The vaccine was “generally safe and well-tolerated,” and appears to create an immune response against the virus.
The first coronavirus vaccine to be tested in people appears to be safe and able to create an immune response against the virus, its manufacturer has announced. In view of these promising results, additional studies will be performed to collect more data on human safety and immunity.
Moderna, a Massachusetts biotechnology company, said in a press release that the vaccine labeled mRNA-1273 triggered the development of antibodies that could fight SARS-CoV-2, the coronavirus responsible for the illness known as COVID-19.
Phase 1 of human trials tested 45 participants between 18-55 years of age, with 15 in each of the dose level groups of 25, 100, and 250 micrograms. According to the available data, eight participants who received low and medium doses of the vaccine created antibodies that were found to be able to stop the virus from replicating. Furthermore, the level of antibodies in the participants’ blood matched the levels found in patients who recovered from the virus, suggesting some level of immunity. According to the press release, at day 43 they showed similar, and in some cases higher, blood-antibody levels as the COVID-19 survivors.
However, Peter Jay Hotez, who is working on a coronavirus vaccine at the Baylor College of Medicine in Houston, Texas, says more information is needed to determine the level of antibodies detected in the participants. Hotez told The Washington Post that, according to the available evidence, many recovered COVID-19 patients do not have high levels of antibodies needed to fight the coronavirus.
Moderna reported that the vaccine, which was also tested in mice, was “generally safe and well-tolerated,” although one participant reported the injection site became red after receiving a medium dosage, and another three experienced systemic symptoms — which include headaches, fever, and muscle pain — after receiving a second dose of the highest level. However, the company said that “all adverse events have been transient and self-resolving.”
The Food and Drug Administration gave Moderna the go-ahead for the second phase of the trial, which the company said will involve 600 people and is set to begin soon, according to the New York Times. A third phase will begin in July. The planning for Phase 2 and Phase 3 is being funded by The Biomedical Advanced Research and Development Authority, a division within the U.S. Department of Health and Human Services.
If the trials go well, a vaccine could become available for widespread use by the end of this year or early 2021, said Dr. Tal Zaks, Moderna’s chief medical officer. Dr. Anthony Fauci, the country’s leading infectious disease expert on the White House Coronavirus Task Force, thinks the vaccine will be ready for the public in 12 to 18 months.