SummaryStakeholders in the COVID-19 pandemic response face regulatory and commercial uncertainties as emergency operations transition and market access of products face both emergency use and full licensure.
As the COVID public health emergency (PHE) continues in the US, manufacturers, regulators, and policy makers must prepare to answer key questions regarding vaccine and therapeutic development as the pandemic response evolves:
- What timelines and regulatory approaches are available to transition existing products from Emergency Use Authorization (EUA) to Biologics License Application (BLA), expand indications, and review new product entrants?
- How will data best support evolving booster recommendations (e.g., homologous vs. heterologous) and the feasibility of a universal booster1 approach?
- How will new or existing regulatory pathways streamline the shift to a commercial landscape when products are fully approved?
PHE Termination Timelines Affect Both Existing and New Products
While it is possible the US government will end the PHE in a single, swift action, agencies are currently operating through multiple statutory mechanisms (Section 319 vs. Section 564). Each of these provisions could change independently. For example, terminating a Section 319 PHE declaration does not invalidate already issued EUAs. However, terminating a Section 564 EUA declaration will cause current EUAs to end immediately.
The Secretary of Health and Human Services must provide advanced notice before an EUA declaration (Section 564) is terminated. Ideally, timing will be sufficient to accommodate unapproved products or an unapproved use of an approved product. The current situation is new to all stakeholders involved, and many questions remain. Manufacturers with products available under EUA need contingency plans, and government decision-makers need to ensure safe and effective vaccines remain available without disrupting supply and distribution.
As contingency plans are developed, expectations around EUA-to-BLA transitions should consider that current statute limits a sponsor from having an EUA and BLA for the same population/indication simultaneously. However, it is possible to have 1 product that straddles both the EUA and BLA for some time based on varying age indications. While the data underlying the use of a product in 1 population may warrant a full BLA, other populations—such as children—may continue to access vaccines via the EUA for a period of time.
Ultimately, EUA and BLA filing strategies and approaches are at the manufacturer’s discretion. However, to prepare for market access and entry through a BLA, each of the following are critical:
- Clarity on the potential shifts in review and approval timelines during PHE transition and after its termination
- Data required to make appropriate regulatory decisions in PHE vs post-PHE scenarios
Data Generation on Variants and Boosters to Evolve
When considering the regulatory and commercial shifts for products as the PHE ends, planning for future multivalent vaccine uptake and the potential need for booster shots will require consolidation of the partnerships and collaborations that have comprised the initial pandemic response. A coordinated effort among regulators and policy makers can help ensure concise recommendations for homologous or heterologous booster shots and provide real-time guidance for other stakeholders. Manufacturers will need to maintain their evidence generation efforts, producing data to inform variable market dynamics and regulatory shifts that will occur as the pandemic response evolves.
Landscape Shifts as Products Become Fully Approved
Full licensure of vaccines will fundamentally change the commercial landscape, accelerating vaccination campaigns as manufacturers’ commercial and medical teams are mobilized. As the current PHE model shifts from government purchase and distribution toward traditional models of coverage and reimbursement, manufacturers will need to be prepared to prioritize the following in commercial planning:
- Expanded supply chain capabilities
- Patient access support services across multiple sites of care
- Provider and payer engagement to solidify coverage and reimbursement
- Marketing and promotion to support vaccine awareness
- Clinical and medical education as patient populations expand due to new clinical data or real-world evidence
A post-PHE shift may see the advent of endemic COVID-19—resembling that of seasonal influenza—which may influence precedence and norms for future public health responses to emerging infectious diseases. Manufacturers need to consider the regulatory, policy, and market access implications while this shift is occurring and, where necessary, drive for changes that enable economic viability for their products in the longer term. Regulatory and policy guidance for transitioning from EUA to BLA will help stakeholders continue to ensure consistent supply, provide clarity on variants, boosters, and immunization timelines, and proactively understand the commercial implications of their decisions in both emergency and post-emergency regulatory landscapes.
Avalere brings a unique combination of extensive regulatory policy knowledge and market-access expertise that help clients enhance the value and predictability of their assets in dynamic, emerging regulatory environments.
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- A “universal booster” refers to a single vaccine product that conveys protection to all authorized populations, agnostic of the original vaccine platform a person received. This concept may rely on accepting heterologous vaccine uptake.
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