CDMO to manufacture SARS-CoV-2 intranasal vaccine

The National Institutes of Health (NIH) has chosen contract research, development, and manufacturing organisation (CRDMO) Exothera SA to develop the manufacturing process for its intranasal vaccine against SARS-CoV-2 coronavirus to treat COVID-19.

As an alternative drug delivery method to traditional injected vaccines, live, replicating, intranasal vaccines have potential for effectively interrupting transmission of COVID-19 by inducing the development of immunity in the respiratory tract.

Intranasal vaccines have previously been used to immunise against conditions such as respiratory viruses, measles and rubella.

NIH’s vaccine candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials, produced in an A549 cell line.

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What will the intranasal vaccine manufacturing project involve?

Exothera will generate current good manufacturing practice (cGMP) material using NIH’s current manufacturing and analytical processes for use in US and African Phase I/II clinical trials.

Prior to manufacture in Exothera’s good manufacturing (GMP) facility in Jumet, Belgium—tech transfer, stability study, CMC study, AS development and QC testing of the intranasal vaccine will be conducted. The Belgian facility is one of the biggest dedicated viral vectors plants in Europe. It can facilitate projects from development through to commercial manufacturing.

Exothera is dedicated to viral vector and nucleic acids production. Hanna Lesch, the company’s Chief Technology Officer announced that it is “proud NIH selected us for this project”.

As part of the Cooperative Research and Development Agreement (CRADA), researchers from Dartmouth Health’s Dartmouth Hitchcock Medical Center (DHMC) and Dartmouth’s Geisel School of Medicine will also be part of the intranasal vaccine manufacturing project.

“We are pleased to join this collaborative effort to develop and assess the safety, immunogenicity, and effectiveness of an adenovirus type 4-based vaccine expressing the SARS-CoV-2 spike protein as a novel approach to the prevention of COVID-19,” commented Dr Peter Wright, infectious disease, and international health physician at Dartmouth Health’s Dartmouth Hitchcock Medical Center (DHMC) and Professor of Paediatrics at Dartmouth’s Geisel School of Medicine.