COMMENT | How to manage vaccine liability in Malaysia
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COMMENT | Public confidence is crucial for the success of Malaysia’s Covid-19 immunisation programme. To build public confidence in the vaccine, we must answer the question of “what happens if there’s an adverse event from the vaccine?”. We would like to explain the situation and propose a framework to manage liability arising from the rare occasions of an adverse event.
For a start, we would like to firmly state that the currently available data for the Pfizer/BioNTech vaccine shows a strong safety profile. The risk of a serious adverse event from a vaccine is extremely low. Among 20 million people worldwide already vaccinated so far with the Pfizer/BioNtech vaccine, the overall adverse event rate reported was approximately 0.02 percent . That is much safer than the effects of actually getting Covid-19.
On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued a Fifth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act.
Tom Shimabukuro, MD, MPH, MBA; Narayan Nair, MD
Great expectations have been placed on the ability of vaccines to bring an end to the current severe acute respiratory syndrome coronavirus 2 pandemic. Nonpharmacologic interventions have resulted in social disruption and disastrous financial consequences for many people.
1 Widespread immunity acquired from a vaccine is anticipated to enable return to a more normal lifestyle. The extraordinary progress in vaccine development and evaluation achieved under Operation Warp Speed, followed by rapid Food and Drug Administration (FDA) authorization, is one of the greatest achievements in vaccinology since development of polio vaccines.
No medical intervention, including vaccines, is devoid of adverse reactions for all people. In recognition of this fact, Congress passed the National Childhood Vaccine Injury Act of 1986 that created the national Vaccine Injury Compensation Program (VICP).
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On January 28, 2021, the Department of Health and Human Services (HHS) issued a Fifth Amendment to HHS’s Declaration under the Public Health Readiness and Emergency Preparedness Act (PREP Act) that provides liability immunity to certain individuals and entities arising from the manufacturing, distribution, administration or use of medical countermeasures (e.g., therapeutics and vaccines) against COVID-19.
According to HHS, the new Secretary of HHS “has determined that there is an urgent need to expand the pool of available COVID-19 vaccinators in order to respond effectively to the pandemic.” Accordingly, the Fifth Amendment to the PREP Act Declaration expands the pool of eligible vaccinators in two ways:
Wolters Kluwer Health: Chief Nurse at Wolters Kluwer and Critical Care Nurse Practitioner Discusses HHS Public Readiness and Emergency Preparedness (PREP) Act
Wolters Kluwer:
What: The U.S. Department of Health and Human Services (HHS) issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified persons authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the U.S. Food and Drug Administration. This action would enable retired or inactive doctors and nurses to administer COVID-19 vaccines.
Why: Creative solutions are needed urgently as the U.S. struggles to disseminate COVID-19 vaccine doses quickly and efficiently to millions of Americans, however there are downstream implications of such changes for hospitals and health systems that are already underwater. A cohesive and rapid onboarding strategy at these facilities is needed to ensure the burden of support