The project would be funded from money already available to the government and won’t require new authority from Congress, one of the people said.There are at least 70 different coronavirus vaccines in development by drugmakers and research groups, according to the World Health Organization. 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.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. "We're working for a fully approved vaccine but we'll also use  ... all of our regulatory tools appropriate to bring vaccine available for the entire American population by January," Secretary of Health and Human Services Alex Azar said at the news conference.In the past, drugs authorized for emergency use have mostly been given to people with terminal illnesses with little to lose. According to the Department of Health and Human Services (HHS), which sponsors the program, Operation Warp Speed aims to "deliver 300 million doses of a safe, effective vaccine … Congress has also appropriated other flexible funding. “There’s never been an emergency use authorization for a vaccine before because it’s by and large a technology that is given to healthy people," said Thomas Bollyky, who directs the global health program at the Council on Foreign Relations.Big ideas are certainly needed, said Lois Privor-Dumm, policy director at the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health.But, she cautioned: "We just need to ensure that decisions are made thoughtfully and in an apolitical manner as to not undermine the existing structures and expertise in place to keep vaccines safe and ensure impact. How many people get immunity after exposure, how robust the pathogen is, and how long it lasts are all still questions. Specifically, Trump said, the U.S. would work with China, despite previous reports that a vaccine from the country where the pandemic began would not be considered for use in the United States. OWS will expand domestic manufacturing and supplies of specialized materials and resources, such as glass vials, that can be necessary for distribution. The White House’s Operation Warp Speed has poured billions of dollars into developing a vaccine in record time, funding several efforts in parallel and buying up … By Jon Cohen Jun. "Operation Warp Speed, that means big and it means fast," Its objective is to finish developing and then manufacture and distribute a proven coronavirus vaccine as fast as possible. "Vaccine or no vaccine, we're back. Operation Warp Speed (OWS) aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 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). Operation Warp Speed is an interagency program that includes components of the President Trump officially announced the public-private partnership in mid-May 2020.The Food and Drug Administration announced on June 30, 2020 that the vaccine will need to be at least 50% effective to gain approval, in at least diminishing the severity of COVID-19 symptoms.As of July, eight companies had been chosen for funding to expedite development and preparation for manufacturing their respective vaccine candidates: Johnson & Johnson (In July, Operation Warp Speed agreed to pay $1.6 billion to Novavax if clinical trials are successful to produce 100 million doses of its candidate vaccine.The goals of the project to develop, manufacture, and distribute hundreds of millions of COVID-19 vaccine doses by the end of 2020 have been criticized as being unrealistic, based on decades of experience in developing viral infection vaccines which normally require years or decades for assuring the chosen vaccine will not be toxic and has adequate efficacy.There is potential that the Warp Speed project will expend effort and funding in direct competition with Warp Speed will not partner with Chinese vaccine development organizations – which have more vaccines in clinical development, as of May 2020 – or with the The proposed haste of Operation Warp Speed to have one or more vaccines sufficiently studied for safety and efficacy, approved internationally, and manufactured in hundreds of millions of doses by the end of 2020 is a potential barrier to public acceptance about safety and need to vaccinate against COVID-19, possibly harming vaccine acceptance.The leader of the Operation Warp Speed project, Moncef Slaoui, had been a American public-private partnership designed to accelerate COVID-19 vaccine development