Sanofi, Merck win FDA nod for 6-in-1 pediatric vaccine Vaxelis

Pharma giants Sanofi and Merck & Co. each have big ambitions in vaccines, and ahead of the new year, the companies secured FDA approval for a six-in-one shot to be marketed as Vaxelis. Don’t expect the new shot to be available right away, though, because the drugmakers plan to spend at least a year to build up supplies.

The FDA approved Vaxelis for children six weeks old through four years of age to protect against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive disease due to Haemophilus influenzae type b. It’s approved as a three-dose series before children reach their fifth birthday.

Merck and Sanofi developed the vaccine together under a U.S. vaccines partnership established in 1991. The companies said they’re ramping up manufacturing and plan to launch in 2020 or later. The vaccine, which is the first childhood shot to cover six diseases at the same time, won European approval in 2016.

According to a Sanofi securities filing from 2017, the FDA previously rejected the vaccine in a Complete Response Letter, but the drugmakers didn't outline details of the CRL.

As they proceed with their U.S.-based joint venture, the companies dissolved their European partnership in March 2016.

Sanofi manufactures antigens for diphtheria, tetanus, pertussis and polio, while Merck makes antigens for Hib and hep B, according to a filing from Merck. Sanofi previously said it expected its shot to be the first hexavalent vaccine available in the U.S.

The manufacturing scale-up for Vaxelis comes as Sanofi and Merck both count on vaccines for future growth. For Sanofi, it also comes after a letdown for another recent vaccine launch, dengue shot Dengvaxia. Merck, for its part, is hoping its pipeline vaccine V114 can compete with Pfizer in the pneumococcal disease vaccine field, where Pfizer's Prevnar 13 currently generates billions of dollars in annual sales.

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