American Enterprise Institute Report Means Big Bucks for Big Pharma

AEI study urges mass vaccination: National Coronavirus Response A ROAD MAP TO REOPENING​

Scott Gottlieb, MD Caitlin Rivers, PhD, MPH Mark B. McClellan, MD, PhD Lauren Silvis, JD Crystal Watson, DrPh, MPH MARCH 28, 2020​.

About the Authors:

• Scott Gottlieb is a resident fellow at the American Enterprise Institute and was the Food and Drug Administration commissioner from 2017 to 2019. He serves on the boards of Pfizer Inc. and Illumina.
  
• Mark McClellan, who directs the Duke-Margolis Center for Health Policy, was commissioner of the Food and Drug Administration from 2002 to 2004. He is an independent board member at Alignment Health Care, Cigna, Johnson & Johnson, and Seer. He is a co-chair of the Health Care Payment Learning and Action Network and receives advisory fees from Arsenal Capital, CRG, and Mitre.
  
• Lauren Silvis is a senior vice president at Tempus Inc. and was previously the deputy director of the Food and Drug Administration’s medical device center and the agency’s chief of staff from 2017 to 2019.
  
• Caitlin Rivers is an epidemiologist and assistant professor at the Johns Hopkins Center for Health Security.
  
• Crystal Watson is a health security expert and assistant professor at the Johns Hopkins Center for Health Security.

Note: The AEI slogan is "Defending and Promoting Freedom, Opportunity, and Enterprise."

Trigger for Switch Toward Mass Vaccination. Once availability of a vaccine or therapeutic is able to meet demand, vaccination can expand beyond priority groups. The CDC, state public-health agencies, and vaccine developers should work together to plan for and execute mass vaccination of large populations in the US. This planning can begin before Phase III because preparation can be made regardless of vaccine availability. 
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Mass Vaccination or Therapeutic Distribution—When Supply Is Abundant. The CDC should work with state and local health officials, health care providers, CMS and health insurers, and other public-health stakeholders to create a national plan for how mass vaccination will be carried out across the country. This plan should identify who will administer vaccinations, where vaccines will be offered, and how data will be collected on vaccination rates, as well as possible adverse events from the vaccine. Indemnification of vaccine developers and manufacturers should also be considered. Congress could enact legislation to support a process for compensation of any individual who has an adverse event from the vaccine, which requires medical care.

Global Vaccine Scale-Up and Vaccination. The CDC, the US Agency for International Development, the State Department, and other US stakeholders should continue to work with WHO and other international organizations and national leaders to plan for how the US will assist other countries (particularly low- and middle-income countries) with obtaining vaccine and implementing mass vaccination. Support from the United States and higher-income nations will be critical for controlling the virus globally and saving lives around the world, as well as reducing the impact that future waves of the pandemic may have on the US population.