Moderna, NIH Bringing Older Americans Into Vaccine Trials And Get $483M To Accelerate Development
The trial originally focused on healthy younger Americans, but the NIH and Moderna are now reaching out to more vulnerable populations, as well. Meanwhile, the company receives a large infusion of money that experts say shows the vaccine’s development has moved far along enough that preparations are under way to test it further and to expand manufacturing.
The Associated Press:
Older Americans Get Chance To Join Virus Vaccine Study
A U.S. study of a potential COVID-19 vaccine is being expanded to include older adults, the age group most at risk from the new coronavirus. The shot, made by the National Institutes of Health and Moderna Inc., is being tested in healthy young and middle-aged adults in Seattle and Atlanta. Moderna announced Thursday the study is expanding to include older adults, divided into two age groups -- 51 to 70 and those over 70. (4/16)
The Wall Street Journal:
Moderna Gets U.S. Funding For Development, Manufacturing Of Experimental Coronavirus Vaccine
Moderna Inc. said Thursday it reached an agreement to receive as much as $483 million in funding from a federal agency to accelerate the development and production of its closely watched experimental vaccine against the new coronavirus. The federal funding will cover advancing the vaccine through a series of studies to potential approval by the U.S. Food and Drug Administration. (Loftus, 4/16)
Federal Government Pledges Up To $483M To Speed Moderna’s Coronavirus Vaccine
Moderna’s chief executive, Stephane Bancel, said Thursday that the money from the government’s Biomedical Advanced Research and Development Authority, or BARDA, will enable the company to supply “millions of doses per month in 2020 and with further investments ― tens of millions per month in 2021 ― if the vaccine candidate is successful in the clinic." That timeline seems more optimistic than those Moderna previously gave for the experimental vaccine. The company said on March 23 that it might seek federal emergency approval of it for some people ― including health care workers ― in the fall, but said the vaccine wouldn’t be commercially available for at least 12 to 18 months. Other vaccine developers gave a similar timeline for their experimental products, all of which would need federal regulatory approval.(Saltzman, 4/16)
Coronavirus Vaccine Could Be Ready For Production By Autumn
A coronavirus vaccine trial by the University of Oxford aims to have administered the shot to 500 volunteers by mid-May, Sarah Gilbert, a professor of vaccinology at the university, told the Lancet. Adults aged 18 to 55 years are being recruited initially in the early- and mid-stage randomized, controlled trial. It will be later extended to older people before an expected phase-3 expansion involving 5,000 volunteers, Gilbert told the medical journal. “The best-case scenario is that by the autumn of 2020, we have an efficacy result from phase 3 and the ability to manufacture large amounts of the vaccine, but these best-case time frames are highly ambitious and subject to change,” Gilbert was quoted as saying. (Gale, 4/17)
She Tested A Coronavirus Vaccine A Month Ago. Here's What The Last 4 Weeks Have Been Like.
As soon as it became clear how quickly coronavirus was spreading across the world, and how deadly it was, the race for the vaccine was on. As of now, there are as many as 115 vaccine programs in the works, reports the journal Science Translational Medicine. One of the first in the world to be tested on humans was created by Moderna, Inc, a biotech company in Massachusetts. One month ago, that vaccine was given to the first set of human subjects as part of a safety trial. (Zaman, 4/19)