Pandemic Influenza Vaccines-Amendment

Authority: 42 U.S.C. 247d-6d.

ACTION:

Notice of amendment to the September 28, 2009 Republished Declaration under the Public Readiness and Emergency Preparedness Act.

SUMMARY:

Amendment to declaration issued on September 28, 2009 (74 FR 51153) pursuant to section 319F-3 of the Public Health Service Act (“the Act”) (42 U.S.C. 247d-6d) to revise covered countermeasures and extend effective date and republication of the declaration to reflect the declaration in its entirety, as amended.

DATES:

The amendment of the republished declaration issued on September 28, 2009 is effective as of March 1, 2010.

FOR FURTHER INFORMATION CONTACT:

Nicole Lurie, MD, MSPH, Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, 200 Independence Avenue, SW., Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free number).

HHS Secretary's Amendment to the September 28, 2009 Republished Declaration for the Use of the Public Readiness and Emergency Prepar edness Act for H5N1, H2, H6, H7, H9 and 2009-H1N1 Vaccines:

Whereas there are or may be multiple animal influenza A viruses, circulating in wild birds and/or domestic animals that cause, or have significant potential to cause, sporadic human infections or have mutated to cause pandemics in humans;

Whereas, these viruses may evolve into virus strains capable of causing a pandemic of human influenza because these viruses may cause infection in and spread among humans and because humans have little or no immunity to these viruses;

Whereas, one such virus is the 2009 H1N1 Influenza Virus;

Whereas, vaccination may be effective to protect persons from the threat of pandemic influenza;

Whereas, Secretary Michael O. Leavitt issued a Declaration for the Use of the Public Readiness and Emergency Preparedness Act dated January 26, 2007 (“Original Declaration”), as amended on November 30, 2007 and October 17, 2008 with respect to certain avian influenza viruses;

Whereas, I amended the declaration on June 15, 2009 with respect to 2009 H1N1 influenza virus and on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution and to add provisions consistent with other declarations, and republished the declaration each time in its entirety;

Whereas, the September 28, 2009 declaration extended through February 28, 2010 for vaccines against influenza virus strains named in the Declaration other than 2009 H1N1 influenza vaccine;

Whereas, modifications are necessary to revise covered countermeasures and to extend the effective date of the Declaration;

Whereas, the findings I made in the declaration issued on September 28, 2009 continue to apply;

Whereas, in accordance with section 319F-3(b)(6) of the Act (42 U.S.C. 247d-6d(b)), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of additional covered countermeasures with respect to the category of disease and population described in sections II and IV of the September 28, 2009 Republished Declaration, as hereby amended, and have found it desirable to encourage such activities for these additional covered countermeasures, and;

Whereas, to encourage the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of medical countermeasures with respect to the category of disease and population described in sections II and IV of the September 28, 2009 Republished Declaration, as hereby amended, it is advisable, in accordance with section 319F-3(a) and (b) of the Act, to provide immunity from liability for covered persons, as that term is defined at section 319F-3(i)(2) of the Act, and to include as such covered persons other qualified persons as I have identified in section VI of the September 28, 2009 Republished Declaration, as amended;

Therefore, pursuant to section 319F-3(b) of the Act, I have determined that there is a credible risk that the spread of influenza A viruses with pandemic potential and resulting disease could in the future constitute a public health emergency and that spread of one of these viruses (2009 H1N1 Influenza) has caused a disease that constitutes a public health emergency.

In order to extend the scope of covered countermeasures and to extend the effective date of the Declaration, the September 28, 2009 Republished Declaration, is hereby amended as follows:

In the title, delete “for H5N1, H2, H6, H7, H9 and 2009 H1N1 Vaccines” and replace with “for Vaccines Against Pandemic Influenza A Viruses and Those with Pandemic Potential”.

In the recitals, delete the first through the fourth “whereas” clauses, and insert two new recitals as follows:

Whereas there are or may be multiple animal influenza A viruses circulating in wild birds and/or domestic animals that cause, or have significant potential to cause, sporadic human infections or have mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus strains capable of causing a pandemic of human influenza because these viruses may cause infection in, and spread among, humans and because humans have little or no immunity to these viruses;

In the sixth “whereas” clause, insert “October 1, 2009, and December 28, 2009” after “July 24, 2009”.

In the “therefore” clause, delete “avian influenza viruses and resulting disease could in the future constitute a public health emergency, and that 2009 H1N1 influenza constitutes a public health emergency” and replace with: “pandemic influenza A viruses and those with pandemic potential and resulting disease does or could constitute a public health emergency”.

In section I, first paragraph, delete “the pandemic countermeasures influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1 vaccines” each time it appears and replace with “vaccines against pandemic influenza A viruses with pandemic potential”.

In section I, at the end of the second sentence, replace “IX” with “X”.

In section II, delete “the virus with (1) highly pathogenic avian influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1 influenza” and replace with “animal and/or human influenza A viruses against which most humans do not have immunity, except those included in seasonal influenza vaccines and/or covered under the National Vaccine Injury Compensation Program, that are circulating in wild birds and/or domestic animals causing or having significant potential to cause sporadic human infections or have mutated to cause pandemics in humans”.

In section III, first paragraph, delete in its entirety and replace with: “The effective period of time of this Declaration commenced as described in the September 28, 2009 Republished Declaration, and extends through February 28, 2012.

In section III, second paragraph, delete “; except that with respect to 2009 H1N1 influenza vaccine, the effective period commences on June 15, 2009 and extends through March 31, 2013” and replace with “through February 28, 2012.”

In section III, add to the end of the section as a new paragraph: “With respect to any covered countermeasure subsequently covered under the National Vaccine Injury Compensation Program, the effective time period expires immediately upon such coverage.”

In section VIII, insert “and use” after “administration in the first sentence, delete “the Act's” from the second sentence and replace with “this”, and delete “Countermeasure” from the second sentence and replace with “Countermeasures”.

In section IX, add to the end of the first sentence: “; and amended on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution and to add provisions consistent with other declarations and republished in its entirety.”

In section X, after the fifth paragraph, insert a new definition as follows:

Pandemic influenza A viruses and those with pandemic potential: Animal and/or human influenza A viruses, except those included in seasonal influenza vaccines and/or covered under the National Vaccine Injury Compensation Program, that are circulating in wild birds and/or domestic animals, that cause, or have significant potential to cause, sporadic or ongoing human infections, or historically have caused pandemics in humans, or have mutated to cause pandemics in humans, and for which the majority of the population is immunologically naïve.

In Appendix I, title and item 32, add “H7,” after “H6”.

Throughout, insert “National” before “Vaccine Injury Compensation Fund”.

All other provisions of the June 15, 2009 Republished Declaration remain in full force.

Republication of HHS Secretary's September 28, 2009 Republished Declaration, as Amended, for the Use of the Public Readiness and Emergency Preparedness Act for Vaccines Against Pandemic Influenza A Viruses and Those with Pandemic Potential.

To the extent any term of the September 28 Republished Declaration, as hereby amended, is inconsistent with any provision of this Republished Declaration, the terms of this Republished Declaration are controlling.

Whereas there are or may be multiple animal influenza A viruses circulating in wild birds and/or domestic animals that cause, or have significant potential to cause, sporadic human infections or have mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus strains capable of causing a pandemic of human influenza because these viruses may cause infection in, and spread among, humans and because humans have little immunity to these viruses;

Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson determined under section 319 of the Public Health Service Act, (42 U.S.C. 247d), that a public health emergency exists nationwide involving the Swine Influenza A virus that affects or has significant potential to affect the national security (now called “2009-H1N1 influenza”);

Whereas, on July 24, 2009, October 1, 2009, and December 28, 2009 I renewed the determination by the Acting Secretary that a public health emergency exists nationwide involving the Swine influenza A virus (now called “2009-H1N1 influenza virus”);

Whereas, vaccination may be effective to protect persons from the threat of pandemic influenza;

Whereas, the possibility of governmental program planners obtaining stockpiles from private sector entities except through voluntary means such as commercial sale, donation, or deployment would undermine national preparedness efforts and should be discouraged as provided for in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (“the Act”);

Whereas, immunity under section 319F-3(a) of the Act should be available to governmental program planners for distributions of Covered Countermeasures obtained voluntarily, such as by (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles;

Whereas, the extent of immunity under section 319F-3(a) of the Act afforded to a governmental program planner that obtains Covered Countermeasures except through voluntary means is not intended to affect the extent of immunity afforded other covered persons with respect to such covered countermeasures;

Whereas, to encourage the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of medical countermeasures with respect to the category of disease and population described in section II and IV it is advisable, in accordance with section 319F-3(a) and (b) of the Act, to provide immunity from liability for covered persons, as that term is defined at section 319F-3(i)(2) of the Act, and to include as such covered persons such other qualified persons as I have identified in section VI;

Whereas, in accordance with section 319F-3(b)(6) of the Public Health Service Act (42 U.S.C. 247d-6d(b)) (“the Act”), I have considered the desirability of encouraging the design, development, clinical testing or investigation, manufacturing and product formulation, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of medical countermeasures with respect to the category of disease and population described in sections II and IV below, and have found it desirable to encourage such activities for the Covered Countermeasures;

Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of pandemic influenza A viruses and those with pandemic potential and resulting disease does or could constitute a public health emergency.

I. Covered Countermeasures (as Required by Section 319F-3(b)(1) of the Act)

Covered Countermeasures are defined at section 319F-3(i) of the Act.

At this time, and in accordance with the provisions contained herein, I am recommending the manufacture, testing, development, distribution, dispensing; and, with respect to the category of disease and population described in sections II and IV, below, the administration and usage of vaccines against influenza A viruses with pandemic potential and any associated adjuvants. The immunity specified in section 319F-3(a) of the Act shall only be in effect with respect to: (1) Present or future Federal contracts, cooperative agreements, grants, interagency agreements, or memoranda of understanding for vaccines against pandemic influenza A viruses with pandemic potential used and administered in accordance with this declaration, and (2) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense the pandemic countermeasures following a declaration of an emergency, as defined in section X below. In accordance with section 319F-3(b)(2)(E) of the Act, for governmental program planners, the immunity specified in section 319F-3(a) of the Act shall be in effect to the extent they obtain Covered Countermeasures through voluntary means of distribution, such as (1) donation; (2) commercial sale; (3) deployment of Covered Countermeasures from Federal stockpiles; or (4) deployment of donated, purchased, or otherwise voluntarily obtained Covered Countermeasures from State, local, or private stockpiles. For all other covered persons, including other program planners, the immunity specified in section 319F-3(a) of the Act shall, in accordance with section 319F-3(b)(2)(E) of the Act, be in effect pursuant to any means of distribution.

This Declaration shall subsequently refer to the countermeasures identified above as Covered Countermeasures.

This Declaration shall apply to all Covered Countermeasures administered or used during the effective time period of the Declaration.

II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the Act)

The category of disease for which I am recommending the administration or use of the Covered Countermeasures is the threat of or actual human influenza that results from the infection of humans following exposure to animal and/or human influenza A viruses, against which most humans do not have immunity, except those included in seasonal influenza vaccines and/or covered under the National Vaccine Injury Compensation Program, that are circulating in wild birds and/or domestic animals causing or have significant potential to cause sporadic human infections or have mutated to cause pandemics in humans.

III. Effective Time Period (as Required by Section 319F-3(b)(2)(B) of the Act)

The effective period of time of this Declaration commenced as described in the September 28, 2009 Republished Declaration and extends through February 28, 2012.

With respect to Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction, the effective period of time of this Declaration commences on the date of a declaration of an emergency and lasts through and includes the final day that the emergency declaration is in effect including any extensions thereof through February 28, 2012.

With respect to any covered countermeasure subsequently covered under the National Vaccine Injury Compensation Program, the effective time period expires immediately upon such coverage.

IV. Population (as Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) confers immunity to manufacturers and distributors of the Covered Countermeasure, regardless of the defined population.

Section 319F-3(a)(3)(C)(i) confers immunity to covered persons who could be program planners or qualified persons with respect to the Covered Countermeasure only if a member of the population specified in the Declaration administers or uses the Covered Countermeasure and is in or connected to the geographic location specified in this Declaration, or the program planner or qualified person reasonably could have believed that these conditions were met.

The populations specified in this Declaration are the following:

(1) All persons who use a Covered Countermeasure or to whom such a Covered Countermeasure is administered as an Investigational New Drug in a human clinical trial conducted directly by the Federal Government, or pursuant to a contract, grant or cooperative agreement with the Federal Government; (2) all persons who use a Covered Countermeasure or to whom such a Countermeasure is administered in a pre-pandemic phase, as defined below; and/or (3) all persons who use a Covered Countermeasure, or to whom such a Covered Countermeasure is administered in a pandemic phase, as defined below.

V. Geographic Area (as Required by Section 319F-3(b)(2)(D) of the Act)

Section 319F-3(a) applies to the administration and use of a Covered Countermeasure without geographic limitation.

VI. Other Qualified Persons (as Required by Section 319F-3(i)(8)(B) of the Act)

With regard to the administration or use of a Covered Countermeasure, Section 319F-3(i)(8)(A) of the Act defines the term “qualified person” as a licensed individual who is authorized to prescribe, administer, or dispense the countermeasure under the law of the State in which such Covered Countermeasure was prescribed, administered or dispensed. Additional persons who are qualified persons pursuant to section 319F-3(i)(8)(B) are the following: (1) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a declaration of an emergency, and (2) Any person authorized to prescribe, administer, or dispense Covered Countermeasures or who is otherwise authorized under an Emergency Use Authorization.

VII. Additional Time Periods of Coverage After Expiration of Declaration (as Required by Section 319F-3(b)(3)(B) of the Act)

A. I have determined that, upon expiration of the applicable time period specified in Section III above, an additional twelve (12) months is a reasonable period to allow for the manufacturer to arrange for disposition of the Covered Countermeasure, including the return of such product to the manufacturer, and for covered persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasure, and the liability protection of section 319F-3(a) of the Act shall extend for that period.

B. The Federal Government shall purchase the entire production of Covered Countermeasures under the contracts specifically listed by contract number in section I for the stockpile under section 319F-2 of the Act, and shall be subject to the time-period extension of section 319F-3(b)(3)(C). Production under future contracts for the same vaccine will also be subject to the time-period extension of section 319F-3(b)(3)(C).

VIII. Compensation Fund

In addition to conferring immunity to manufacturers, distributors, and administrators of the Covered Countermeasures, the Act provides benefits to certain individuals who sustain a covered injury as the direct result of the administration or use of the Covered Countermeasure. The Countermeasures Injury Compensation Program (CICP) within the Health Resources and Services Administration (HRSA) administers this compensation program. Information about the CICP is available at 1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/default.htm.

IX. Amendments

The Declaration for the Use of the Public Readiness and Emergency Preparedness Act for H5N1 was published on January 26, 2007; amended on November 30, 2007 to add H7 and H9 vaccines; amended on October 17, 2008 to add H2 and H6 vaccines; amended on June 15, 2009 to add 2009 H1N1 vaccines and republished in its entirety; and amended on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution and to add provisions consistent with other declarations and republished in its entirety. This Declaration incorporates all amendments prior to the date of its publication in the Federal Register. Any future amendment to this Declaration will be published in the Federal Register, pursuant to section 319F-2(b)(4) of the Act.

X. Definitions

For the purpose of this Declaration, including any claim for loss brought in accordance with section 319F-3 of the PHS Act against any covered persons defined in the Act or this Declaration, the following definitions will be used:

Administration of a Covered Countermeasure: As used in section 319F-3(a)(2)(B) of the Act includes, but is not limited to, public and private delivery, distribution, and dispensing activities relating to physical administration of the countermeasures to recipients, management and operation of delivery systems, and management and operation of distribution and dispensing locations.

Authority Having Jurisdiction: Means the public agency or its delegate that has legal responsibility and authority for responding to an incident, based on political or geographical (e.g., city, county, Tribal, State, or Federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.

Covered Persons: As defined at section 319F-3(i)(2) of the Act, include the United States, manufacturers, distributors, program planners, and qualified persons. The terms “manufacturer,” “distributor,” “program planner,” and “qualified person” are further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.

Declaration of Emergency: A declaration by any authorized local, regional, State, or Federal official of an emergency specific to events that indicate an immediate need to administer and use pandemic countermeasures, with the exception of a Federal declaration in support of an emergency use authorization under section 564 of the FDCA unless such declaration specifies otherwise.

Pandemic influenza A viruses and those with pandemic potential: Animal and/or human influenza A viruses, except those included in seasonal influenza vaccines and/or covered under the National Vaccine Injury Compensation Program, that are circulating in wild birds and/or domestic animals, that cause, or have significant potential to cause, sporadic or ongoing human infections, or historically have caused pandemics in humans, or have mutated to cause pandemics in humans, and for which the majority of the population is immunologically naïve.

Pandemic Phase: The following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006): (4) First Human Case in North America; and (5) Spread Throughout United States.

Pre-pandemic Phase: The following stages, as defined in the National Strategy for Pandemic Influenza: Implementation Plan (Homeland Security Council, May 2006): (0) New Domestic Animal Outbreak in At-Risk Country; (1) Suspected Human Outbreak Overseas; (2) Confirmed Human Outbreak Overseas; and (3) Widespread Human Outbreaks in Multiple Locations Overseas.

APPENDIX

I. List of U.S. Government Contracts—Covered H5N1, H2, H6, H7, H9, and 2009-H1N1 Vaccine Contracts

1. HHSN266200400031C

2. HHSN266200400032C

3. HHSN266200300039C

4. HHSN266200400045C

5. HHSN266200205459C

6. HHSN266200205460C

7. HHSN266200205461C

8. HHSN266200205462C

9. HHSN266200205463C

10. HHSN266200205464C

11. HHSN266200205465C

12. HHSN266199905357C

13. HHSN266200300068C

14. HHSN266200005413C

15. HHSO100200600021C (formerly 200200409981)

16. HHSO100200500004C

17. HHSO100200500005I

18. HHSO100200700026I

19. HHSO100200700027I

20. HHSO100200700028I

21. HHSO100200600010C

22. HHSO100200600011C

23. HHSO100200600012C

24. HHSO100200600013C

25. HHSO100200600014C

26. HHSO100200600022C (formerly 200200511758)

27. HHSO100200600023C (formerly 200200410431)

28. CRADA No. AI-0155 NIAID/MedImmune

29. HHSO100200700029C

30. HHSO100200700030C

31. HHSO100200700031C

32. All present, completed and future Government H5N1, H2, H6, H7, H9, and 2009-H1N1 vaccine contracts not otherwise listed.