The biotech firm Moderna announced what appear to be very positive results from its first human trial of its experimental Covid-19 vaccine on Monday. Not only did the vaccine lead to the creation of antibodies in eight human test subjects, but the vaccine also kept the virus that causes Covid-19 from replicating in the lungs of mice.
Moderna (ticker: MRNA) said that eight individuals treated with the vaccine at two different dose levels developed the same levels of antibodies in their blood as is found in the serum of people who have recovered from Covid-19 infections.
Coronavirus: Moderna CEO on the promising preliminary results of early-stage study
The levels of antibodies in the mice, which was sufficient to block the virus, was also the same as the levels found in the humans dosed with the vaccine.
Though data on antibody levels are only available now for 8 patients, a larger number of subjects have been given the vaccine. The company said that three patients at the highest dose level experienced what it called “grade 3 systemic systems,” including fever, after receiving their second dose of the vaccine. That dose level will not be given in the Phase 2 trial. One patient at a lower dose level experienced redness at the injection site.
The announcement represents the first positive data on human trials of a Covid-19 vaccine, and could boost confidence across the market that the pharmaceutical industry will be able to make a vaccine available.
The company said that the vaccine appeared safe and well tolerated, and no serious adverse events had been reported.
The data is early, and only involves a handful of participants. But it is a strongly positive sign for Moderna’s vaccine. The company now says it will begin the Phase 3 trial of the vaccine in July. It has previously said it hoped to have doses ready for an emergency use authorization in the fall.
“We are really thrilled,” Moderna CEO Stéphane Bancel told Barron’s early Monday morning. “We lost another 800 Americans in the last 24 hours, 89,000 deaths so far. We believe this is coming back in the fall. We are already racing the clock, so we are super happy.”
Moderna’s vaccine is among the most advanced Covid-19 vaccine programs. In a report in Barron’s this past weekend, the magazine classed it as one of the “hares” —a fast-moving program based on a relatively unproven vaccine approach. The vaccine is made of messenger RNA; no mRNA vaccines have ever been approved by the Food and Drug Administration.
Excitement over the vaccine has driven Moderna shares up 241% so far this year. Barron’s warned this past weekend that shares of Moderna, along with a handful of other small and midsize biotechs developing Covid-19 vaccines that have seen their share prices skyrocket in recent months, face some risk of collapse if their vaccine programs flame out. Monday’s announcement goes some way toward de-risking the Moderna vaccine.
“The data they released today look fairly promising,” says Vincent Chen, an analyst at Bernstein Research. Chen does not cover Moderna, but has been tracking the Covid-19 vaccine race closely. Chen noted that many questions remain, including how protective the antibodies will be, and how the mice data will translate into human data. Still, he said that the data was good news for the vaccine effort overall.
“The initial data are certainly promising for the Covid vaccine field, generally speaking,” Chen said.
Still, there remains a way to go before the Moderna vaccine could achieve emergency approval . A Phase 2 trial is in the final days of ethics review, Bancel said.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection,” said the company’s chief medical officer, Tal Zaks, in a statement. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
The company said it had now selected two midrange dose levels for the Phase 2 study, and would continue the Phase 1 study at an additional dose level that wasn’t previously included.
On an investor call on Monday morning, Bancel said that the company had yet to finalize its analysis on the pricing of the vaccine. Unlike some of the major pharmaceutical companies developing Covid-19 vaccines, Moderna, which has no marketed products, has not said it will not seek a profit on its vaccine during the course of the pandemic. “We want to do a deep-dive analysis of value,” Bancel said. “When you think about the health care costs and the health care system, we want to understand the value of the vaccine.”
Moderna stock is up 23% to $82.25 in Monday morning trading. The S&P 500 index is up 3.2%.
Moderna’s Coronavirus Vaccine Appears to Work in Early Trials. What Comes Next.
The biotech firm Moderna announced what appear to be very positive results from its first human trial of its experimental Covid-19 vaccine on Monday.
