive’ first trial in people
The company behind a novel coronavirus vaccine candidate announced Monday that its first phase of human trials showed promising results, giving the green light for additional studies to gather more data on human safety and immunity.
The Massachusetts biotechnology company called Moderna said the vaccine, coined mRNA-1273, sparked the development of antibodies that could fight SARS-CoV-2 — the coronavirus behind the pandemic, according to a press release.
What’s more, the level of antibodies in the participants’ blood was similar to levels found in patients who recovered from the disease, which suggests some level of immunity.
“We are very, very happy because first the vaccine was generally safe,” Moderna Chief Executive Stephane Bancel told The Washington Post. “The piece that was really exciting and was the big question, of course, was can you find antibodies in people in enough quantities” to prevent COVID-19, the disease the coronavirus causes.
The company has dabbled in vaccine work for coronaviruses in the past, such as the Middle East Respiratory Syndrome (MERS) that spread from the Arabian Peninsula in 2012.
The vaccine for MERS “provided significant insights” for the development of mRNA-1273, but prior to this study, Moderna “had not previously tested a coronavirus vaccine in humans,” the company’s website says.
Phase 1 of human trials tested 45 participants between 18-55 years of age, with 15 individuals in each of the dose level groups of 25, 100 and 250 micrograms.
Available data shows that eight participants who received low and medium doses of the vaccine “elicited neutralizing antibodies,” meaning their bodies produced a positive immune response against the coronavirus.
At day 43, they showed similar, and in some cases higher, blood-antibody levels as COVID-19 survivors, the press release said.
The vaccine was “generally safe and well tolerated,” the company noted, aside from one individual whose injection site became red after receiving a medium dosage and another three who experienced “systemic symptoms” after receiving a second dose of 250 micrograms, the highest level.
Those symptoms included headaches, fever and muscle pains, according to The New York Times.
“All adverse events have been transient and self-resolving,” the company said in the release.
The vaccine was also tested in mice in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), according to the company. The vaccine prevented coronavirus replication in the mice’s lungs.
But one expert thinks more information is needed to clarify just how many antibodies were detected in the trial’s participants, according to The Washington Post.
Peter Jay Hotez is also working on a coronavirus vaccine at the Baylor College of Medicine in Houston, Texas. He told The Washington Post that many recovered COVID-19 patients do not have high levels of antibodies needed to fight the virus, according to available evidence.
Going forward, Moderna said it will use data from Phase 1 to guide doses used in Phase 2, which was officially approved by the U.S. Food and Drug Administration (FDA) on May 7 before the results were known. It’s set to begin ”shortly,” with a larger number of participants — 600 of them, according to The New York Times.
The fast-track means the FDA doesn’t have to wait until all steps of the trials are completed and analyzed to push the process forward, McClatchy News previously reported.
Dr. Anthony Fauci, the country’s leading infectious disease expert on the White House Coronavirus Task Force, says he thinks the vaccine will be ready for the public in 12 to 18 months, but others think that’s an ambitious goal, based on the history of vaccine development.
“Tony Fauci is saying a year to 18 months — I think that’s optimistic,” Hotez told CNN. “Maybe if all the stars align, but probably longer,” more like years rather than months.
Moderna is “finalizing protocol” for Phase 3 slated to begin in July.
The Biomedical Advanced Research and Development Authority, a division within the U.S. Department of Health and Human Services, is funding the planning for Phase 2 and Phase 3, the company said.
This story was originally published May 18, 2020 at 12:42 PM with the headline "Coronavirus vaccine shows early promise after ‘positive’ first trial in people."
