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Biotech firm Moderna Inc’s experimental vaccine for COVID-19 showed it was safe and provoked immune responses in all 45 healthy volunteers in an ongoing early-stage study, U.S. researchers reported on Tuesday.
It revved up people’s immune systems just the way scientists had hoped, researchers reported. “No matter how you slice this, this is good news,” Dr Anthony Fauci, the U.S. government’s top infectious disease expert had said.
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.
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.
No study volunteers experienced a serious side effect, but more than half reported mild or moderate reactions such as fatigue, headache, chills, muscle aches or pain at the injection site. These were more likely to occur after the second dose and in people who got the highest dose.
Those early volunteers developed what is called neutralizing 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. Moderna was the first to start human testing of a vaccine for the novel coronavirus on March 16, 66 days after the genetic sequence of the virus was released.
Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the results “good news,” noting that the study found no serious adverse events and the vaccine produced “reasonably high” levels of virus-killing or neutralising antibodies.
“If your vaccine can induce a response comparable with natural infection, that’s a winner. That’s why we’re very pleased by the results, ” The Hindu reported after a telephonic interview with Dr Fauci.
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 aren’t public yet but regulators are evaluating them, and 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.
Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain’s Oxford University also are entering the final testing stages.
The 30,000-person study will mark the world’s largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn’t the only one set for such massive U.S. testing, crucial to spot rare side effects.
The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study. Moderna shares jumped more than 15% in after-hours trading on Tuesday.
The U.S. government is supporting Moderna’s vaccine with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials. A successful vaccine could be a turning point for Cambridge, Massachusetts-based Moderna, which has never had a licensed product.
“Our goal is to have a vaccine available for broad distribution by year-end or early next year,” Moderna president Stephen Hoge had told in May, after seeing preliminary data on the Phase 1 trial.
“If we and others build data that shows that the vaccine has potential for benefit, that it’s safe and has a potential for efficacy, then, of course, there are circumstances where the vaccine could be deployed to high-risk populations earlier under something called an Emergency Use Authorization. Really though, that’s a decision that regulators, in particular the FDA, have to make. We need multiple vaccines. We need vaccines for the world, not only for our own country.”
Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.
Article Written By Ishani Panda
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