First COVID-19 vaccine from US poised for final testing

AP – The first COVID-19 vaccine tested in the United States (US) revved up people’s immune systems just the way scientists hoped, researchers reported on Tuesday – as the shots are poised to begin key final testing.

“No matter how you slice this, this is good news,” the US government’s top infectious disease expert Dr Anthony Fauci told The Associated Press.

The experimental vaccine, developed by Fauci’s colleagues at the National Institutes of Health and Moderna Inc, will start its most important step around July 27 – A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But on Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralising antibodies in their bloodstream – molecules key to blocking infection – at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

“This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection,” said Dr Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There’s no guarantee but the government hopes to have results around the end of the year – record-setting speed for developing a vaccine.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that are not uncommon with other vaccines – fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose is not being pursued.

Some of those reactions are similar to coronavirus symptoms but they are temporary, lasting about a day and occur right after vaccination, researchers noted.

“Small price to pay for protection against COVID,” said Dr William Schaffner of Vanderbilt University Medical Center, a vaccine expert who was not involved with the study. He called the early results “a good first step”, and is optimistic that final testing could deliver answers about whether it’s really safe and effective by the beginning of next year. “It would be wonderful. But that assumes everything’s working right on schedule,” Schaffner cautioned.

Moderna’s share price jumped nearly 15 per cent in trading after US markets closed. Shares of the company, based in Cambridge, Massachusetts, nearly quadrupled this year.

Tuesday’s results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19. Those results are not public yet but regulators are evaluating them. Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus — and Black and Latino populations likewise affected.