Second potential COVID-19 vaccine in US starts safety test

Tuesday, 2020-04-07 10:45:46
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(Illustrative Image). Numerous research groups around the world are attempting to make vaccines against COVID-19 using different methods in hopes at least one will offer protection.
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A second US company is poised to begin safety test of a vaccine against COVID-19 on Monday (April 6).

Inovio Pharmaceuticals said Monday that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for INO-4800, its DNA vaccine candidate designed to prevent COVID-19 infection, paving the way for Phase 1 clinical testing in healthy volunteers beginning this week.

The Phase 1 study will enroll up to 40 healthy adult volunteers in Philadelphia and Kansas City, where screening of potential participants has already begun, said the company.

The first dosing is planned for Monday. Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.

Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial, according to the company.

The study is a first step to see if the vaccine appears safe enough for larger tests needed to prove whether it will protect. Even if the research goes well, it is expected to take over a year before any vaccine could be widely available.

The first safety test in people of a different vaccine candidate, developed by the US National Institutes of Health and Moderna Inc., began in Seattle last month.

Numerous research groups around the world are attempting to make vaccines against COVID-19 using different methods in hopes at least one will offer protection.

* US President Donald Trump said on April 5 that Americans are bracing for probably the toughest week during which a lot of deaths will occur due to COVID-19.

"The US will reach a horrific point in terms of death," Trump said, while voicing his optimism that "it will be a point where things will start changing for the better."

The president said that some 1.6 million people in the country have been tested for COVID-19 and received results.

The number of confirmed COVID-19 cases in the United States reached 337,620 as of midnight on April 5 local time (0400 GMT on April 6), with 9,643 deaths, according to the Center for Systems Science and Engineering at Johns Hopkins University.

Trump, who made the remarks during the White House Coronavirus Task Force news briefing, also said that by Tuesday (April 7), 3,000 military and public health workers will be deployed across the nation to cope with the pandemic.

The federal government will be sending some 600,000 N95 respirators on April 6 to New York State, the national epicenter of the coronavirus outbreak.

Meanwhile, the country is stepping up the development of treatments for COVID-19 patients, including experimenting with anti-malarial drug hydroxychloroquine and blood-related therapies.

At the same briefing, US Vice President Mike Pence said hydroxychloroquine will be used in a trial covering 3,000 patients at a hospital in Detroit, Michigan, and the results will be tracked in a formal study.

Last week, Trump said hydroxychloroquine was being administered to 1,100 patients in New York along with Z-Pak, or azithromycin.

Xinhua