Moderna Reports Positive Results From Early CCP Virus Vaccine Trial

Wednesday, 20 May, 2020

It typically takes several years to develop a vaccine.

Vaccines are biological products. The levels of antibodies in the mice, which was sufficient to block the virus, was also the same as in the humans dosed with the vaccine. As compared to drugs, vaccines are administered to vulnerable sections of society to help them obtain immunity from a disease without getting sick.

Dr. Moncef Slaoui recently resigned from Moderna's board of directors so he could be the chief scientist for "Operation Warp Speed", the Trump administration's newly announced campaign to secure a vaccine by the end of the year. It is being led by the National Institutes of Health's National Institute of Allergy and Infectious Diseases. "That being said, this is a new kind of vaccine platform, and some of the safety signals may take time to be recognized".

Gross proceeds from the offering will be about $1.34 billion, topping the company's stated goal of $1.25 billion.

Shares in Nasdaq-listed Moderna nevertheless skyrocketed as much as 34.7 percent to $87.00 on the news.

Earlier today, the biotech company Moderna reported positive results from a phase 1 study of its experimental COVID-19 vaccine, which was was among the first to begin testing in healthy human volunteers in mid-March.

Asian shares jumped on Tuesday (May 19) and oil extended gains on optimism the global economy would recover quickly following a successful early-stage trial of a coronavirus vaccine, while the euro hovered near a two-week top. The phase-one study, which is still ongoing, will also change to include a 50 microgram dose cohort across each of the three age groups.

Volunteers received doses of 25 micrograms, 100 micrograms, or 250 micrograms almost a month apart.

After receiving a single dose of the vaccine, called mRNA-1273, all 45 of the participants in the trial developed detectable levels of antibodies within 15 days, according to a statement from Moderna, which is based in Cambridge, Massachusetts.

The company acknowledged that a single participant at 100 µg experienced grade 3 erythema (redness) around the injection site, while at the 250 µg dose level, three participants showed grade 3 systemic symptoms, but only following the second dose.

The company has said that it is proceeding on an accelerated timetable, with the second phase involving 600 people to begin soon, and a third phase to begin in July involving thousands of healthy people.

The promising results that Moderna reported were just a sample from the small, first study created to look at the safety of the shot in human volunteers.

The interim data revealed by Moderna reports no serious adverse effects from the vaccine, across all dose cohorts.

The results are promising enough for Moderna to move forward and start a Phase 2 clinical trial, Robin Robinson, the chief scientific officer at RenovaCare, tells STAT. But generally speaking, the company's past mRNA studies have shown T cell activity in both preclinical and clinical studies.

The company is looking to receive regulatory approval in 2021.