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FDA Accepts Biologic License Application for Merck's Ebola Vaccine

SEP 17, 2019 | MICHAELA FLEMING
The US Food and Drug Administration (FDA) has accepted a Biologic License Application for the investigational Ebola vaccine V920, Merck announced today. The vaccine was also granted priority review for the prevention of Ebola Zaire virus.

The vaccine, which is also referred to as rVSV-ZEBOV-GP, has been deployed for use in the ongoing Ebola outbreak in the Democratic Republic of the Congo. In July 2016, the vaccine was granted a Breakthrough Therapy Designation by the FDA.

According to Merck, the vaccine was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and then licensed to a subsidiary of NewLink Genetics Corporation. During the western Africa Ebola outbreak in 2014, Merck licensed the vaccine and began working with external collaborators to bolster a clinical development program.

The program has received funding from the US Department of Health and Human Services’ (HHS) Biomedical Advanced Research Development Authority and the Department of Defenses’ Threat Reduction Program, along with the Joint Vaccination Acquisition Program and others.

According to the WHO’s latest situation report, 217,172 individuals in the Democratic Republic of the Congo have been vaccinated with the investigational candidate.

Since May 2018, Merck has donated and shipped more than 245,000 doses of the investigational vaccine to the World Health Organization (WHO). Additionally, more than 190,000 doses are currently available to ship if the WHO requests.

In June, Merck initiated updating a replenishment strategy to increase the supply of the vaccine, following consultation with HHS, WHO, and Gavi the Vaccine Alliance. Under this strategy, an estimated 650,000 doses of the vaccine will be released and made available in phases over the next 6-to-18 months. Therefore, the total number of doses will amount to more than 900,000.

“We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak. Merck appreciates and continues to work closely with our collaborators and is inspired by the relentless determination of everyone involved, especially frontline responders, working to contain this unique and dangerous outbreak,” Paula Annunziato, MD, vice president, Merck Research Laboratories, said in Merck’s statement.

The Prescription Drug User Fee Act, or target action date, for V920 is set for March 14, 2020.
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