Fluvax report: production process changed after fevers
The findings of a lengthy investigation into the cause of the 2010 adverse events confirm that as a result of the company's standard method of manufacture, virus components in that year's formulation of Fluvax combined to overstimulate the immune system of some children, triggering increased fever and convulsions.
According to the company, laboratory studies have shown that increasing the levels of the virus splitting agent, taurodeoxycholate (TDOC), in the manufacturing process could prevent the potential for Fluvax to cause excessive febrile reactions.
The company has implemented changes to its manufacturing process, which have resulted in a modified vaccine.
A company spokesperson told MO it has now initiated a clinical development program in the US to assess the safety of the vaccine in children.
The trial will be a staged program over several years due to commence in August in children aged 5–9