Re: Reasons why I will not be getting injected for the Wuhan
Posted: Mon Sep 27, 2021 9:55 pm
This following excerpt from the Gottlieb book is not an attempt to persuade to get vaccinated or not get vaccinated. Just gives you insight into what it takes to develop a vaccine.
And, anyone ever know about this? "This prompted federal officials to finance the formation of secretive flocks of chickens located in sprawling, indoor facilities that were spread across thirty-five sites in the eastern United States."
Vinny
Even though the government had been worried about the risk of a pandemic flu for a number of years, up until that point relatively few resources were focused on developing reliable countermeasures. The NIH’s entire flu research budget for 2005 was about $119 million. HHS had created an initial stockpile of just 2.3 million treatment courses of oseltamivir, the only approved drug that had shown activity against a range of potentially dangerous influenzas.37 It was a paltry amount for a country of nearly 300 million people. In a real pandemic, it was estimated that at least 100 million doses would be needed, and perhaps more if it took a long time to develop a vaccine.
Making a vaccine can be hard. The development work might take years. Part of the challenge is the way that flu vaccines are manufactured, using chicken eggs to culture the virus and grow the critical proteins that are used as the stock for the vaccines. Under this process, a fertilized chicken egg is inoculated with a strain of influenza. The virus is allowed to replicate in the yolk, before it’s harvested, inactivated, and incorporated into vaccines. In this way, the eggs serve as incubators for the development of the viral proteins that are used for the vaccine.
This outdated approach is the backbone for producing the seasonal flu vaccine. But there were serious concerns in 2005 that it wouldn’t be adequate—or even feasible—in the event of a pandemic bird flu. For one thing, there was fear that there wouldn’t be enough chicken eggs if there was a surge in demand for the vaccine. This prompted federal officials to finance the formation of secretive flocks of chickens located in sprawling, indoor facilities that were spread across thirty-five sites in the eastern United States.38 About $44 million was invested in a five-year program to harden the sites, to make sure there would be a sufficient supply of eggs.39 The US government even classified these chicken farms as part of the nation’s “critical infrastructure,” shielding them from public view. One person who worked for me at the FDA, and toured the locations, described walking into one cavernous installation and seeing an endless sea of white chickens. The hens would all run away from you, she said, and the roosters would all charge toward you.
The next concern was whether the chickens—and their eggs—could survive a pandemic bird flu long enough to support the production of a vaccine. A bird flu, by its very nature, kills poultry. It could wipe out the chickens. The same strain could prove deadly to the eggs and to the developing embryos that are needed to grow the viral stock that’s used to produce the vaccines. Getting a developing chicken egg to survive inoculation with a bird flu may not be feasible. So, as a fail-safe, the team established a backup plan to build manufacturing sites that wouldn’t be dependent on chickens or their eggs, relying instead on cells derived from mammals rather than chicken embryos as the medium on which to grow the influenza virus and harvest its proteins.
The presumption is that mammalian cells would be less likely to be killed outright by a strain of bird flu. Moreover, because the cell cultures could be incubated in large bioreactors, it made it potentially faster, and easier, to produce the vaccine stock in large quantities. These processes were also easier to expand if we needed to surge the production of vaccines. In the manufacturing of pharmaceutical products that are derived from biological sources, it’s often said that the process is the product. The characteristics of a vaccine or other biological are closely tied to how it’s manufactured. There are a lot of things that can go wrong, and many of them are hard to predict—and detect. It’s estimated that 70 percent of the time and resources related to the manufacture of a vaccine is focused on quality control.40 The biggest risk often comes from “scaling up” production—expanding an existing manufacturing line to boost its output—and “scaling out” a process—partnering with other manufacturers to broaden your production capabilities and teaching other plants how to reliably make the complex product. The cell-based process was easier to expand; lots of manufacturing plants could accept cell lines and grow them in their existing vats, often with minor modifications. You didn’t need to wait for eggs to be laid.
There were other advantages to the cell-based process. The virus obtained in cell cultures can be made to more carefully match the circulating strain of flu. The mammalian cell cultures can more closely mimic the human cells that the virus is ultimately programmed to target. In this way the virus that gets churned out from these cultures can also be made to look just like the viral copies that will be produced when the virus naturally infects its human host. A virus manufactured in a mammalian cell culture doesn’t need to adapt as much to its new growing environment as a virus grown in eggs. If the virus was already trained to infect human cells, then replicating it in a mammalian cell culture doesn’t require it to change its ways.
By contrast, virus manufactured in eggs often undergoes adaptation to the chickens, a process called “antigenic modification.” These modifications are small changes that make the virus more closely suited to growing in a chicken egg. But the adaptation can also change the conformation of the virus’s proteins, making them less likely to be recognized by a human immune system, and more likely to be recognized by a chicken’s. That can make the vaccine less potent in stimulating our immune system. If these viral proteins undergo too many changes, then once they are injected into our arms, the proteins could end up stimulating the production of human antibodies that aren’t as well suited to attacking the real virus.41 They become adapted to attacking a version of the virus that had itself been modified to replicate in chickens. This is what happened in 2017, when I was FDA commissioner. The flu vaccine didn’t work well that year, probably because it had undergone too much “egg adaptation.” The vaccine was only about 25 percent effective against the principal strain of influenza that circulated that winter.42
Recognizing these vulnerabilities, and the unique challenges they’d pose in a pandemic, there were earlier efforts to expand our domestic capacity to make flu vaccines in cell cultures and not chicken eggs. In the early 2000s, as part of this effort, the government refurbished and enlarged some domestic manufacturing sites.43 Building these plants would take many years and require an enormous investment of capital. Yet, after some initial efforts, attention would turn away from these priorities. The focus on building out our domestic capability to make flu vaccine, in facilities that could be impervious to a pandemic strain of bird flu, would ultimately give way to other priorities. We didn’t stick with it. Even with a lot of planning and a huge sum of money, only one significant facility would result from this effort; a single cell-based manufacturing site located in North Carolina.44 The plant was built for the production of a seasonal flu vaccine (and was eventually sold off to a foreign owner and wasn’t leveraged by the US government to boost vaccine manufacturing during COVID). Even after the plant was built, developing flu vaccines from this cell culturing process would run into regulatory hurdles. The first seasonal flu vaccine based on these new cell-culturing techniques wouldn’t be licensed by the FDA until 2012, almost a decade after these efforts first got under way.45
The path to building better resiliency would be protracted and uncertain, and ultimately many immune system. If these viral proteins undergo too many changes, then once they are injected into our arms, the proteins could end up stimulating the production of human antibodies that aren’t as well suited to attacking the real virus.41 They become adapted to attacking a version of the virus that had itself been modified to replicate in chickens. This is what happened in 2017, when I was FDA commissioner. The flu vaccine didn’t work well that year, probably because it had undergone too much “egg adaptation.” The vaccine was only about 25 percent effective against the principal strain of influenza that circulated that winter.42
Recognizing these vulnerabilities, and the unique challenges they’d pose in a pandemic, there were earlier efforts to expand our domestic capacity to make flu vaccines in cell cultures and not chicken eggs. In the early 2000s, as part of this effort, the government refurbished and enlarged some domestic manufacturing sites.43 Building these plants would take many years and require an enormous investment of capital. Yet, after some initial efforts, attention would turn away from these priorities. The focus on building out our domestic capability to make flu vaccine, in facilities that could be impervious to a pandemic strain of bird flu, would ultimately give way to other priorities. We didn’t stick with it. Even with a lot of planning and a huge sum of money, only one significant facility would result from this effort; a single cell-based manufacturing site located in North Carolina.44 The plant was built for the production of a seasonal flu vaccine (and was eventually sold off to a foreign owner and wasn’t leveraged by the US government to boost vaccine manufacturing during COVID). Even after the plant was built, developing flu vaccines from this cell culturing process would run into regulatory hurdles. The first seasonal flu vaccine based on these new cell-culturing techniques wouldn’t be licensed by the FDA until 2012, almost a decade after these efforts first got under way.45
The path to building better resiliency would be protracted and uncertain, and ultimately many aspects of our plans would be set aside. The dangers persisted longer than our attention to the risks.
And, anyone ever know about this? "This prompted federal officials to finance the formation of secretive flocks of chickens located in sprawling, indoor facilities that were spread across thirty-five sites in the eastern United States."
Vinny
Even though the government had been worried about the risk of a pandemic flu for a number of years, up until that point relatively few resources were focused on developing reliable countermeasures. The NIH’s entire flu research budget for 2005 was about $119 million. HHS had created an initial stockpile of just 2.3 million treatment courses of oseltamivir, the only approved drug that had shown activity against a range of potentially dangerous influenzas.37 It was a paltry amount for a country of nearly 300 million people. In a real pandemic, it was estimated that at least 100 million doses would be needed, and perhaps more if it took a long time to develop a vaccine.
Making a vaccine can be hard. The development work might take years. Part of the challenge is the way that flu vaccines are manufactured, using chicken eggs to culture the virus and grow the critical proteins that are used as the stock for the vaccines. Under this process, a fertilized chicken egg is inoculated with a strain of influenza. The virus is allowed to replicate in the yolk, before it’s harvested, inactivated, and incorporated into vaccines. In this way, the eggs serve as incubators for the development of the viral proteins that are used for the vaccine.
This outdated approach is the backbone for producing the seasonal flu vaccine. But there were serious concerns in 2005 that it wouldn’t be adequate—or even feasible—in the event of a pandemic bird flu. For one thing, there was fear that there wouldn’t be enough chicken eggs if there was a surge in demand for the vaccine. This prompted federal officials to finance the formation of secretive flocks of chickens located in sprawling, indoor facilities that were spread across thirty-five sites in the eastern United States.38 About $44 million was invested in a five-year program to harden the sites, to make sure there would be a sufficient supply of eggs.39 The US government even classified these chicken farms as part of the nation’s “critical infrastructure,” shielding them from public view. One person who worked for me at the FDA, and toured the locations, described walking into one cavernous installation and seeing an endless sea of white chickens. The hens would all run away from you, she said, and the roosters would all charge toward you.
The next concern was whether the chickens—and their eggs—could survive a pandemic bird flu long enough to support the production of a vaccine. A bird flu, by its very nature, kills poultry. It could wipe out the chickens. The same strain could prove deadly to the eggs and to the developing embryos that are needed to grow the viral stock that’s used to produce the vaccines. Getting a developing chicken egg to survive inoculation with a bird flu may not be feasible. So, as a fail-safe, the team established a backup plan to build manufacturing sites that wouldn’t be dependent on chickens or their eggs, relying instead on cells derived from mammals rather than chicken embryos as the medium on which to grow the influenza virus and harvest its proteins.
The presumption is that mammalian cells would be less likely to be killed outright by a strain of bird flu. Moreover, because the cell cultures could be incubated in large bioreactors, it made it potentially faster, and easier, to produce the vaccine stock in large quantities. These processes were also easier to expand if we needed to surge the production of vaccines. In the manufacturing of pharmaceutical products that are derived from biological sources, it’s often said that the process is the product. The characteristics of a vaccine or other biological are closely tied to how it’s manufactured. There are a lot of things that can go wrong, and many of them are hard to predict—and detect. It’s estimated that 70 percent of the time and resources related to the manufacture of a vaccine is focused on quality control.40 The biggest risk often comes from “scaling up” production—expanding an existing manufacturing line to boost its output—and “scaling out” a process—partnering with other manufacturers to broaden your production capabilities and teaching other plants how to reliably make the complex product. The cell-based process was easier to expand; lots of manufacturing plants could accept cell lines and grow them in their existing vats, often with minor modifications. You didn’t need to wait for eggs to be laid.
There were other advantages to the cell-based process. The virus obtained in cell cultures can be made to more carefully match the circulating strain of flu. The mammalian cell cultures can more closely mimic the human cells that the virus is ultimately programmed to target. In this way the virus that gets churned out from these cultures can also be made to look just like the viral copies that will be produced when the virus naturally infects its human host. A virus manufactured in a mammalian cell culture doesn’t need to adapt as much to its new growing environment as a virus grown in eggs. If the virus was already trained to infect human cells, then replicating it in a mammalian cell culture doesn’t require it to change its ways.
By contrast, virus manufactured in eggs often undergoes adaptation to the chickens, a process called “antigenic modification.” These modifications are small changes that make the virus more closely suited to growing in a chicken egg. But the adaptation can also change the conformation of the virus’s proteins, making them less likely to be recognized by a human immune system, and more likely to be recognized by a chicken’s. That can make the vaccine less potent in stimulating our immune system. If these viral proteins undergo too many changes, then once they are injected into our arms, the proteins could end up stimulating the production of human antibodies that aren’t as well suited to attacking the real virus.41 They become adapted to attacking a version of the virus that had itself been modified to replicate in chickens. This is what happened in 2017, when I was FDA commissioner. The flu vaccine didn’t work well that year, probably because it had undergone too much “egg adaptation.” The vaccine was only about 25 percent effective against the principal strain of influenza that circulated that winter.42
Recognizing these vulnerabilities, and the unique challenges they’d pose in a pandemic, there were earlier efforts to expand our domestic capacity to make flu vaccines in cell cultures and not chicken eggs. In the early 2000s, as part of this effort, the government refurbished and enlarged some domestic manufacturing sites.43 Building these plants would take many years and require an enormous investment of capital. Yet, after some initial efforts, attention would turn away from these priorities. The focus on building out our domestic capability to make flu vaccine, in facilities that could be impervious to a pandemic strain of bird flu, would ultimately give way to other priorities. We didn’t stick with it. Even with a lot of planning and a huge sum of money, only one significant facility would result from this effort; a single cell-based manufacturing site located in North Carolina.44 The plant was built for the production of a seasonal flu vaccine (and was eventually sold off to a foreign owner and wasn’t leveraged by the US government to boost vaccine manufacturing during COVID). Even after the plant was built, developing flu vaccines from this cell culturing process would run into regulatory hurdles. The first seasonal flu vaccine based on these new cell-culturing techniques wouldn’t be licensed by the FDA until 2012, almost a decade after these efforts first got under way.45
The path to building better resiliency would be protracted and uncertain, and ultimately many immune system. If these viral proteins undergo too many changes, then once they are injected into our arms, the proteins could end up stimulating the production of human antibodies that aren’t as well suited to attacking the real virus.41 They become adapted to attacking a version of the virus that had itself been modified to replicate in chickens. This is what happened in 2017, when I was FDA commissioner. The flu vaccine didn’t work well that year, probably because it had undergone too much “egg adaptation.” The vaccine was only about 25 percent effective against the principal strain of influenza that circulated that winter.42
Recognizing these vulnerabilities, and the unique challenges they’d pose in a pandemic, there were earlier efforts to expand our domestic capacity to make flu vaccines in cell cultures and not chicken eggs. In the early 2000s, as part of this effort, the government refurbished and enlarged some domestic manufacturing sites.43 Building these plants would take many years and require an enormous investment of capital. Yet, after some initial efforts, attention would turn away from these priorities. The focus on building out our domestic capability to make flu vaccine, in facilities that could be impervious to a pandemic strain of bird flu, would ultimately give way to other priorities. We didn’t stick with it. Even with a lot of planning and a huge sum of money, only one significant facility would result from this effort; a single cell-based manufacturing site located in North Carolina.44 The plant was built for the production of a seasonal flu vaccine (and was eventually sold off to a foreign owner and wasn’t leveraged by the US government to boost vaccine manufacturing during COVID). Even after the plant was built, developing flu vaccines from this cell culturing process would run into regulatory hurdles. The first seasonal flu vaccine based on these new cell-culturing techniques wouldn’t be licensed by the FDA until 2012, almost a decade after these efforts first got under way.45
The path to building better resiliency would be protracted and uncertain, and ultimately many aspects of our plans would be set aside. The dangers persisted longer than our attention to the risks.
