Annex A: NIVMS Objectives Crosswalk to EO13887

Objective 1.1: Partner with manufacturers and other private sector stakeholders to promote the development and production of non-egg-based influenza vaccines that are safe and effective in all populations.

Explore options to expand the production capacity of cell- and recombinant-based vaccine candidates used by industry (EO: 4(a)(iv)(B))

Objective 1.2: Develop and implement a sustainable investment strategy with the private sector that allows flexibility in financing for advanced development, licensure, and manufacturing of current and promising new vaccine candidates and vaccine production platforms.

Estimate the cost of expanding and diversifying domestic vaccine-manufacturing capacity to use innovative, faster, and more scalable technologies, including cell-based and recombinant vaccine manufacturing, through cost-sharing agreements with the private sector, which shall include an agreed-upon pricing strategy during a pandemic (EO: 4(a)(i)(A)) 

Estimate the cost of expanding domestic production capacity of adjuvants in order to combine such adjuvants with both seasonal and pandemic influenza vaccines (EO: 4(a)(i)(B)) 

Estimate the cost of expanding domestic fill-and-finish capacity to rapidly fulfill antigen and adjuvant needs for pandemic response (EO: 4(a)(i)(C)) 

Evaluate incentives for the development and production of vaccines by private manufacturers and public-private partnerships, including, in emergency situations, the transfer of technology to public-private partnerships — such as the HHS Centers for Innovation and Advanced Development and Manufacturing or other domestic manufacturing facilities — in advance of a pandemic, in order to be able to ensure adequate domestic pandemic manufacturing capacity and capability (EO: 4(a)(i)(E))

Provide OMB with a cost estimate for transitioning DoD’s annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, scalable, and more innovative technologies (EO: 4(b)(i)) 

The Secretary of VA shall provide OMB with a cost estimate for transitioning its annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, scalable, and more innovative technologies (EO: 4(c))

Objective 2.2: Improve influenza vaccines, diagnostics, and therapeutics using an aligned and integrated research agenda across government agencies, the private sector, and academic institutions to facilitate the transition to alternative technologies. 

Support, in coordination with the DOD, NIH, and VA, a suite of clinical studies featuring different adjuvants to support development of improved vaccines and further expand vaccine supply by reducing the dose of antigen required (EO: 4(a)(i)(F)) 

Update, in coordination with other relevant public health agencies, the research agenda to dramatically improve the effectiveness, efficiency, and reliability of influenza vaccine production (EO: 4(a)(i)(G)) 

Identify opportunities to use DoD’s vaccine research and development enterprise, in collaboration with HHS, to include both early discovery and design of influenza vaccines, as well as later stage evaluation of candidate influenza vaccines (EO: 4(b)(iv))

Direct, in coordination with the VA, CDC, and other components of HHS, the conduct of epidemiologic studies of vaccine effectiveness to improve knowledge of the clinical effect of the currently licensed influenza vaccines (EO: 4(b)(ii))

Use DoD’s network of clinical research sites to evaluate the effectiveness of licensed influenza vaccines, including methods of boosting their effectiveness (EO: 4(b)(iii))

Accelerate, in collaboration with HHS, research regarding rapidly scalable prophylactic influenza antibody approaches to complement a universal vaccine initiative and address gaps in current vaccine coverage (EO: 4(b)(vii))

Expand vaccine effectiveness studies to more rapidly evaluate the effectiveness of cell based and recombinant influenza vaccines relative to egg-based vaccines (EO 4(a)(iv)(A)) 

Further support the conduct, in collaboration with the DoD, BARDA, CDC, of applied scientific research regarding developing cell lines and expression systems that markedly increase the yield of cell-based and recombinant influenza vaccine manufacturing processes (EO 4(a)(iii)(C))  

Investigate, in collaboration with HHS, alternative correlates of immune protection that could facilitate the development of next generation influenza vaccines (EO: 4(b)(v)) 

Objective 1.3: Sustain, leverage, and expand current domestic manufacturing facilities to transition to faster and more scalable vaccine production platforms.

Assess, in coordination with BARDA and relevant vaccine manufacturers, the use and potential effects of using advanced manufacturing platforms for influenza vaccines (EO: 4(a)(iii)(D))  

Direct the conduct of a study to assess the feasibility of using DoD’s advanced manufacturing facility for manufacturing cell-based or recombinant influenza vaccines during a pandemic (EO: 4(b)(vi))

Objective 1.4: Increase and sustain domestic seasonal influenza vaccine production capacity using alternative technologies that can be leveraged for pandemic response to deliver first doses of a finished vaccine within 12 weeks of an influenza pandemic declaration.

Further implement vaccine production process improvements to reduce the time required for vaccine production (e.g., through the use of novel technologies for vaccine seed virus development and through implementation of improved potency and sterility assays) (EO: 4(a)(ii)(A))

Develop, in conjunction with the CDC, proposed alternatives for the timing of vaccine virus selection to account for potentially shorter timeframes associated with non-egg-based manufacturing and to facilitate vaccines optimally matched to the circulating strains (EO: 4(a)(iii)(B)) 

Objective 2.1: Promote innovative approaches to enhance domestic and global surveillance, characterize seasonal and pandemic influenza viruses, and monitor vaccine effectiveness.

Develop a plan to expand domestic capacity for whole genome characterization of influenza viruses (EO: 4(a)(iv)(C)) 

Objective 2.3: Apply the full range of regulatory authorities and expedited programs to promote the licensure of new influenza vaccine candidates and the approval of other relevant MCMs. 

Objective 2.4: Advance the development of a universal influenza vaccine that provides robust, long-lasting protection against multiple subtypes of influenza and is suitable for all populations.

Through the Director of NIH, provide to the Task Force estimated timelines for implementing NIH’s strategic plan and research agenda for developing influenza vaccines that can protect individuals over many years against multiple types of influenza viruses (EO: 4(a)(ii))  

Objective 3.1: Increase and expedite access to influenza vaccines across all recommended populations.  

Through the administrator of CMS, examine the current legal, regulatory, and policy framework surrounding payments for influenza vaccines, and assess adoption of domestically manufactured vaccines that have positive attributes for pandemic response (such as scalability and speed of manufacturing) (EO: 4(a)(v)) 

Increase influenza vaccine use through enhanced communication and by removing barriers to vaccination (EO: 4(a)(iv)(D))   

Objective 3.2: Improve the public’s understanding of influenza risk, as well as confidence in vaccine safety and effectiveness, through evidence-based messaging.

Objective 3.3: Promote influenza immunization across recommended populations.

Enhance communication to healthcare providers about the performance of influenza vaccines in order to assist them in promoting the most effective vaccines for their patient populations (EO: 4(a)(iv)(E))

Objective 3.4: Improve existing methods and develop alternative methods for influenza vaccine administration. 

Estimate the cost of developing, evaluating, and implementing delivery systems to augment limited supplies of needles and syringes and to enable the rapid and large-scale administration of pandemic influenza vaccines (EO: 4(a)(i)(D))

Objective 3.5 Improve capabilities and capacity for management and tracking of influenza vaccination.