The United States Grants Immunity from Liability For Manufacture, Development, Testing, Distribution, Administration and Use Of Certain COVID Medications Including COVID Vaccine

DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary

HHS IS SUBMITTING THIS DOCUMENT TO THE FEDERAL REGISTER FOR PUBLICATION. THE FORMATTING MAY CHANGE. THE VERSION IN THE FEDERAL REGISTER WILL BE THE OFFICIAL VERSION.

ACTION:  Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19.

SUMMARY:  The Secretary is issuing this Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide liability immunity for activities related to medical countermeasures against COVID-19.

DATES:  The Declaration is effective as of February 4, 2020.

FOR FURTHER INFORMATION CONTACT: Robert P. Kadlec, MD, MTM&H, MS, 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.

SUPPLEMENTARY INFORMATION:

The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.  This Declaration is subject to amendment as circumstances warrant.  

The PREP Act was enacted on December 30, 2005, as Public Law 109-148, Division C, Section 2.  It amended the Public Health Service (PHS) Act, adding Section 319F-3, which addresses liability immunity, and Section 319F-4, which creates a compensation program.  These sections are codified at 42 U.S.C. 247d-6d and 42 U.S.C. 247d-6e, respectively.

The Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), Public Law 113-5, was enacted on March 13, 2013.  Among other things, PAHPRA added sections 564A and 564B to the Federal Food, Drug, and Cosmetic (FD&C) Act to provide new authorities for the emergency use of approved products in emergencies and products held for emergency use.  PAHPRA accordingly amended the definitions of “Covered Countermeasures” and “qualified pandemic and epidemic products” in Section 319F-3 of the Public Health Service Act (PREP Act provisions), so that products made available under these new FD&C Act authorities could be covered under PREP Act Declarations.  PAHPRA also extended the definition of qualified pandemic and epidemic products that may be covered under a PREP Act Declaration to include products or technologies intended to enhance the use or effect of a drug, biological product, or device used against the pandemic or epidemic or against adverse events from these products.

COVID-19 is an acute respiratory disease caused by the SARS-CoV-2 betacoronavirus or a virus mutating therefrom.  This virus is similar to other betacoronaviruses, such as Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Although the complete clinical picture regarding SARS-CoV-2 or a virus mutating therefrom is not fully understood, the virus has been known to cause severe respiratory illness and death in a subset of those people infected with such virus(es).

In December 2019, the novel coronavirus was detected in Wuhan City, Hubei Province, China. Today, over 101 countries, including the United States have reported multiple cases. Acknowledging that cases had been reported in five WHO regions in one month, on January 30, 2020, WHO declared the COVID-19 outbreak to be a Public Health Emergency of International Concern (PHEIC) following a second meeting of the Emergency Committee convened under the International Health Regulations (IHR). 

To date, United States traveler-associated cases have been identified in a number of States and community-based transmission is suspected.  On January 31, 2020, Secretary Azar declared a public health emergency pursuant to section 319 of the PHS Act, 42 U.S.C. 247d, for the entire United States to aid in the nation’s health care community response to the COVID-19 outbreak.1 The outbreak remains a significant public health challenge that requires a sustained, coordinated proactive response by the Government in order to contain and mitigate the spread of COVID-19. 2

Description of this Declaration by Section

Section I. Determination of Public Health Emergency or Credible Risk of Future Public Health Emergency

Before issuing a Declaration under the PREP Act, the Secretary is required to determine that a disease or other health condition or threat to health constitutes a public health emergency or that there is a credible risk that the disease, condition, or threat may constitute such an emergency.  This determination is separate and apart from the Declaration issued by the Secretary on January 31, 2020 under Section 319 of the PHS Act that a disease or disorder presents a public health emergency or that a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, or other Declarations or determinations made under other authorities of the Secretary.  Accordingly in Section I of the Declaration, the Secretary determines that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease, COVID-19, constitutes a public health emergency for purposes of this Declaration under the PREP Act. 

Section II. Factors Considered by the Secretary

In deciding whether and under what circumstances to issue a Declaration with respect to a Covered Countermeasure, the Secretary must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the countermeasure. In Section II of the Declaration, the Secretary states that he has considered these factors.

Section III. Activities Covered by this Declaration Under the PREP Act’s Liability Immunity

The Secretary must delineate the activities for which the PREP Act’s liability immunity is in effect.  These activities may include, under conditions as the Secretary may specify, the manufacture, testing, development, distribution, administration, or use of one or more Covered Countermeasures (Recommended Activities).  In Section III of the Declaration, the Secretary sets out the activities for which the immunity is in effect.

Section IV. Limited Immunity

The Secretary must also state that liability protections available under the PREP Act are in effect with respect to the Recommended Activities.  These liability protections provide that, “[s]ubject to other provisions of [the PREP Act], a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.”  In Section IV of the Declaration, the Secretary states that liability protections are in effect with respect to the Recommended Activities.

Section V. Covered Persons

Section V of the Declaration describes Covered Persons, including Qualified Persons.  The PREP Act defines Covered Persons to include, among others, the United States, and those that manufacturer, distribute, administer, prescribe or use Covered Countermeasures.  This Declaration includes all persons and entities defined as Covered Persons under the PREP Act (PHS Act 317F-3(i)(2)) as well as others set out in paragraphs (3), (4), (6), (8)(A) and (8)(B). 

The PREP Act’s liability immunity applies to “Covered Persons” with respect to administration or use of a Covered Countermeasure.  The term “Covered Persons” has a specific meaning and is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.  The PREP Act further defines the terms “manufacturer,” “distributor,” “program planner,” and “qualified person” as described below.

A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.

A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices , including but not limited to: manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.

A program planner means a state or local government, including an Indian tribe; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s Declaration.  Under this definition, a private sector employer or community group or other “person” can be a program planner when it carries out the described activities.

A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure was prescribed, administered, or dispensed; or a person within a category of persons identified as qualified in the Secretary’s Declaration.  Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons. Section V describes other qualified persons covered by this Declaration.

The PREP Act also defines the word “person” as used in the Act: A person includes an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.

Section VI. Covered Countermeasures

As noted above, Section III of the Declaration describes the activities (referred to as “Recommended Activities”) for which liability immunity is in effect.  Section VI of the Declaration identifies the Covered Countermeasures for which the Secretary has recommended such activities.  The PREP Act states that a “Covered Countermeasure” must be a “qualified pandemic or epidemic product,” or a “security countermeasure,” as described immediately below; or a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act.

A qualified pandemic or epidemic product means a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is (i) manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.

A security countermeasure is a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that (i)(a) The Secretary determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and (ii) is determined by the Secretary of Health and Human Services to be a necessary countermeasure to protect public health.

To be a Covered Countermeasure, qualified pandemic or epidemic products or security countermeasures also must be approved or cleared under the FD&C Act; licensed under the PHS Act; or authorized for emergency use under Sections 564, 564A, or 564B of the FD&C Act.

A qualified pandemic or epidemic product also may be a Covered Countermeasure when it is subject to an exemption (that is, it is permitted to be used under an Investigational Drug Application or an Investigational Device Exemption) under the FD&C Act and is the object of research for possible use for diagnosis, mitigation, prevention, treatment, or cure, or to limit harm of a pandemic or epidemic or serious or life-threatening condition caused by such a drug or device.

A security countermeasure also may be a Covered Countermeasure if it may reasonably be determined to qualify for approval or licensing within 10 years after the Department’s determination that procurement of the countermeasure is appropriate.

Section VI lists medical countermeasures against COVID-19 that are Covered Countermeasures under this declaration. 

Section VI also refers to the statutory definitions of Covered Countermeasures to make clear that these statutory definitions limit the scope of Covered Countermeasures.  Specifically, the Declaration notes that Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

Section VII. Limitations on Distribution

The Secretary may specify that liability immunity is in effect only to Covered Countermeasures obtained through a particular means of distribution.  The Declaration states that liability immunity is afforded to Covered Persons for Recommended Activities related to (a) present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, or memoranda of understanding or other federal agreements; or (b) activities authorized in accordance with the public health and medical response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute, or dispense the Covered Countermeasures following a Declaration of an emergency.

Section VII defines the terms “Authority Having Jurisdiction” and “Declaration of an emergency.”  We have specified in the definition that Authorities having jurisdiction include federal, state, local, and tribal authorities and institutions or organizations acting on behalf of those governmental entities.

For governmental program planners only, liability immunity is afforded only to the extent they obtain Covered Countermeasures through voluntary means, 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.  This last limitation on distribution is intended to deter program planners that are government entities from seizing privately held stockpiles of Covered Countermeasures.  It does not apply to any other Covered Persons, including other program planners who are not government entities.

Section VIII. Category of Disease, Health Condition, or Threat

The Secretary must identify in the Declaration, for each Covered Countermeasure, the categories of diseases, health conditions, or threats to health for which the Secretary recommends the administration or use of the countermeasure.  In Section VIII of the Declaration, the Secretary states that the disease threat for which he recommends administration or use of the Covered Countermeasures is COVID -19 caused by SARS- CoV-2 or a virus mutating therefrom.

Section IX. Administration of Covered Countermeasures

The PREP Act does not explicitly define the term “administration” but does assign the Secretary the responsibility to provide relevant conditions in the Declaration.  In Section IX of the Declaration, the Secretary defines “Administration of a Covered Countermeasure,” as follows:

Administration of a Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution, and dispensing of the countermeasures to recipients; management and operation of countermeasure programs; or management and operation of locations for purpose of distributing and dispensing countermeasures.

The definition of “administration” extends only to physical provision of a countermeasure to a recipient, such as vaccination or handing drugs to patients, and to activities related to management and operation of programs and locations for providing countermeasures to recipients, such as decisions and actions involving security and queuing, but only insofar as those activities directly relate to the countermeasure activities.  Claims for which Covered Persons are provided immunity under the Act are losses caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a Covered Countermeasure consistent with the terms of a Declaration issued under the Act.  Under the definition, these liability claims are precluded if they allege an injury caused by a countermeasure, or if the claims are due to manufacture, delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.

Thus, it is the Secretary’s interpretation that, when a Declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct. Likewise, the Act precludes a liability claim relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location that alleges, for example, lax security or chaotic crowd control.  However, a liability claim alleging an injury occurring at the site that was not directly related to the countermeasure activities is not covered, such as a slip and fall with no direct connection to the countermeasure’s administration or use.  In each case, whether immunity is applicable will depend on the particular facts and circumstances.

Section X. Population

The Secretary must identify, for each Covered Countermeasure specified in a Declaration, the population or populations of individuals for which liability immunity is in effect with respect to administration or use of the countermeasure.  Section X of the Declaration identifies which individuals should use the countermeasure or to whom the countermeasure should be administered–in short, those who should be vaccinated or take a drug or other countermeasure.  Section X provides that the population includes “any individual who uses or who is administered a Covered Countermeasure in accordance with the Declaration.”

It should be noted that under the PREP Act, liability protection extends beyond the Population specified in the Declaration.  Specifically, liability immunity is afforded (1) To manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population, and (2) to program planners and qualified persons when the countermeasure is either used by or administered to this population or the program planner or qualified person reasonably could have believed the recipient was in this population.  Section X of the Declaration includes these statutory conditions in the Declaration for clarity.

Section XI. Geographic Area

The Secretary must identify, for each Covered Countermeasure specified in the Declaration, the geographic area or areas for which liability immunity is in effect, including, as appropriate, whether the Declaration applies only to individuals physically present in the area or, in addition, applies to individuals who have a described connection to the area.  Section XI of the Declaration provides that liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.  This could include claims related to administration or use in countries outside the U.S. It is possible that claims may arise in regard to administration or use of the Covered Countermeasures outside the U.S. that may be resolved under U.S. law.

In addition, the PREP Act specifies that liability immunity is afforded (1) to manufacturers and distributors without regard to whether the countermeasure is used by or administered to individuals in the geographic areas, and (2) to program planners and qualified persons when the countermeasure is either used or administered in the geographic areas or the program planner or qualified person reasonably could have believed the countermeasure was used or administered in the areas. Section XI of the Declaration includes these statutory conditions in the Declaration for clarity.

Section XII. Effective Time Period

The Secretary must identify, for each Covered Countermeasure, the period or periods during which liability immunity is in effect, designated by dates, milestones, or other description of events, including factors specified in the PREP Act.  Section XII of the Declaration extends the effective period for different means of distribution of Covered Countermeasures through October 1, 2024.

Section XIII. Additional Time Period of Coverage

The Secretary must specify a date after the ending date of the effective time period of the Declaration that is reasonable for manufacturers to arrange for disposition of the Covered Countermeasure, including accepting returns of Covered Countermeasures, and for other Covered Persons to take appropriate actions to limit administration or use of the Covered Countermeasure.  In addition, the PREP Act specifies that, for Covered Countermeasures that are subject to a Declaration at the time they are obtained for the Strategic National Stockpile (SNS) under 42 U.S.C. 247d-6b(a), the effective period of the Declaration extends through the time the countermeasure is used or administered.  Liability immunity under the provisions of the PREP Act and the conditions of the Declaration continue during these additional time periods.  Thus, liability immunity is afforded during the “Effective Time Period,” described under Section XII of the Declaration, plus the “Additional Time Period” described under Section XIII of the Declaration.

Section XIII of the Declaration provides for 12 months as the Additional Time Period of coverage after expiration of the Declaration. Section XIII also explains the extended coverage that applies to any product obtained for the SNS during the effective period of the Declaration.

Section XIV. Countermeasures Injury Compensation Program

Section 319F-4 of the PHS Act, 42 U.S.C. 247d-6e, authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to eligible individuals who sustain a serious physical injury or die as a direct result of the administration or use of a Covered Countermeasure.  Compensation under the CICP for an injury directly caused by a Covered Countermeasure is based on the requirements set forth in this Declaration, the administrative rules for the Program, and the statute.  To show direct causation between a Covered Countermeasure and a serious physical injury, the statute requires “compelling, reliable, valid, medical and scientific evidence.”  The administrative rules for the Program further explain the necessary requirements for eligibility under the CICP.  Please note that, by statute, requirements for compensation under the CICP may not align with the requirements for liability immunity provided under the PREP Act. Section XIV of the Declaration, “Countermeasures Injury Compensation Program,” explains the types of injury and standard of evidence needed to be considered for compensation under the CICP.

Further, the administrative rules for the CICP specify that if countermeasures are administered or used outside the United States, only otherwise eligible individuals at United States embassies, military installations abroad (such as military bases, ships, and camps) or at North Atlantic Treaty Organization (NATO) installations (subject to the NATO Status of Forces Agreement) where American servicemen and servicewomen are stationed may be considered for CICP benefits.  Other individuals outside the United States may not be eligible for CICP benefits.

Section XV. Amendments

Section XV of the Declaration confirms that the Secretary may amend any portion of this Declaration through publication in the Federal Register.

Declaration

Declaration for Public Readiness and Emergency Preparedness Act Coverage for medical countermeasures against COVID-19.

I. Determination of Public Health Emergency

42 U.S.C. 247d-6d(b)(1)

I have determined that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID -19 constitutes a public health emergency.

II. Factors Considered

42 U.S.C. 247d-6d(b)(6)

I have considered the desirability of encouraging the design, development, clinical testing, or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, and use of the Covered Countermeasures.

III. Recommended Activities

42 U.S.C. 247d-6d(b)(1)

I recommend, under the conditions stated in this Declaration, the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.

IV. Liability Immunity

42 U.S.C. 247d-6d(a), 247d-6d(b)(1)

Liability immunity as prescribed in the PREP Act and conditions stated in this Declaration is in effect for the Recommended Activities described in Section III.

V. Covered Persons

42 U.S.C. 247d-6d(i)(2), (3), (4), (6), (8)(A) and (B)

Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.

In addition, I have determined that the following additional persons are qualified persons: (a) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction, as described in Section VII below, to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a Declaration of an emergency; (b) any person
authorized to prescribe, administer, or dispense the Covered Countermeasures or who is otherwise authorized to perform an activity under an Emergency Use Authorization in accordance with Section 564 of the FD&C Act; and (c) any person authorized to prescribe, administer, or dispense Covered Countermeasures in accordance with Section 564A of the
FD&C Act.

VI. Covered Countermeasures

42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)

Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.

 Covered Countermeasures must be “qualified pandemic or epidemic products,” or “security countermeasures,” or drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.

VII. Limitations on Distribution

42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)

I have determined that liability immunity is afforded to Covered Persons only for Recommended Activities involving Covered Countermeasures that are related to:

  1. Present or future federal contracts, cooperative agreements, grants, other transactions, interagency agreements, memoranda of understanding, or other federal agreements; or
  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 Covered Countermeasures following a Declaration of an emergency.

As used in this Declaration, the terms Authority Having Jurisdiction and Declaration of Emergency have the following meanings:

  1. The 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.
  2. A Declaration of Emergency means any 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 the Covered Countermeasures, with the exception of a federal Declaration in support of an Emergency Use Authorization under Section 564 of the FD&C Act unless such Declaration specifies otherwise;

I have also determined that, for governmental program planners only, liability immunity is afforded only to the extent such program planners obtain Covered Countermeasures through voluntary means, 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.

VIII. Category of Disease, Health Condition, or Threat

42 U.S.C. 247d-6d(b)(2)(A)

The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is COVID-19 caused by SARS-CoV-2 or a virus mutating therefrom.

IX. Administration of Covered Countermeasures

42 U.S.C. 247d-6d(a)(2)(B)

Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures.

X. Population

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)

The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population.

XI. Geographic Area

42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)

Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation.

Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area.

XII. Effective Time Period

42 U.S.C. 247d-6d(b)(2)(B)

Liability immunity for Covered Countermeasures through means of distribution, as identified in Section VII(a) of this Declaration, other than in accordance with the public health and medical response of the Authority Having Jurisdiction and extends through October 1, 2024.

Liability immunity for Covered Countermeasures administered and used in accordance with the public health and medical response of the Authority Having Jurisdiction begins with a Declaration and lasts through (1) the final day the emergency Declaration is in effect, or (2) October 1, 2024, whichever occurs first.

XIII. Additional Time Period of Coverage

42 U.S.C. 247d-6d(b)(3)(B) and (C)

I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures.

Covered Countermeasures obtained for the SNS during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS.

XIV. Countermeasures Injury Compensation Program

42 U.S.C 247d-6e

The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures.  The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation.  The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.  Information about the CICP is available at the toll-free number 1-855-266-2427 or http://www.hrsa.gov/cicp/.

XV.       Amendments

42 U.S.C. 247d-6d(b)(4)

Amendments to this Declaration will be published in the Federal Register, as warranted.

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

Dated: March 10, 2020.

Alex M. Azar II

Secretary of Health and Human Services.

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Life at Up Up and Away Investment Management International: Chapter 10: (A serialized novel by Robert K. Stephen)

Chapter 10

Downsizing: See who your friends are

As they say in times of trouble you will notice who your real friends are. Some whom you thought were your friends quickly scatter and avoid contact with a fired employee on the premise it is bad luck. Some are gloating as they feel they are in a better position than you assuming of course they are still employed.

Real friends offer empathy, compassion and help you in your job search by referring you to possible helpful networking contacts. Sympathy is not what the downsized person wants. Sympathy is feeling sorry for the victim but empathy goes further by trying to eliminate the victim’s distress and anguish by doing something for that person.

I’ll throw you examples your way of some negative experiences I had with “friends”.

Bile Mikeman was who I thought was a “family friend”. We had visited each other’s house several times and our children played together. Bile had worked with my wife at her largecorp for several years until he got wind of his upcoming Blessed Event and jumped ship just in time.

Keeping Bile in the loop I managed to network into the office of the President of Bile’s largecorp employer. The meeting went far better than I had expected. I had the skills and the attitude the President was looking for. The President consulted with Bile. You know what that prick said about me. I did not have the soft skills needed and would not “fit in”.

Later the truth filtered out through a third-party mutual friend. Bile felt threatened by me and was afraid of the potential competition. That asshole cut off my legs before I had the chance to go through a few perfunctory “you got the job” Human Resources Department interviews. How about that for a mistaken impression of friendship! Instead of empathy his reaction to me joining his largecorp employer was self-preservation and self-interest. The Blessed Event really sped up my evaluation of our “friendship”. I hope to repay the favour one day. My vendetta list was beginning to grow. By the way Bile went in a downsizing some 4 months later. I can say I felt neither sympathy nor empathy for him.

I turned to another family “friend”, Jenny Bark, a lawyer I had worked with at CRAP. She was general counsel of a less than largecorp and required another lawyer to assist her. “Need someone more junior” was her line. “You have too much experience”. Another real friend.

Finally, there was Jim Moonrush a very senior partner with the insurance practice group at a major law firm I had referred hundreds of thousands of dollars to in legal assignments. We had got along very well over the years and been out for many lunches and sporting events together. To get me on my feet and on the basis a contract position would have made me a much more attractive employment prospect would have been appreciated. The offer of a contract never happened despite my hints.

I had a whole host of colleagues at CRAP, all from the business unit I served as legal counsel for in the Legal Department, who contacted me the next day after my Blessed Event and we all went to a few bars to bitch and complain. One or two offered leads during my unemployment but for the rest I was yesterday’s meal soon to be forgotten

Perhaps the nicest experience of all was from Tommy Bland a colleague and a person who I had become to view as a friend from the ranks of the clients I had served. As a General Counsel of a large automobile manufacturing company located in Ontario he spent two hours with me on the phone “the day of” trying to get a handle on what had just happened. Had I been willing to relocate there was a job waiting for me. Unfortunately, Tommy was turfed in a Blessed Event several months later. Ah, such is the nature of largecorp. Rather like the dark days of Stalinism or Hitler where you were here today and gone tomorrow. Not that I am making any linkage between these nasty ideologies and largecorp!

There is nothing like the Blessed Event to help you decide who your friends are. Call me petty but do unto others what they have done to you. Isn’t that one of the Ten Commandments?

Life at Up Up and Away Investment Management International: Chapter 9: (A serialized novel by Robert K. Stephen)

Chapter 9

Downsizing: A dirty hit to your family

Your ego may be somewhat bruised after your firing. However, on top of that you must communicate the Blessed Event to your family. It is a difficult and often a humiliating endeavour. My teenage daughter Lexia was in shock wondering how “they” could do this to me. If there was anything positive she gained a glimpse of how brutal largecorp could be. I found it touching how she offered to turn over to me her savings account.

My spouse was shocked but also working for a largecorp was not completely bowled over. I had previously related to her my meeting with Brian Cochon of Ooze & Ooze months ago when he said to me “you’ll” be terminated if you don’t refund pension fund expenses to his client. It was becoming quite apparent it was not the termination of the business relationship between his client and CRAP but the termination of my employment relationship with CRAP. Poker and Cochon were working hand in hand on this one. And it was clear to me my conspiracy theory was right on the money.

Your spouse may be your strongest supporter of you as you struggle back to your feet like a deer hit by a car. Yet at times, due to your sensitivity, negative comments from family and friends can cut deep. Don’t expect a happy June or Ward Cleaver. Your blood from the corporate hit is splattered all over your spouse too. The insult to you is also an insult to your spouse. Your embarrassment and humiliation may become a family affair. This is a hard cross to bear.

I sense for many termination victims a deep distrust, hatred and cynicism concerning largecorp and its Senior Management Team is born. The SMT is the perpetrator of the shattered family. It isn’t in the Marxist textbooks or the in the pocket of largecorp MBA curriculums that will define the future of Canadian corporate life. It is in the vast collection of dirty little Blessed Events, the increasingly public disclosure of soaring executive compensation and the racist, sexist and homophobic composition of largecorp’s SMTs and boards of directors and that will shape perceptions of largecorp and possibly that of its very survival.

However, as employees fear of losing the next paycheque keeps employees in line there is silence in the ranks (at least publicly) concerning the butchery and mismanagement by largecorp of its employees. Hopefully in some distant time and place the private truthful cynicism about largecorp will outweigh the tons of largecorp propaganda and perhaps at that time the secret greed and manipulation of largecorp by the SMT will be in full public view. Apollo’s wings will be melted by the heat of securities regulators and crown prosecutors.

In the meantime, what more can you do but limp on and hope for a new job and of course a chance for revenge? Again, as for anger, control and manage your urge for revenge. Both these emotions can be powerful motivators in your job search if properly regulated.

Both you and your family have been hurt. Best that you do not get wound up in family embroilments if they bubble over. Better times are coming.

Can You Be Fired In Ontario As An Employee For Raising Concerns about COVID-19?

On an annual basis a farm recruited Mexican agricultural workers who were living in bunkhouses which were divided into 4 apartments where 13 people lived. In one apartment there were shared bathrooms and bedrooms. Unfortunately, COVID hit the farm and one worker died from it. A worker raised his concerns about safety to a supervisor. The owner then confronted the worker and accused him of ratting to the media and attempted to send him back to Mexico by arranging for a flight back to Mexico.

The Ontario Relations Board (OLRB) sided with the worker stating he had every right to raise concerns about safety at the farm and that the employer had a duty to take every reasonable precaution to improve workplace safety. The reprisal by the employer in effectively terminating the worker was prohibited under health and safety legislation in Ontario. The OLRB ordered the employer to pay the worker $25,000 in damages. There is a reverse onus in reprisal cases which will require the employer to show it did not implement a reprisal against a worker.

The case was Flores v. Scotlynn Sweetpac Growers Inc.

Photp by Tom Steepe/CBC

Life at Up Up and Away Investment International: Chapter 8: (A serialized novel by Robert K. Stephen)

Chapter 8

Will the Doberman lawyers be needed in your “downsizing”?

So, you have a termination package in your hand. There is a line for you to sign before the law will consider it binding. Never sign anything on the spot! The first thing you should do is to determine how long largecorp’s offer is good for so you can take appropriate action before the expiration date which just might mean asking for an extension. The second thing you should do is review the terms of the severance offer for reasonableness. Then I would recommend you should retain legal counsel to review the offer and then help you negotiate a better offer if so advised or if all else fails then to litigate.

Lawyers speak of a “notice period” terminated employees are entitled to. This is essentially a common law term which has evolved from a series of court decisions. It measures the time a court would think it would take you to find alternative employment. This depends how senior you are, your age and skill set amongst other things. For example, a senior employee with a high executive functioning ability who is close to 65 ordinarily would face a lengthier job search that a 35-year-old with less seniority. The common law ordinarily gives a month’s notice per year of service. If you are entitled to a notice period of nine months you will receive 9 months of salary. The employer can also give you working notice where you continue to be employed during the notice period. This extremely rare as once you are fired you are no longer trusted so best to clear you out.

There is a ritual to termination offers given by largecorp. Largecorp’s counsel knows exactly what you are entitled to under both statutory and common law but in most cases they’ll low ball you. Then your counsel will up the ante to more than you would be legally entitled to and they’ll settle somewhere in the middle of the difference knowing full well most people will not litigate to recover their full legal entitlement. Litigation is awfully expensive and largecorp knows this so you’ll almost always be lowballed.

Now where things may be a bit less creative are if you had signed an employment contract with largecorp where you have agreed to a notice period upon termination. However even then there still may be benefits and bonus issues that need to be negotiated. Your employment contract may not be as tight as largecorp thought it was.

Depending on what province you reside in instead of an hourly fee payable to your lawyer you may be able to proceed by a contingency fee where there are no hourly legal fees but your lawyer gets a cut of any additional amount your lawyer obtains for you that exceeds largecorp’s original severance offer.

I don’t wish to bog you down with too many legal details but here are some key points you should be aware of concerning a termination offer by largecorp;

  1. Employment Contract: You may have signed one when you accepted largecorp’s offer of employment. It may set forth fully or partially what you are entitled to upon termination. Simply because you agreed to it does not necessarily close the book on what your notice period is and your entitlement to other employment benefits. Often clauses in the employment contract can be ambiguous and poorly drafted. They may be worth a legal challenge.
  2. Notice Period: Statutory law and both the common law offer differing notice periods. Statutory law usually offers a less substantial period (usually based upon years of service) than common law but common law can always come into play. The common law provides about a month per year of employment capping around two year’s notice. The higher the seniority of the victim, the years of service of the victim, the age of the victim and skill set of the victim are taken into consideration in establishing the common law notice period.
  3. In Addition to the Standard Notice Period Punitive Damages May be Awarded; If you were fired in an oppressive and embarrassing manner the court may offer you what is called punitive damages punishing largecorp for treating you in a harsh and oppressive way.
  4. Beware of the Americans: American law is far more parsimonious than Canadian law when it deals with notice periods which is generally speaking a week for each year of employment. If you are in a Canadian largecorp which is a subsidiary of an American largecorp don’t settle for the American standard.
  5. Pay Careful Attention to Benefits: Pay close attention to all benefits like dental and health insurance, bonus payments, life insurance, professional fees, pension plan contributions and employment benefit plan contributions. These benefits should continue to be payable during the notice period. Of course there is the possibility you could be paid off in a lump sum as opposed to salary continuation.
  6. Termination for Cause: The law offers virtually no protection if you were terminated “for cause” which means amongst other things, fraud, theft, incompetence, misappropriation of confidential information or trashing largecorp on social media! Again, consult a lawyer on this point as cause can be manufactured and it is often difficult for largecorp to show cause!
  7. Your Duty to Mitigate: The common law provides you have a duty to mitigate your losses which means if you are on salary continuance during your notice period you must expend some effort to find alternative employment. How rigorous this may be in many respects depends on your age and skills. If you are 63 years old I highly doubt largecorp will relentlessly pursue and monitor your efforts to find new employment but be a good boy and girl and attend those outplacement sessions. It rather depends on largecorp’s attitude. Do keep a journal of your outplacement activities, networking activities and job interviews as you may be asked by the Human Resources Department to provide updates to prove you have been mitigating your losses. If they think you haven’t been trying hard enough they may turn off the taps.
  8. Don’t Cheat: Your severance offer will turn off the taps of salary continuance either completely or pay you a certain incentive amount if you find employment during the notice period. If you feel like you have been fucked over by largecorp there is the thought that may cross your mind not to tell them you have been hired thus enabling a double salary. Do so at your own risk as there will be a clause in your severance offer requiring you to notify your largecorp if you have found employment. Beware that largecorp will be more than willing to hire a private detective. CRAP had me tailed twice. I am sure they would have clapped their hands in glee if they had found out I was going off to work without advising them I had found new employment.
  9. Be Wary of Indemnification and Release Agreements: Once you settle there will be a possible indemnification and release agreement to be signed between largecorp and you. Pay attention to any restrictive covenants prohibiting you from accepting offers of employment from largecorp’s competitors for a certain period of time and in a certain geographic area. As you may have a very specific skill set this may be deadly to you. These types of agreements really do require an employment lawyer review.

OK then you have had your initial employment lawyer consultation. You can accept the offer. You can negotiate the offer on your own with your lawyer’s advice. You can have the offer negotiated between your lawyer and largecorp’s lawyer. Eventually you may decide to litigate which is very expensive. It rather is a matter of dollar-based math on what to do.

I should mention the concept of “constructive dismissal”. This is the situation where largecorp in effect demotes you in a variety of ways such as reducing the amount of your direct reports, reducing benefits or salary taking away your office or other actions that would humiliate a reasonable person. In this case you can pull the employment relationship plug and seek damages. Before pulling the plug do consult with an employment lawyer.

Let me emphasize that many of you dislike or are suspicious of lawyers. But when you have a termination offer in front of you I urge you to consult with a lawyer who specializes in employment law.

Life at Up Up and Away Investment Management International; Chapter 7: (A serialized novel by Robert K. Stephen)

Chapter 7

Your new friend the outplacement counsellor

Largecorp and the in its pocket management faculties have obliterated the word “fired”. A gentler term to use is “downsized”. This gentle term was no doubt invented by some management faculty whiz years ago. It has been so effective that in addition to the Human Resources Department using the term that employees of largecorp now also use this neutral sounding term or an equally polite term “let go”.

I am certain these captive management institutes, mostly named after successful capitalists who have donated a shitload of money to have these business faculties named after them, also invented the term “outplacement counselling”.

Outplacement services were historically offered to more senior management types but recently have been extended to many fired employees. Outplacement firms are a variety of remora feeding off largecorp. They are paid by largecorp. The sooner you find a new job the less severance largecorp pays. Outplacement is not for your own good but rather for that of largecorp! Largecorp cares for employees! If they don’t they bear a reputational risk.

The public relations spin put out by largecorp is that offering outplacement services shows the deep concern and care largecorp bestows to its former employees. Since when has largecorp ever shown any true compassion for its employees? Lies, lies and more lies. The fuel that largecorp is powered by.

Most severance packages are not in lump sum payments but rather salary continuance for the period of your notice period. Should you find employment before your notice period and severance payments end you usually are required to forfeit to largecorp all or part of the value of the remaining severance. So getting you back to work quickly is in the financial interest of largecorp hence the utility of outplacement counselling firms. I have found the more senior the employee the higher calibre of outplacement firm is used in the realization it is more profitable to get those with enormous amounts of severance being paid to off the payroll than lesser expensive fired employees.

An outplacement counsellor was at my termination meeting offering gentle support and compassion and written details about his firm’s outplacement services. Being a child of the 1950’s and sixties I was really not interested in any immediate counselling. We Boomers often pride ourselves on being tough and are quick to reject any form of psychological assistance.

Congratulations, you are on an assembly line of rejected, dejected, frustrated and bitter ex-employees now burdened with a new job of getting a job. You are told by your outplacement firm this is a 9-5 task for you! Even in your aggravated and miserable state you are now a commodity for a largecorp service provider. My advice to you is take some time off to recuperate from your traumatic firing. Your riled-up mind and exhausted body really require some healing time before subjecting yourself to more corporate babble you’ll hear from your outplacement firm.

These outplacement counsellors are not accredited by any professional body like lawyers, doctors or nurses. Often they have been terminated themselves and created a new business of outplacement counselling because they could not find themselves a job! People who could not manage to find a job are teaching you how to find a job! Although you and your outplacement counsellors share the fact that you are both largecorp rejects your outplacement counsellor is paid by largecorp and most likely receives a bonus for getting you back in a new job before your severance payments cease. These folks are not on your side and do not have your interests at heart. You are nothing but a broken-down human being to be quickly shovelled back into another largecorp.

You may not appreciate their relationship with the largecorp that terminated you but they speak the same lingo and spout the same old tired dogma that their largecorp Human Relations Department contacts run to like lemmings. They are your method actor teachers helping you fit the mould a future employer can feel comfortable with. You are the monkey to be trained to play the tricks to get the big banana. You have “transferable skills” You are a “team player”. You are “client driven”. You “have the big picture” but are “technically proficient”. You “thrive and grow with challenges”. “Global diversity and inclusion” are essential corporate goals. Blah, blah and more blah.

You’ll be fed much hackneyed jargon in outplacement meetings and you’ll recognize much of it from those largecorp personal development sessions you previously attended. So, don’t expect too much originality here. You are now going to be prepackaged as a new improved commodity in the same marketplace to the same tired legions of largecorp employers.

The outplacement firm is just a resource to be used. I say use what they have to offer which could be word-processing services, a new business number with voicemail, resume preparation and interview preparation. They may even offer quick psychological testing so you will better know your personality and its flaws from an employer’s perspective.

If you believe you are going to obtain true emotional support from outplacement counsellors, I doubt it. The emotional healing you will receive is from your fellow victims so many of whom are excellent employees but made a powerful enemy or were part of a giant soulless “reorganization” largecorp snaps into place when profits are lagging. So many of the victims I encountered were from largecorp financial institutions who thought nothing of firing thousands at the whim of a psychopathic CEO. How did that person become a CEO? He or she was most likely a brutal and efficient killer wiping out enemies and competitors with “extreme prejudice”.

The same largecorp advertising compassion, care and devotion to their employees and customers, donating huge philanthropic sums to charities and universities then turn around and fire thousands and before you know it their CEO is the United Way hero of the year or in The Canadian Business Hall of Fame. Employees are like in some giant abattoir butchered in the name of shareholder returns in the marketplace and in silence obscene executive compensation makes a joke of the term “shareholder value”.

It is ironic that the Senior Management Team states the mass terminations were done to protect the jobs of existing employees but the survivors have extra work heaped upon them to the point that burnout reaches epic proportions and disability costs spiral upwards due to workplace stress. Yes, there is mental wreckage amongst those “let go” and those “lucky” enough to have escaped mass firings.

Matters usually get so bad the blood on the floor is mopped up by the Inhuman Resources Department before it seeps into the management suite and is sanitized as best it can be to “manage effectively” the terror of the survivors and the fear that they may be next. The prime motivator in the SMT ranks of largecorp is the never-ending bottomless pit of greed. The prime motivator of the largecorp employee is economic survival and that direct deposit into heir bank account.

Bear in mind outplacement counsellors are rarely brilliant. They simply recycle what can be found in self help books. You may be a bit rusty on the lying, cheating and sanitizing that is needed to weasel yourself into your next position and that’s why they are there so use them. It would seldom seem that in an interview you speak from your heart but rather from a multi-purpose script. If only largecorp would respect honesty. Perhaps this explains why an increasing number of Canadians are deserting largecorp and setting up their own businesses!

COVID Vaccinations: Has there been a lack of communication on side effects?

Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes.

By JoNel Aleccia and Liz SzaboNOVEMBER 12, 2020

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A health worker injects a woman during clinical trials for a COVID-19 vaccine at Research Centers of America in Hollywood, Florida, on Sept. 9. (EVA MARIE UZCATEGUI / BLOOMBERG VIA GETTY IMAGES)

Drugmaker Pfizer is expected to seek federal permission to release its COVID-19 vaccine by the end of November, a move that holds promise for quelling the pandemic, but also sets up a tight time frame for making sure consumers understand what it will mean to actually get the shots.

This story also ran on NBC News. It can be republished for free.

This vaccine, and likely most others, will require two doses to work, injections that must be given weeks apart, company protocols show. Scientists anticipate the shots will cause enervating flu-like side effects — including sore arms, muscle aches and fever — that could last days and temporarily sideline some people from work or school. And even if a vaccine proves 90% effective, the rate Pfizer touted for its product, 1 in 10 recipients would still be vulnerable. That means, at least in the short term, as population-level immunity grows, people can’t stop social distancing and throw away their masks.

Left out so far in the push to develop vaccines with unprecedented speed has been a large-scale plan to communicate effectively about those issues in advance, said Dr. Saad Omer, director of the Yale Institute for Global Health.

“You need to be ready,” he said. “You can’t look for your communication materials the day after the vaccine is authorized.”

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Omer, who declined to comment on reports he’s being considered for a post in the new administration of President-elect Joe Biden, called for the rollout of a robust messaging campaign based on the best scientific evidence about vaccine hesitancy and acceptance. The Centers for Disease Control and Prevention has created a strategy called “Vaccinate with Confidence,” but it lacks the necessary resources, Omer said.

“We need to communicate, and we need to communicate effectively, and we need to start planning for this now,” he said.

Such broad-based outreach will be necessary in a country where, as of mid-October, only half of Americans said they’d be willing to get a COVID-19 vaccine. Initial doses of any vaccine would be limited at first, but experts predict they may be widely available by the middle of next year. Discussing potential side effects early could counter misinformation that overstates or distorts the risk.

“The biggest tragedy would be if we have a safe and effective vaccine that people are hesitant to get,” said Dr. Preeti Malani, chief health officer and a professor of medicine at the University of Michigan in Ann Arbor.

Pfizer and its partner, the German firm BioNTech, on Monday said their vaccine appears to protect 9 in 10 people from getting COVID-19, although they didn’t release underlying data. It’s the first of four COVID-19 vaccines in large-scale efficacy tests in the U.S. to post results.

Data from early trials of several COVID-19 vaccines suggests that consumers will need to be prepared for side effects that, while technically mild, could disrupt daily life. A senior Pfizer executive told the news outlet Stat that side effects from the company’s COVID-19 vaccine appear to be comparable to standard adult vaccines but worse than the company’s pneumonia vaccine, Prevnar, or typical flu shots.

The two-dose Shingrix vaccine, for instance, which protects older adults against the virus that causes painful shingles, results in sore arms in 78% of recipients and muscle pain and fatigue in more than 40% of those who take it. Prevnar and common flu shots can cause injection-site pain, aches and fever.

“We are asking people to take a vaccine that is going to hurt,” said Dr. William Schaffner, a professor of preventive medicine and health policy at Vanderbilt University Medical Center. “There are lots of sore arms and substantial numbers of people who feel crummy, with headaches and muscle pain, for a day or two.”

Persuading people who experience these symptoms to return in three to four weeks for a second dose — and a second round of flu-like symptoms — could be a tough sell, Schaffner said.

How public health experts explain such effects is important, Omer said. “There’s evidence that suggests that if you frame pain as a proxy of effectiveness, it’s helpful,” he said. “If it’s hurting a little, it’s working.”

At the same time, good communication will help consumers plan for such effects. A COVID-19 vaccine is expected to be distributed first to health care staffers and other essential workers, who may not be able to work if they feel sick, said Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care.

“A lot of folks don’t have sick leave. A lot of our essential workers don’t have health insurance,” he said, suggesting that essential workers should be granted three days of paid leave after they’re vaccinated. “These are the things a well-functioning government should provide for to get our economy going again.”

Making sure consumers know that a COVID-19 vaccine likely will require two doses — and that it could take a month for full effectiveness to kick in — is also crucial. The Pfizer phase 3 trial, which has enrolled nearly 44,000 people, started in late July. Participants received a second dose 21 days after the first. The reported 90% efficacy was measured seven days after the second dose.

Communicating effectively will be vital to ensuring that consumers follow through with the shots and — assuming several vaccines are approved — that their first and second doses are from the same maker. Until full protection kicks in, Omer said, people should continue to take measures to protect themselves: wearing masks, washing hands, social distancing. It’s important to let people know that taking appropriate action now will pay off later.

“If we just show them the tunnel, not the light, then that results in this mass denial,” he said. “We need to say, ‘You’ll have to continue to do this in the medium term, but the long term looks good.”

The best communication can occur once full data from the Pfizer trial and others are presented, noted Dr. Paul Offit, a vaccinologist at the Children’s Hospital of Philadelphia who sits on the federal Food and Drug Administration’s advisory board considering COVID-19 vaccines.

“When you look at those data, you can more accurately define what groups of people are most likely to have side effects, what the efficacy is, what we know about how long the efficacy lasts, what we know about how long the safety data have been tested,” he said. “I think you have to get ready to communicate that. You can start getting ready now.”

JoNel Aleccia: jaleccia@kff.org, @JoNel_Aleccia

Liz Szabo: lszabo@kff.org, @LizSzabo

COVID Vaccinations: Know the efficacy and risk

Covid-19: Vaccine candidate may be more than 90% effective, interim results indicate

BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4347 (Published 09 November 2020)Cite this as: BMJ 2020;371:m4347Read our latest coverage of the coronavirus outbreak

Rapid Response:

Covid-19 vaccine candidate is unimpressive: NNTV is around 256

Dear Editor

Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant?

We already know that current Covid-19 vaccine trials are unlikely to show a reduction in severe illness or deaths. (Doshi, BMJ 2020;371:m4037, October 21) Will they be like seasonal influenza vaccines, which have not proved to be lifesavers, and may even have increased overall mortality in the elderly? (Anderson et al, Ann Intern Med 2020;172:445) We need a lot more time and a lot more data, especially in view of massive uncertainties about Covid-19 case definitions and statistics.

ALLAN S. CUNNINGHAM 13 November 2020

Competing interests: No competing interests13 November 2020Allan S. CunninghamRetired pediatricianCooperstown NY 13326 USA <crabarbicus62@gmail.com

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COVID Vaccination: Buyer Beware (or at least in a position to give informed consent!): Why are physicians in the United States so vaccine hesitant?

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What the Covid Vaccine Hype Fails to Mention

covid vaccine

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TAGS Health

11/24/2020Gilbert Berdine, MD

Listen to the Audio Mises Wire version of this article.

Pfizer recently announced that its covid vaccine was more than 90 percent “effective” at preventing covid-19. Shortly after this announcement, Moderna announced that its covid vaccine was 94.5 percent “effective” at preventing covid-19. Unlike the flu vaccine, which is one shot, both covid vaccines require two shots given three to four weeks apart. Hidden toward the end of both announcements, were the definitions of “effective.”

Both trials have a treatment group that received the vaccine and a control group that did not. All the trial subjects were covid negative prior to the start of the trial. The analysis for both trials was performed when a target number of “cases” were reached. “Cases” were defined by positive polymerase chain reaction (PCR) testing. There was no information about the cycle number for the PCR tests. There was no information about whether the “cases” had symptoms or not. There was no information about hospitalizations or deaths. The Pfizer study had 43,538 participants and was analyzed after 164 cases. So, roughly 150 out 21,750 participants (less than 0.7 percent) became PCR positive in the control group and about one-tenth that number in the vaccine group became PCR positive. The Moderna trial had 30,000 participants. There were 95 “cases” in the 15,000 control participants (about 0.6 percent) and 5 “cases” in the 15,000 vaccine participants (about one-twentieth of 0.6 percent). The “efficacy” figures quoted in these announcements are odds ratios.

There is no evidence, yet, that the vaccine prevented any hospitalizations or any deaths. The Moderna announcement claimed that eleven cases in the control group were “severe” disease, but “severe” was not defined. If there were any hospitalizations or deaths in either group, the public has not been told. When the risks of an event are small, odds ratios can be misleading about absolute risk. A more meaningful measure of efficacy would be the number to vaccinate to prevent one hospitalization or one death. Those numbers are not available. An estimate of the number to treat from the Moderna trial to prevent a single “case” would be fifteen thousand vaccinations to prevent ninety “cases” or 167 vaccinations per “case” prevented which does not sound nearly as good as 94.5 percent effective. The publicists working for pharmaceutical companies are very smart people. If there were a reduction in mortality from these vaccines, that information would be in the first paragraph of the announcement.

There is no information about how long any protective benefit from the vaccine would persist. Antibody response following covid-19 appears to be short lived. Based on what we know, the covid vaccine may require two shots every three to six months to be protective. The more shots required, the greater the risk of side effects from sensitization to the vaccine.

There is no information about safety. None. Government agencies like the Centers for Disease Control (CDC) appear to have two completely different standards for attributing deaths to covid-19 and attributing side effects to covid vaccines. If these vaccines are approved, as they likely will be, the first group to be vaccinated will be the beta testers. I am employed by a university-based medical center that is a referral center for the West Texas region. My colleagues include resident physicians and faculty physicians who work with covid patients on a daily basis. I have asked a number of my colleagues whether they will be first in line for the new vaccine. I have yet to hear any of my colleagues respond affirmatively. The reasons for hesitancy are that the uncertainties about safety exceed what they perceive to be a small benefit. In other words, my colleagues would prefer to take their chances with covid rather than beta test the vaccine. Many of my colleagues want to see the safety data after a year of use before getting vaccinated; these colleagues are concerned about possible autoimmune side effects that may not appear for months after vaccination.

These announcements by Pfizer and Moderna are encouraging. I certainly hope that these vaccines protect people from the harm of covid-19. I certainly hope that these vaccines are safe. If both of these conditions are true, nobody will need to be coerced into taking the vaccine. However, you should pay even more attention about what is left out of an announcement than about what is stated. The pharmaceutical companies are more than happy for patients to misunderstand what is meant by efficacy. Caveat emptor (buyer beware)!Author:

Gilbert Berdine, MD

Gilbert Berdine is an associate professor of medicine at Texas Tech University Health Sciences Center and an affiliate of the Free Market Institute at Texas Tech University.

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