Novartis influenza vaccine receives positive CHMP opinion

Novartis has announced that its Optaflu influenza vaccine has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA).

In clinical studies of the compound, over 3,400 patients received the vaccine, with data showing that Optaflu satisfied all the immunogenicity criteria from the CHMP, with the decision regarding marketing approval to be made within the next three months.

Optaflu is produced through cell-culture manufacturing, rather than the existing standard process making use of chicken eggs, while the compound, administered via intramuscular injection, has a comparable efficacy to egg-based vaccines.

Dr Jorg Reinhardt, chief executive officer of vaccines and diagnostics at Novartis, said: “Novartis Vaccines is pleased with this positive recommendation for Optaflu, the first cell-culture derived influenza vaccine and the first major innovation in influenza vaccine manufacturing in more than 50 years.”

He added that the vaccine will meet increasing public demand for seasonal influenza vaccines, with the promise of rapid scale-up of vaccine manufacturing if a pandemic occurs.

Last week, Novartis announced the acquisition of the worldwide rights to CYT002-NicQb, a candidate therapeutic vaccine against addiction to nicotine. The rights to the compound were purchase from Cytos Biotechnology for CHF 35 million (14.5 million pounds).