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August 25, 2021

Coronavirus company news summary – EU approves new sites for Pfizer/BioNTech and Moderna vaccine manufacturing – Gennova moves India’s first mRNA jab into Phase II/III trials

By Chris Lo

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved additional production sites to manufacture the mRNA Covid-19 vaccines of PfizerBioNTech and Moderna for the European Union. Pfizer-BioNTech vaccine Comirnaty will be produced at a site run by Delpharm in Saint Rémy sur Avre, France. A new line at BioNTech’s manufacturing site in Marburg, Germany also secured approval. CHMP has further approved a site operated by Catalent to produce Moderna’s Spikevax jab in Bloomington, Indiana, US.

India’s first mRNA-based Covid-19 vaccine developed by Gennova Biopharmaceuticals is set to enter Phase II/III trials after demonstrating safety and efficacy in a Phase I trial. The vaccine, HGCO19, was tolerable and immunogenic in Phase I subjects. The Phase II/III trial received the Drugs Controller General of India’s approval to proceed and will be conducted at 10-15 sites in Phase II and 22-27 sites in Phase III.

A new clinical trial partially funded by the UK Government is set to evaluate the ability of a third Covid-19 vaccine dose to improve the immune response in immunocompromised individuals with weakened immune systems. Named OCTAVE DUO, the study is led by the University of Glasgow and the University of Birmingham. Building on the OCTAVE trial in immunocompromised people, the new trial will assess a third dose of Pfizer, Moderna or Novavax Covid-19 vaccines in up to 1,200 participants. Preliminary data from OCTAVE DUO is expected this year.

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