Welcome to European Tribune. It's gone a bit quiet around here these days, but it's still going.
Fourth large-scale COVID-19 vaccine trial begins in the United States, 23 Sep
A fourth Phase 3 clinical trial evaluating an investigational vaccine for coronavirus disease 2019 (COVID-19) has begun enrolling adult volunteers. The trial is designed to evaluate if the investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
One of these is UC-San Diego, also administering Moderna, AstraZenca.
The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, are funding the trial.
"Four COVID-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia," said NIAID Director Anthony S. Fauci, M.D. "It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose."
The Phase 3 trial is being conducted in collaboration with Operation Warp Speed(link is external) (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19. OWS and CoVPN also are assisting with additional COVID-19 preventive candidate vaccines, including mRNA-1273, an investigational vaccine co-developed by NIAID and the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and AZD1222, a vaccine candidate being developed by United Kingdom-based biopharmaceutical company AstraZeneca.
Adults who are interested in joining this study can visit Coronaviruspreventionnetwork.org(link is external) or ClinicalTrials.gov and search identifier NCT04505722.
archived Sun Aug 4th, 2019, Tue Jun 4th, 2019, Mon Jan 14th, 2013
by Cat on Fri Oct 9th, 2020 at 09:08:50 PM EST
[ Parent ]
U.S. signs agreement with AstraZeneca to develop, supply COVID-19 antibody treatment [?!]
One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months, in about 5,000 participants, while the second trial will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.
walks and talks like a vaccine, but
Trump credited Regeneron Pharmaceuticals Inc's REGN.O therapeutic for his recovery. Trump received Regeneron's treatment last week after he was diagnosed with COVID-19.
Johnson & Johnson fetus stem cell oppo campaign developing ...
by Cat on Fri Oct 9th, 2020 at 10:14:10 PM EST
[ Parent ]
by Cat on Tue Oct 13th, 2020 at 02:54:45 AM EST
[ Parent ]

Abbott wins U.S. emergency use authorization for new COVID-19 antibody test
"Abbott has already received emergency use authorization for seven tests"
by Cat on Tue Oct 13th, 2020 at 03:04:31 AM EST
[ Parent ]
Programming a blood tester. Abbott knows how to work the Feds.  

Interesting observations:
US approval five to seven years of foreign testing.
Longest European delay: Germany six months. Germany re-ran all our test themselves.
Shortest approval: UK. One month, accepted our test reports as gospel. Delay for paper processing.
IIRC France re-ran some tests but not all. Even Italy did some tests.

The blood testing machine sold for about one million dollars but the real money was in the reagent, $10K per liter. Management continually urged us to speed up the tests so the machine would use reagent faster.
Only USA & Europe paid full price for the machine. Maybe Japan. I don't recall us marketing there. Third world got it either greatly reduced or free. Still had to buy the reagent.

by StillInTheWilderness on Tue Oct 13th, 2020 at 03:20:48 PM EST
[ Parent ]
It is always a good corporate strategy to jack up the price on things that are essential to life. If they could patent breathing oxygen they would. That is why corporations have to be tightly regulated.

"It is not necessary to have hope in order to persevere."
by ARGeezer (ARGeezer a in a circle eurotrib daught com) on Thu Oct 15th, 2020 at 12:41:53 AM EST
[ Parent ]
It's sort of like the H-P ink strategy.
by StillInTheWilderness on Thu Oct 15th, 2020 at 03:31:37 AM EST
[ Parent ]
Can the reagent not be sourced from a third party generic manufacturer?

Index of Frank's Diaries
by Frank Schnittger (mail Frankschnittger at hot male dotty communists) on Thu Oct 15th, 2020 at 11:04:28 AM EST
[ Parent ]
No, patented.
by StillInTheWilderness on Fri Oct 16th, 2020 at 08:14:15 AM EST
[ Parent ]
Truly hope it works well ....

Abbott ID NOW CoV-2 molecular point-of-care test for novel coronavirus

May 2020: FDA Alert Inaccuracy Abbott ID NOW

by Oui on Thu Oct 15th, 2020 at 02:33:23 PM EST
[ Parent ]
One of the few companies that I worked for that was serious about software testing. More man-hours on testing than development. Many more. The other serious one was S&C Electric that made High Voltage Switch Gear.

PC software is the worst. "Looks like it works, push it out the door. All software has bugs."  Cell phone backbone software is in between." I still remember a hard guideline from a company that shall remain nameless: "Hold onto the line as long as the billing data isn't lost. The last thing to lose is the billing data."

by StillInTheWilderness on Fri Oct 16th, 2020 at 08:21:41 AM EST
[ Parent ]

Diversity is the key to economic and political evolution.
by Cat on Tue Oct 13th, 2020 at 11:40:14 PM EST
[ Parent ]


Occasional Series