J&J to receive almost €50m in grants to help manufacture Ebola vaccines

EFPIA has given J&J subsidiary Crucell Holland and partner Bavarian Nordic €47.6m ($54.9m) to accelerate development of an candidate Ebola vaccine.

The grant is in addition to funding already provided by the Innovative Medicines Initiative (IMI) – a partnership between EFPIA and the European Union – and brings the total given to Johnson & Johnson (J&J) to €100m ($115m).

The money is being used speed up both the development and production of J&J’s Ebola vaccine candidate and to fund a patient education programme. Specific projects include three focused on accelerating clinical trials.

A Phase I trial led by Oxford Vaccines Group is currently underway with studies in Africa being planned.

The Phase II and III trials in Europe and Africa, subject to review of the preliminary Phase I data, will be carried out in parallel, J&J said. A fourth project will investigate ways and technology to raise awareness and acceptance of vaccination campaigns.

Professor Andrew Pollard and Matthew Snape, who are leading the Phase I and II Ebola vaccine trials at the University of Oxford for IMI, said "the initial testing of vaccines for Ebola is already underway at the University with an astonishing response from the public to volunteer for the trials, to provide the earliest possible information to guide further studies of a prime boost vaccine, that if approved, may help control the Ebola outbreak in West Africa."

Manufacturing

Crucell, in partnership with Bavarian Nordic, has already produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015.

A total of 2 million regimens is projected to be available throughout 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period.

One of the primary reasons more vaccines have yet to be manufactured is that Ebola vaccines can only be manufactured in facilities with an appropriate biosafety rating.

Relatively few manufacturers have the biosafety rating required for the manufacture of Ebola vaccines, and this is slowing down the production of vaccine candidates,” according to the European Commission.

In the short term, the funding from IMI and EFPIA will ensure the delivery of sufficient quantities of two vaccine regimens to support the developing clinical trials. The funding will also help create additional vaccine production capacity to allow for the rapid preparation of large quantities of vaccines.

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