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Nov 9, 2012

Hold Lifted on Novartis Flu Vaccines

  • The Italian Medicines Agency (AIFA) lifted its temporary halt on use in Italy of Novartis’ Agrippal® and Fluad® seasonal flu vaccines after the agency affirmed additional information from the pharma giant attesting to the safety and efficacy of the medicines.

    AIFA halted the use of Agrippal and Fluad on Oct. 24 as a precaution, after Novartis reported higher than usual levels of protein aggregates observed in one batch of seasonal influenza vaccine not released for use. Novartis says the aggregates—formed by proteins essential to the vaccine—occur naturally in very small quantities, and typically dissolve when shaken.

    Italy is the regulatory reference country for the vaccines within the 27-nation European Union, which is why AIFA took the lead for the EU to investigate the protein aggregates, and whether a permanent ban was warranted. The two Novartis vaccines are sold in Italy under the names Influpozzi sub unità and Influpozzi adiuvato.

    Earlier this month, Canada and Switzerland lifted similar restrictions on the sale of Agrippal and Fluad, following tests by health agencies that concluded the vaccines were safe. Agrippal is sold as Agriflu in Canada, where the Public Health Agency advised doctors to shake their vaccine products and check them for white floating material before injecting them into patients.

    Also banning the Novartis vaccines temporarily were Spain, France, Germany, and the U.K.

    According to Novartis, more than 1 million doses of Agrippal and Fluad have been administered since the start of this year’s flu season, with no unexpected adverse events reported to date. The two vaccines are not available in the U.S.

    Switzerland, like Italy, has seen a shortage of flu vaccine after Netherlands-based Crucell, a vaccine subsidiary of Johnson & Johnson, suspended a delivery of seasonal flu vaccine last month. On Oct. 17, Italy’s health ministry announced that Crucell stopped a shipment of 2.36 million doses to Italy after two out of 32 lots failed to pass quality inspections. Italian authorities have said their nation uses between 10 million and 12 million flu vaccine doses annually.


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