The federal government, in concert with private industry, has greatly accelerated efforts to develop vaccines and therapeutics for COVID-19 through Operation Warp Speed. This partnership is spending more than $10 billion on six vaccine candidates. A typical vaccine development process can take approximately 10 years or longer.
In addition to the $10 billion for six vaccine candidates, Operation Warp Speed has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option).
In a separate effort to speed access to medical products, the Food and Drug Administration (FDA) has so far issued four emergency use authorizations, referred to as EUAs, that temporarily allow use of unapproved therapeutics. The Government Accountability Office (GAO) says FDA’s rationale for doing so has not always been clear.
FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support A GAO review found that FDA’s COVID-19 therapeutic authorization decisions have not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics.
Representatives of state and local public health officials and healthcare providers told GAO that the federal government’s planning efforts to date have been helpful, and they have heard that additional information is forthcoming. They also noted several areas where additional information and assistance may be necessary. For example, in an October 2020 public letter to the administration, the National Governors Association noted that additional guidance and clarification is needed on the roles and expectations of states in distributing any COVID-19 vaccine. In another letter, the association had questions about funding for vaccine administration, the formula for allocation of vaccine, and what information would be shared publicly on each vaccine.Meanwhile, associations representing state and territorial health officials, including immunization managers, stated the need for $8.4 billion in additional resources to support COVID19 vaccine distribution activities, including workforce recruitment and training, and communication outreach.
GAO found that additional information is needed on the IT systems providers will be required to use and how they will be required to track and report certain information. Providers will be required to record and report information within 24 hours of administration in their jurisdiction’s current Immunization Information System or an alternative federal system if their current system does not meet CDC’s data reporting requirements, according to the updated interim playbook.
The updated interim playbook also stated that additional information on these data requirements is forthcoming.
Representatives from one provider group and one group representing state officials GAO spoke with stated that some providers are not adequately prepared for any new IT systems. Providers enrolled in the federal COVID-19 Vaccination Program will order and monitor vaccines and ancillary supplies at no cost through new and existing IT systems, according to the interim playbook. CDC recommended jurisdictions use its existing Vaccine Tracking System (VTrckS) for this purpose, but indicated that it may also develop a new IT system to supplement VTrckS.
The updated interim playbook also specifies that providers will be required to update their vaccine inventory daily in VaccineFinder, which the public can check online to find COVID-19 vaccination clinics. Several provider groups supported the use of existing IT infrastructure rather than the implementation of a new system to reduce any potential reporting or ordering problems that may come with learning and using a new system.
Other areas where additional information is required include vaccine handling and storage, and the method for allocating available vaccines to jurisdictions.
Representatives from three groups representing providers and state and local public health officials told GAO that public messaging and clear communications are key to effective deployment of COVID-19 vaccines, and one said that they would like to see a federal communication plan or strategy. Agency officials said they plan to develop additional communication resources for jurisdictions and tribal organizations to use so that entities can tailor messages for special populations in their communities.
GAO’s November 17 report recommends that FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. The Department of Health and Human Services said it shared GAO’s goal of transparency and would explore approaches to achieve this goal.