Trials begin ahead of schedule for COVID vaccine in USA

Trials begin ahead of schedule for COVID vaccine in USA
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NEW YORK: First trials have begun on a vaccine for the novel coronavirus ahead of the expected schedule, according to US President Donald Trump.

“This is one of the fastest vaccine development launches in history,” he said at a news briefing on Monday. The private company, Moderna, which developed the vaccine, said that it had been injected to the first volunteer in Phase I of the trial. Forty-five volunteers were participating in the trial.

Called mRNA-1273, it has to go through two more phases of trials to check for side effects and for efficacy before it can be deployed for mass vaccinations and the process can take at least a year.

Moderna added that it was already preparing for Phase II trials of the vaccine, which could start in a few months. Trump said efforts to develop medications to treat the disease were also moving fast.

“We’re also racing to develop antiviral therapies and other treatments. And we’ve had some promising results — early results, but promising — to reduce the severity and the duration of the symptoms,” he said.

Anthony Fauci, the administration’s leading scientist dealing with the coronavirus crisis, said that he had expected it would take two to three months before the vaccine could be ready for trial, but it was ready in 65 days. “I believe (this) is the record.”

The 45 healthy volunteers between the ages of 18 and 55 “will be followed for one year - both for safety and whether it induces the kind of response that we predict would be protective”, he said.

Fauci is the director of the National Institute of Allergy and Infectious Disease of the National Institute of Health, which is collaborating with Moderna in developing the vaccine.

The trial is being conducted at the Kaiser Permanente Washington Health Research Institute in Seattle, Washington State where the first cluster of the disease in the US was found.

In the first phase, Fauci said that the volunteers will be given “two injections: one at zero day — first one; then 28 (after) days, there will be three separate doses: 25 milligrams, 100 milligrams, 250 milligrams”. Moderna said it “continues to prepare for rapid acceleration of its manufacturing capabilities that could allow for the future manufacture of millions of doses should mRNA-1273 prove to be safe and effective”. (IANS)

Clinical trials in China, Russia & Japan: China has authorised clinical trials on its first vaccine developed to combat the new coronavirus, according to a report in the ruling Communist Party's People's Daily. The researchers are led by Chen Wei, of China's Academy of Military Medical Sciences, it said.

RUSSIA: Russian scientists have begun to test vaccine prototypes for the new coronavirus, and plan to present the most effective one by June, a laboratory chief at a state biotech institute said. Russia has reported 93 cases of infection but no deaths, according to official numbers published on Tuesday.

"The prototypes have been created. We are starting laboratory testing on animals, to ensure effectiveness and safety," Ilnaz Imatdinov of the Vector Institute in Siberia told the Vesti Novosibirsk television channel on Monday. "In June we will present one or two showing the best results."

Vector Institute is a State Virology and Biotechnology Centre in Novosibirsk, which previously worked on vaccines for the Ebola virus. According to the State health watchdog, which oversees the institute, Russia has tested about 116,000 people for the coronavirus since March 16. The country has announced it is closing borders to all foreign nationals beginning Wednesday as part of measures to halt the spread of the virus.

JAPAN: The Takeda Pharmaceutical Co on Tuesday said its plasma-derived therapy against coronavirus currently in development has the potential to be among the first approved treatments for the deadly pathogen.

The Japanese pharmaceutical company could have an edge because the treatment involves a process that already has approval from regulators. The key point in negotiations with regulators for approval is whether it has the necessary concentration of the antibody, or titer, needed to fight the Covid-19 disease, said Julie Kim, Zurich-based president of Takeda's plasma-derived therapies unit. The process to manufacture the therapy, using antibodies from recovered patients, is the same as Takeda's other immunoglobulin products, which have approval from regulatory bodies around the world including the U.S. Food & Drug Administration, Kim said. (Agencies)

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