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08/05/2020 | Press release | Archived content

Operation Warp Speed Excels, While Biden Spreads False Information

PRESIDENT TRUMP IS LEADING AN UNPRECEDENTED EFFORT TO ENSURE AMERICANS RECEIVE A CORONAVIRUS VACCINE AS SOON AS POSSIBLE

TOP VACCINE MAKERS HAVE SAID THAT THEY ARE ON TRACK TO HAVE AN EFFECTIVE VACCINE DEVELOPED AS SOON AS POSSIBLE

MEANWHILE JOE BIDEN HAS OPENLY QUESTIONED OPERATION WARP SPEED, IN CONTRAST TO THE EXPERTS WHO SAY THE U.S. SHOULD EXPECT A SAFE AND EFFECTIVE VACCINE SOON DUE TO THE PRESIDENT'S PROGRAM

PRESIDENT TRUMP IS LEADING AN UNPRECEDENTED EFFORT TO ENSURE AMERICANS RECEIVE A CORONAVIRUS VACCINE AS SOON AS POSSIBLE

The Trump Administration's Operation Warp Speed Is Investing In Eight Different Vaccine Developments To Ensure Americans Receive A Coronavirus Vaccine By Early 2021

The Trump Administration's Operation Warp Speed Aims To Deliver 300 Million Doses Of An Effective Vaccine For COVID-19 By January 2021. ' 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).' ( HHS , 6/16/20)

  • The Program Is Making Investments In Vaccine Development To Ensure A Successful Product And Quick Distribution. 'The federal government is making investments in the necessary manufacturing capacity at its own risk, giving firms confidence that they can invest aggressively in development and allowing faster distribution of an eventual vaccine. Manufacturing capacity for selected candidates will be advanced while they are still in development, rather than scaled up after approval or authorization. Manufacturing capacity developed will be used for whatever vaccine is eventually successful, if possible given the nature of the successful product, regardless of which firms have developed the capacity.' ( HHS , 6/16/20)

Last Week, Moncef Slaoui, Chief Adviser To Operation Warp Speed, Said That The Trump Administration's Program Is Going To Fund Eight Different Coronavirus Vaccines. 'Moncef Slaoui, chief adviser to Operation Warp Speed, told CNN's Elizabeth Cohen on Thursday that the program was going to fund eight different coronavirus vaccines. These include vaccines made by Moderna and Pfizer, which started advanced trials in volunteers on Monday; a vaccine from AstraZeneca and University of Oxford in the UK that is in Phase 3 trials in the United Kingdom, Brazil, and South Africa and which is expected to start US trials in August; and vaccines made by Johnson & Johnson and Novavax scheduled to begin Phase 3 trials in September. The Sanofi-Glaxo joint effort would be the sixth to be named as part of the program.' ( CNN , 7/31/20)

So Far Operation Warp Speed Has Named Six Candidates To Be A Part Of The Program. 'These include vaccines made by Moderna and Pfizer, which started advanced trials in volunteers on Monday; a vaccine from AstraZeneca and University of Oxford in the UK that is in Phase 3 trials in the United Kingdom, Brazil, and South Africa and which is expected to start US trials in August; and vaccines made by Johnson & Johnson and Novavax scheduled to begin Phase 3 trials in September. The Sanofi-Glaxo joint effort would be the sixth to be named as part of the program.' ( CNN , 7/31/20)

  • On Friday, The U.S. Federal Government Announced A $2.1 Billion Contract With Drug Giants GlaxoSmithKline And Sanofi Pasteur To Produce Up To 100 Million Doses Of A Vaccine Next Year, With An Option For 500 Million More Doses. 'Drug giants GlaxoSmithKline and Sanofi Pasteur said Friday they had won a commitment from the US federal government to pay up to $2.1 billion to help the two companies move forward with their proposed joint coronavirus vaccine as part of Operation Warp Speed. The companies had said in April they would work together to make a vaccine against Covid-19, using Sanofi's flu vaccine technology and Glaxo's adjuvant -- a compound that boosts the power of a vaccine. Now they have a deal with the US government to produce up to 100 million doses of vaccine next year, with an option for 500 million more doses. It's the largest funding announcement for an Operation Warp Speed vaccine so far.' ( CNN , 7/31/20)
  • In July, The Trump Administration Announced A $2 Billion Contract With Pfizer And A Smaller German Biotechnology Company For Up To 600 Million Doses Of A Coronavirus Vaccine. 'The Trump administration on Wednesday announced a nearly $2 billion contract with the pharmaceutical giant Pfizer and a smaller German biotechnology company for up to 600 million doses of a Covid-19 vaccine, with the companies on track to manufacture the first 100 million doses by December.' ( The New York Times , 7/22/20)
    • The Deal Would Allow The Federal Government To Obtain The First 100 Million Doses For $1.95 Billion, 'With Rights To Acquire Up To 500 Million More,' And 'Americans Would Receive The Vaccine For Free.' 'Under the arrangement, the federal government would obtain the first 100 million doses for $1.95 billion, with the rights to acquire up to 500 million more. Americans would receive the vaccine for free.' ( The New York Times , 7/22/20)
  • On June 1, 2020, HHS Announced A Task Order With Emergent BioSolutions, Which Will Advance Manufacturing Capabilities For A Potential Coronavirus Vaccines, And Therapeutics, Worth Approximately $628 Million. 'June 1: HHS announced a task order with Emergent BioSolutions to advance domestic manufacturing capabilities and capacity for a potential COVID-19 vaccine as well as therapeutics, worth approximately $628 million.' ( HHS , 6/16/20)
  • In May, The Trump Administration Provided $1.2 Billion In Support For AstraZeneca And The University Of Oxford's Candidate Vaccine, With AnAgreement To Make Available At Least 300 Million Doses For Americans. '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 and Phase 3 clinical studies beginning this summer with approximately 30,000 volunteers in the United States.' ( HHS , 6/16/20)
  • In April, The Trump Administration Provided $483 Million In Support For Moderna's Candidate Vaccine, Which Began Phase 1 Trials On March 16 And Received A Fast-Track Designation From The FDA . '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.' ( HHS , 6/16/20)
    • Moderna Has Been Working Closely With The Trump Administration, And Remains On Track To Be Able To Deliver About '500 Million Doses Per Year, And Possibly 1 Billion Doses Per Year, Beginning In 2021.' 'Moderna is working closely with Operation Warp Speed (OWS) and the NIH, including NIAID's COVID-19 Prevention Trials Network (COVPN), to conduct the Phase 3 COVE study. Working together with collaborators like NIH, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society. Moderna has completed manufacture of vaccine required to start the Phase 3 study. With the Phase 3 dose being finalized at 100 μg, the Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company's internal U.S. manufacturing site and strategic collaboration with Lonza.' (Moderna, Press Release , 7/14/20)
  • On March 30, 2020, The Trump Administration Announced $456 Million In Support For Johnson & Johnson's Candidate Vaccine, With Phase 1 Clinical Trials Set To Begin This Summer. 'March 30: HHS announced $456 million in funds for Johnson & Johnson's candidate vaccine, with Phase 1 clinical trials set to begin this summer.' ( HHS , 6/16/20)

Experts Agree That Operation Warp Speed Will Greatly Increase The Odds Americans Will Have Access To At Least One Effective Vaccine

Thomas Triomphe, Executive Vice President And Global Head Of Sanofi Pasteur, Said That Operation Warp Speed's Plan To Invest In More Than One Vaccine Is Key As 'The Global Need For A Vaccine To Help Prevent COVID-19 Is Massive And No Single Vaccine Or Company Will Be Able To Meet The Global Demand Alone.' 'The global need for a vaccine to help prevent COVID-19 is massive, and no single vaccine or company will be able to meet the global demand alone,' Thomas Triomphe, executive vice president and global head of Sanofi Pasteur, said in a statement. ( CNN , 7/31/20)

US Health And Human Services Secretary Alex Azar Said, 'The Operation Of Vaccines Being Assembled For Operation Warp Speed Increases The Odds That We Will Have At Least One Safe, Effective Vaccine As Soon As The End Of This Year.' 'The portfolio of vaccines being assembled for Operation Warp Speed increases the odds that we will have at least one safe, effective vaccine as soon as the end of this year,' US Health and Human Services Secretary Alex Azar said in a statement distributed by Glaxo. ( CNN , 7/31/20)

TOP VACCINE MAKERS HAVE SAID THAT THEY ARE ON THE RIGHT TRACK TO HAVE AN EFFECTIVE VACCINE DEVELOPED AS SOON AS POSSIBLE

Top Vaccine Makers Have Announced They Are On Track To Have A Vaccine By Early 2021

Drug Makers Have Said They Are On The Right Track To Have An Effective Vaccine 'As Soon As Possible' While Following All Safety And Regulatory Guidelines Put In Place. 'Speaking before a House subcommittee Tuesday, executives from AstraZeneca, Johnson & Johnson, Merck, Moderna and Pfizer said their goal is to have effective vaccines available as soon as possible while following all safety and regulatory guidelines.' ( USA Today , 7/21/20)

  • Top Vaccine Makers Are Predicting A 'Vaccine Or Vaccines May Be Available As Early As The Beginning Of 2021.' 'Top vaccine makers predict a vaccine or vaccines may be available as early as the beginning of 2021 and at least two pledged doses will be free or low-cost for all Americans.' ( USA Today , 7/21/20)

Recently, Moderna Launched It's Phase 3 Trial, And Researchers Continue To See Positive Results From The Vaccine Development

Last Week, Moderna A Massachusetts- Based Biotech Company, Launched Its Phase 3 Trial. 'On Monday the Moderna vaccine, which has backing from Operation Warp Speed, launched its Phase 3 trial.' ( News Week , 7/31/20)

  • A Day After It Was Launched, Researchers Found That 'Monkeys Given The Vaccine And Infected With The Coronavirus Were Protected From The Germ And Cleared It From Their Lungs.' 'A day later, the researchers wrote in the New England Journal of Medicine that monkeys given the vaccine and infected with the coronavirus were protected from the germ and cleared it from their lungs.' ( News Week , 7/31/20)

In Phase 2, Moderna's COVID-19 Vaccine 'Led Patients To Produce Antibodies That Can Neutralize The Novel Coronavirus That Causes The Disease.' 'Moderna's Covid-19 vaccine led patients to produce antibodies that can neutralize the novel coronavirus that causes the disease, though it caused minor side effects in many patients, according to the first published data from an early-stage trial of the experimental shot.' ( Stat News , 7/14/20)

Oxford University And AstraZeneca Have Announced Positive Results From A Large, Early Stage Human Trial For The Coronavirus, And Say Their Vaccine Could Be Ready As Early As September 2020

In Mid-July, A Potential Coronavirus Vaccine Developed By Oxford University And AstraZeneca 'Produced A Promising Immune Response In A Large, Early-Stage Human Trial.' 'A potential coronavirus vaccine developed by Oxford University in the U.K. with pharmaceutical giant AstraZeneca has produced a promising immune response in a large, early-stage human trial, according to newly released data published Monday in the medical journal The Lancet. The researchers are calling their experimental vaccine ChAdOx1 nCoV-19. It combines genetic material from the coronavirus with a modified adenovirus that is known to cause infections in chimpanzees. The phase one trial had more than 1,000 participants in people aged 18 to 55.' ( CNBC ,7/20/20)

The Results Found That The Oxford Candidate Vaccine 'Led To Strong Immune Responses For Nearly Two Months In A Trial That Continues To Track More Than 1,000 Healthy Adults.' 'A paper published Monday gave hope to the overall success of possible vaccines. The results showed the Oxford candidate vaccine, AZD-1222, led to strong immune responses for nearly two months in a trial that continues to track more than 1,000 healthy adults.' ( USA Today , 7/21/20)

  • The Latest Results Show That Researchers Are On Schedule To Have A Vaccine Ready For Mass Production As Soon As September. 'The early but promising Phase 1-2 results mean researchers remain on their schedule to have the shot-described by the World Health Organization's chief scientist last month as the world's most-advanced vaccine candidate-ready for mass production as soon as September.' ( The Wall Street Journal , 7/20/20)

BioNTech And Pfizer Have Found Promising Results As They Continue To Phase Three

BioNTech And Pfizer Found Promising Results From Their Phase I/II Trials, As Volunteers Produced Antibodies Against COVID-19, As Well As Immune Cells That Responded To The Virus. 'The German company BioNTech has entered into collaborations with Pfizer, based in New York, and the Chinese drug maker Fosun Pharma to develop their mRNA vaccine. In July, they posted preliminary results from their Phase I/II trials in the United States and Germany. They found that the volunteers produced antibodies against SARS-CoV-2, as well as immune cells called T cells that respond to the virus' ( New York Times , 8/3/20)

  • BioNTech And Pfizer Launched Their Phase 2/3 Trial Last Week And Is Expected To Be Active In 120 Clinical Investigational Sites Around The World Including 39 States Across The United States. 'The Phase 2/3 trial is designed as a 1:1 vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response, and efficacy data needed for regulatory review. The trial's primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups. The study also will explore prevention of infection by SARS-CoV-2, the virus that causes COVID-19. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic COVID-19 disease. The trial design allows for interim analyses and unblinded reviews by an independent external Data Monitoring Committee. By the end of the trial, the Phase 2/3 study is expected to be active at approximately 120 clinical investigational sites around the world, including 39 states across the United States and countries including Argentina, Brazil, and Germany. Investigator sites are selected based on factors including scientific expertise and capabilities, the epidemiology of the disease, and prior experience conducting clinical trials.' ( Pfizer , Press Release, 7/27/20)

MEANWHILE JOE BIDEN HAS OPENLY QUESTIONED OPERATION WARP SPEED, IN CONTRAST TO THE EXPERTS WHO SAY THE U.S. SHOULD EXPECT A SAFE AND EFFECTIVE VACCINE SOON DUE TO THE PRESIDENT'S PROGRAM

Joe Biden Falsely Criticized The President's Efforts To Develop The Vaccine By Doubting If The Vaccine Would Even Be Real, Even Though Experts Have Said That Efficiency Rates Could Be Near 90%

Last Week, Joe Biden Said He Doubted If The Coronavirus Vaccine Developed In Coordination With The White House Would Even Be Real. 'Joe Biden is preemptively doubting whether a coronavirus vaccine will be 'real,' and has cast doubt on whether the vaccine would be distributed with 'any degree of equity and realization' -- seemingly contradicting public health experts even as the White House touts vaccine progress.' ( Fox News , 7/31/20)

Moncef Slaoui, The Chief Advisor Of Operation Warp Speed, And Former Head Of Pharmaceutical Giant GlaxoSmithKline's Vaccines Department, Said That He Believes The Vaccine Will Be 'Highly Efficacious,' And 'Wouldn't Be Surprised If It's In The 90% Range.' 'I think it will be a very effective vaccine. That's my prediction,' said Moncef Slaoui, chief adviser of Operation Warp Speed. 'My personal opinion based on my experience and the biology of this virus, I think this vaccine is going to be highly efficacious. I wouldn't be surprised if it's in the 90% range.' ( CNN , 7/31/20)

Biden Has Also Questioned Whether The Vaccine Would Be Safe For Americans, While The Trump Administration Has Stated They Will Not Authorize A Vaccine That Doesn't Follow The FDA's Extensive Safety Protocols

Biden Made Remarks Questioning If The Developed Vaccine Would Be Safe For Americans, And If The Trump Administration Would Be Transparent. ''How are you going to distribute the vaccine when it arrives, when it arrives, when it's there?' Biden asked Tuesday. 'And the question of whether it's real, when it's there, that requires enormous transparency. You got to make all of it available to other experts across the nation, so they can look and see. So there's consensus, this is a safe vaccine'' ( Fox News , 7/31/20)

Stephen Hahn, The FDA Commissioner, Stated That 'If The Vaccine Isn't Safe, The FDA Will Not Authorize It, Regardless Of How Effective It Appears To Be.' 'Hahn added on Thursday that if a vaccine isn't safe, the FDA will not authorize it, regardless of how effective it appears to be. ( CNBC , 7/30/20)

  • Hahn Said That The FDA Will Be 'Carefully Looking' At Safety Data And Will Continue To Be Transparent While A Vaccine Is Being Developed. ''If we get to 50% but it's not safe, to me, it's not a vaccine that we can authorize,' he said. 'We're going to be very, very, very carefully looking at those safety data and we're going to be transparent, Howard, about what we've seen.'' ( CNBC , 7/30/20)
  • The FDA Has Been Using New Effective Strategies And Technology To Streamline Data Collection From Clinical Trials In Order To 'More Quickly And Frequently Collect Data Safety.' 'He said the FDA is using new strategies and technology to streamline data collection from clinical trial participants in order to more quickly and frequently collect data on safety. The FDA will also continue to monitor the safety of the vaccines after they are authorized and administered to the public, he said.' ( CNBC , 7/30/20)

Vaccine Makers And Health Experts Have Praised The Trump Administration 'Extensive Guidance' In Order To Provide A Safe And Effective Vaccine

The FDA Released 'Extensive Guidance' On What Would Be Necessary For A Vaccine To Be Approved, Including Allowing That Any Vaccine Be 'At Least 50% Effective At Preventing COVID-19 Infections.' 'The Food and Drug Administration released extensive guidance covering what would be necessary for a vaccine to be approved on June 30. One of the requirements was that any vaccine be at least 50% effective at preventing COVID-19 infections.' ( USA Today , 7/21/20)

Barry Bloom, An Immunologist And Professor Of Public Health At The Harvard T.H. Chan Of Public Health In Boston, Said 'That Threshold Would Have Been What I Would Have Chosen Since That Is Around What Flu Vaccines Do That Save Lives'.' 'That threshold 'would have been what I would have chosen since that is around what flu vaccines do that save lives,' said Barry Bloom, an immunologist and professor of public health at the Harvard T.H. Chan School of Public Health in Boston.' ( USA Today , 6/30/20)

Executive Vice President Menelas Pangalos, Said That 'None Of AstraZeneca's Interactions With Regulators Have Indicated There Have Been Any Lowering Standards.' 'None of AstraZeneca's interactions with regulators have indicated there has been any lowering standards, said Executive Vice President Menelas Pangalos.' ( USA Today , 7/21/20)

Dr. Julie Gerberding, Executive Vice President And Chief Patient Officer For Merck, Said That The Company Was 'Relieved' When The FDA Announced That They Were Applying The Same Safety Restrictions It Applies To All Vaccines. 'Dr. Julie Gerberding, executive vice president and chief patient officer for Merck, said the company was 'relieved' the FDA insisted on applying the same safety restrictions it applies to all vaccines.' ( USA Today , 7/21/20)

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