Sanofi's (SNY) Influenza Vaccine Gets FDA Approval For Kids

Sanofi (PA:SASY) (NASDAQ:SNY) announced that the FDA has approved the 0.5mL dose of its influenza vaccine, Fluzone Quadrivalent, for treating children falling within the six to 35-month age bracket. The 0.5 mL dosage is already approved for use in patients aged three years and above along with the lesser 0.25 mL dose, which is approved for kids in the six to 35-month age category. Both medicinal measures of the vaccine will be available for the upcoming 2019-2020 flu season.

The approval was based on data from a phase IV safety and immunogenicity study, which evaluated approximately 2,000 children. Data from the program showed that one or two doses of 0.5 mL vaccine in kids had a safety profile, comparable to one or two doses of 0.25 mL vaccine with no new safety concerns observed.

Apart from the Fluzone Quadrivalent vaccine, Sanofi’s influenza vaccine portfolio includes Flublok Quadrivalent and Fluzone High-Dose vaccine, approved for adults aged 18 years and older and senior subjects aged 65 years and above, respectively.

Sanofi possesses one of the world’s leading vaccine operations. Apart from influenza vaccines, the company’s portfolio includes pediatric vaccines, adult and adolescent booster vaccines, meningitis vaccines plus travel and endemic vaccines. Sanofi also has a strong position in both seasonal and pre-pandemic influenza vaccine spaces.

Notably, in December 2018, the FDA approved Sanofi’s pediatric vaccine, Vaxelis, which is developed for active immunization to prevent six different diseases in six-week to four-year-old minor patients.

Vaxelis has been jointly developed by Sanofi and Merck (NYSE:MRK) . Both companies are working on its production with a commercial launch expected not before 2020.

Also, last November, the European Commission granted a marketing authorization to Sanofi’s dengue vaccine, Dengvaxia. The vaccine is already available across 20 countries for the prevention of dengue.

Total sales of the company’s vaccine division, Sanofi Pasteur, in the first nine months of 2018 were 3.6 billion euros, which declined slightly at constant exchange rate (CER).

Shares of Sanofi have lost 6.5% in the past year, comparing unfavorably with the industry’s decline of 1%.

Zacks Rank and Stocks to Consider

Sanofi currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include H Lundbeck A/S (OTC:HLUYY) and Eli Lilly and Company (NYSE:LLY) . While H Lundbeck sports a Zacks Rank #1 (Strong Buy), Eli Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

H Lundbeck’s earnings estimates have been raised 5.2% for 2019 over the past 60 days.

Eli Lilly’s earnings estimates have moved 1.4% north for 2019 over the past 60 days. The stock has rallied 40.9% in a year.

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