Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health, 49935-49939 [2019-20804]

Agencies

• Executive Office of the President

[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

[[Page 49935]]

                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

[[Page 49936]]

                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.

[[Page 49937]]

                    (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

[[Page 49938]]

  (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

[[Page 49939]]

(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