FDA News

FDA approves Tdap vaccine Adacel for repeat vaccination

David P. Greenberg, MD
David P. Greenberg

The FDA has approved the expanded use of Adacel for repeat vaccination to help protect against tetanus, diphtheria and pertussis, Sanofi Pasteur announced.

Adacel is the only Tdap vaccine to be approved in the United States for repeat vaccination in patients aged 10 to 64 years who received their first vaccination at least 8 years before.

“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity,” David P. Greenberg, MD, regional medical head for North America at Sanofi Pasteur, said in a news release. “The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules.”

According to Sanofi Pasteur, the FDA decision was based on data from a phase 4 clinical trial of repeat Tdap vaccination in more than 1,300 adults aged 18 to 64 years. Participants received either Adacel or tetanus-diphtheria (Td) vaccine 8 to 12 years after a previous dose of the Tdap vaccine. Researchers found no significant differences in adverse events between the two cohorts.

According to the results, which were published in the Journal of the Pediatric Infectious Diseases Society, 87.7% of the Tdap vaccine recipients and 88% of the Td vaccine recipients had at least one infection-site reaction.

The CDC recommends a single dose of Tdap vaccine for adolescents and adults, and for pregnant woman during every pregnancy. Despite the recommendation, three of four adults have not received a Tdap vaccine, according to the release.

Reference:

Halperin SA, et al. J Pediatric Infect Dis. 2018;doi:10.1093/jpids/pix113.

Disclosure: Greenberg is employed by Sanofi Pasteur.

David P. Greenberg, MD
David P. Greenberg

The FDA has approved the expanded use of Adacel for repeat vaccination to help protect against tetanus, diphtheria and pertussis, Sanofi Pasteur announced.

Adacel is the only Tdap vaccine to be approved in the United States for repeat vaccination in patients aged 10 to 64 years who received their first vaccination at least 8 years before.

“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity,” David P. Greenberg, MD, regional medical head for North America at Sanofi Pasteur, said in a news release. “The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules.”

According to Sanofi Pasteur, the FDA decision was based on data from a phase 4 clinical trial of repeat Tdap vaccination in more than 1,300 adults aged 18 to 64 years. Participants received either Adacel or tetanus-diphtheria (Td) vaccine 8 to 12 years after a previous dose of the Tdap vaccine. Researchers found no significant differences in adverse events between the two cohorts.

According to the results, which were published in the Journal of the Pediatric Infectious Diseases Society, 87.7% of the Tdap vaccine recipients and 88% of the Td vaccine recipients had at least one infection-site reaction.

The CDC recommends a single dose of Tdap vaccine for adolescents and adults, and for pregnant woman during every pregnancy. Despite the recommendation, three of four adults have not received a Tdap vaccine, according to the release.

Reference:

Halperin SA, et al. J Pediatric Infect Dis. 2018;doi:10.1093/jpids/pix113.

Disclosure: Greenberg is employed by Sanofi Pasteur.