In this March 16, 2020, file photo, a subject receives a shot in the first-stage safety study clinical trial of a potential vaccine by Moderna for COVID-19, the disease caused by the new coronavirus, at the Kaiser Permanente Washington Health Research Institute in Seattle.
Ted S. Warren | AP
Moderna shares soared more than 8% in premarket trading Monday after the biotech company announced it received an additional $472 million from the U.S. government to support the development of its potential coronavirus vaccine.
The additional funding from the Biomedical Advanced Research and Development Authority will support Moderna’s late-stage development of its vaccine including the phase three study, which begins Monday and will include at least 30,000 participants. Moderna received $483 million from the federal agency in April.
There are no FDA-approved drugs or vaccines for the coronavirus, which has infected nearly 16 million people worldwide and killed at least 648,900 in less than seven phmonths, according to data compiled by Johns Hopkins University. There are more than 150 vaccines under development, according to the World Health Organization, with 25 vaccines already in human trials.
Moderna’s experimental vaccine, which is being developed with the help of the National Institutes of Health, contains genetic material called messenger RNA, or mRNA, which scientists hope provokes the immune system to fight the virus.
It became the first candidate to enter a phase one human trial in March. Pharmaceutical giant Pfizer and AstraZeneca, which are also conducting human trials for potential coronavirus vaccines, have previously received funding from BARDA.
The results from Moderna’s late-stage trial could be released as soon as October, Moderna CEO Stephane Bancel said Monday during an interview with CNBC’s “Squawk Box.” “It’s a really optimistic scenario. It could be November. Again, at this stage, it’s impossible for us to know precisely. It will depend on the event rate, the attack rate of infection.”
The phase three trial will enroll 30,000 participants across 87 locations, according to ClinicalTrials.gov. Participants will receive a 100 microgram dose of the potential vaccine on the first day and another 29 days later. Some patients in the trial will also receive a placebo.
Earlier this month, the biotech company released promising data on its potential coronavirus vaccine trial, saying it generated a “robust” immune response. The vaccine candidate produced neutralizing antibodies, which scientists believe is important for building immunity against the virus, in all 45 patients tested in the trial, Moderna scientists reported in the New England Journal of Medicine.
The company said it remains on track to deliver between 500 million and 1 billion doses per year starting next year.