Gavi, The Vaccine Alliance Approves New Ebola Vaccine Stockpile Of 500,000 Doses

Gavi, the Vaccine Alliance approved on Thursday an investment of US$178 million over the next five years to establish a global stockpile of 500,000 doses of Ebola vaccines that have been “pre-qualified” by the World Health Organization –  WHO’s quality seal of approval that also makes vaccines and drugs eligible for preferential terms of purchase and use in countries. An additional US$11.6 million was allocated by the Gavi Board to fund three ongoing pilots for the world’s first malaria vaccine in Kenya, Ghana, and Malawi, to assess the feasibility of rolling out the vaccine more widely in Africa as part of national vaccine programmes.

“Let me highlight two decisions: first is the… creation of a new Gavi Support for Ebola programme, which includes creation of a global stockpile of WHO-prequalified Ebola vaccines,” Gavi CEO Seth Berkley announced in a press conference following the Board meeting in Delhi, India on Thursday.

“The second is the continuation of funding for the world’s first malaria vaccine, and this is funding for vaccine pilots that are taking place in Malawi, Ghana, and Kenya, vaccinating about 360,000 children per year,” he added.

A healthcare worker gives a child a dose of the malaria vaccine, RTS,S.

The moves represent new strategic directions for the international private-public partnership, which until recently had focused mostly on strengthening routine vaccination systems in low- and lower-middle-income countries. While the organization currently manages the global Yellow Fever vaccine stockpile for outbreak response, and supports vaccines for eight other diseases, Berkley noted that this is the first time the Board has  supported creation of a stockpile for a brand-new vaccine for a disease such as Ebola, which will come with its own set of challenges.

As of now, only one Ebola vaccine, Ervebo, which is produced by Merck & Co. and received regulatory approval by the European Medicines Agency just last month, followed by WHO prequalification approval , is eligible to be included in the global stockpile. But the stockpile, which will aim to hold at least 500,000 doses, may be expanded as new Ebola vaccines hit the market, Berkley said.

There there are currently 7 other candidate vaccines for the Zaire strain of Ebola, the most common strain of the virus, Berkley noted. A second Ebola vaccine candidate, developed by Johnson & Johnson, recently began clinical trials in the Democratic Republic of Congo, which has been wracked by an Ebola outbreak that lasted for more than a year, killing over 2000 people.

A second Board decision voted to continue Gavi’s support for landmark pilots of the world’s first malaria vaccine, RTS,S in Malawi, Kenya, and Ghana that began this year, aiming to assess the feasibility for rolling out the vaccine on a national scale in other African countries with a moderate- to high-malaria burden. The vaccine requires four separate doses, which can be difficult to deliver to populations with low access to health care.

From 2021 to 2023, Gavi will allocate US $11.6 million towards funding these pilots, which represents approximately 50% of the total funding needs. The remaining 50% will be funded by the Global Fund for AIDS, Tuberculosis, and Malaria, and Unitaid.

The two major decisions were made at the last meeting of the Gavi Board before the private-public partnership holds its next replenishment conference in London on June 4, 2020, hosted by the United Kingdom. The organization hopes to raise US $7.41 billion to fund its next cycle of activities from 2021-2023.

Gavi’s Two-Part Ebola Support Program

According to Berkley, Gavi’s new Ebola Support Program will be composed of two main components; managing a global stockpile of vaccine for future outbreaks, and looking into potential preventative use of the Ebola vaccine.

Countries that are eligible for Gavi vaccine donations, will be able to access the stockpile free of charge and will also receive support for operational costs. Non-Gavi-eligible countries can still access the stockpile but will need to eventually pay Gavi back for the vaccines and cover their own operational costs.

A health care worker preparing a dose of Ebola vaccine

The organization will also be looking into ways the Ebola vaccine can be used outside of outbreak settings. There have been 29 outbreaks of Ebola virus on record since the virus was first identified, although only the West African 2014-2016 outbreak and the ongoing outbreak in the DRC have surpassed 400 cases. Thus, it is unclear whether huge outbreaks would be the norm in the future, and Gavi must be prepared to take an “active learning agenda” in establishing its new Ebola support program, especially with an eye towards learning how best to carry out preventative vaccination, says Berkley.

Up until now, the candidate Ebola vaccines have only been used during the two recent big outbreaks, Berkley noted.  The Merck vaccine, and now the Johnson&Johnson candidate, have been deployed under “compassionate-use” protocols, which allow new health products that have demonstrated safety and efficacy but may not have finished full regulatory processes, to be used in emergency settings.

“The obvious countries [to consider for preventative vaccination] are those that have indigenous transmission of Ebola… We could also consider countries that have transmission of Ebola through travelers. We suspect it will include workers in hospitals, in front-line clinics, lab workers,” said Berkley.

Front-line health workers bore the brunt of the brutal outbreak in West Africa from 2014-2016, where its estimated that health care workers had more than 21 times the risk of contracting Ebola than the average person. Berkley said that preliminary modelling done by Gavi suggests that preventative vaccination in 10% of the healthcare workforce, targeting those working in areas likely to see outbreaks, might help protect those most at risk in a future outbreak, although more work needs to be done to clearly outline a preventative vaccination strategy.

 

Image Credits: WHO/M. Nieuwenhof, Twitter: @WHO.