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Operation Warp Speed: Fast-Tracking the COVID-19 Vaccine

A historic undertaking brings vaccines, therapeutics, and diagnostics to the American public in record time.

We’ve heard Operation Warp Speed (OWS) described in the news as an initiative that will quickly develop a vaccine for COVID-19. But what is Operation Warp Speed, and how is it different than traditional vaccine development, and more importantly, is it safe?

While coronavirus’s origins are being debated and the pandemic has turned into a political football during an election year, thousands of men and women are working above the fray to develop a safe and effective COVID-19 vaccine and other countermeasures. They’ve been at it day and night since the beginning of the year. Federal agencies, universities, research institutions, biotech, pharma, and other industries combine their efforts into a singular mission aimed at vanquishing COVID-19 now rather than later.OWS was formed after examining traditional timelines for producing and delivering a vaccine proved unacceptable. OWS is overseen by HHS Secretary Alex Azar and Defense Secretary Mark Esper. The chief advisor is former pharmaceutical executive, Dr. Moncef Slaoui, and the COO is a top immunologist, General Gustave F. Perna.

According to Secretary Azar, OWS is designed to “compress and wring out every inefficiency in the process, take out every unused day, and also scale up at the same time, manufacturing, so that as we get vaccines that work, we’ll be actually able to distribute them right away because we’re manufacturing at the same time.”

An Unprecedented Effort

OWS’s overall strategy is to accelerate the development, manufacturing, and distribution of COVID-19 countermeasures consisting of vaccines, therapeutics, and diagnostics. The initiative aims to produce and deliver 300 million doses of FDA-approved, safe, effective vaccines with the first doses available to Americans by January 2021. Through investment and coordination of countermeasure development, patients will have access to vaccines and therapeutics more quickly without compromising safety and efficacy standards.

Federal agencies are working in partnership under OWS. Involved are public health agencies under 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 works with companies in the private sector and other agencies, including the Department of Energy (DoE), Department of Agriculture (USDA), and the Department of Veterans Affairs (VA). HHS’s efforts already underway are also being coordinated by OWS, including NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, NIH’s Rapid Acceleration of Diagnostics (RADx) initiative, and work performed by BARDA.

Developing COVID-19 Countermeasures

OWS only selects the most promising candidates whose countermeasures development demonstrates scrupulous safety and efficacy protocols. These candidates are provided with coordinated government support. By aligning safety and efficacy protocols overseen by the federal government, trials can begin much faster than with traditional protocols that pharmaceutical companies determine for public-private partnerships.

According to HHS, instead of cutting steps from traditional timelines, steps can progress simultaneously. For example, large-scale vaccine manufacturing can occur before vaccine safety and efficacy is demonstrated. There is a tremendous financial risk involved, but with no product risk.

On May 15, 2020, fourteen promising candidates were selected from over 100 vaccine candidates. Some already had clinical trials underway with federal government support. The fourteen candidates were narrowed to several covering a range in technology options, including nucleic acid, viral vector, and protein subunit. Only the most promising candidates proceed to large-scale randomized trials.

Manufacturing and Distribution

To meet manufacturing capacity, the federal government is investing in firms at its own risk. This way, manufacturers can increase manufacturing capabilities in preparation for quicker distribution. The manufacturing of a vaccine coincides with only the most promising candidates’ vaccine development. Once the FDA approves the vaccine, it can be quickly distributed to the public.

A plan is being developed between OWS and private firms to deliver a safe and effective vaccine as quickly as possible to the American people. While HHS experts are leading vaccine development, the CDC and other HHS components are partnering with DoD to coordinate the supply, production, and distribution of vaccines. Some of the efforts include over 100 million prefilled syringes ready for distribution by the end of 2020, producing 164 million Valor Glass vials per year that provide chemical durability which minimizes particulate contamination, and designating a central distributor of future COVID-19 vaccines and related supplies for administering pandemic vaccinations.On September 16, 2020, documents were issued detailing the Administration’s strategy for quickly delivering safe and effective COVID-19 vaccine doses to Americans. The documents include a strategic distribution overview and an interim playbook guiding state, tribal, territorial, and local public health programs, and their partners on how to plan and place into operation a COVID-19 vaccination response.

COVID-19 countermeasures will be available at no or low cost to Americans. Doses of vaccine or therapeutic purchases with U.S. taxpayer dollars will be given to the American population at no charge. Congress allocated nearly $10 billion toward this effort through supplemental funding. Over $6.5 billion was directed for countermeasure development through BARDA and $3 billion for NIH research. OWS is on track for vaccine delivery by the end of this year.

Photos: Department of Defense