Naobios partners with European Vaccine Initiative to accelerate RSV vaccine development

EUROPE—Naobios, a Contract Development and Manufacturing Organization (CDMO) specializing in bioprocess development and the GMP production of clinical batches of virus-based products, has announced a new collaboration with the European Vaccine Initiative (EVI).

EVI is a leading European non-profit Product Development Partnership (PDP), and together, they will work on manufacturing a Respiratory Syncytial Virus (RSV) challenge agent.

This collaboration forms part of the Inno4Vac project, a public-private partnership led by EVI and funded by the Innovative Health Initiative.

Inno4Vac’s goal is to overcome scientific challenges in vaccine development, particularly through the use of Controlled Human Infection Models (CHIM).

Although financial details of the agreement have not been made public, it is known that Inno4Vac receives funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 101007799.

This initiative is supported by the European Union’s Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

Naobios has a proven track record in developing Human Viral Challenge Agents (HVCA) for clinical trials globally.

These agents are used in controlled clinical trials known as CHIM, where volunteers are exposed to a carefully calculated pathogen dose.

This method helps test the effectiveness of vaccines or treatments. Naobios has successfully developed and manufactured 15 GMP batches for various viral strains, including SARS-CoV-2, RSV, and hMPV.

By utilizing this innovative approach, the company is able to accelerate the vaccine development process significantly.

Eric Le Forestier, the general manager of Naobios, emphasized that the company’s cutting-edge facilities and expertise in challenge agent manufacturing allow them to address critical global needs in virology.

He highlighted that this partnership with EVI is a significant step toward leveraging HVCA to speed up the development of vaccines, especially in regions facing challenges with preventing virus outbreaks.

Once the HVCA is developed to cGMP standards, it will play a key role in CHIM studies.

These studies, which are conducted in countries like the US, the UK, the Netherlands, and Belgium, will provide early and cost-effective evaluations of RSV vaccines.

This will ultimately help accelerate the development of affordable and effective vaccines against RSV.

A 2019 report by the World Health Organization (WHO) highlighted RSV as a major cause of severe respiratory illness.

The study estimated that RSV leads to around 33 million cases of acute lower respiratory infections each year, resulting in over 3.2 million hospitalisations and up to 149,400 deaths, primarily affecting young infants.

The burden of RSV is particularly high in low- and middle-income countries, especially in Sub-Saharan Africa, where easily accessible vaccines could make a significant difference.

Ole Olesen, executive director of EVI, noted that CHIM studies are a powerful tool for accelerating the traditional vaccine development process.

These studies can help bring new vaccines to market by generating early evidence of vaccine efficacy.

He also emphasized the importance of Naobios’ high-quality HVCA in ensuring the success of their joint efforts in combating RSV.

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