Real-world adverse events reported after bivalent MenB vaccination in college students

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

Fatigue occurred in 35% of 1,707 students after dose one, in 31% of 1,395 after dose two, and in 39% of 609 students after dose three. Myalgia was a side effect in 47% of 1,726 students after dose one, in 37% of 1,395 after dose two, and in 16% of 609 students after dose three. Headache was an adverse event in 16% of 1,725 students after one dose, 11% of 1,395 after two doses, and 16% of 609 after three doses. Adverse events such as chills and fever occurred in 15% or fewer students after any of the three doses.

Serious adverse events, such as any allergic reaction; difficulty breathing; hives, welts, or a severe rash; and swelling of the face, mouth, or throat occurred in fewer than 5% of students after any of the three doses, the investigators reported.

“We found an overall lower rate of headache within our sample relative to the rates in reported clinical trials. The rates of injection site pain, fatigue, thermometer-confirmed fevers (100.4° F or higher), and chills were approximately similar in our study as in clinical trials. The rate of myalgia was higher for our sample than in clinical trials following the first and second doses of the vaccine, but similar after the third dose of vaccine,” Dr. Fiorito and her associates wrote.

Read more at (Pediatr Infect Dis J. 2017. doi: 10.1097/INF.0000000000001742).

cnellist@frontlinemedcom.com

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

Fatigue occurred in 35% of 1,707 students after dose one, in 31% of 1,395 after dose two, and in 39% of 609 students after dose three. Myalgia was a side effect in 47% of 1,726 students after dose one, in 37% of 1,395 after dose two, and in 16% of 609 students after dose three. Headache was an adverse event in 16% of 1,725 students after one dose, 11% of 1,395 after two doses, and 16% of 609 after three doses. Adverse events such as chills and fever occurred in 15% or fewer students after any of the three doses.

Serious adverse events, such as any allergic reaction; difficulty breathing; hives, welts, or a severe rash; and swelling of the face, mouth, or throat occurred in fewer than 5% of students after any of the three doses, the investigators reported.

“We found an overall lower rate of headache within our sample relative to the rates in reported clinical trials. The rates of injection site pain, fatigue, thermometer-confirmed fevers (100.4° F or higher), and chills were approximately similar in our study as in clinical trials. The rate of myalgia was higher for our sample than in clinical trials following the first and second doses of the vaccine, but similar after the third dose of vaccine,” Dr. Fiorito and her associates wrote.

Read more at (Pediatr Infect Dis J. 2017. doi: 10.1097/INF.0000000000001742).

cnellist@frontlinemedcom.com

Reported rates of side effects of a bivalent serogroup B meningococcal vaccine given to college students were lower or similar to those in clinical trials, said Theresa M. Fiorito, MD, of Brown University, Providence, R.I., and her associates.

In February 2015, two unlinked, culture-confirmed cases of Neisseria meningitidis serogroup B (MenB) disease occurred at a local college in Rhode Island, and a bivalent MenB vaccine subsequently was administered. After the first-dose vaccination clinic, a 94% coverage rate was achieved, and there were no other cases of MenB disease. Injection site pain occurred in 78% of 1,736 students after dose one, in 64% of 1,395 after dose two, and in 71% of 609 students after dose three.

Micah Young/istockphoto

Fatigue occurred in 35% of 1,707 students after dose one, in 31% of 1,395 after dose two, and in 39% of 609 students after dose three. Myalgia was a side effect in 47% of 1,726 students after dose one, in 37% of 1,395 after dose two, and in 16% of 609 students after dose three. Headache was an adverse event in 16% of 1,725 students after one dose, 11% of 1,395 after two doses, and 16% of 609 after three doses. Adverse events such as chills and fever occurred in 15% or fewer students after any of the three doses.

Serious adverse events, such as any allergic reaction; difficulty breathing; hives, welts, or a severe rash; and swelling of the face, mouth, or throat occurred in fewer than 5% of students after any of the three doses, the investigators reported.

“We found an overall lower rate of headache within our sample relative to the rates in reported clinical trials. The rates of injection site pain, fatigue, thermometer-confirmed fevers (100.4° F or higher), and chills were approximately similar in our study as in clinical trials. The rate of myalgia was higher for our sample than in clinical trials following the first and second doses of the vaccine, but similar after the third dose of vaccine,” Dr. Fiorito and her associates wrote.

Read more at (Pediatr Infect Dis J. 2017. doi: 10.1097/INF.0000000000001742).

cnellist@frontlinemedcom.com