In clinical trials of Pfizer’s PENBRAYA pentavalent meningococcal vaccine, trial participants received either a dose of PENBRAYA meningococcal vaccine (MenABCWY) or meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY) and TRUMEMBA meningococcal Group B (MenB) vaccine (MenB+MenACWY-CRM) at the first vaccination visit. At the second vaccination visit, trial participants received either PENBRAYA or a dose of MenB (TRUMEMBA).
The safety evaluation of PENBRAYA in clinical trials involved three studies of individuals between the ages of 10 and 25 years of age. 2,744 individuals received PENBRAYA and 1,802 received MenACWY-CRM and MenB at the first vaccination visit. and MenB only at the second vaccination visit. A total of 1,792 participants in both groups had previously received a dose of a MenACWY vaccine. None of the trial participants had previously received a dose of MenB. Clinical trials on the use of PENBRAYA given at the same time as other vaccines were not conducted.
Adverse events reported by Pfizer in the pre-licensing clinical trials of PENBRAYA meningococcal vaccine included: injection site pain, redness, and swelling, fatigue, headache, muscle and joint pain, vomiting, diarrhea, fever, and chills. Females (87.2 percent) who received PENBRAYA reported higher rates than males (75.6 percent) of systemic reactions. Headache and fatigue were the most frequently reported systemic adverse reactions reported.
Within 30 days of vaccination, a total of 9.8 percent of participants in the PENBRAYA and 8.8 percent of participants in the MenB+MenACWY-CRM group reported at least one adverse event following any dose of vaccination. The most commonly reported adverse events were categorized as being related to an infection or infestation or to an injury, poisoning or procedural complication. Falls among both groups were the most commonly reported adverse reaction.
After the first dose of vaccination, 3.6 percent of MenABCWY recipients and 4.2 percent of MenB+MenACWY-CRM recipients sought medical attention within 30 days of vaccination. After the second vaccine dose, 3.6 percent of MenABCWY recipients and 2.8 percent of the MenB recipients sought a medical evaluation. Most of the medical evaluations were reported to be related to a diagnosis of COVID-19.
Among clinical trial participants, one participant in the MenB+MenACWY-CRM group reported new diagnosis of a neuroinflammatory disorder (restless leg syndrome) and two participants reported a new autoimmune disorder (alopecia areata, Hashimoto thyroiditis). There were no reports of newly diagnosed chronic medical conditions among individuals who received PENBRAYA.
Three clinical trial participants reported a total of five serious adverse events (SAE) following PENBRAYA vaccination within 30 days of vaccination. These included spinal injury resulting from a motor vehicle accident, an attempted suicide with a subsequent diagnosis of anxiety and depression six days after the first vaccine dose in an individual with a history of auditory hallucinations and ongoing friendship stressors, and a hospitalization for disruptive mood disorder 14 days after the second vaccine dose in a male with a past history of multiple psychiatric disorders (psychosis, ADHD, oppositional defiant disorder, depression, anxiety). There were no SAEs in the MenB+MenACWY-CRM group. No SAEs were considered by Pfizer’s clinical trial investigators or the FDA to be related to vaccination.
From one month after the second vaccination visit to the six-month follow-up visit, four individuals in the PENBRAYA group and four in the MenB group reported an SAE. Two individuals in the PENBRAYA group reported a diagnosis of depression, and there was one tibial fracture and one post-tonsillectomy bleed. Among the MenB group, the reported SAEs included E Coli Urinary Tract infection, appendicitis, migraine, and a drug overdose. Pfizer’s clinical trial investigators and the FDA determined that none of the SAEs reported at the six-month follow-up visit were related to vaccination.
There were no deaths reported during the clinical trial.
