trending Market Intelligence /marketintelligence/en/news-insights/trending/ZrEwn1J7qBf6tDDQX6DMgg2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us
In This List

Sanofi's vaccine Adacel gets US FDA nod for repeat use

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help


Sanofi's vaccine Adacel gets US FDA nod for repeat use

The U.S. Food and Drug Administration approved the expanded use of Sanofi's Adacel to include repeat vaccination for tetanus, diphtheria and pertussis.

The French pharmaceutical giant said Adacel is the first and only vaccine in the U.S. approved for a repeat dose to protect people 10 to 64 years of age against the diseases eight years or more after their first vaccination.

Tetanus, also known as lockjaw, is caused by caused by the bacterium Clostridium tetani and leads to contraction of muscles, while Diphtheria is an infectious disease caused by the bacterium Corynebacterium diphtheria, which mainly infects the throat and upper airways and produces a toxin affecting other organs.

Pertussis, also known as whooping cough, is a highly contagious respiratory disease and is caused by the bacterium Bordetella pertussis.

David Greenberg, regional medical head of North America at Sanofi Pasteur, said a single immunization does not offer lifetime protection against pertussis due to waning immunity but Adacel's use as repeat vaccination will help patients manage their immunization.

The FDA's approval was based on data from a trial showing the safety and effectiveness of repeat Adacel vaccination in adults aged 18 through 64 years. The trial consisted of 1,300 people, who received either Adacel or a tetanus-diphtheria vaccine 8 to 12 years after a previous dose of Adacel, and showed that there were no significant differences in adverse events between the two vaccine groups.

Sanofi said the data of the trial has been provided to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices for use in future recommendations.