Novartis has announced that the path to EU approval for Focetria, the company’s influenza A(H1N1) 2009 vaccine has been cleared following positive feedback from a European Medicines Agency (EMEA) committee.
The Committee for Medicinal Products for Human Use (CHMP) gave its recommendation for the vaccine, which had already received mock-up approval in the EU in 2007 as preparation in the case of a pandemic.
Focetria is an inactivated influenza virus vaccine indicated for active immunisation of those aged six months older. The vaccine was developed using an egg-based formulation and contains MF59, a proprietary adjuvant that can elicit protective antibody levels with a lower dose.
Novartis Vaccines and Diagnostics CEO Andrin Oswald said that only three months after the declaration of the pandemic by the World Health Organization (WHO), Novartis was able to ship the first batches of the vaccine under quarantine to governments in Europe pending EU approval.
“This CHMP positive opinion paves the way for EU approval, which will allow governments to begin their vaccination campaigns,” Oswald said.
“Several recent clinical trials suggest that just one dose of pandemic vaccine can protect healthy adults, which means that now the vaccine can be provided to more people than if two doses were needed.”
Novartis began shipping pandemic vaccines under quarantine to governments in Europe immediately after the WHO declared a pandemic, despite the initially low yields with the current production seed strain.