Biotechnology company Moderna announced Monday that the novel coronavirus vaccine it has been developing is showing such promising results that it plans to launch expanded clinical trials in July.
According to the company, in a phase 1 trial, eight patients who received doses of the vaccine at the lowest and middle dose levels tested all produced antibodies to the virus within 15 days of a single dose.
Two weeks after receiving a second dose, the company reported that people who received the smallest dose of the vaccine created the same levels of antibodies as people who had recovered from the COVID-19 virus. Those who received a second dose of the medium dose level of vaccine produced significantly more antibodies than someone who had been infected by the virus and recovered.
Antibodies are proteins created by the body to bind to and destroy foreign substances such as viruses and toxins.
“The Moderna team continues to focus on moving as fast as safely possible to start our pivotal phase 3 study in July and, if successful, file a (biologics license application),” Chief Executive Stephane Bancel said. “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.”
A phase 2 trial has already been approved by the Food and Drug Administration. Bancel said the company is pushing forward with the phase 3 trial and is ramping up its capacity to manufacture the vaccine.
Massachusetts-based Moderna is working with the National Institute of Allergy and Infectious Diseases on the trials.
According to Moderna, the first human subject was given a dose of the vaccine on March 16. It was tested on subjects from 18-55 years old. The company had previously been testing the vaccine in mice.
In the study, 45 volunteers were given two doses of the vaccine – at either a low, medium and high dosage level.
While the results of all 45 volunteers were not reported, all of the subjects’ results that were reported showed that their immune system developed “binding antibodies” after they were exposed to the virus. That means their immune system developed a response to the virus.
Binding antibodies do not stop a virus from infecting cells.
However, according to Moderna’s reporting, eight of the volunteers reported producing “neutralizing antibodies,” or antibodies that do stop a virus from infecting a cell.
According to the data, the vaccine was well-tolerated in the volunteers. One person experienced redness at the site of the injection, the only minor adverse reaction recorded, Moderna said.
Three of those in the study who received the large dosage of the vaccine experienced flu-like symptoms that lasted less than 24 hours, Moderna reported.
Officials at the company said that if all goes well with further testing the hope is that the vaccine could be ready for distribution between January and June of next year.
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