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Italian authorities last week began recalling two lots of Novartis' ($NVS) influenza vaccine Fluad after more than a dozen deaths were reported in people who had taken the vaccine. But on Monday the Italian Pharmaceutical Agency cleared the manufacturing of the vaccines, saying that the initial analyses of the lots came back "negative."
"Test results confirm the safety of the flu vaccine, exclude the presence of endotoxins and showed that the lots conform to the appearance and content of the vaccine antigen of influenza virus," according to a translated version of a statement on the agency's website. It said that there are now 19 reports of deaths in people vaccinated from 8 different lots; most of them were over the age of 80. Given the test results, the agency said the increase is "attributable to the greater sensitivity shown by health professionals and the general population to the phenomenon" because of media reports in recent days.
Novartis had assured the agency that the vaccine was safe. Novartis spokeswoman Liz Power told FierceVaccines that "extensive analysis" had uncovered no link between the vaccinations and the deaths. She said that all of Novartis' Fluad batches have passed "extensive analytical and safety testing and fulfill all required quality standards."
Novartis found itself having to defend Fluad, as well as its Agrippal and Influpozzi vaccines, in 2012 when Italy, and then a number of other European authorities, suspended their use because some vials contained particles. As in this case, Novartis stood by their manufacturing, quality and the safety of the vaccines but suspended sales of the products for several weeks until authorities began to lift the bans.
Novartis will soon be out of the vaccine business. It has agreed to sell its influenza manufacturing operations to CSL in a deal that gets the Australian vaccinemaker the portfolio and three manufacturing plants for just $275 million. That includes plants in the U.K., Germany and the U.S., where its $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, is the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Novartis, which has been losing money on its vaccine business, is taking a $1.1 billion charge on the sale. Novartis had earlier worked a multimillion-dollar deal for GlaxoSmithKline ($GSK) to take over the rest of its vaccine operations, a business Novartis has struggled in from the beginning.
- here's Monday's update
- here's the initial report