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Health and Humans Services (HHS) Secretary Alex Azar will visit Iowa on Thursday, Oct. 15. Secretary Azar will join Gov. Kim Reynolds at two Iowa locations – PMG Research at McFarland Clinic and LifeServe Blood Center. Both are helping lead the fight against COVID-19.

“The Trump Administration has been equipping states like Iowa with the tools needed to beat the virus, from testing supplies and data expertise to PPE shipments, therapeutics and an eventual vaccine,” Sec. Azar said. “I look forward to meeting with, hearing from and thanking Iowans working to combat the coronavirus, including the teams at PMG Research at McFarland Clinic and LifeServe Blood Center, who are working each day to improve the health of our fellow Americans.”

According to an HHS spokesperson, President Donald J. Trump has led an unprecedented, whole-of-America response through COVID. Among the Trump administration’s accomplishments, building a national testing initiative for a novel disease from scratch, standing up Operation Warp Speed and making an effort to deliver safe and effective vaccines and therapeutics to the American people.

Secretary Azar is traveling the country as the response continues, meeting with frontline healthcare workers, health system officials and personnel supporting the ongoing COVID-19 response.

Secretary Azar and Gov. Reynolds will meet with leadership at PMG Research of McFarland Clinic in Ames to learn about ongoing clinical trials with Regeneron’s antibody treatment. Both Secretary Azar and Gov. Reynolds will meet with physicians leading the trials and learn more about how the clinic has adapted to provide care safely throughout the pandemic.

They will also visit LifeServe Blood Center, which is contributing to the fight against COVID-19 by collecting convalescent plasma to distribute to local hospitals, testing for antibodies and continuing their blood donation mission.

While much of the mainstream media focus has been on developing a vaccine, the progress the Trump administration has made on therapeutics like antibodies and convalescent plasma has gotten lost.

These therapeutics have been critical to America’s ability to beat COVID-19. The people of Iowa are at the forefront of these crucial developments.

WHAT IS OPERATION WARP SPEED

Operation Warp Speed has a goal of delivering 300 million doses of a safe, effective vaccine for COVID-19 by January of 2021 as part of a broader strategy to accelerate the development, manufacturing and distribution of COVID-19 vaccines, therapeutics and diagnostics.

There are currently more than 310 clinical trials of potential COVID-19 drugs and biological products underway. Operation Warp Speed is a partnership among components of the Department of Health and Human Services, 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), as well as the Department of Defense (DoD).

In addition, private firms and other federal agencies are engaged with Operation Warp Speed.

Operation Warp Speed has been selecting the most promising candidates and providing coordinated government support while maintaining the FDA’s standards for safety and efficacy. With protocols for the demonstration of safety and efficacy being aligned, the trials will proceed more quickly. Protocols for the trials will be overseen by the federal government rather than the traditional public-private partnerships in which pharmaceutical companies decide on their own protocols.

Steps will not be eliminated from traditional development timelines, they will instead proceed simultaneously Industrial scale manufacturing of vaccine doses will run in parallel with clinical trials before a candidate’s safety and efficacy are demonstrated, presenting only financial risk. Doing so will allow doses to be immediately distributed to the American people once a candidate receives FDA EUA or licensure.

With the federal government making investments in the necessary manufacturing capacity at its own risk, firms have the confidence to invest aggressively in development. The investments also will allow for faster distribution of the eventual vaccine.

Manufacturing capacity for select candidates will advance while still in development rather than be scaled up after approval or authorization. Manufacturing capacity developed will be used for whatever vaccine is eventually successful regardless of which firms have developed the capacity.

Prior to authorization or approval, the program will build necessary plans and infrastructure for distribution. The HHS currently plans for a tiered approach to vaccine distribution that builds on allocation methodology developed as part of pandemic flu planning. It will be adjusted based on experience during the first save of the COVID-19 response, data on the virus and its impact on populations and the performance of each vaccine, as well as the needs of the essential workforce.

Jacob Hall

Author: Jacob Hall