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Sanofi Wins FDA Nod for Pediatric Hexavalent Combo Vaccine

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Sanofi (SNY - Free Report) announced that the FDA has approved its pediatric vaccine Vaxelis, which has been developed for active immunization to prevent six different diseases in children aged six weeks to four years.

Vaxelis has been jointly developed by Sanofi and Merck (MRK - Free Report) . Both companies are working on the vaccine production with a commercial launch expected not before 2020.

The hexavalent combination vaccine is indicated for immunizing children to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenzae type b. Vaxelis is approved as a 3-dose series for pediatric children prior to their fifth birthday.

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

Notably, in November this year, the European Commission gave marketing authorization to Sanofi’s dengue vaccine, Dengvaxia. The vaccine is already available across 20 countries for the prevention of dengue.

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

Sanofi is focused on expanding its vaccine business further. At the end of October 2018, the company’s pipeline included 40 pharmaceutical new molecular entities and vaccine candidates, which were in phase III studies or under a regulatory review.

Shares of Sanofi have dipped 1.3% year to date, comparing unfavorably with the industry’s decline of 1.2%.

Zacks Rank & Stocks to Consider

Sanofi currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company (BMY - Free Report) and Roche Holding AG (RHHBY - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Bristol-Myers’ earnings estimates have been revised 0.8% upward for 2018 and 2.7% for 2019 over the past 60 days.

Roche’s earnings estimates have moved 0.4% north for 2018 and 2.6% for 2019 over the past 60 days.

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