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Merck Pharma: Is it ethical to put humans on trial?

In most Ebola outbreaks in the DRC — this is the country’s ninth — remote settings have been a mixed blessing. They make it hard for response teams to travel to and within the outbreak area. But they also minimize the risk the disease will spread to larger centers where more people would be at risk., reports Bloomberg Businessweek (Subscribe now in Pakistan).

The World Health Organization said it is putting everything in place to be able to use the experimental vaccine to help extinguish a worrisome outbreak in a remote area in the western part of the Democratic Republic of the Congo — though using the vaccine there will require some herculean efforts.

“This is a highly complex, sophisticated operation in one of the most difficult terrains on earth,” Dr. Peter Salama, WHO’s deputy director-general for emergency preparedness and response, said during a news conference in Geneva.

The country’s government still must agree to authorize the vaccine — which has not yet been licensed — under a compassionate use protocol, Salama said, adding the WHO expects to receive a go-ahead “in the coming days.”

“And in the meantime, we are preparing as if it will be a green light,” he said, noting that Gavi, the vaccine alliance, has agreed to pay for the vaccination campaign, if it occurs.

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There are currently 4,300 doses of Merck’s V920 vaccine in Geneva, held by the WHO, the company told STAT in an email. Merck has given its permission for that stock to be used in DRC.

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“Merck also is collaborating with WHO to provide additional doses beyond those already present in Geneva as needed to support the current response,” the company added. Merck has a stockpile of more than 300,000 additional doses in the United States.
Deploying vaccine will take military-like planning. For one thing, the vaccine must be kept at sub-zero temperatures — minus 76 to minus 112 Fahrenheit. In a region where electricity is spotty, that will require freezers and generators to maintain what is called the “cold chain.”

“This is not a simple logistical effort,” Salama said.

The epidemic, in and around a town called Bikoro, has set off major alarm bells. Although the outbreak was only declared on May 8, the WHO believes there may have already been at least 34 cases, including three health care workers, with infections dating back into April. Of those people, as many as 18 have already died; one of the health workers is among the dead.

In most Ebola outbreaks in the DRC — this is the country’s ninth — remote settings have been a mixed blessing. They make it hard for response teams to travel to and within the outbreak area. But they also minimize the risk the disease will spread to larger centers where more people would be at risk.

Bikoro’s link to major waterways connects it to a number of large cities. To the north there is Bangui (population 800,000), the capital of the Central African Republic. To the south is the DRC capital, Kinshasa (population 11.5 million), as well as Brazzaville (population 1.9 million), the capital of the neighboring Republic of the Congo. Salama said the WHO has put nine neighboring countries on high alert.

Closer still is Mbandaka, the provincial capital of Equateur, the province Bikoro is in. It has a population of about 1 million people.

“If we see a town of that size infected with Ebola, then we’re going to have a major urban outbreak, which is going to be a real challenge in order to respond,” Salama warned. “As we saw in … West Africa, once Ebola gets into urban areas, especially poor urban slums, it’s extremely difficult to get rid of the disease.”

Last year about this time there was another Ebola outbreak in DRC. The country’s health ministry was slow to authorize emergency use of the Merck vaccine then. By the time they agreed, the outbreak was contained and the vaccine was not used.

 

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