Emergent to make Novavax’s Covid-19 vaccine candidate for Ph I trials

Emergent says Covid-19 vaccine candidate it is making for Novavax will be ready for trials within four months.

Novavax hired Emergent BioSolutions to make the experimental vaccine this week. The vaccine was developed using Novavax’s recombinant protein nanoparticle platform and Matrix-M adjuvant technology.

Emergent said it has already started work on making clinical trial supplies of the vaccine, explaining that drug substance will be produced at the Baltimore-Bayview facility while the product itself will be made at its Baltimore-Camden plant.

Image: iStock/CasPhotography

The firm also said it has mobilized its integrated clinical and commercial development and manufacturing network to provide development services out of its Gaithersburg, Maryland location as well as manufacturing services out of its two Baltimore, Maryland facilities.

Emergent predicted the candidate will enter Phase I development within four months.

CEO Robert Kramer highlighted Emergent’s history of vaccine and therapeutics development and manufacturing as key to its efforts.

“The increasing threat of COVID-19 requires a comprehensive response and we continue to evaluate various vaccine, therapeutic, and CDMO approaches to enable us to marshal resources to make a meaningful impact on this global public health emergency.”

Vaccines and CDMOs

The number of Covid-19 vaccine candidates in development has increased rapidly in the past few weeks.

Sanofi Pasteur is working to reverse engineer proteins isolated from the virus to produce DNA-based vaccine.

Johnson & Johnson’s unit Janssen Pharmaceutical is looking to repurpose developmental vaccines against Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS).

More recently GlaxoSmithKline teamed with Clover Biopharmaceuticals to help develop a preclinical protein-based vaccine candidate.

Likewise Vir Biotechnology and Alnylam Pharmaceuticals expanded a collaboration to include development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes Covid-19

Moderna Therapeutics recently shipped the first batch of a messenger RNA vaccine mRNA-1273 to the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase I study.