First, to explain what an FDA Emergency Use Authorisation is.
Under section 564 of the Federal Food, Drug, and Cosmetic Act, to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency.
This also waivers current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution, and even labelling in some approvals.
The first 4 ham fisted rushed Emergency FDA approvals were:
1. CDC 4th February to do anything necessary with even less quality control measure
2. Wadsworth center New York 29th February with about equal control as the CDC
Then, within 24 hours of application, both within a day of each other:
3. Roche Cobas Antigen Swab Test 12th March
4. Thermo Fisher TaqPath COVID-19 Combo Kit Antigen swab Test 13th March
The European Union slapped a CE mark on at least Thermo Fisher and Roche tests IMMEDIATELY which is no way enough time to assure the test complies with the European Union’s In vitro Diagnostic Directive
UK ACTIONS TAKEN BY DATE ORDER🔶
Tried Luxembourg-based manufacturer Eurofins
I can find no approval for their tests at all, just a lot of marketing.
These had to be rejected/delayed due to core parts of tests being contaminated with coronavirus.
“a lot of the tests look very similar and probably come from the same factory in China” , of which none met the Medicines and Healthcare products Regulatory Agency (MHRA) standards.
3.5 million antibody finger-prick tests had to be discarded by the UK government due to inaccuracy
UK ordered 100,000 Thermo Fisher a day by the end April.
(Yes, those unapproved tests with no quality control that the
EU slapped a CE stamp on)
AstraZeneca and GlaxoSmithKline set up a new testing lab with Cambridge university, which aimed to process 30,000 samples a day by the start of May.
U.K. Paid $20 Million up front for Antibody tests from 2 Chinese companies that didn’t work and unknown if got any money back.
PHE scientist says in-house tests that have been in use since February appear to be less sensitive than commercial kits, such as the one developed by the Swiss company Roche (no antibody test FDA approved yet, so was he talking about antigen).
Primerdesign Ltd IVD-CE PCR swab test got FDA EUA approval
Abbott Antibody test FDA Emergency approved
UK Signed a 6 month contract starting May 4 Novacyt to supply 288,000 Primerdesign Ltd tests per week which boasted to produce results in less than two hours. .. in “collaboration with AstraZeneca, GSK and the University of Cambridge”
(Yes, another unapproved test with no quality control)
Roche Elecsys Antibody test gets FDA EUA
AstraZeneca, GSK and the University of Cambridge failed to set up labs. UK had to send about 50,000 coronavirus tests to the US for processing after “operational issues” in UK labs.
Abbott Antigen PCR swab est FDA Emergency approved
10 Million Antibody tests approved by Public Health England, to supply them to NHS laboratories, and looking at 3 others.
Abbott Laboratories (FDA EUA approved 26th April)
alongside Roche (Approved 2nd May).
(Yes, MORE unapproved test with no quality control)
Here is where is gets REAL “Fun”. Remember the FIRST emergency FDA approval?…
Internal investigations launched by the Department of Health and Human Services into why the Centers for Disease Control and Prevention (CDC) shipped defective coronavirus test kits that contained contaminated reagents to public health laboratories.
🔶Some independent evaluations have taken place and the FDA are beginning to actually REVOKE EUA’s
Given that NONE OF THESE TESTS ARE APPROVED, and
ARE NOT SUBJECT TO ANY QUALITY CONTROL, and the
Department of Health and Human Services reported “These tests are so sensitive that this contamination could have been caused by a single person walking through an area with positive control material and then later entering an area where test reagents were being manipulated,”
HOW DO YOU TRUST THEM NOW?… EH??!
Lets add to some more facts here, that in the UK, a “public Health Officer”, who can be anyone, can appoint “anyone” to carry out the nursing duty of delivering these tests, along with everyone else inbetween to handle, ship and deliver. It is extremely plausible that the test itself has FAR TOO MUCH opportunity to be pre contaminated, unsafe, and unreliable. None of the tests have been properly approved.