Can Operation Warp Speed save Trumps presidency

Trump has begun a reward incisive program to producers of vaccine.  Operation Warp Speed

.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). 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.

Development: 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

• Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them already in clinical trials with U.S. government support.
• The 14 vaccine candidates are being narrowed down to about seven candidates, representing the most promising candidates from a range of technology options, which will go through further testing in early-stage clinical trials.
• Large-scale randomized trials for the demonstration of safety and efficacy will proceed for the most promising candidates.

Manufacturing: 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.

Select actions to support OWS manufacturing efforts so far include:

• The May 21, April 16, and March 30 HHS agreements with AstraZeneca, Moderna, and Johnson & Johnson respectively include investments in manufacturing capabilitie

Distribution: Before the countermeasures are approved or authorized, the program will build the necessary plans and infrastructure for distribution.

HHS plans for a tiered approach to vaccine distribution, which will build on allocation methodology developed as part of pandemic flu planning and be adjusted based on experience during the first wave of the COVID-19 response, data on the virus and its impact on populations and the performance of each vaccine, and the needs of the essential workforce. OWS will expand domestic manufacturing and supplies of specialized materials and resources, such as glass vials, that can be necessary for distribution. DoD’s involvement will enable faster distribution and administration than would have otherwise been possible.

HHS Secretary Alex Azar and Defense Secretary Mark Esper oversee OWS, with Dr. Moncef Slaoui designated as chief advisor and General Gustave F. Perna nominated to be chief operating officer. To allow these OWS leaders to focus on operational work, in the near future the program will be announcing separate points of contact, with deep expertise and involvement in the program, for communication with Congress and the public.

Congress has directed almost $10 billion to this effort through supplemental funding, including the CARES Act. Congress has also appropriated other flexible funding. The almost $10 billion specifically directed includes more than $6.5 billion designated for countermeasure development through BARDA and $3 billion for NIH research.

Source of text.

https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html 

If this comes to approval by the cdc fed authority authorised the department of defense.to assist with manufacturing and distribution systems of the vaccine. 

He will need a viable vaccine in hand by the end of September to aggressively distribute the serum before election day schedual.

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics today wrote the President Trump.

Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!

Response of lobbyists for the pharmaceutical industry states. 

Politics must stay out of the conduct and interpretation of clinical trials aimed at evaluating the efficacy and safety of Covid vaccines, as public trust in the results is paramount to ending the pandemic,” said John Maraganore, the chief executive of Alnylam Pharmaceuticals.

Jeremy Levin, chairman of BIO, the biotechnology industry lobbying group, said, “Developing those critical medicines depends on the independent rigorous reviews, integrity and scientific and medical capability of the FDA. The FDA has assisted and supported the industry to become what it has, and is deeply respected in the USA and abroad in response to the Presidents accusations.

I guess if you do wager on American presidential politics then you must factor that if a vaccine comes to frutritiin before the election nov 3rd. 

Then Trump could easily drop to neg 400 in futures.if not pos 400 is practical. Hence that utilize the data and significant fluctuation in odds would be  likely pre data release of trial studies.

And the possibility of having an effective vaccine for immediate release in epicenter hot spots... 

This is the micro trial I am focused on for moderna Corp headquarters is Cambridge mass this conducted by LDS.  

A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent symptomatic coronavirus disease 2019 (COVID-19) in adults has begun. The vaccine, known as mRNA-1273, was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19.

“Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic,” said NIAID Director Anthony S. Fauci, M.D. “Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”

Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial. The Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding support for the trial. The vaccine efficacy trial is the first to be implemented under Operation Warp Speed, a multi-agency collaboration led by HHS that aims to accelerate the development, manufacturing and distribution of medical countermeasures for COVID-19.

“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” said NIH Director Francis S. Collins, M.D., Ph.D. “The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”

The NIH Coronavirus Prevention Network (CoVPN)(link is external) will participate in conducting the trial. The network brings together expertise from existing NIAID-supported clinical research networks. The mRNA-1273 vaccine candidate will be tested at approximately 89 clinical research sites in the United States, 24 of which are part of the CoVPN. Investigators will use public health data and incidence trajectory modeling to identify sustained high-incidence areas and emerging hot zones, so sites near these locations can be prioritized for enrollment.

“Thanks to President Trump’s leadership and the hard work of American scientists, the investigational vaccine developed by NIH and Moderna has reached this Phase 3 trial at record pace,” said HHS Secretary Alex Azar. “Operation Warp Speed is supporting a portfolio of vaccines like the NIH/Moderna candidate so that, if the results of clinical trials meet FDA’s gold standard, these products can reach Americans without a day’s delay.”

NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). SARS-CoV-2 is the virus that causes COVID-19; the spike protein on its surface facilitates entry into a cell. Moderna’s mRNA-1273 uses the mRNA (messenger RNA) delivery platform to encode for an S-2P immunogen. The investigational vaccine directs the body’s cells to express the spike protein to elicit a broad immune response. A Phase 1 clinical trial found the candidate vaccine to be safe, generally well-tolerated and able to induce antibodies with high levels of virus-neutralizing activity. Moderna initiated Phase 2 testing of the vaccine in May 2020.

Hana M. El Sahly, M.D., principal investigator of the NIAID-funded Infectious Diseases Clinical Research Consortium site at Baylor College of Medicine in Houston; Lindsey R. Baden, M.D., principal investigator of the NIAID-funded Harvard HIV Vaccine Clinical Trials Unit at Brigham and Women’s Hospital in Boston; and Brandon Essink, M.D., principal investigator and medical director of Meridian Clinical Research, will serve as co-principal investigators for the Phase 3 trial of mRNA-1273.

As part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, NIH and other HHS agencies and government partners, in collaboration with representatives from academia, philanthropic organizations and numerous biopharmaceutical companies, advised on the trial protocol design and endpoints to ensure a harmonized approach across multiple vaccine efficacy trials.

The trial is designed to evaluate the safety of mRNA-1273 and to determine if the vaccine can prevent symptomatic COVID-19 after two doses. As secondary goals, the trial also aims to study whether the vaccine can prevent severe COVID-19 or laboratory-confirmed SARS-CoV-2 infection with or without disease symptoms. The trial also seeks to answer if the vaccine can prevent death caused by COVID-19 and whether just one dose can prevent symptomatic COVID-19, among other objectives.

Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned 1:1 to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.

Volunteers must provide informed consent to participate in the trial. They will be asked to provide a nasopharyngeal swab and a blood sample at an initial screening visit and additional blood samples at specified time points after each vaccination and over the two years following the second vaccination. Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.

Investigators will closely monitor participant safety. They will call participants after each vaccination to discuss any symptoms and will provide participants with a diary to record symptoms and a thermometer for temperature readings.

If a participant is suspected to have COVID-19, the participant will be asked to provide a nasal swab for testing within 72 hours. If the test is positive for SARS-CoV-2 infection, the participant will be followed closely and referred for medical care if symptoms worsen. Participants will be asked to provide a daily assessment of symptoms through resolution and have saliva sampled periodically, so investigators can test for SARS-CoV-2 infection.

Study investigators will regularly review trial safety data. An independent data and safety monitoring board (DSMB) will review blinded and unblinded data—including safety data and cases of COVID-19 in both groups—at scheduled data review meetings.

Adults who are interested in joining this study can visit www.coronaviruspreventionnetwork.org(link is external) or visit ClinicalTrials.gov and search identifier NCT04470427 to find a study center to volunteer. ClinicalTrials.gov includes a complete listing of study locations.

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs

Source. https://www.nih.gov/news-events/news-releases/phase-3-clinical-trial-investigational-vaccine-covid-19-begins

Through ACTIV, NIH brings together government agencies, nonprofit organizations, and numerous biopharmaceutical companies.

WHO chief hopes pandemic can be ended in less than two years

Trump is paranoid to accuse Food and drug administration of delaying vaccine.  Scientists would rather resign than to approve a vaccine that isn't proven safe and effective.  But Trump cares more about his political reelection than American lives.    Russia already released a vaccine by bypassing further clinical trials.  But public health experts of other countries remain skeptical because Russia hasn't provided scientific evidences.  Oddly silenced is US center for disease control which historically has been the top public health organization handling vaccine distribution.  Even if a vaccine is available now, US can lag behind other countries because of distribution problems.  For example, polls suggest only half of all Americans are willing to be vaccinated when at least 70% of population is needed to achieve herd immunity.  Many people don't even wear masks, avoid crowds, stay home when sick, practice social distancing and hygiene.

So when ever the fda can approve this for.limited use there decision will be based on the best science availible.