Measles / Mumps / Rubella

Priorix by GlaxoSmithKline (Measles/Mumps/Rubella)

Captured 2022-11-14
Document Highlights

Initial U.S. Approval: 2022

PRIORIX is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella…

There is a risk of febrile seizure following administration of PRIORIX.

Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX.

Live attenuated rubella vaccine virus has been detected in the nose and throat of individuals 7 to 28 days after vaccination with a rubella virus containing vaccine.

Postmarketing Experience
– Thrombocytopenia, thrombocytopenic purpura.
– Vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome).
– Anaphylactic reactions.
Meningitis, measles-like illness, mumps-like illness (including orchitis, epididymitis, and parotitis).
– Arthralgia, arthritis.
– Encephalitis, cerebellitis, cerebellitis-like symptoms (including transient gait disturbance and transient ataxia), Guillain-Barré syndrome, transverse myelitis, peripheral neuritis, afebrile seizures, syncope.
– Erythema multiforme.

[L]actating postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants

PRIORIX contains… live attenuated measles virus… live attenuated mumps virus… both propagated in chick-embryo fibroblasts from embryonated eggs… and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells.

Each dose may also contain… ovalbumin… bovine serum albumin…

PRIORIX has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.

Comments

Priorix is manufactured using human aborted fetal cells (WI-38) and was not tested for safety in a double-blind, saline placebo-control study.