Excellent News For DRC [And Tanzanian?] Ebola Contacts — And For Merck…

Overnight in the EU, Merck’s vaccine, which it bought from NewLink, and then took on / financed / finished the related multi-jurisdictional global regulatory process. . . and now distributes. . . in sub-Saharan Africa. . . has won a conditional approval from the EMA. Decidedly good news, for. . . humanity.

As the bon mot oft’ intones, “a success has many parents” — and among those not getting enough due credit include the Canadian health agencies that pioneered the research in the early 1990s, even though they knew it would likely never be a money-maker, and to a lesser extent, then Iowa based NewLink, which in-licensed the Canadian project’s IP, and advanced in from 2010 to 2014. [Then of course there is Merck, nowhere mentioned in the WHO presser — but Mr. Frazier deserves humanitarian credit, here. And now he may. . . just make some coin, on it.]

This news means the rVSV-zEBOV-GP vaccine may be sold anywhere inside the EU, should a suspected outbreak occur. [As a practical matter, however, should any suspected outbreak occur on this side of the globe, given the clinical data already on file, US FDA would approve it immediately. It is awaiting final green-lighting here.]

There are others in development, and trials, including J&J’s two dose regimen — but Kenilworth holds the only one dose approved vaccine, with over 99 per cent efficacy, at two years longitudinal duration. Here’s a bit, from the WHO presser:

. . . .The World Health Organization (WHO) welcomes the European Medicines Agency (EMA) announcement recommending a conditional marketing authorization for the rVSV-ZEBOV-GP vaccine, which has been shown to be effective in protecting people from the Ebola virus. . . .

“The conditional authorization of the world’s first Ebola vaccine is a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “My deepest gratitude is to the studies’ volunteers, researchers, health workers in Guinea, other countries and the Democratic Republic of the Congo who have put themselves at risk to ensure people are protected with this vaccine.”

In the past five years, WHO has convened experts to review the evidence on various Ebola vaccine candidates, informed policy recommendations, and mobilized a multilateral coalition to accelerate clinical evaluations. The EMA review was unique in that WHO and African regulators actively participated through an innovative cooperative arrangement put in place by WHO, which will help accelerate registration for the countries most at risk.

A randomized trial for the vaccine began during the West Africa Ebola outbreak in 2015. When no other organization was positioned to run a trial in Guinea during the complex emergency, the government of Guinea and WHO took the unusual step to lead the trial.

A global coalition of funders and researchers provided the critical support required. Funders included the Canadian Government (through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre, Global Affairs Canada); the Norwegian Ministry of Foreign Affairs (through the Research Council of Norway’s GLOBVAC programme); the Wellcome Trust; the UK government through the Department for International Development; and Médecins Sans Frontières.

Anticipating that in coming years there will be higher Ebola vaccine demand during and between outbreaks, WHO is working with Gavi, UNICEF and other partners to develop a Global Ebola Vaccines Security Plan, as increased supply capacity and multiple manufacturers will be needed in the short- to medium-term to meet this demand and ensure vaccine security. . . .

There are eight vaccines undergoing clinical evaluation. WHO continues to work with partners towards an internationally coordinated governing mechanism to ensure access according to risk criteria, and manage supply and stockpiles, especially as supply will remain limited until a full manufacturing capacity is established or other vaccines are licensed. . . .

Now you know — onward to a great fall weekend. . . much joy to come. Grin.


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