One of the companies in the lead to develop a vaccine against the virus that causes Covid-19 has started its Phase III clinical trial while also receiving additional money from a federal government body overseeing efforts against the disease.
Cambridge, Massachusetts-based Moderna said Monday it had started the Phase III COVE study of mRNA-1273, its vaccine against the SARS-CoV-2 virus. Meanwhile, it said on Sunday that under an update to its contract with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, it had received a commitment of funding worth up to $472 million on top of the up to $483 million it had received from BARDA in April.
Shares of Moderna were up more than 8% in premarket trading on the Nasdaq following the news.
The company said that the initial funding amount was based on plans for a Phase III trial with a smaller number of participants than the 30,000 whom COVE is now expected to enroll.
The Phase III study, which the National Institute of Allergy and Infectious Diseases is cosponsoring, is anticipated to be completed in late October 2022, according to a trial page posted on ClinicalTrials.gov.
Participants – all adults – receive a first dose of 100 micrograms on day 1, followed by a booster shot on day 29. The trial has four primary endpoints, measuring the number of participants with a first occurrence of Covid-19 starting 14 days after their second dose of the vaccine; who experience adverse events leading to withdrawal from the study; who experience solicited local and systemic adverse reactions; and who experience unsolicited adverse events. The study has 87 sites, all in the U.S.
Moderna published data from the Phase I NIAID study two weeks ago, in The New England Journal of Medicine. The published data showed that among the 15 participants who received the vaccine at the 100-microgram dose, mean concentrations of neutralizing antibodies against SARS-CoV-2 were 2.1-4.1 times higher than those seen in convalescent plasma from recovered Covid-19 patients, depending on the test used. However, it remains to be seen whether that results in immunity against the virus, or for how long. AstraZeneca and CanSino Biologics are also among companies that have published early vaccine data in recent months.
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