White House Unveils Plans to Advance COVID-19 Vaccine Development

The Trump Administration recently released framework and leadership for Operation Warp Speed (OWS), a new program designed to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, according to an HHS press release.

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Operation Warp Speed is a public-private partnership to facilitate the development, manufacturing, and distribution of COVID-19 countermeasures, including vaccines, therapeutics, and diagnostics, between components of HHS.

The administration appointed Moncef Slaoui, MD, as chief executive and General Gustave F. Perna as chief operating officer. 

Slaoui is a venture capitalist and former chairman of Global Research and Development and chairman of global Vaccines at GlaxoSmithKline, where he led the development of five major novel vaccines. 

General Perna is the four-star general in charge of the US Army Material Command and oversees the global supply chain and installation and material readiness for the US Army, including more than 190,000 military, civilian, and contract employees. 

"In addition to deploying 62,000 military service members in direct support of fighting COVID-19 on frontlines across the globe, the Department of Defense is racing towards a vaccine," Mark T. Esper, defense secretary, said in the announcement. 

"Through our research and development labs such as DARPA and the Defense Health Agency, and our massive logistical knowledge and capacity, we are committed to achieving the goal of Operation Warp Speed for the American people. I am confident that, as with any mission our military undertakes, we will adapt and overcome all obstacles in our path."

Congress has directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES Act. Lawmakers have also appropriated other flexible funding, HHS stated. Over $6.5 billion has been designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research.

Operation Warp Speed aims to have substantial quantities of a safe and effective vaccine available for Americans by January 2021.

"President Trump's vision for a vaccine by January 2021 will be one of the greatest scientific. Dr. Slaoui and General Perna are ideal leaders for this unprecedented effort to get vaccines, therapeutics, and diagnostics to American patients much faster than ever before. Since January, America's scientists and innovators have been working day and night on this national effort,” and humanitarian accomplishments in history, and this is the team that can get it done," said HHS Secretary Alex Azar. 

“President Trump has refused to accept business-as-usual timelines for vaccines and other essential tools, and instead has insisted that America, and the world, needs answers faster. Under the President's leadership, his administration and American industry will squeeze every last inefficiency out of the process and pour every resource we can into this effort."

Initiatives under Operation Warp Speed will advance several efforts already underway to develop a COVID-19 vaccine, most notably those undertaken by BARDA.

BARDA has supported COVID-19 efforts, setting aside $5 billion to support vaccine development and allocating nearly $1 billion to major pharmaceutical companies to support their COVID-19 efforts. The agency also intends to support up to six COVID-19 vaccines.

At the end of April, HHS replaced Rick Bright as the director of the US agency charged with developing potential COVID-19 drugs and vaccines, according to national news sources.

Bright served as an advisor for the World Health Organization (WHO) after starting his career in influenza vaccine and drug development at the CDC. He is an expert in vaccines and therapeutics and will oversee the acceleration of testing platforms for COVID-19 going forward.

The move resulted in a whistleblower compliant filed by Bright, which alleged that the Trump administration fired him, among many other reasons, for his opposition to the use of the  antimalarial drug hydroxychloroquine as a COVID-19 treatment.

Bright’s former deputy, Gary Disbrow, will take his place as acting director of BARDA.