… why Operation Warp Speed (OWS) is so quickly making available effective vaccines and treatments for COVID-19?
… why Operation Warp Speed (OWS) is so quickly making available effective vaccines and treatments for COVID-19?
Imminence of Availability of Vaccines and Treatments
When the President announced that we may have a COVID-19 vaccine available by the end of 2020, maybe even before the election, many found this hard to believe in light of various news outlet assertions, based on the opinions of various experts, that rolling out a new vaccine generally takes years rather than months. Nonetheless, at this point in time, it seems almost certain that by the end of this year effective vaccines, therapeutics (treatments), and diagnostics (testing) will be available and accessible to the general public. Therapeutics are drugs used to treat people afflicted with COVID-19. The availability of the vaccines and therapeutics is imminent, right around the corner. The progress has been so promisingly fast that the New York Times noted on Monday, October 12 that “Experts are saying…that the pandemic in the United States will be over far sooner than they expected [Italics inserted]…. The Times further notes “… Despite the chaos in day-to-day politics and the fighting over issues like masks and lockdowns, Operation Warp Speed … appears to have been working with remarkable efficiency” [Italics added]. Right now the quibbling seems to be over whether the countermeasures (vaccines and treatment) will be ready in early November, late November, or December.1How have we been able to do this so fast, in a matter of months rather than years? What is the basis of the New York Times’ optimistic assessment? For the New York Times to have given such an optimistic assessment, the writing had to be on the wall and the Times surely wanted its readers to say that it was on top of this important development. What it is about Operation Warp Speed (OWS) that made this possible?
WARP Speed and Massive Scale
The word warp has been around a long time in association with the weaving of cloth. One meaning is changing the shape of something in an unusual way. It’s warped. The term warp speed was introduced by the science fiction show Star Trek. We all remember Captain Kirk telling Mr. Sulu, or one of his crew members, to go to warp speed. It meant faster than light travel. So the idea behind Operation Warp Speed (OWS) was to speed up the development of vaccines and therapeutics to the point where the whole process takes only months rather than years. In reply to a question from President Trump, researchers and scientists said it would take two (2) years to develop a vaccine. The President’s response was that two years was too long; they had to get it done in a year. And it seems that it will be done in about one year or less.
OWS is a massive operation. The Federal Government has arranged for the development, manufacture, and distribution of hundreds of millions of doses of vaccines and therapeutics through contracts with private companies and universities. Massive amounts of money ($10 billion or so) has been allocated to this operation, and hundreds of millions of doses of the vaccines and therapeutics are to be distributed and given to people at no cost (free) starting in the fall of 2020. The medications will be free to individuals because the Federal Government has already paid for the development, manufacture, and distribution of the vaccines and therapeutics.
Mission and Vision of Operation Warp Speed
According to the Department of Defense (DoD), “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.”2It appears that OWS is on track to achieve its goal and will be able to begin implementing it before January 2021.
The following updated reports, from the Department of Health and Human Services OWS factsheet, are examples of activities undertaken under Operation Warp Speed.
Moderna began Phase 1 trials of its candidate vaccine, on March 16 and received a fast-track designation from FDA. 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.
Johnson & Johnson “began Phase I trials for its candidate vaccine 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).”
On 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 [Emergency Use Authorization] or licensure. AstraZeneca’s large-scale Phase 3 clinical trial began on August 31, 2020.”
On 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 [Emergency Use Authorization] or licensure.”
Pfizer. Large Phase 3 clinical trial of its candidate vaccine began July 27, 2020. HHS provided 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.
As I am writing this blog, a CNN news alert reports that drug maker Pfizer will begin testing its experimental coronavirus vaccine in children as young as 12 and the a “team at Cincinnati Children’s Hospital will begin vaccinating teenagers aged 16 and 17 this week…”
Novavax 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.
On the Ingraham Angle on October 13, 2020, Dr. Moncef Slaoui, chief science advisor for OWS, said two of the vaccines had finished efficacy trials and will be ready by Thanksgiving.
Other companies partnering with the Federal Government are GlaxoSmithKline, Grand River Aseptic Manufacturing, Inc., Api-jet, Corning, Materials Science, and Mckesson Corporation.
Federal Government Participants
- Department of Health & Human Services: the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, Biomedical Advanced Research and Development Authority;
- Department of Defense (DoD);
- The departments of Agriculture, Energy and Veterans Affairs.
This whole operation is under the auspices of the Department of Health & Human Services and the Department of Defense. Therefore, “Health and Human Services Secretary Alex M. Azar II and Defense Secretary Dr. Mark T. Esper are overseeing the effort. Former pharmaceutical executive Dr. Moncef Slaoui is the chief science advisor for the project, and Army Gen. Gustave F. Perna is the chief operating officer.”3 The Department of Defense is playing such a critical role because the President views the COVID-19 pandemic as an attack that requires the mobilization of the military and the military is able to effectively deal with the enormous logistical operation that OWS entails given that it specializes in such logical operations. When necessary, it can move very swiftly.
Why We Have Been Able to Achieve Warp Speed
1. Early Recognition of the Reality of a Severe Emergency
According to officials of OWS, “Government agencies and private drug firms began working on medical countermeasures when the coronavirus first became known late last year” [fall of 2019]. Please note that this was before the first confirmed case of coronavirus in the U. S. in January 2020.
2. Federal Government Funding
Federal Government funding to the tune of $10 billion means that the financial risks are assumed by the Federal Government. Besides research and development risks of failure, the Federal Government has taken on another enormous financial risk by starting the manufacturing of the countermeasures (vaccines and therapeutics) before clinical trials are finished. The risk exists because there is a chance that that countermeasures will not work; vaccines and therapeutics are being manufactured when there is no guarantee that they will work. A private entity could and would not assume such risk. It is right and proper for the government to take on such a task. Finding a cure and vaccine for this virus is in the nature of a true public good with widespread and incalculable benefits to the society at large.
Officials of OWS stated it this way, “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”.
3. We Were Not Starting From Scratch
COVID-19 is not the first coronavirus. In other words, scientists have been researching the nature of coronaviruses for years. Dr. Moncef Slaoui, chief science advisor for OWS, noted that 80 to 90 percent of how you make a vaccine was already predefined.
Operation Warp is the vision of President Donald Trump. A pertinent question each citizen and voter needs to ask is this: Would a new administration be able to execute this operation as effectively as the person whose vision it is? Do we want to change horses in mid-stream? The choice is yours. This is literally a matter of life and death.
Notes and References
1. Mark Terry (October 12, 2020). Operation warp speed boss projects COVID-19 vaccine EUA by Thanksgiving, BioSpace. Accessed at https://www.biospace.com/article/operation-warp-speed-boss-1st-covid-19-vaccine-eua-likely-around-thanksgiving/
2. Department of Defense. Fact Sheet: Explaining Operation Warp Speed. Accessed at https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
3. Jim Garamone (August 12, 2020). Operation Warp Speed on track for end-of-year vaccine delivery, DOD News. Accessed at https://www.defense.gov/Explore/News/Article/Article/2311177/operation-warp-speed-on-track-for-end-of-year-vaccine-delivery/#:~:text=Operation%20Warp%20Speed%20on%20Track%20for%20End%2Dof%2DYear%20Vaccine%20Delivery,-Aug.&text=Operation%20Warp%20Speed%20is%20a,the%20end%20of%20the%20year.
4. Featured image is taken from the Jim Garamone article cited above.