Study subjects who received Moderna’s Covid-19 vaccine had positive early results, according to a press release issued Monday by the biotech company, which partnered with the National Institutes of Health to develop the vaccine.
These early data come from a Phase 1 clinical trial, which typically study a small number of people and focus on whether a vaccine is safe. The information has not been peer reviewed, nor published in a medical journal.
Race for a vaccine: Moderna, based in Cambridge, Massachusetts, is one of eight developers worldwide already doing human clinical trials of potential vaccines against the novel coronavirus, according to the World Health Organization. Two others, Pfizer and Inovio, are also in the United States, one is at the University of Oxford in the UK, and three others are in China.
"All eight initial participants" in the Moderna trial developed neutralizing antibodies to the virus at levels reaching or exceeding those seen in people who have naturally recovered from Covid-19, according to the press release.
Neutralizing antibodies bind to the virus, disabling it from attacking human cells. The presence of such antibodies at the levels of people who have naturally had the infection is an important indicator in vaccine studies
"These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 μg," according to Dr. Tal Zaks, chief medical officer at Moderna, who used the scientific name for the Moderna vaccine.
The US Food and Drug Administration has cleared the company to begin Phase 2 trials, which typically involve a larger number of people, and the company expects to begin Phase 3 trials in July. Phase 3 involves large-scale testing of the vaccine, typically in tens of thousands of patients.
The length of such trials varies greatly, and the press release doesn't indicate how long they might take, or when the vaccine might be available to the public.
At the highest dose, three participants had "the most notable adverse events," which resolved, and no serious adverse events were reported, the company said, not specifying what the adverse events were.
The company indicated that the Phase 3 trials will be done with lower doses.