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Pfizer injects first US patients in Covid-19 vaccine clinical trial, more on way

US pharmaceutical giant Pfizer Inc has administered the first US patients with its experimental vaccine and Regeneron Pharmaceuticals said an antibody treatment could be available by this fal.Several US companies are racing to develop vaccines against the coronavirus disease (Covid-19), which has affected more than 3.5 million and killed 257,207 people across the world.

US pharmaceutical giant Pfizer Inc has administered the first US patients with its experimental vaccine and Regeneron Pharmaceuticals said an antibody treatment could be available by this fall.

Gilead Sciences Inc is working to expand manufacturing of its virus treatment, remdesivir, for use around the world.

Regeneron said an experimental antibody treatment for Covid-19 could be available as soon as this fall, an expedited timeline for a drug that’s scheduled to be studied in humans for the first time in June.

Regeneron’s chief scientific officer George Yancopoulos said on Tuesday during a conference call with investors that to meet the fall timeline will “depend on a lot of factors,” including whether the treatment works as well as hoped, “and there is obviously a lot of risk”.

“We’ve sort of done it before but now we are trying to take it to the next level,” Yancopoulos said.

The trials by Pfizer, which has partnered with Germany’s BioNTech SE, are being conducted at the New York University Grossman School of Medicine in Manhattan and the University of Maryland School of Medicine in Baltimore, the drugmaker said on Tuesday.

The short, less than four-month time-frame in which we’ve been able to move from preclinical studies to human testing is extraordinary,” Pfizer’s chief executive officer Albert Bourla said in a statement.

Researchers said they have begun injecting volunteers with the first of four vaccine shot, which uses a gene-based technology known as messenger RNA, from Pfizer and BioNTech. The first person was vaccinated on Monday.

The RNA, after being injected into the body, slips into human cells and tells them to produce the viral proteins that then cause the body to develop protective antibodies. It’s not a technology that has been approved for use yet.

The short, less than four-month time-frame in which we’ve been able to move from preclinical studies to human testing is extraordinary,” Pfizer’s chief executive officer Albert Bourla said in a statement.

Researchers said they have begun injecting volunteers with the first of four vaccine shot, which uses a gene-based technology known as messenger RNA, from Pfizer and BioNTech. The first person was vaccinated on Monday.

The RNA, after being injected into the body, slips into human cells and tells them to produce the viral proteins that then cause the body to develop protective antibodies. It’s not a technology that has been approved for use yet.

The RNA technology has an advantage as it can move faster into trials because it doesn’t involve brewing batches of protein or inactivated viral particles in living cells, which can take months.

The trial has begun with healthy, young people between the ages of 18 and 55. But as safety is established in that population, it will expand to an older group of study participants—people up to the age of 85.

The trial will help researchers evaluate whether the vaccine candidates are safe, which produces the strongest immune response that could fend off the coronavirus and what the doses should be.

The study is being conducted on 360 people whose results could come as early as next months.

Kathrin Jansen, Pfizer’s head of vaccine research and development, however, said the vaccine will still need to undergo additional testing in more patients. She added they will track the study’s progress to pick the most promising vaccine candidate.

Bourla told The Wall Street Journal last week that a vaccine against coronavirus could be ready for emergency use as early as the falls if everything goes well.

Pfizer and BioNTech are also in a race with Moderna, Johnson & Johnson and dozens of other biopharmaceutical outfits and academic groups to come up with a safe and effective vaccine against the illness within the next year to 18 months.

A handful is in human trials already, including Moderna’s and ones from CanSino Biologics Inc, the Beijing Institute of Biotechnology and Inovio Pharmaceuticals Inc.

Moderna is pursuing a similar RNA approach and started testing its vaccine on patients in March.

Via: BBC

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