Measles / Mumps / Rubella

MMR II by Merck (Measles/Mumps/Rubella)

Captured 2022-11-14
Document Highlights

Initial U.S. Approval: 1978

M-M-R II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella.

There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with M-M-R II vaccine.

Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions… subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine.

[T]hrombocytopenia has been reported within 4-6 weeks following vaccination with measles, mumps and rubella vaccine.

ADVERSE REACTIONS
– Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
– Vasculitis.
– Pancreatitis; diarrhea; vomiting; parotitis [mumps]; nausea.
Diabetes mellitus*
– Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
– Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.
– Arthritis; arthralgia; myalgia.
– Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.
– Pneumonia; pneumonitis; sore throat; cough; rhinitis.
– Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).
– Nerve deafness; otitis media [ear infection].
– Retinitis; optic neuritis; papillitis; conjunctivitis.
– Epididymitis; orchitis.
Death*

[R]ubella virus propagated in WI-38 human diploid lung fibroblasts.

Each dose is calculated to contain… recombinant human albumin… fetal bovine serum

M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Comments

MMR II is manufactured using human aborted fetal cells (WI-38) and was not tested for safety in a placebo-controlled clinical trial.

Why this is important.

*These adverse events were removed from the insert when updated in July 2020, see link to archived version below.

The archived version of the MMR II package insert also stated the following:

"Due caution should be employed in administration of M-M-R II to persons with a history of cerebral injury, individual or family histories of convulsions, or any other condition in which stress due to fever should be avoided." (Page 4)

"Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination." (Page 5)

"[T]ransmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk." (Page 5)

"However, transmission of the rubella vaccine virus to infants via breast milk has been documented." (Page 5)

Archived version of the MMR II insert from June 2020 can be viewed, here.

Additional MMR Vaccine licensed for used in Europe: MMRVaxPro