WASHINGTON, D.C. – U.S. Senator Tammy Baldwin (D-WI) joined 11 of her Senate Democratic colleagues, led by Senator Mazie K. Hirono (D-HI), in urging Health and Human Services (HHS) Secretary Alex Azar and Centers for Disease Control and Prevention (CDC) Director Dr. Robert Redfield to work with state, Tribal, territorial, and local stakeholders to identify gaps in ultra-cold storage capability, particularly in rural and underserved communities, and use existing authority to prevent shortages of supplies needed for vaccine distribution and administration. This information will be especially important in light of recent news that Pfizer/BioNTech may soon apply for Emergency Use Authorization (EUA) for their COVID-19 vaccine candidate, which requires ultra-cold temperature storage capabilities that many providers currently lack. The absence of guidance and support from the federal government about how to secure cold chain integrity is a critical challenge for states working to craft and eventually implement their immunization programs.
The lawmakers ask HHS and CDC to urgently provide additional information to ensure that stakeholders nationwide can be prepared to distribute, store, and administer vaccines requiring ultra-cold storage as soon as one is approved or authorized, which could be as soon as next month.
“While we understand that some logistical details may be unknowable at this time given that a vaccine has yet to be granted an Emergency Use Authorization (EUA), it is alarming that the federal government has not provided more detailed guidance or additional resources to help state, territorial, and local governments understand the most likely mechanisms for distribution or requirements and recommendations for maintaining the cold chain, funding projections, or critical risks that should be addressed,” the Senators wrote. “This lack of guidance has severely hindered the ability of state, Tribal, territorial, and local public health officials to develop distribution plans and of individual clinics to prepare to accept, store, handle, and administer vaccines, and to share their comprehensive plans with CDC. Additionally, unknowns around cold chain storages issues add to the already difficult task of ensuring vaccination locations can schedule vaccine clinics to administer the doses quickly while also adhering to public health protocols like social distancing.
The Senators continued, “The time to get ahead of potential distribution issues and cold chain requirements is now. The federal government should be looking ahead to secure our supply chains and prepare to adequately transport and distribute whatever vaccine becomes available first. Communities around the country are still trying to compensate for the federal government’s failure to secure adequate and sustainable supplies of personal protective equipment earlier this year and throughout the pandemic. That failure has had tragic results, and your agencies should be doing everything in your power to avoid such a fiasco with the distribution of a vaccine.”
In addition to Baldwin and Hirono, Senators Cory Booker (D-NJ), Jeff Merkley (D-OR), Tina Smith (D-MN), Tammy Duckworth (D-IL), Kirsten Gillibrand (D-NY), Chris Van Hollen (D-MD), Sherrod Brown (D-OH), Elizabeth Warren (D-MA), Amy Klobuchar (D-MN), and Brian Schatz (D-HI) also signed the letter.