Dear Vice President Pence and Secretary Azar:
I am writing to urge you to take immediate steps to ensure America is prepared to acquire, manufacture, and distribute the supplies needed to administer a Coronavirus vaccine to protect the health and safety of the American people. Once a vaccine is developed, doctors and health care providers will need devices to effectively transport and administer the vaccine to millions of patients - including vials, needles, syringes or other delivery mechanisms. In a December report, I raised concerns about our nation’s shortage of critical drugs, syringes, and other medical supplies. Without swift action from the Administration, our nation will not be prepared to effectively administer a vaccine once it is developed.
We have already seen the impact of medical supply shortages during this pandemic, including personal protective equipment such as N95 respirators, masks, and gloves. A vaccine will be a vital part of controlling the spread of the virus and containing this pandemic, and we must take aggressive steps today to ensure the United States will be able to manufacture and supply needles, syringes, or other delivery systems that will allow millions of Americans to be vaccinated.
The Department of Health and Human Services’ 2005 Pandemic Influenza Plan addressed the critical importance of vaccine development, but failed to address the production of delivery devices as “critical components" necessary to administer vaccines. Fifteen years later, our medical supply chains are increasingly dependent on foreign sources of supply, and we are not well positioned to quickly scale up domestic production of key drugs or medical supplies, including delivery devices needed for any vaccine. As I raised in my December report, the United States does not have the capability to domestically manufacture enough needles and syringes needed to administer vaccines during a pandemic.
The former Director of the Department of Health and Human Services’ Strategic National Stockpile, Greg Burel, warned that “the current manufacturing capability for licensed products cannot keep pace with predicted threats." As an example, Burel stated that “we know that demand will outpace commercial supply for just needles and syringes during a pandemic influenza outbreak" and that the United States is “working with domestic supply chain partners to identify alternatives to reduce reply on foreign suppliers … [and] toward potential development of innovative new drug delivery devices to decrease reliance on limited supply chain capability."
The successful development and approval of a safe, effective Coronavirus vaccine will not truly save lives until we can ensure the widespread availability of delivery devices necessary to administer the vaccine. We must move rapidly and seamlessly from development and testing to nationwide deployment. That effort must be underway now. In light of this urgency, please provide me as soon as possible, but not later than Monday, May 18, 2020, with the details explaining exactly how the Task Force and HHS are preparing to ensure sufficient production and delivery of a vaccine once it is developed.
Source: U.S. Senate Committee on Homeland Security and Governmental Affairs