Chattanooga Times Free Press

Experiment­al vaccine showing promise

- BY ROBERT LANGRETH

An experiment­al vaccine from Moderna Inc. showed promising early signs that it can create an immune-system response in the body that could help fend off the new coronaviru­s, according to sampling of data from a small, first human trial of the inoculatio­n.

The study was primarily designed to look at the safety of the shot and showed no major warning signs in a small phase one trial, the company said in a statement Monday. The trial is being run with the U.S. government, and Moderna plans to continue advancing it to wider testing.

A vaccine is considered a crucial step toward lifting socialdist­ancing measures and safely reopening economies, schools and events around the globe. The new coronaviru­s, known as SARS-CoV-2, has infected more than 4.7 million people and killed more than 300,000, spurring a global race by drugmakers, academic institutio­ns and government­s to find a vaccine.

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 plans to report full results from the trial later.

Researcher­s also looked at blood samples from the test subjects and whether the vaccine helped them generate antibodies that could fight off

an infection. The researcher­s found that at two lower dose levels used in the study, levels of antibodies found after getting a second booster shot of the vaccine either equaled or exceeded the levels of antibodies found in patients who had recovered from the virus.

“This is a very good sign that we make an antibody that can stop the virus from replicatin­g,” Moderna Chief Executive Officer Stephane Bancel said in an interview. The data “couldn’t have been better,” he said.

Bancel said that safety profile appeared to be good, and the reactions were typical of vaccines. They included injection site pain and redness, as well as temporary fever or chills that quickly go away on their own, he said.

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 two 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 three trial will likely include many thousands of healthy volunteers.

Researcher­s also looked at blood samples from the test subjects and whether the vaccine helped them generate antibodies that could bind to the virus and ones that can fight off an infection. The looked at both the quantity of coronaviru­s antibodies produced, and in a smaller subset of people, whether those antibodies were sufficient to prevent the virus from infecting cells in test tube experiment­s.

In 25 people who got either of the two smaller doses used in the study, researcher­s reported that the levels of antibodies equaled or exceeded the levels of antibodies found in patients who had recovered from the virus.

The second test, evaluating the quality of those antibodies, was only available for eight of the people because it takes longer to perform. But in all eight

“This is a very good sign that we make an antibody that can stop the virus from replicatin­g.”

– STEPHANE BANCEL, MODERNA CHIEF EXECUTIVE OFFICER

people, the vaccine successful­ly stimulated the body to create antibodies capable of neutralizi­ng the virus in the test tube, so it can no longer infect cells.

Most vaccines either consist of inactive pieces of a virus or proteins from a virus made through genetic engineerin­g. When injected into the body, they trigger a lasting immune response similar to that of a person who has been infected and recovered.

By contrast, the mRNA technology being used by Moderna and several others 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 viruslike 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.

While the technology is new and hasn’t been used in an approved vaccine before, it allows researcher­s to move fast into trials. Moderna started working on its COVID-19 vaccine as soon as Chinese scientists put out the gene sequence for the virus in January. By late February, Moderna’s scientists had already delivered the first batch of candidate vaccines to researcher­s at the U.S. National Institutes of Health. In mid-March, the first healthy volunteer received a dose in the government-sponsored safety trial.

Former GlaxoSmith­Kline Plc executive Moncef Slaoui, who is set to become the chief scientist for Operation Warp Speed, the White House effort to turbocharg­e vaccine developmen­t, has been a board member at Moderna since 2017. According to a person familiar with the matter, he will leave that and other board seats once he starts the position.

 ?? AP PHOTO/TED S. WARREN ?? A pharmacist gives Jennifer Haller the first shot in the firststage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronaviru­s, at the Kaiser Permanente Washington Health Research Institute in Seattle, over the weekend.
AP PHOTO/TED S. WARREN A pharmacist gives Jennifer Haller the first shot in the firststage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronaviru­s, at the Kaiser Permanente Washington Health Research Institute in Seattle, over the weekend.

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