AZIERTA Collaborates with REIG JOFRE to make possible the manufacture of JANSSEN’S Vaccine in Spain

The science and health consultancy firm has supported the Catalonian pharmaceutical company in biosecurity areas

Madrid, 11 May 2021

AZIERTA, a consultancy firm specialised in science and health, has completed a biosecurity project for the pharmaceutical company Reig Jofre, in order to ensure the biosecurity level necessary for handling the vaccine of the Belgium company Janssen Pharmaceutical, of Johnson & Johnson Group. The support provided by AZIERTA has been based on the comprehensive review of the information available on the organism used for manufacturing the vaccine, as well as the activities to be fulfilled at Reig Jofre facilities in order to identify the possible biosecurity risks derived from them. In parallel, a detailed study has been already carried out on the existing regulations and literature, as well as the relevant background.

The COVID-19 vaccine developed by Janssen was approved by the EMA on 11 March, 2021, and ratified last 20 April. This vaccine is based on a genetically modified adenovirus (hereinafter, GMO) in order to present the gene encoding the spike S protein of SARS-CoV-2. Therefore, this vaccine does not contain the virus as such and, consequently, cannot cause the disease.

In addition to the investigation and development that lead to obtaining them, the challenge in the management of these GMOs is, therefore, their subsequent classification. This will condition the containment measures and the conditions of contained use that all manufacturing plants, research and analysis areas, and final distribution areas must have. As the GMOs to be used may be organisms, plants or animals, the characteristics of safety, pathogenicity or environmental risk of the recipient organisms, the genetic material of the donor used, the vector and the resulting GMO will be considered. This will lead to a GMO classification in the biosecurity level (BSL) and the activities of contained use of GMO will be included in one of the four types of activities established.

In addition, according to the current regulations, the contained use, voluntary release and marketing of genetically modified organisms (GMO) must be authorised by the Interministerial GMO Council (CIOMG – Consejo Interministerial OMG) that, together with the evaluation performed by the National Biosecurity Commission (CNB- Comisión Nacional de Bioseguridad), provides scientific and legal guarantee to perform this type of activities.

In this context, the thorough work performed by the scientific team of the scientific consultancy firm AZIERTA for the pharmaceutical company Reig Jofre has allowed to obtain the optimum risk classification from the viewpoint of security, based on the detailed justification made of the existing risks. Furthermore, AZIERTA has coordinated the notifications of contained uses and the obtention of the required authorisations from the Interministerial Council and the National Biosecurity Commission. It is estimated that, from next June, Reig Jofre will be ready to produce over 250 million vials of vaccines a year.

Azierta CEO, Ángel Navarro, has expressed his “great satisfaction” with the job of the company in collaboration with the Catalonian company, which will reserve up to 80% of its production capacity to the manufacturing needs of this product. “Reig Jofre has placed its trust in us and together we have performed a dynamic, sound team work, that in the next months will contribute to our country returning to normal”, he assured. Navarro has also highlighted that Azierta feels very “proud” of being part of “the solution to this pandemic crisis”. “Science saves lives and this is a clear example of it”, he concluded.

Contact:

Pablo Navarro (Dircom)                                                               Elena Díaz Dapena (Media)

pnavarro@azierta.com I (+34) 627 973 657                     ediaz@azierta.com I (+34) 677 097 922