Moderna Begins Final-Stage Trial - COVID-19 Clinical Trial
Breaking News | COVID-19

Moderna Begins Final-Stage Trial

Moderna’s vaccine against Covid-19 could be rolled out by the end of this year, US officials said on Monday, after the drug maker announced the start of a 30,000-subject trial to demonstrate it is safe and effective, the final hurdle before approval by global regulators.The study also seeks to determine whether the vaccine can prevent coronavirus-related deaths.

Trial volunteers will receive two injections about 28 days apart of either 100 micrograms of mRNA-1273 or a placebo.Results of a small early-stage study published earlier this month showed volunteers who got two doses of Moderna’s vaccine had levels of virus-killing antibodies that exceeded the average seen in people who had recovered from Covid-19.


US Biotech Uses AI to Pick Antiviral for COVID-19 Trial

US biotech AI Therapeutics has begun a phase 2 trial of its LAM-002A, an antiviral drug that has shown promise against the SARS-CoV-2 coronavirus in the lab.The company develops drugs that have been identified with a proprietary artificial intelligence (AI) algorithm that matches drugs to new indications.

The randomised, double-blind, placebo-controlled study will recruit up to 142 patients and will test the safety, tolerability and efficacy of LAM-002A in reducing viral lead in people with confirmed COVID-19.

Other measures in the Yale University-partnered study will test death, hospitalisation and oxygen saturation.The company cited a large-scale study, which picked LAM-002A as the most promising from a group of other potential antivirals.


FDA Authorizes First COVID-19 Test for Screening People Without Symptoms

The FDA has authorized its first COVID-19 diagnostic for broad-based screening—including for people who have not shown any symptoms and those that do not suspect they have come into contact with someone with the disease.

Previously, the agency’s testing green lights were reserved for people showing early signs of an infection, such as a fever, as well as high-risk individuals and front-line healthcare workers—both to conserve testing resources and because most diagnostics had not been proven accurate enough for screening large numbers of people without unacceptable numbers of false positive or negative results.

The new regulatory expansion goes to LabCorp’s coronavirus diagnostic test, which was first authorized by the FDA in mid-March. The agency also endorsed its use for batch testing, which allows up to five samples to be combined and analyzed at once to stretch testing supplies and speed up screening efforts.  

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