Merck & Co – known as MSD outside the US and Canada – has announced that, in response to the Sudan Ebola virus outbreak in Uganda, it is planning to produce and donate doses of its investigational Sudan Ebola virus vaccine candidate to the International AIDS Vaccine Initiative (IAVI), a global nonprofit scientific research organisation, for further clinical research use.
Merck said it expects to provide about 50,000 doses to IAVI by the end of 2022 and is working with the organisation towards a formal agreement.
The doses will be produced from the existing investigational bulk drug substance previously manufactured by Merck and are intended to be used as part of the World Health Organization’s (WHO’s) efforts to fight the outbreak in Uganda.
There have been more than 90 confirmed and probable cases of Ebola in Uganda since the start of the outbreak, including at least 44 deaths, according to WHO.
“We are moving with urgency to prepare these vials and donate them to IAVI as quickly as possible to help support the efforts of WHO and the people of Uganda as they grapple with this outbreak,” said Beth-Ann Coller, executive director, global clinical development vaccines, Merck Research Laboratories.
The virus circulating in Uganda is the Sudan strain of Ebola, for which there is no proven vaccine, unlike the Zaire strain that has been the most common cause of Ebola outbreaks over the past 20 years.
The doses use a replication-competent, live, attenuated recombinant vesicular stomatitis virus vaccine construct, which is similar to that used for Merck’s Ervebo vaccine.
The Ervebo vaccine is approved in the UK, the EU, the US, Switzerland and ten countries in Africa as a single dose for adults 18 years and older, to protect against the Zaire Ebola virus..
Dr Mark Feinberg, president and chief executive officer of IAVI, said: “We are very grateful to Merck for supplying the investigational vaccine for IAVI, which will help accelerate IAVI’s programme. IAVI looks forward to working with partners responding to the ongoing Sudan Ebola outbreak to evaluate vaccine effectiveness and safety.
“We hope that our efforts may contribute to the response in Uganda should the outbreak persist, and also enable the world to be better prepared for future Sudan Ebola outbreaks.”
Πηγή: pmlive.com