FDA approves Seqirus' Fluad, the first U.S. adjuvanted flu vaccine

The U.S. has its first publicly available adjuvanted seasonal flu vaccine in Fluad, formerly a Novartis ($NVS) shot that is now owned by CSL's Seqirus unit.

The vaccine, first approved in Italy in 1997 and now licensed in 38 countries, received FDA accelerated approval for people aged 65 and older last week. With the decision, CSL's flu vaccines unit Seqirus has its first regulatory blessing since its formation in October.

Since the vaccine was cleared through the FDA's accelerated approval pathway, a postmarketing study will be required to confirm the vaccine's clinical benefit. According to Seqirus' statement, data from nearly 40 clinical trials have demonstrated "a strong immune response" and "an acceptable safety profile" for the jab. The FDA's nod follows a panel recommendation in September in favor of accelerated approval.

Adjuvants, which can be added to vaccines for additional strength, have encountered resistance in the U.S. over the years as the public and some officials have raised concerns with ingredients such as the preservative thimerosal. However, vaccine companies continue to look for ways to more effectively immunize seniors, who have weaker immune systems and weaker vaccine responses than people in other age groups.

Seqirus head Gordon Naylor

According to CDC figures, people aged 65 and older have accounted for 50% to 70% of seasonal flu-related hospitalizations and 80% to 90% of seasonal flu-related deaths. The agency adds that vaccination is "especially important" for the age group due to the complications. In a statement, Seqirus President Gordon Naylor said Fluad will provide "a new option" for the age group and U.S. healthcare providers.

Since its debut nearly two decades ago, more than 81 million doses of Fluad have been distributed. It hasn't been without controversy, though, as late last year Italian regulators temporarily banned the vaccine following 19 post-vaccination deaths. Officials later said that tests confirmed the vaccine's safety.

The vaccine contains the proprietary MF59 adjuvant, which is an oil-in-water emulsion of squalene oil, a naturally occurring substance in humans, animals and plants. The only other adjuvanted flu vaccine in the U.S., which is being stockpiled and is not available to the public, contains the AS03 adjuvant.

CSL branded its flu vaccines subsidiary as Seqirus in October following its $275 million purchase of Novartis' flu vaccines business over the summer. It's now the world's second-largest flu vaccine provider behind Sanofi Pasteur.

- here's the FDA's statement
- and Seqirus' release