RE: Bird Flu:
From Meryl Nass:
This is what happened yesterday. A PREP Act declaration, which allows the FDA Commissioner to simply decide (with or without data) that the benefit of a bird flu vaccine, drug, test or medical device is likely greater than the risk, and thereby issue an Emergency Use Authorization (EUA) for the product. Without a license, without standard testing (and possibly with no human testing) an EUA can be issued. It gives the manufacturer, the government, the doctor, the clinic, the shipper—everyone—a waiver of liability for the product.
And the American Medical Association issued a set of CPT codes for doctors to use when administering a CSL Sequirus bird flu shot, last Friday.
CSL Sequirus made the H5N8 bird flu vaccine being used in Finland right now, where the first humans are receiving a Sequirus bird flu vaccine grown in chicken eggs (and not made in the US). 15 EU countries have order 665,000 doses with an option for 40 million total.
The US government has ordered 4.8 million doses of bird flu vaccine from CSL Sequirus, made in the US, grown in MDCK dog kidney cells in a factory in Holly Springs, North Carolina with a troubled past.
This factory was supposed to be a big deal. $500 million dollars from the USG and $500-700 million from Novartis were used to create a more rapid way of making vaccines for pandemics. The strategy was discussed during the GWB administration, but ground was broken for the factory in 2009, and Obama’s DHHS Sec Sibelius attended.
Using MDCK cells to make vaccines was a new idea. But something happened. It did not work out well. FDA wouldn’t approve the plant.
Finally they got an FDA approval in 2014, and then the plant was immediately sold for $275 million to Sequirus—around a quarter of what it was supposed to be worth. Perhaps a reader can tell me what the problem(s) were.
Subsequently there were additional delays, but in 2022 Sequirus announced they were approved to produce 150 million doses of seasonal or pandemic flu vaccines for the US government.
Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that the company’s manufacturing facility in Holly Springs, North Carolina, has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines as outlined by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).1 With this recognition, the U.S. government confirms that Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.
That could be the declaration published in the Federal Register yesterday—Nass
Seqirus has taken numerous steps toward achieving this status, further proving itself capable of delivering innovative pandemic solutions at industrial scale and speed. Seqirus developed the first and only adjuvanted, cell-based influenza A(H5N1) monovalent pandemic vaccine, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2020 in a single dose, prefilled syringe and subsequently approved in 2021 in a multi-dose vial formulation.
That was the Sequirus vaccine whose brand name is Audenz, for which the mortality rate in its clinical trial was 0.5% in the vaccinated group and 0.1% in the placebo group. Newsguard fact-checked me on this—but I was quoting from the label:
As if that isn’t bad enough, Sequirus is experimenting with a self-amplifying mRNA (sa-mRNA) vaccine for bird flu or seasonal flu in Holly Springs, in addition to its canine kidney bird flu vaccine:
Here are a list of the vaccines I know about for bird flu, but it is not a complete list. Pfizer is making an mRNA vaccine too, and presumably lots of companies want to cash in. Moderna’s stock price soared 40% after it was announced that bird flu was infecting cows.
All 3 vaccines that received FDA licenses for bird flu had very concerning safety profiles in clinical trials. I discussed the clinical trials in a CHD-TV show with Brian Hooker that should be out tomorrow or Saturday.
Watch out! The Bird Flu vaccines are coming!
And the only justification to vaccinate humans en masse would be a release of a new bird flu strain that has gained two functions simultaneously: virulence for humans, and transmissibility. Gaining both functions at once only happens in labs.
https://www.cslseqirus.us/news/seqirus-holly-springs-manufacturing-facility-designated-by-us-government-as-pandemic-readyRE: Bird Flu:
From Meryl Nass:
This is what happened yesterday. A PREP Act declaration, which allows the FDA Commissioner to simply decide (with or without data) that the benefit of a bird flu vaccine, drug, test or medical device is likely greater than the risk, and thereby issue an Emergency Use Authorization (EUA) for the product. Without a license, without standard testing (and possibly with no human testing) an EUA can be issued. It gives the manufacturer, the government, the doctor, the clinic, the shipper—everyone—a waiver of liability for the product.
And the American Medical Association issued a set of CPT codes for doctors to use when administering a CSL Sequirus bird flu shot, last Friday.
CSL Sequirus made the H5N8 bird flu vaccine being used in Finland right now, where the first humans are receiving a Sequirus bird flu vaccine grown in chicken eggs (and not made in the US). 15 EU countries have order 665,000 doses with an option for 40 million total.
The US government has ordered 4.8 million doses of bird flu vaccine from CSL Sequirus, made in the US, grown in MDCK dog kidney cells in a factory in Holly Springs, North Carolina with a troubled past.
This factory was supposed to be a big deal. $500 million dollars from the USG and $500-700 million from Novartis were used to create a more rapid way of making vaccines for pandemics. The strategy was discussed during the GWB administration, but ground was broken for the factory in 2009, and Obama’s DHHS Sec Sibelius attended.
Using MDCK cells to make vaccines was a new idea. But something happened. It did not work out well. FDA wouldn’t approve the plant.
Finally they got an FDA approval in 2014, and then the plant was immediately sold for $275 million to Sequirus—around a quarter of what it was supposed to be worth. Perhaps a reader can tell me what the problem(s) were.
Subsequently there were additional delays, but in 2022 Sequirus announced they were approved to produce 150 million doses of seasonal or pandemic flu vaccines for the US government.
Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that the company’s manufacturing facility in Holly Springs, North Carolina, has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines as outlined by the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).1 With this recognition, the U.S. government confirms that Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.
That could be the declaration published in the Federal Register yesterday—Nass
Seqirus has taken numerous steps toward achieving this status, further proving itself capable of delivering innovative pandemic solutions at industrial scale and speed. Seqirus developed the first and only adjuvanted, cell-based influenza A(H5N1) monovalent pandemic vaccine, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2020 in a single dose, prefilled syringe and subsequently approved in 2021 in a multi-dose vial formulation.
That was the Sequirus vaccine whose brand name is Audenz, for which the mortality rate in its clinical trial was 0.5% in the vaccinated group and 0.1% in the placebo group. Newsguard fact-checked me on this—but I was quoting from the label:
As if that isn’t bad enough, Sequirus is experimenting with a self-amplifying mRNA (sa-mRNA) vaccine for bird flu or seasonal flu in Holly Springs, in addition to its canine kidney bird flu vaccine:
Here are a list of the vaccines I know about for bird flu, but it is not a complete list. Pfizer is making an mRNA vaccine too, and presumably lots of companies want to cash in. Moderna’s stock price soared 40% after it was announced that bird flu was infecting cows.
All 3 vaccines that received FDA licenses for bird flu had very concerning safety profiles in clinical trials. I discussed the clinical trials in a CHD-TV show with Brian Hooker that should be out tomorrow or Saturday.
Watch out! The Bird Flu vaccines are coming!
And the only justification to vaccinate humans en masse would be a release of a new bird flu strain that has gained two functions simultaneously: virulence for humans, and transmissibility. Gaining both functions at once only happens in labs.
https://www.cslseqirus.us/news/seqirus-holly-springs-manufacturing-facility-designated-by-us-government-as-pandemic-ready
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