10-01-2020, 09:48 AM
(This post was last modified: 10-01-2020, 09:49 AM by awakened53.)
Two-Shot Vaccine Requirement Will Lead To Vaccine Chaos
On the day that a COVID-19 vaccine is approved, a vast logistics operation will need to awaken. Millions of doses must travel hundreds of miles from manufacturers to hospitals, doctor’s offices, and pharmacies, which in turn must store, track, and eventually get the vaccines to people all across the country. The Centers for Disease Control and Prevention, along with state and local health departments, coordinates this process. These agencies distributed flu vaccines during the 2009 H1N1 pandemic this way, and they manage childhood vaccines every day. But the COVID-19 vaccine will be a whole new challenge.
The leading vaccine candidates both deploy a new, long-promised technology. Their core is a piece of mRNA, genetic material that in this case encodes for the spike protein—the bit of the coronavirus that helps it enter human cells. The vaccine induces cells to take up the mRNA and make the spike protein and, hopefully, stimulates an immune response.
By using mRNA, vaccine makers do not need to produce viral proteins or grow viruses, methods that are used in more traditional vaccines and that add time to the manufacturing process. This is why Moderna and Pfizer/BioNTech have been able to get their vaccines into clinical trials so quickly. Moderna went from a genetic sequence of the coronavirus to the first shot in an arm in a record 63 days.
To get a naked strand of mRNA inside a cell, scientists have learned to encase it in a package called a lipid nanoparticle. mRNA itself is an inherently unstable molecule, but it’s the lipid nanoparticles that are most sensitive to heat. If you get the vaccine cold enough, “there’s a temperature at which lipids and the lipid structure stop moving, essentially. And you have to be below that for it to be stable,” says Drew Weissman, who studies mRNA vaccines at the University of Pennsylvania and whose lab works with BioNTech. Keep the vaccine at too high a temperature for too long, and these lipid nanoparticles simply degrade. Moderna’s and Pfizer/BioNTech’s vaccines have to be shipped frozen at –4 degrees and –94 degrees Fahrenheit, respectively. Once thawed, Moderna’s vaccine can then last for 14 days at normal fridge temperatures; Pfizer’s, for five days.
The freezer temperature required by Moderna’s vaccine makes it difficult to ship; the ultracold temperature required by Pfizer and BioNTech’s vaccine is nearly impossible to maintain outside of a large hospital or academic center with specialized freezers. For this reason, Pfizer has devised “thermal shippers” that, unopened, can keep the vaccines frozen for up to 10 days; once opened for the first time, they have to be replenished with dry ice within 24 hours, then every five days. These shippers are supposed to be opened no more than twice a day to take out vials, and must be closed within one minute. The real catch, though, is that these shippers hold, at a minimum, 975 doses of the COVID-19 vaccine.
Read more: Two-Shot Vaccine Requirement Will Lead To Vaccine Chaos
Vast Military Operation To Deliver 300 Million Doses Of COVID Vaccine
When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”
The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact.
Now, an organizational chart of the $10 billion initiative, obtained by STAT, reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists.
The labyrinthine chart, dated July 30, shows that roughly 60 military officials — including at least four generals — are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies.
Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.
“This is a massive scientific and logistical undertaking,” said Mango. “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”
Despite the military’s dominance, the chart also includes Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases who was almost fired by Trump in February for warning the public about the growing Covid-19 pandemic. Public health and drug industry officials told STAT that Messonnier and Gen. Paul Ostrowski, her direct superior, serve as the initiative’s main contacts on all questions related to the distribution of an eventual vaccine. One public health official said that Ostrowksi, an expert on military acquisition, defers to Messonnier on matters of public health.
Read more: Vast Military Operation To Deliver 300 Million Doses Of COVID Vaccine
On the day that a COVID-19 vaccine is approved, a vast logistics operation will need to awaken. Millions of doses must travel hundreds of miles from manufacturers to hospitals, doctor’s offices, and pharmacies, which in turn must store, track, and eventually get the vaccines to people all across the country. The Centers for Disease Control and Prevention, along with state and local health departments, coordinates this process. These agencies distributed flu vaccines during the 2009 H1N1 pandemic this way, and they manage childhood vaccines every day. But the COVID-19 vaccine will be a whole new challenge.
The leading vaccine candidates both deploy a new, long-promised technology. Their core is a piece of mRNA, genetic material that in this case encodes for the spike protein—the bit of the coronavirus that helps it enter human cells. The vaccine induces cells to take up the mRNA and make the spike protein and, hopefully, stimulates an immune response.
By using mRNA, vaccine makers do not need to produce viral proteins or grow viruses, methods that are used in more traditional vaccines and that add time to the manufacturing process. This is why Moderna and Pfizer/BioNTech have been able to get their vaccines into clinical trials so quickly. Moderna went from a genetic sequence of the coronavirus to the first shot in an arm in a record 63 days.
To get a naked strand of mRNA inside a cell, scientists have learned to encase it in a package called a lipid nanoparticle. mRNA itself is an inherently unstable molecule, but it’s the lipid nanoparticles that are most sensitive to heat. If you get the vaccine cold enough, “there’s a temperature at which lipids and the lipid structure stop moving, essentially. And you have to be below that for it to be stable,” says Drew Weissman, who studies mRNA vaccines at the University of Pennsylvania and whose lab works with BioNTech. Keep the vaccine at too high a temperature for too long, and these lipid nanoparticles simply degrade. Moderna’s and Pfizer/BioNTech’s vaccines have to be shipped frozen at –4 degrees and –94 degrees Fahrenheit, respectively. Once thawed, Moderna’s vaccine can then last for 14 days at normal fridge temperatures; Pfizer’s, for five days.
The freezer temperature required by Moderna’s vaccine makes it difficult to ship; the ultracold temperature required by Pfizer and BioNTech’s vaccine is nearly impossible to maintain outside of a large hospital or academic center with specialized freezers. For this reason, Pfizer has devised “thermal shippers” that, unopened, can keep the vaccines frozen for up to 10 days; once opened for the first time, they have to be replenished with dry ice within 24 hours, then every five days. These shippers are supposed to be opened no more than twice a day to take out vials, and must be closed within one minute. The real catch, though, is that these shippers hold, at a minimum, 975 doses of the COVID-19 vaccine.
Read more: Two-Shot Vaccine Requirement Will Lead To Vaccine Chaos
Vast Military Operation To Deliver 300 Million Doses Of COVID Vaccine
When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”
The initiative — to accelerate the development of Covid-19 vaccines and therapeutics — lacks the scale, and the degree of secrecy, of the effort to build the atomic bomb. But Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact.
Now, an organizational chart of the $10 billion initiative, obtained by STAT, reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists.
The labyrinthine chart, dated July 30, shows that roughly 60 military officials — including at least four generals — are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies.
Operation Warp Speed’s central goal is to develop, produce, and distribute 300 million doses of a coronavirus vaccine by January — and the military is intimately involved, according to Paul Mango, HHS’ deputy chief of staff for policy. It has already helped prop up more than two dozen vaccine manufacturing facilities — flying in equipment and raw materials from all over the world. It has also set up significant cybersecurity and physical security operations to ensure an eventual vaccine is guarded very closely from “state actors who don’t want us to be successful in this,” he said, adding that many of the Warp Speed discussions take place in protected rooms used to discuss classified information.
“This is a massive scientific and logistical undertaking,” said Mango. “We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”
Despite the military’s dominance, the chart also includes Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases who was almost fired by Trump in February for warning the public about the growing Covid-19 pandemic. Public health and drug industry officials told STAT that Messonnier and Gen. Paul Ostrowski, her direct superior, serve as the initiative’s main contacts on all questions related to the distribution of an eventual vaccine. One public health official said that Ostrowksi, an expert on military acquisition, defers to Messonnier on matters of public health.
Read more: Vast Military Operation To Deliver 300 Million Doses Of COVID Vaccine