MAKING THE IMPOSSIBLE
POSSIBLE

3MEUR for COVID19 vaccine awarded to KI

2020-03-09

CAMP HQ plasmid and pre-GMP projects pave way for Corona vaccine project

Matti Sällberg from Karolinska Institutet is leading a consortium that has been awarded 3 million Euros from the European Commission in the recent emergency funding call for development and phase I clinical trial testing of a DNA vaccine against COVID19.

Named ’OpenCorona’ the project will utilise the recent partnership established between the Karolinska Institute pre-GMP facility and contract manufacturer Cobra Bio under the CAMP project ”Harmonizing HQ plasmid production between pre-GMP and GMP sites” and facilities established under the pre-GMP CAMP project.

Matti Sällberg and Gustaf Ahlén at the Department of Laboratory Medicine, Karolinska Institutet, will lead the project to develop a vaccine against the coronavirus, a process they began already in January 2020. As a DNA vaccine, the plasmid is delivered to patient muscle, which then produces a viral antigen against which the immune system reacts. They plan to start testing in animal models within a couple of weeks and to have humans trials in 2021 at the Karolinska University Hospital. Other partners include Karolinska University hospital, FoHM, IGEA, Adlego AB and Giessen University.

Funding of this project is confirmation of Sweden’s world class capacity to lead the science and manufacture of DNA based vaccines from academic science to pre-GMP and to the final product for patient delivery.

In terms of ATMP classification, if the developed vaccine product treats pathologies caused by the infection it would be classified as a GTMP, if it only treats/prevent the viral infection, it is classified as a vaccine. DNA vaccines can be classified as either ATMPs/GTMPs or medicinal products.

LINKS:

https://www.ema.europa.eu/en/documents/presentation/presentation-advanced-therapy-medicinal-products-atmps-support-developers-p-celis_en.pdf

https://news.ki.se/three-ki-led-coronavirus-projects-selected-in-eu-funding-round