US begins clinical trial of investigational vaccine for coronavirus

Supported by a global coalition founded by India and rway, US has begun phase one clinical trial of an investigational vaccine designed to protect against coronavirus disease which has claimed lives of over 7,000 people globally.

trial began at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle as first participant received investigational vaccine.

"I'm pleased to report today that a vaccine candidate has begun phase one clinical trial. This is one of fastest vaccine development launches in history. t even close. We're also racing to develop antiviral rapies and or treatments," Trump told reporters at a White House news conference on Monday.

National Institute of Allergy and Infectious Diseases (NIAID), part of National Institutes of Health (NIH), is funding trial. open-label trial will enrol 45 healthy ult volunteers d 18 to 55 years over approximately six weeks.

"Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority," said NIAID Director Anthony S Fauci.

"This Phase 1 study, launched in record speed, is an important first step towards achieving that goal," he said.

According to NIH, study is evaluating different doses of experimental vaccine for safety and its ability to induce an immune response in participants. This is first of multiple steps in clinical trial process for evaluating potential benefit of vaccine.

vaccine is called mRNA-1273 and was developed by NIAID scientists and ir collaborators at biotechlogy company Moderna, Inc., based in Cambridge, Massachusetts.

Coalition for Epidemic Preparedness Invations (CEPI) supported manufacturing of vaccine candidate for Phase 1 clinical trial, NIH said.

Conceived in 2015, CEPI was founded in Davos in 2017 by governments of rway and India, Bill & Melinda Gates Foundation, Wellcome Trust, and World Ecomic Forum.

According to its website, CEPI so far has secured USD 760 million toward its USD 1 billion funding target, with multi-year funding from rway, UK, Germany, Japan, Cana, Ethiopia, Australia, Bill & Melinda Gates Foundation, and Wellcome.

Among its 12 voting members are Cherry Gagandeep Kang from Christian Medical College Vellore and Rajeev Venkayya Vaccine Business Unit, Takeda Pharmaceutical Company Limited. Indian Soumya Swaminathan is a n-voting member and represents World Health Organization (WHO) in Board.

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Early this week, CEPI, organisation set up to accelerate development of vaccines against emerging infectious diseases, me an urgent call for USD 2 billion to support development of a vaccine against virus responsible for COVID-19.

In a statement, NIH said that infection with SARS-CoV-2, virus that causes COVID-19, can cause a mild to severe respiratory illness and include symptoms of fever, cough and shortness of breath.

number of deaths due to coronavirus has passed 7,000 worldwide. More than 175,530 cases have been recorded in 145 countries.

COVID-19 cases were first identified in December 2019 in China's Wuhan in Hubei province. As of March 15, WHO has reported 153,517 cases of COVID-19 and 5,735 deaths worldwide. More than 2,800 confirmed COVID-19 cases and 58 deaths have been reported in United States as of March 15, according to Centers for Disease Control and Prevention (CDC).

"Currently, approved vaccines exist to prevent infection with SARS-CoV-2," NIH said, ding that investigational vaccine was developed using a genetic platform called mRNA (messenger RNA).

investigational vaccine directs body's cells to express a virus protein that, it is hoped, will elicit a robust immune response. mRNA-1273 vaccine has shown promise in animal models, and this is first trial to examine it in humans, it said.

Scientists at NIAID's Vaccine Research Center (VRC) and Moderna were able to quickly develop mRNA-1273 because of prior studies of related coronaviruses that cause severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS).

Phase 1 trial is led by Lisa A Jackson, MD, senior investigator at KPWHRI. Study participants will receive two doses of vaccine via intramuscular injection in upper arm approximately 28 days apart. Each participant will be assigned to receive a 25 microgram (mcg), 100 mcg or 250 mcg dose at both vaccinations, with 15 people in each dose cohort, according to a statement.

first four participants will receive one injection with low dose, and next four participants will receive 100 mcg dose. Investigators will review safety data before vaccinating remaining participants in 25 and 100 mcg dose groups and before participants receive ir second vaccinations. Ar safety review will be done before participants are enrolled in 250 mcg cohort.

"This work is critical to national efforts to respond to threat of this emerging virus. We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007," Dr Jackson said. 

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