Italian regulators have lifted a temporary ban on two Novartis flu vaccines in which high levels of protein aggregates were detected.
The Swiss pharmaceutical firm announced the decision last week , explaining that it had provided the Italian Mediciens Agency (AFIA) with additional information reaffirming the products' safety and efficacy. Italy is the European reference country for the two vaccines.
Spokeswoman Elizabeth Power told in-Pharmatechnologist.com that: “The safety and efficacy of our seasonal influenza vaccines have been reaffirmed with the lifting of the precautionary halt by the Italian health authorities.
She said it is too early to say what impact the ban - and others in Austria, Spain, Germany and France - have had on Novartis’ vaccines business, but did say the firm has already completed more than “90 per cent of our shipments to the US, which is our largest market.”
Power added that added that distribution has already resumed in Canada, Switzerland and Singapore and reiterated that Novartis is working with regulators where bans remain in place.
“The safety and efficacy of Agrippal and Fluad are supported by extensive clinical and surveillance data, including more than one million doses administered this season. We are not advising people to see their doctors because we are confident in the strong scientific data that reinforces that the efficacy and safety of the vaccines.”
AIFA’s decision fits with what Novartis told this publication when the original ban was imposed.
Spokesman Eric Althoff told us that: "Protein aggregates are naturally occurring in vaccines in very small quantities and not uncommon. These aggregates are formed by proteins expected in the vaccine and can occur in the manufacturing process."
FDA OK for Colorado
In other news, the US Food and Drug Administration (FDA) has given a Novartis facility in Colorado a clean bill of health.
According to Reuters, CEO Joseph Jimenez on Friday that: “In Bloomfield, Colorado, the FDA confirmed to us just today after an inspection that the plant is in such a condition. This development makes me confident. We are on the right track but must not stop.”
Novartis’ operations have been the subject of considerable regulatory scrutiny following an FDA warning letter in December that criticised the firm for violations of manufacturing regulations at the Colorado plan and two others in North Carolina and Quebec, Canada.
Additionally, in January a Novartis plant in Lincoln, Nebraska was hit with a 483 . However, in September Jimenez said the firm is on track to correct the problems and expects to restart shipments soon.