Drugmaker Moderna said on Monday that the first batch of its vaccine against the coronavirus is ready for the government to start testing on humans.
The therapeutics and vaccines company said it has shipped vials of the medicine, called mRNA-1273, to the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland. The NIAID expects to begin the clinical trial with 20 to 25 healthy subjects by the end of April to evaluate the vaccine's safety and efficacy against infection, the Wall Street Journal reported. That would mark a three-month period between vaccine design and human testing, with first results becoming available as early as July, according to the report.
"Going into a Phase One trial within three months of getting the sequence is unquestionably the world indoor record. Nothing has ever gone that fast," said Dr. Anthony Fauci, director of NIAID, according to the WSJ.
News of the coming vaccine test sent Moderna's stock price up 19% Tuesday to about $22 a share. Despite that jump, the vaccine's efficacy is unknown. Other drugmakers also are racing to develop vaccines against the coronavirus, including Sanofi, Inovio Pharmaceuticals, Novavax and Johnson & Johnson. Gilead Sciences is also exploring whether one of its existing drugs could work against the disease.
The coronavirus, officially known as COVID-19, has infected more than 80,000 people and killed nearly 3,000.
It could also take a year for the Moderna vaccine to clear regulatory hurdles and become widely available. NIAID told CBS MoneyWatch that a first-phase clinical trial will be held at the Kaiser Permanente Washington Health Research Institute in Seattle, but that it does not have a firm start date.
Founded in 2010, Moderna develops medicines based on so-called messenger RNA for infectious and rare diseases and more.
"It is possible it's going to work, but we have to wait and see," Moderna's CEO Stéphane Bancel told the WSJ.
Moderna said in a statement it is "proud to be included among the many companies and public health agencies working on a possible response to this continuing global health emergency."
NIAID on Tuesday said it has begun its first clinical trial of Gilead's remdesivir on coronavirus patients. It is the first clinical trial in the U.S. to evaluate an experimental treatment for COVID-19. An American passenger who was docked in Japan is participating in the study.
"We urgently need a safe and effective treatment for COVID-19. Although remdesivir has been administered to some patients with COVID-19, we do not have solid data to indicate it can improve clinical outcomes," NIAID director Anthony Fauci said in a press release. Clinical trials are also taking place in China.
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