RCS - IAVI - IAVI to advance Sudan Ebola vaccine candidate

Merck & CoAnnouncement

25/10/2022 13:15

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RNS Number : 9627D  IAVI  25 October 2022

 IAVI to Accelerate Promising Investigational Sudan Ebolavirus Vaccine
Development for Potential Outbreak Research and Response

Merck will provide the investigational vaccine based on a proven platform
technology

NEW YORK, NY / ACCESSWIRE / October 25, 2022 / IAVI
(https://pr.report/9uhVjowH) , a nonprofit scientific research organization,
and Merck, known as MSD outside the United States and Canada, have entered
into an agreement that could enable IAVI to accelerate the entry of a
promising Sudan ebolavirus (SUDV) vaccine candidate that IAVI is developing
into clinical evaluation in response to the rapidly spreading outbreak of SUDV
disease in Uganda.

Merck plans to produce and provide vials of candidate vaccine from existing
investigational drug substance to IAVI to supplement IAVI's ongoing SUDV
vaccine development program. The investigational vaccine being produced is
based on the same vesicular stomatitis virus (VSV) viral vector platform that
is used in ERVEBO®, Merck's highly efficacious, single-dose Zaire ebolavirus
(EBOV) vaccine that has achieved regulatory approval by the U.S. FDA, the
European Medicines Agency (EMA) and a number of regulatory authorities in
Africa.

IAVI and Merck have been in discussions with the World Health Organization
(WHO), the Coalition for Epidemic Preparedness Innovations (CEPI), and other
stakeholders regarding the potential production and supply of doses of
investigational SUDV vaccine to help support the WHO's efforts to conduct a
clinical trial of vaccine candidates in Uganda, in partnership with the
Government of Uganda.

Mark Feinberg, M.D., Ph.D., president and CEO of IAVI, said, "We are grateful
to Merck for supplying the vaccine material, and we look forward to the
opportunity to demonstrate vaccine effectiveness and safety so that we are
prepared for future outbreaks of SUDV, as well as the SUDV outbreak in Uganda
should it not be promptly contained by public health measures alone. Outbreak
response is more effective at containing disease spread when countermeasures
work quickly, and we are hopeful that this one-dose vaccine, which is likely
to generate a rapid immune response, will be a critical part of Sudan virus
containment efforts in the future."

"We are proud to work together with IAVI in support of the World Health
Organization's response to address the Sudan Ebola outbreak in Uganda," said
Beth-Ann Coller, executive director, Global Clinical Development Vaccines,
Merck Research Laboratories. "We are moving with urgency to prepare these
vials and donate them to IAVI as quickly as possible to help support the
efforts of the WHO and the people of Uganda as they grapple with this
outbreak."

Production schedules and quantities are still being defined. Based on the
quantities of available bulk drug substance and current plans, Merck hopes to
be able to deliver approximately 55,000 doses by the end of the year. IAVI is
actively working to accelerate the manufacture of additional doses of IAVI's
VSV-SUDV vaccine should they be needed. The number of doses provided by Merck
should be sufficient for conducting Phase I and efficacy studies as well as
for public health response if the outbreak in Uganda continues or spreads and
should the vaccine be shown to be safe and efficacious.

IAVI will act as developer and regulatory sponsor and will be responsible for
all aspects of future development of the vaccine candidate.

No SUDV vaccines have been approved to date, and existing EBOV vaccines and
treatments are not effective against SUDV. In the midst of the ongoing SUDV
disease outbreak, ensuring that all promising vaccine candidates are evaluated
for safety and efficacy could enable vaccine stockpiles to be established for
use in future outbreaks.

Vesicular stomatitis virus is the vector that underpins ERVEBO(®) as well as
IAVI's portfolio of emerging infectious disease vaccine candidates
(https://pr.report/QYbe2Tku) . These include the SUDV vaccine candidate
supported by the Biomedical Advanced Research and Development Authority
(BARDA) at the U.S. Department of Health and Human Services; a Lassa fever
virus vaccine candidate currently in a Phase I trial
(https://pr.report/zqnMSCTJ)  and supported by the Coalition for Epidemic
Preparedness Innovations (CEPI) and the European & Developing Countries
Clinical Trials Partnership (EDCTP); a Marburg virus vaccine candidate
supported by the Defense Threat Reduction Agency (DTRA) of the U.S. Department
of Defense (DOD) and BARDA; and an intranasal SARS-CoV-2 vaccine candidate
supported by the Japan Ministry of Finance. VSV is a harmless animal virus; in
the vaccine platform, it is engineered to encode a surface protein from a
target pathogen - in this case, SUDV - that stimulates an immune response.

IAVI holds a nonexclusive license to the VSV vaccine candidates from the
Public Health Agency of Canada (PHAC). The vector was developed by scientists
at PHAC's National Microbiology Laboratory.

About IAVI

IAVI is a nonprofit scientific research organization dedicated to addressing
urgent, unmet global health challenges including HIV, tuberculosis, and
emerging infectious diseases. Its mission is to translate scientific
discoveries into affordable, globally accessible public health solutions. Read
more at iavi.org (https://pr.report/jTKfhGmr) .

Funders who have made the development of IAVI's VSV-vectored vaccine
candidates possible include the Bill & Melinda Gates Foundation; the
Government of Canada; the Danish Ministry of Foreign Affairs; the Government
of Japan; the Irish Department of Foreign Affairs and Trade; the Netherlands
Ministry of Foreign Affairs; the Norwegian Agency for Development Cooperation;
the U.K Department for International Development; the U.S. National Institutes
of Health (NIH); and through the generous support of the American people from
the United States Agency for International Development (USAID).

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IAVI Media Contact

Karie Youngdahl

Head, Global Communications
kyoungdahl@iavi.org (mailto:kyoungdahl@iavi.org)

+1 332-282-2890

SOURCE: IAVI

 

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