Note: Haste makes waste. Measure twice, cut once. A stitch in time, saves nine. But does a vax in time save any... when not tested according to standards? I realize most AofAers would not participate in this or any vaccine trial. But many will rush to the tests. Here is the call to participants from Kaiser. There is payment of up to $1100 for participation. Here is the survey.
...ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical trials will outweigh the risks. “Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct. Often our decision to do so seems unwise in retrospect,” wrote Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, in an email to STAT. Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals
Researchers fast-track coronavirus vaccine by skipping key animal testing first
A clinical trial for an experimental coronavirus vaccine has begun recruiting participants in Seattle, but researchers did not first show that the vaccine triggered an immune response in animals, as is normally required.
Now, biomedical ethicists are calling the shortcut into question, according to Stat News.
"Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct," Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, wrote in an email to Stat News. "Often our decision to do so seems unwise in retrospect."
Typically, vaccine development can take 15 to 20 years, start to finish, Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, told Stat News. The lengthy process requires that scientists first give the vaccine to animals to determine whether it's safe and effective at preventing the disease in question. Only after passing through iterative tests in animal models, and being adjusted along the way, can a formulation be tested in human trials.
"When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches," Feinberg said.
From Seattle Pi on March 10:
COVID-19 vaccine trials to begin soon, volunteers being recruited in Seattle
The vaccine has never before been administered to humans, but it is similar to vaccines developed previously for the Zika virus.
"When injected into the body, the mRNA causes cells to make that protein, which can trigger an immune response. If the person is later infected with the SARS-CoV-2 virus, their prior immune response may help them react to the infection with an increased immune response to fight the invading virus. The vaccine mRNA breaks down naturally and does not remain in the body," Kasier Permanente said in its post.
Eligible volunteers include healthy adults ages 18 to 55. People with certain medical conditions affecting the immune system will not be eligible. Volunteers who take part in the study are expected to go to 11 in-person study visits -- one initial screening, two vaccination visits and eight follow-ups -- and participate in four phone calls over the course of 14 months.
The study will include three groups -- each made up of 15 people -- who will get varying doses of the vaccine, all 28 days apart. The first group will receive 25 microgram doses, the second 100 microgram and the third 250 microgram.
Participants will receive $100 for each visit they attend, with a total of $1,100 for attending all of the visits. Those interested are asked to fill out a survey online.
Please read James Lyons-Weiler's new article:-