UPDATED: Sanofi makes case for Fluzone superior clinical benefit label

In August, Sanofi ($SNY) gave a first look at eagerly anticipated data from Phase III comparing its high-dose Fluzone vaccine with a standard jab. The data prompted Sanofi to talk up its chances of getting a label for superior efficacy data in people aged over 65, and this week it began making its case.

Sanofi Pasteur director of scientific and medical affairs Dr. David Greenberg presented more details of the trial data to the Advisory Committee on Immunization Practices (ACIP), a panel that helps the Centers for Disease Control and Prevention (CDC) form vaccine recommendations. Greenberg said the previously disclosed 24.2% increase in efficacy associated with the high-dose jab has a 95% confidence interval ranging from 9.7% to 36.5%. While the bottom end of this range is notably lower than 24.2%, Greenberg said it still meets FDA criteria for showing superior clinical benefit.

Observer reaction to the data was mixed. Speaking to the Associated Press, vaccine researcher Dr. Edward Belongia said: "I wouldn't call it great." Others were more effusive. Vaccine researcher Dr. Lisa Jackson told CIDRAP News: "I don't know if ACIP will make a preferential recommendation for high-dose flu vaccine, but they should, in my opinion." Jackson is a vaccine researcher who had seen some of the Sanofi presentation, but is not an ACIP member.

Sanofi must now hope ACIP shares Jackson's view. The Sanofi clinical team is still going over the data ahead of an anticipated FDA submission in early 2014 and publication in medical journals. Positive real-world data and an ACIP recommendation should help Sanofi boost sales of Fluzone. While the FDA approved the vaccine in 2009, four out of 5 seniors who got vaccinated last year received a different product. Fluzone costs more than standard vaccines, but Sanofi thinks uptake is limited by data, not cost.

In the third quarter, sales of several of Sanofi's other vaccines were affected by problems at its plant in Toronto, Canada. FDA hit the plant with a warning letter last year, and Sanofi then found an "anomaly" in routine testing. This anomaly limited supply of Sanofi's pertussis-containing vaccines Pentacel, Adacel and Daptacel and ultimately led to a fall in sales. Vaccine revenue was down 7.2% in the third quarter. Sanofi expects production to pick up through the fourth quarter.

- read the AP article
- here's CIDRAP's take
- check out FiercePharmaManufacturing's results story

Editor's note: This story has been updated with details of Sanofi's results.