Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health

 
CONTENT
Federal Register, Volume 84 Issue 185 (Tuesday, September 24, 2019)
[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Presidential Documents]
[Pages 49935-49939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20804]
                        Presidential Documents
Federal Register / Vol. 84, No. 185 / Tuesday, September 24, 2019 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
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                Executive Order 13887 of September 19, 2019

Modernizing Influenza Vaccines in the United
                States to Promote National Security and Public Health
                By the authority vested in me as President by the
                Constitution and the laws of the United States of
                America, including section 301 of title 3, United
                States Code, it is hereby ordered as follows:
                Section 1. Findings. (a) Influenza viruses are
                constantly changing as they circulate globally in
                humans and animals. Relatively minor changes in these
                viruses cause annual seasonal influenza outbreaks,
                which result in millions of illnesses, hundreds of
                thousands of hospitalizations, and tens of thousands of
                deaths each year in the United States. Periodically,
                new influenza A viruses emerge from animals, including
                birds and pigs, that can spread efficiently and have
                sustained transmission among humans. This situation is
                called an influenza pandemic (pandemic). Unlike
                seasonal influenza, a pandemic has the potential to
                spread rapidly around the globe, infect higher numbers
                of people, and cause high rates of illness and death in
                populations that lack prior immunity. While it is not
                possible to predict when or how frequently a pandemic
                may occur, there have been 4 pandemics in the last 100
                years. The most devastating pandemic occurred in 1918-
                1919 and is estimated to have killed more than 50
                million people worldwide, including 675,000 Americans.
                    (b) Vaccination is the most effective defense
                against influenza. Despite recommendations by the
                Centers for Disease Control and Prevention (CDC) that
                nearly every American should receive the influenza
                vaccine annually, however, seasonal influenza
                vaccination levels in the United States have currently
                reached only about 45 percent of CDC goals.
                    (c) All influenza vaccines presently in use have
                been developed for circulating or anticipated influenza
                viruses. These vaccines must be reformulated for each
                influenza season as well as in the event of a pandemic.
                Additional research is needed to develop influenza
                vaccines that provide more effective and longer-lasting
                protection against many or all influenza viruses.
                    (d) The current domestic enterprise for
                manufacturing influenza vaccines has critical
                shortcomings. Most influenza vaccines are made in
                chicken eggs, using a 70-year-old process that requires
                months-long production timelines, limiting their
                utility for pandemic control; rely on a potentially
                vulnerable supply chain of eggs; require the use of
                vaccine viruses adapted for growth in eggs, which could
                introduce mutations of the influenza vaccine virus that
                may render the final product less effective; and are
                unsuitable for efficient and scalable continuous
                manufacturing platforms.
                    (e) The seasonal influenza vaccine market rewards
                manufacturers that deliver vaccines in time for the
                influenza season, without consideration of the speed or
                scale of these manufacturers' production processes.
                This approach is insufficient to meet the response
                needs in the event of a pandemic, which can emerge
                rapidly and with little warning. Because the market
                does not sufficiently reward speed, and because a
                pandemic has the potential to overwhelm or compromise
                essential government functions, including defense and
                homeland security, the Government must take action to
                promote faster and more scalable manufacturing
                platforms.
                Sec. 2. Policy. It is the policy of the United States
                to modernize the domestic influenza vaccine enterprise
                to be highly responsive, flexible, scalable, and more
                effective at preventing the spread of influenza
                viruses. This is a public
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                health and national security priority, as influenza has
                the potential to significantly harm the United States
                and our interests, including through large-scale
                illness and death, disruption to military operations,
                and damage to the economy. This order directs actions
                to reduce the United States' reliance on egg-based
                influenza vaccine production; to expand domestic
                capacity of alternative methods that allow more agile
                and rapid responses to emerging influenza viruses; to
                advance the development of new, broadly protective
                vaccine candidates that provide more effective and
                longer lasting immunities; and to support the promotion
                of increased influenza vaccine immunization across
                recommended populations.
                Sec. 3. National Influenza Vaccine Task Force. (a)
                There is hereby established a National Influenza
                Vaccine Task Force (Task Force). The Task Force shall
                identify actions to achieve the objectives identified
                in section 2 of this order and monitor and report on
                the implementation and results of those actions. The
                Task Force shall be co-chaired by the Secretary of
                Defense and the Secretary of Health and Human Services,
                or their designees.
                    (b) In addition to the Co-Chairs, the Task Force
                shall consist of a senior official from the following
                executive branch departments, agencies, and offices:
(i) the Department of Defense (DOD);
(ii) the Department of Justice;
(iii) the Department of Agriculture;
(iv) the Department of Veterans Affairs (VA);
(v) the Department of Homeland Security;
(vi) the United States Food and Drug Administration;
(vii) the Centers for Disease Control and Prevention;
(viii) the National Institutes of Health (NIH);
(ix) the Centers for Medicare and Medicaid Services (CMS); and
(x) the Biomedical Advanced Research and Development Authority (BARDA).
                    (c) The Co-Chairs may jointly invite additional
                Federal Government representatives, with the consent of
                the applicable executive department, agency, or office
                head, to attend meetings of the Task Force or to become
                members of the Task Force, as appropriate.
                    (d) The staffs of the Department of State, the
                Office of Management and Budget (OMB), the National
                Security Council, the Council of Economic Advisers, the
                Domestic Policy Council, the National Economic Council,
                and the Office of Science and Technology Policy (OSTP)
                may attend and participate in any Task Force meetings
                or discussions.
                    (e) The Task Force may consult with State, local,
                tribal, and territorial government officials and
                private sector representatives, as appropriate and
                consistent with applicable law.
                    (f) Within 120 days of the date of this order, the
                Task Force shall submit a report to the President,
                through the Assistant to the President for National
                Security Affairs, the Assistant to the President for
                Domestic Policy, the Director of the Office of
                Management and Budget, and the Director of the Office
                of Science and Technology Policy. The report shall
                include:
(i) a 5-year national plan (Plan) to promote the use of more agile and
scalable vaccine manufacturing technologies and to accelerate development
of vaccines that protect against many or all influenza viruses;
(ii) recommendations for encouraging non-profit, academic, and private-
sector influenza vaccine innovation; and
(iii) recommendations for increasing influenza vaccination among the
populations recommended by the CDC and for improving public understanding
of influenza risk and informed influenza vaccine decision-making.
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                    (g) Not later than June 1 of each of the 5 years
                following submission of the report described in
                subsection (f) of this section, the Task Force shall
                submit an update on implementation of the Plan and, as
                appropriate, new recommendations for achieving the
                policy objectives set forth in section 2 of this order.
                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:
                    (a) The Secretary of HHS shall:
(i) through the Assistant Secretary for Preparedness and Response and
BARDA:
  (A) 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;
  (B) estimate the cost of expanding domestic production capacity of
adjuvants in order to combine such adjuvants with both seasonal and
pandemic influenza vaccines;
  (C) estimate the cost of expanding domestic fill-and-finish capacity to
rapidly fulfill antigen and adjuvant needs for pandemic response;
  (D) 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;
  (E) 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;
  (F) 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; and
  (G) update, in coordination with other relevant public health agencies,
the research agenda to dramatically improve the effectiveness, efficiency,
and reliability of influenza vaccine production;
(ii) 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;
(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
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  (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.
                Sec. 5. Termination. The Task Force shall terminate
                upon direction from the President or, with the approval
                of the President, upon direction from the Task Force
                Co-Chairs.
                Sec. 6. General Provisions. (a) Nothing in this order
                shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or
the head thereof; or
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(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
                    (b) This order shall be implemented consistent with
                applicable law and subject to the availability of
                appropriations.
                    (c) This order is not intended to, and does not,
                create any right or benefit, substantive or procedural,
                enforceable at law or in equity by any party against
                the United States, its departments, agencies, or
                entities, its officers, employees, or agents, or any
                other person.


                    (Presidential Sig.)
                THE WHITE HOUSE,
                    September 19, 2019.
[FR Doc. 2019-20804
Filed 9-23-19; 8:45 am]
Billing code 3295-F9-P