Milo said that Trumps plan to use the military to distribute the vaccine in record time was a really good plan and he can't imagine why the biden did not go with it. Oh... he says he still thinks the True Dough is dreamy tho.
lazs
63 cases in the US.
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Milo said that Trumps plan to use the military to distribute the vaccine in record time was a really good plan and he can't imagine why the biden did not go with it. Oh... he says he still thinks the True Dough is dreamy tho.
lazs
Did he use the military?
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Milo said that Trump had it all set up but it is too bad that not enough doses were available when he left office... but that it would have worked really really well. Oh... he also said that he can not help but say that the True Dough is dreamy.
lazs
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Milo said that Trump had it all set up but it is too bad that not enough doses were available when he left office... but that it would have worked really really well. Oh... he also said that he can not help but say that the True Dough is dreamy.
spaz
Milo said that Trumps plan to use the military to distribute the vaccine in record time was a really good plan and he can't imagine why the biden did not go with it. Oh... he says he still thinks the True Dough is dreamy tho.
spaz
So he didn't use the military.
So lies were told about the number of doses available, 20 million vaccinated by the end of Dec. -
Someone asked "What was Trump's plan?"
Display MoreDevelopment
To accelerate development while maintaining standards for safety and efficacy, OWS has been selecting the most promising countermeasure candidates and providing coordinated government support.
Protocols for the demonstration of safety and efficacy are being aligned, which will allow the trials to proceed more quickly, and the protocols for the trials will be overseen by the federal government, as opposed to traditional public-private partnerships, in which pharmaceutical companies decide on their own protocols. Rather than eliminating steps from traditional development timelines, steps will proceed simultaneously, such as starting manufacturing of the vaccine at industrial scale well before the demonstration of vaccine efficacy and safety as happens normally. This increases the financial risk, but not the product risk.
Select actions to support OWS vaccine and therapeutic development so far include:
March
March 30: HHS announced $456 million in funds for Johnson & Johnson's (Janssen) candidate vaccine. Phase 1 clinical trials began in Belgium on July 24th and in the U.S on July 27th. Janssen's large-scale Phase 3 clinical trial began on September 22, 2020, making them the fourth OWS candidate to enter Phase 3 clinical trials in the United States. 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.
April
April 16: HHS made up to $483 million in support available for Moderna's candidate vaccine, which began Phase 1 trials on March 16 and received a fast-track designation from FDA. This agreement was expanded on July 26 to include an additional $472 million to support late-stage clinical development, including the expanded Phase 3 study of the company's mRNA vaccine, which began on July 27th.
May
May 21: HHS announced up to $1.2 billion in support for AstraZeneca's candidate vaccine, developed in conjunction with the University of Oxford. The agreement is to make available at least 300 million doses of the vaccine for the United States, with the first doses delivered as early as October 2020, if the product successfully receives FDA EUA or licensure. AstraZeneca's large-scale Phase 3 clinical trial began on August 31, 2020.
July
July 7: HHS announced $450 million in funds to support the large-scale manufacturing of Regeneron's COVID-19 investigational anti-viral antibody treatment, REGN-COV2. This agreement is the first of a number of OWS awards to support potential therapeutics all the way through to manufacturing. As part of the manufacturing demonstration project, doses of the medicine will be packaged and ready to ship immediately if clinical trials are successful and FDA grants EUA or licensure.
July 7: HHS announced $1.6 billion in funds to support the large-scale manufacturing of Novavax's vaccine candidate. By funding Novavax's manufacturing effort, the federal government will own the 100 million doses expected to result from the demonstration project.
July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th.
July 31: HHS announced approximately $2 billion in funds to support the advanced development, including clinical trials and large scale manufacturing, of Sanofi and GlaxoSmithKline's (GSK) investigational adjuvanted vaccine. By funding the manufacturing effort, the federal government will own the approximately 100 million doses expected to result from the demonstration project. The adjuvanted vaccine doses could be used in clinical trials or, if the FDA authorizes use, as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.
August
August 5: HHS announced approximately $1 billion in funds to support the large-scale manufacturing and delivery of Johnson & Johnson's (Janssen) investigational vaccine candidate. Under the terms of the agreement, the U.S. Government will own the resulting 100 million doses of vaccine, and will have the option to acquire more. The company's investigational vaccine relies on Janssen's recombinant adenovirus technology, AdVac, a technology used to develop and manufacture Janssen's Ebola vaccine with BARDA support; that vaccine received European Commission approval and was used in the Democratic Republic of the Congo (DRC) and Rwanda during the 2018-2020 Ebola outbreak that began in the DRC.
August 11: HHS announced up to $1.5 billion in funds to support the large-scale manufacturing and delivery of Moderna's investigational vaccine candidate. Under the terms of the agreement, the U.S. Government will own the resulting 100 million doses of vaccine, and will have the option to acquire more. The vaccine, called mRNA-1273, has been co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID has continued to support the vaccine's development including nonclinical studies and clinical trials. Additionally, BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States.
August 23: As part of the agency's efforts to combat COVID-19, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma. Based on available scientific evidence, the FDA determined convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in hospitalized patients, and that the known and potential benefits of the product outweigh the known and potential risks. The EUA authorizes the distribution of convalescent plasma in the U.S. as well as its administration by health care providers, as appropriate, to treat suspected or confirmed cases of COVID-19. Learn more about EUAs.
October
October 9: HHS announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company's COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent COVID-19. The goal of AstraZeneca's partnership with the U.S. Government is to develop a monoclonal antibody cocktail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.
October 28: HHS announced a $375 million agreement with Eli Lilly and Company to purchase the first doses of the company's COVID-19 investigational antibody therapeutic bamlanivimab, also known as LY-CoV555. Bamlanivimab currently is being evaluated in Phase 3 clinical trials funded by Eli Lilly, in addition to clinical trials as part of the ACTIV public-private partnership. The FDA is reviewing bamlanivimab as a possible treatment for COVID-19 in outpatients. Monoclonal antibodies, which mimic the human immune system, bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
November
November 10: HHS announced plans to allocate initial doses of Eli Lilly and Company's investigational monoclonal antibody therapeutic, bamlanivimab, which received emergency use authorization from the FDA on November 9, for the treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19. A data-driven system will ensure continued fair and equitable distribution of these new products. Weekly allocations to state and territorial health departments will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform. To find out how much bamlanivimab has been allocated to specific states, territories, and jurisdictions, visit the allocation dashboard. This dashboard will be updated each distribution week until the FDA issues a revised EUA indicating the U.S. government involvement in the allocation and distribution process is no longer needed.
November 23: HHS announced plans to allocate initial doses of Regeneron's investigational monoclonal antibody therapeutic, casirivimab and imdevimab, which received emergency use authorization from the U.S. Food and Drug Administration on November 21, 2020, for treatment of non-hospitalized patients with mild or moderate confirmed cases of COVID-19 at high risk of hospitalization. In July, the federal government announced federal funding to support large-scale manufacturing of the therapeutic with approximately 300,000 doses of the medicine expected to result from the project. HHS will allocate these government-owned doses equitably on a weekly basis to state and territorial health departments which, in turn, will determine which healthcare facilities receive the infusion drug. To find out how much of Regeneron's therapeutic has been allocated to specific states, territories, and jurisdictions, visit the allocation dashboard. This dashboard will be updated each distribution week until the FDA issues a revised EUA indicating the U.S. government involvement in the allocation and distribution process is no longer needed.
December
December 11, 2020: HHS announced an agreement with Moderna to acquire an additional 100 million doses of their COVID-19 vaccine candidate, bringing the total doses of mRNA-1273 owned by the federal government to 200 million. Under the agreement, Moderna will leverage its U.S.-based manufacturing capacity to fill, finish and ship vials of mRNA-1273 as the bulk material is produced. The additional doses ordered today provide for continuous delivery through the end of June 2021. This federal funding brings the total provided to Moderna for this vaccine, including vaccine development, clinical trials and manufacturing, to $4.1 billion. The government also has the option to acquire up to an additional 300 million doses of the Moderna vaccine.
December 11, 2020: The FDA issued an Emergency Use Authorization (EUA) for Pfizer-BioNTech’s COVID-19 vaccine candidate, allowing the vaccine to be distributed in the U.S. The totality of the available data provides clear evidence that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information. The Pfizer-BioNTech COVID-19 vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. Read more about the EUA.
December 18, 2020: The FDA issued an Emergency Use Authorization (EUA) for Moderna's COVID-19 vaccine candidate, the second COVID-19 vaccine authorized for distribution in the U.S. The totality of the available data provides clear evidence that the known and potential benefits outweigh the known and potential risks, supporting the vaccine's use in millions of people 18 years of age and older. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus's mRNA that instructs cells in the body to make the virus's distinctive "spike" protein. After a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2. Read more about the EUA.
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Apparently someone discovered that a variant of hydro is effective in preventing the wuflu.... hmmm. It is the variant used to treat gout instead of malaria
lazs
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More deadly? That goes against all research into how virii evolve.
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Yep..... they always get less deadly.
lazs
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Which means someone released an upgraded version.
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Apparently someone discovered that a variant of hydro is effective in preventing the wuflu.... hmmm. It is the variant used to treat gout instead of malaria
lazs
Does this mean that Trump was....<gasp>...right again?
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Apparently someone discovered that a variant of hydro is effective in preventing the wuflu.... hmmm. It is the variant used to treat gout instead of malaria
lazs
BS! They are not even close to the same thing or a variant of each other,but as usual.....
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Actually they are and have very similar effects. Plus... both have been in widespread use for decades.
lazs
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Just because they have been around for years doesnt mean they are the same or have similar effects.Did you look them up or are you just spouting off as usual?
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Did you look em up? they have similar chemical makeups and were used for the same things.
lazs
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Dr. Fauci is the highest paid "employee" in the entire federal government. $400K plus per year to keep telling us;
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Still no-one listens to the shit.
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Dr. Fauci is the highest paid "employee" in the entire federal government. $400K plus per year to keep telling us;
419,696 dead Americans and counting.
This Wuflu will kill more Americans than WWII before it's over. Possibly *a lot* more.
I bet by now you know people who have died from it. I know three, including a half-cousin back in Kentucky.
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