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EUROPEAN UNION AND UNITED
STATES APPROVE MERCK’S EBOLA
VACCINE
Pamela Berkowsky
INTRODUCTION
A former Pentagon official, Pamela (Pam) Berkowsky is the president
of Blue Sapphire Strategies, a public affairs and business consultancy.
As an active champion of enhancements to DOD and government-wide
biodefense capabilities, and as the wife of otolaryngologist Dr. Adam
Shapiro, she maintains a deep concern about potential biological
threats to the United States, including infectious diseases such as
COVID-19, and a keen interest in the development of vaccines to treat
them.
In 2019, both the European Union and the US Food & Drug
Administration (FDA) announced approval of the world’s first
vaccine for the viral disease Ebola. Developed by Merck, the
vaccine Ervebo received conditional marketing authorization from
the European Medicines Agency, allowing it to be approved on an
accelerated schedule and with less required clinical data than a
typical new drug. Given the public health imperative, the FDA also
completed its evaluation of the safety and effectiveness of this
vaccine on an expedited timetable.
Ervebo underwent trials during ebola outbreaks in Guinea, and
the Democratic Republic of Congo, and in additional studies in
Liberia and Sierra Leone. Antibody responses to Ervebo were also
tested on individuals in Canada, Spain and the United States.
Administered as a single-dose injection, the vaccine is approved for
people over the age of 18 to protect against Ebola Zaire, the virus’
most common subtype.

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European Union and United States Approve Merck’s Ebola Vaccine

  • 1. EUROPEAN UNION AND UNITED STATES APPROVE MERCK’S EBOLA VACCINE Pamela Berkowsky
  • 2. INTRODUCTION A former Pentagon official, Pamela (Pam) Berkowsky is the president of Blue Sapphire Strategies, a public affairs and business consultancy. As an active champion of enhancements to DOD and government-wide biodefense capabilities, and as the wife of otolaryngologist Dr. Adam Shapiro, she maintains a deep concern about potential biological threats to the United States, including infectious diseases such as COVID-19, and a keen interest in the development of vaccines to treat them.
  • 3. In 2019, both the European Union and the US Food & Drug Administration (FDA) announced approval of the world’s first vaccine for the viral disease Ebola. Developed by Merck, the vaccine Ervebo received conditional marketing authorization from the European Medicines Agency, allowing it to be approved on an accelerated schedule and with less required clinical data than a typical new drug. Given the public health imperative, the FDA also completed its evaluation of the safety and effectiveness of this vaccine on an expedited timetable.
  • 4. Ervebo underwent trials during ebola outbreaks in Guinea, and the Democratic Republic of Congo, and in additional studies in Liberia and Sierra Leone. Antibody responses to Ervebo were also tested on individuals in Canada, Spain and the United States. Administered as a single-dose injection, the vaccine is approved for people over the age of 18 to protect against Ebola Zaire, the virus’ most common subtype.