Gavi Says 1.3 Million Doses Of Merck’s Ebola Vaccine Will Be Made Available; MSF Says Field Supply “Extremely Low” & “Sporadic”

There is no shortage of Merck’s life-saving Ebola vaccine on the ground in the Democratic Republic of Congo, and more doses will be produced, sufficient to immunise 1.3 million people over the next 6-18 months, a spokesman for Gavi, the Vaccine Alliance, told Health Policy Watch on Tuesday. Meanwhile, Merck, producer of the V920 investigational vaccine, confirmed that it is ramping up production in both US and German production sites to make more vaccines available as soon as possible.

But those upbeat statements, contrast sharply with reports by Médecins Sans Frontières (MSF) from ground zero of the outbreak in the Democratic Republic of Congo, where vaccine stocks are reported to be “extremely low”, supply is “sporadic”, and a ring vaccine strategy focused on immunising contacts of Ebola victims is no longer sufficient to contain the disease outbreak, extending across some 500 square kilometres, and to the borders of Rwanda and Uganda.

Health worker administers Merck vaccine in Ugandan community of Kirombe, near DRC border.

Merck Says Vaccine Available Right Now for Shipment

“We have informed our collaborators that there are 245,000 1.0 mL doses currently in Merck control and available for shipment,” said Pam Eisele, a spokesperson for Merck, in an emailed response to a query by Health Policy Watch. Based on the current dosing strategy of .5mL, that would be enough vaccine to immunise nearly 500,000 more people.

“Beyond the doses already donated and shipped to the WHO, Merck is now forecasting a cumulative targeted investigational supply of ~900,000 1.0 mL doses over the next 6 to 18 months,” Eisele added. “These new doses will be produced by both leveraging efforts at our manufacturing facility in Germany as part of ongoing registration activities, and temporarily, leveraging a clinical manufacturing facility the company has in the United States.”

The Merck supply can cover “an additional 1,300,000 people” over the next 6-18 months, said a Gavi spokesman, noting the fact that the recommended vaccine dose has been halved from 1.0 mL to .5mL.

“We have not experienced any shortage of vaccine so far during this outbreak and there is enough vaccine on the ground to meet the current needs based on the current vaccination strategy,” said the spokesman, who asked not to be referred to by name. However, he cautioned that “whether or not the increased doses are sufficient to fulfill the demands depends on the evolution of the outbreak, access to the communities on the ground and evolution in vaccination response strategy.”

MSF Sees a Different Picture on the Ground

However, the Gavi and Merck statements contrast sharply with the picture painted by MSF field workers. In comments relayed from the DRC, Isabelle Defourny, MSF Director of Operations, said “DRC’s stock of vaccines is extremely low, usually less than 1,000 doses.”

“With its supply only sporadic, and issues with contact tracing, we’re not yet able to say this is an emergency response strategy,” she added, referring to last week’s World Health Organization declaration of the outbreak as Public Health Emergency of International Concern.

“People in DRC understand the usefulness of vaccination and, in fact, are asking to be immunised. However, with just around 50 contacts of one confirmed case vaccinated, it’s likely that only one-quarter to one-third of those at risk are protected,” she observed.

Defourny said that a broader vaccination strategy should be adopted, in line with recommendations already made by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) in May, involving faster use of the Merck vaccine as well as “testing” of other alternative vaccines – a clear reference to a second formulation in-the-waiting, produced by Johnson & Johnson.

“The number of people vaccinated is too small to contain the spread of the epidemic,” Defourny said in her remarks, noting that contact identification must be carried out in communities in a contact zone, beset by high levels of mistrust.

“Until now, the main obstacle to implementing extended vaccination has been the small stock of Merck vaccine — the only one shown to be effective in an epidemic,’’ she said. “In May, the [WHO] SAGE group’s experts recommended modifying the vaccination strategy in DRC so that more people can be vaccinated. If, indeed, more doses are available, then “there is no longer any good reason for not immediately stepping up vaccination,” she stressed.

Issues of vaccine strategy and supply have dogged the Ebola crisis for the past 10 days.

At a high level meeting convened by the UN’s Office for the Coordination of Humanitarian Affairs on 15 July, Wellcome Trust’s Josie Golding suggested that the second trial vaccine, produced by Johnson and Johnson, and currently warehoused in Europe, should be deployed as a second-line response to combat the widening circle of infection, reserving the more limited quantities of the Merck formulation for front-line response.

However, DRC’s government, which must agree, has so far resisted introducing a second formulation, which some fear could fuel miscommunication after a hard-won battle to gain acceptance for the Merck vaccine, which has proven to be highly effective as well as fast-acting. The J&J formula, while apparently effective against more diverse strains of Ebola, takes much longer to provoke immunity and while it has been tested in healthy volunteers, it has not ever been deployed in actual field conditions.

On Monday, outgoing DRC Health Minister Oly Ilunga, blew open any semblance of unity between government and aid workers. In his parting remarks before resigning, Ilunga blasted what he described as pressures by unnamed actors to introduce the second vaccine, saying that it didn’t have the field record of the Merck formulation, and therefore would mean an “experiment” with people in the DRC.

Meanwhile, over 1700 people have died from the DRC Ebola epidemic since the outbreak began, including new cases daily over the past week, in the city of Beni and other areas in the North Kivu and Ituri regions where the outbreak has been centered. Some 729 people have recovered, according to the most recent DRC Health Ministry reports.

Image Credits: WHO/AFRO.

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