Kevyn wrote:
Biden is of course his own man, a centrist with a long history and record of pubic service. He is lucid and a much better public speaker than the Idiot Pumpkinfuhrer. The only way there is an ice cubes chance in hell of Trumps re-election is his supporters can ignore these truths and con people with a lie that Biden is secretly a communist, suffering from dementia and the puppet of some unseen secret cabal. Letβs hope Americans are not stupid enough to buy the lie.
Joe Biden criticizes Trump over pandemicPresident Trump's response:
Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).
By investing in and coordinating countermeasure development, OWS will allow countermeasures such as a vaccine to be delivered to patients more rapidly while adhering to standards for safety and efficacy.
OWS is a partnership among components of the Department of Health and Human Services (HHS), including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), and the Department of Defense (DoD). OWS engages with private firms and other federal agencies, including the Department of Agriculture, the Department of Energy, and the Department of Veterans Affairs. It will coordinate existing HHS-wide efforts, including the NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH's Rapid Acceleration of Diagnostics (RADx) initiative, and work by BARDA.
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.
* 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.
* April 16: HHS made exit disclaimer icon 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.
* May 21: HHS announced up to $1.2 billion in support for AstraZeneca's candidate vaccine,
* 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.
* July 7: HHS announced $1.6 billion in funds to support the large-scale manufacturing of Novavax's vaccine candidate.
* 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.
* 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.
* 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.
* 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.
* 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.