American biotech firm Moderna announced on Monday (May 18) that a phase-one human trial of its experimental coronavirus vaccine produced COVID-19 antibodies in every one of its participants.
The study was primarily designed to look at the safety of the shot and showed no major warning signs in a small phase 1 trial, the statement by the company further added .
The trial is being jointly runby National Institute of Allergy and Infectious Diseases (NIAID) and Moderna plans to continue advancing it to wider testing.
Providing details of the trial, the company said that two vaccine doses of 25 micrograms showed that, by day 43 of the trial, humans developed antibody levels consistent with those who have recovered from coronavirus. Participants who received 100-microgram doses had antibodies that “significantly exceeded levels” found in recovered patients.
“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 [micrograms],” Tal Zaks, the chief medical officer at Moderna, said in a statement.
The trial also found that the vaccine produced neutralizing antibodies in at least eight participants — four of whom received a 25-microgram dose, while the other four received 100 mcg. When tested against a live virus, Moderna said the levels of neutralizing antibodies were at or above levels seen in blood samples.
“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,” Zaks added.
Moderna shares surged 26% in trading before the market opened in New York. Broader markets rose as well, with S&P 500 futures and European stocks trading near session highs.
The company’s Chief Executive Stephane Bancel told the Wall Street Journal that the company aimed to have a “pivotal” phase-three study in July. “We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” she stated.
Bancel said the company felt it needed to release the interim data from the trial because of the high level of interest in the vaccine. A phase 2 trial is expected to begin shortly, and Moderna said in its statement that a final-stage trial will begin in July. Bancel said the phase 3 trial will likely include many thousands of healthy volunteers.
Moderna uses a proprietary mRNA platform for vaccine developemnt. mRNA relies on the body’s own cells to produce viral proteins. Once injected into the body, the RNA slips into human cells and tells them to make virus-like proteins, in this case the “spike" protein on the surface of the coronavirus. If the vaccine works, those proteins then trigger the body to generate protective antibodies.
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