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>Sec. 4. Agency Implementation. The heads of executive departments and agencies shall also implement the policy objectives defined in section 2 of this order, consistent with existing authorities and appropriations, as follows:
(iii) through the Commissioner of Food and Drugs:
(A) 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);
(B) 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;
(C) further support the conduct, in collaboration with the DOD, BARDA, and 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; and
(D) assess, in coordination with BARDA and relevant vaccine manufacturers, the use and potential effects of using advanced manufacturing platforms for influenza vaccines;
(iv) through the Director of the CDC:
(A) expand vaccine effectiveness studies to more rapidly evaluate the effectiveness of cell based and recombinant influenza vaccines relative to egg-based vaccines;
(B) explore options to expand the production capacity of cell-based vaccine candidates used by industry;
(C) develop a plan to expand domestic capacity for whole genome characterization of influenza viruses;
(D) increase influenza vaccine use through enhanced communication and by removing barriers to vaccination; and
(E) 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; and
(v) through the Administrator of CMS, examine the current legal, regulatory, and policy framework surrounding payment for influenza vaccines and assess adoption of domestically manufactured vaccines that have positive attributes for pandemic response (such as scalability and speed of manufacturing).
(b) The Secretary of Defense shall:
(i) provide OMB with a cost estimate for transitioning DOD’s annual procurement of influenza vaccines to vaccines manufactured both domestically and through faster, more scalable, and innovative technologies;
(ii) direct, in coordination with the VA, CDC, and other components of HHS, the conduct of epidemiological studies of vaccine effectiveness to improve knowledge of the clinical effect of the currently licensed influenza vaccines;
(iii) use DOD’s network of clinical research sites to evaluate the effectiveness of licensed influenza vaccines, including methods of boosting their effectiveness;
(iv) 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;
(v) investigate, in collaboration with HHS, alternative correlates of immune protection that could facilitate development of next-generation influenza vaccines;
(vi) 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; and
(vii) 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.
(c) 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 with faster, more scalable, and innovative technologies.