HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us e
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approv al: 1978
-------------------------------INDICATIONS AND USAGE-------------------------------
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months of
age and older. (1)
-------------------------- DOSAGE AND ADMINISTRATION--------------------------
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
• The first dose is administered at 12 to 15 months of age. (2.1)
• The second dose is administered at 4 to 6 years of age. (2.1)
------------------------DOSAGE FORMS AND STRENGTHS -----------------------
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using accompanying sterile diluent. (3)
---------------------------------- CONTRAINDICATIONS ----------------------------------
• Hypersensitivity to any componentof the vaccine. (4.1)
• Immunosuppression. (4.2)
• Moderate or severe febrile illness. (4.3)
• Active untreated tuberculosis. (4.4)
• Pregnancy. (4.5, 8.1)
-------------------------- WARNINGS AND PRECAUTIONS --------------------------
• Use caution when administering M-M-R II to individuals with a
history of febrile seizures. (5.1)
• Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity following egg ingestion.
(5.2)
• Use caution when administering M-M-R II to individuals with a
history of thrombocytopenia. (5.3)
• Immune Globulins (IG) and other blood products should not be
given concurrently with M-M-R II. (5.4, 7.2)
----------------------------------ADVERSE REACTIONS----------------------------------
See full prescribing information for adverse reactions occurring duri ng
clinical trialsor the post-marketing period. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-8 7 7 -
888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
-----------------------------------DRUG INTERACTIONS----------------------------------
• Administration of immune globulins and other blood products
concurrently with M-M-R II vaccine may interfere with the
expected immune response. (7.2)
• M-M-R II vaccination may result in a temporary depression of
purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)
-------------------------- USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: Do not administer M-M-R II to females who are
pregnant. Pregnancy should be avoided for 1 month following
vaccination with M-M-R II. (4.5, 8.1, 17)
See 17 for PATIENT COUNSELING INFORMATION and FDA
approv ed patient labeling.
Rev ised: 06/2020
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation andAdministration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunosuppression
4.3 Moderate or Severe Febrile Illness
4.4 Active Untreated Tuberculosis
4.5 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
5.2 Hypersensitivity to Eggs
5.3 Thrombocytopenia
5.4 Immune Globulins and Transfusions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
7.2 Immune Globulinsand Transfusions
7.3 Tuberculin Skin Testing
7.4 Use with Other Live Viral Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.6 Persistence of Antibody Responses After Vaccination
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Efficacy
14.2 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing info rma tion
are not listed.
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and
rubella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose and Schedule
Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6
years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum
interval of one month between the doses of measles, mumps and rubella virus vaccine, live {1-2}.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first
birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to
complete the vaccination series [see Clinical Studies (14.2)].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours
after exposure.
2.2 Preparation and Administration
Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or
reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To
reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other
antiviral substances which might inactivate the vaccine.
Withdraw the entire volume of the supplied diluent from its vial and inject into lyophilized vaccine vial.
Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.
Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously into the outer
aspect of the upper arm (deltoid region) or into the higher anterolateral area of the thigh.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Visually inspect the vaccine before and after
reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow
compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or
discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used
immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from
light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
3 DOSAGE FORMS AND STRENGTHS
M-M-R II vaccine is a suspension for injection supplied as a single dose vial of lyophilized vaccine to
be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How
Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubellacontaining vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
3
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3F
(>38.5C).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives,
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion
may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children
with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous
dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during postapproval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems
Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System
Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
4
Nervous System
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.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
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).
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy,
including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease
due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulinsand Transfusions
Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may
interfere with the expected immune response {9-11} [see Warnings and Precautions (5.4)]. The ACIP has
specific recommendations for intervals between administration of antibody containing products and live
virus vaccines.
7.3 Tuberculin Skin Testing
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with
tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously
with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines
M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given
concurrently, M-M-R II vaccine should be given one month before or one month after administration of
other live viral vaccines to avoid potential for immune interference.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy
with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have
been observed following infection with wild-type measles during pregnancy. {12,13} Wild-type mumps
infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection
occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital
Rubella Syndrome (CRS). Congenital rubella syndrome in the infant includes but is not limited to eye
manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and
intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It
is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman.
There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant
women.
5
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received
M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated
background rates (see Data).
Data
Human Data
A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978
through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine
occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the
prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women
received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The
outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4
cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella
syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine viruses can
cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been
shown to infect the placenta {14}, but there is no evidence that it causes congenital malformations or
disease in the fetus or infant .
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received
rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated
pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital
Rubella Syndrome (CRS) in the enrolled women {15}.
8.2 Lactation
Risk Summary
It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have
shown that lactatingpostpartum women vaccinated with live attenuated rubella vaccine may secrete the
virus in breast milk and transmit it to breast-fed infants.{16,17} In the breast-fed infants with serological
evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one
exhibited mild clinical illness typical of acquired rubella.{18,19}
The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from
the underlying maternal condition. For preventive vaccines, the underlying maternal condition is
susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness
of measles vaccine in infants below the age of 6 months have not been established [see Clinical Studies
(14)]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have
not been established.
8.5 Geriatric Use
Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and
over to determine whether they respond differently from younger subjects.
11 Description
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose(1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative.
6
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection
which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme
linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectivenes s studies that
were previously conducted for the component vaccines of M-M-R II were used to define levels of serum
antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies (14)].
12.6 Persistence of Antibody Responses After Vaccination
Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-
100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination. {22-28}
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of
fertility.
14 CLINICAL STUDIES
14.1 Clinical Efficacy
Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind
controlled trials. {29-34} These studies also established that seroconversion in response to vaccination
against measles, mumps and rubella paralleled protection. {35-38}
14.2 Immunogenicity
Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated
that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles
HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of
susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in
childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live
(previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable
neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus
Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies {39}. When the 6-month-old infants
of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody
titers similar to those of toddlers who were vaccinated previously at 15-months of age.
15 REFERENCES
1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR
43(RR-1): 1-38, January 28, 1994.
2. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, a n d Co n g e nita l Ru b e lla
Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practice s (ACIP), M M WR
47(RR-8): May 22, 1998.
3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gel atin , J.
Allergy Clin. Immunol. 91: 867-872, 1993.
4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Cl i n . In fect. Di s. 2 9 :
855-861, 1999.
5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 1 0 4 -1 06 ,
1998.
6. Cecinati V, et al. Vaccine administration and the development of immune thrombocyto pe ni c p urp u ra i n ch i ld re n. Hu m an
Vaccines & Immunotherapeutics 9:5, 2013.
7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic
Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating th e ri sk
of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042‐6.
9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MM WR 3 9 (RR-1 5 ): 1 -1 8 ,
November 23, 1990.
7
10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatri cs,
344-357, 1997.
11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22,
December 29, 1989.
12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801,
November 1993.
13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta
Paediatr Scand. 66: 367-372, May 1977.
14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the hu m a n p l ace n ta . N En g l J M e d .
1974;290(13):710‐712.
15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II.
Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666,1982.
17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I.
Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal i mm un izatio n , J.
Pediatr. 97: 465-467, 1980.
19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studiesof immunization with living rubella virus: Trialsin children with a strain culture d
from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fi bro b la sts: Evi d e n ce fo r
reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Labo ra tory Stu d ie s o f
Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. So c. Exp . Bi ol. M e d. 1 6 5 :
323-326, 1980.
23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles RevaccinationAmong School-Entry Age Ch i ld re n,
31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
24. Unpublished data from the files of Merck Research Laboratories.
25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in a n M M R -Va ccina ted
Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a
Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine,
JID 199:552– 60 , February 2009.
28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella
Vaccine, JID 200:888–99, September 2009.
29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten MeaslesVirusVa cci n e , JAM A
206(3): 587-590, 1968.
30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Fiel d
Evaluation,N. Engl. J. Med. 276: 245-251, 1967.
31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al:Live, Attenuated Mumps VirusVaccine 4. ProtectiveEfficacy as Measure d i n
a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First
International Conference on VaccinesAgainst Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, M a y
1967.
34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-1 3 6,
February 1972.
35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363,
1970.
8
37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for
Experimental Biology and Medicine, 123: 768-775, 1966.
38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. o f Pu b l ic He a lth ,
52(2):44-56, 1962.
39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles
Vaccine Era, Pediatrics, 93(6): 939-943, 1994.
16 HOW SUPPLIED/STORAGE AND HANDLING
No. 4681 ⎯ M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)
Exposure to light may inactivate the vaccine viruses.
Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F, (2°C to 8°C).
Store accompanying diluent in the refrigerator with the lyophilized vaccine or separately at room
temperature (68° to 77°F, 20° to 25°C). Do not freeze the diluent.
Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately,
reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8
hours. Discard reconstituted vaccine if it is not used within 8 hours.
For information regarding the product or questions regarding storage conditions, call 1-800-
MERCK-90 (1-800-637-2590).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).
Discuss the following with the patient:
• Provide the required vaccine information to the patient, parent, or guardian.
• Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
• Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine
or other measles-, mumps-, or rubella-containing vaccines.
• Question females of reproductive potential regarding the possibility of pregnancy. Inform female
patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and
Use in Specific Populations (8.1)].
• Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100%
protection from measles, mumps, and rubella infection.
• Instruct patients, parents, or guardians to report any adverse reactions to their health-care
provider. The U.S. Department of Health and Human Services has established a Vaccine
Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, including but not limited to the reporting of events required
by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine
reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at
https://www.vaers.hhs.gov.
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Your honor, 
My opening statement is as simple as this, 
Because of her/
A lot of these problems exist, 
Because I'm hurt/
I have these bandaids on my wrists,
Because of her/
I'm here requesting from you this writ,
....
I'm accusing the defendant of mental Incontinence,
Now Please be warned/
She is more than mentally competent,
She believes her words are to go without consequence,
Then has the gaul to think she deserves compliments,
I mean I'm sure there's a reason for this verbal diarrhea,
Some irreversible treason diva persona supersedes her,
Known to do the most/
While sayin the least,
My heart is the house/
She stopped paying her lease,
Karma's almost as scary , dreary, and tricky as guilt,
How she stopped paying the taxes on the house that we built,
How she just machine wash memories made outta silk,
Just stopped watering her feelings/ causing them to decay and wilt,
Got this heart on my sleeves/
Gotta fill this empty CHAMBER man,
Cause if you tryin to make magic/
Gotta make some major changes man,
These mental blocks so emphatic/
R.I.P Craig sager man,
But its loose ball fouls when I dive to save our plans,
Spent way to much time buildin fences, I'm defenseless,
But still I get defensive,
Payin you attention gets expensive,
I need some time to clear my head/
I may need an extension,
On second thought/
I'm gettin sick of blockin my ascension,
So I'm sueing you for custody of my heart,
I knew you liked to play games/
Knew that from the start,
But when a ***** played too/
You never laughed at that part,
Your body was a masterpiece/
but your mind was the art,
I ****** hate you/
But I loved our conversations,
Kinda how I hate school/
But I love my education,
Now I'm trying to make moves/
That boost my concentration,
cause I cant take losin/
And you're suess when it comes to complication,
Of our useless fights/
I can make a compilation,
Preferred the premium *****/
That prize is the consolation,
Jus when things are lookin up/
I'm in bed with the constellations,
Now I keep **** to myself/
Purposeful constipation,
I told her hit me with your best shot/
Now I'm feelin vaccinated,
Tried to tell her stay woke/
And now she still decaffeinated,
Now I'm Standing in the doorway/
Leonardo decapitated,
Little did I know/
Twas your name on the affidavit,
Tryin fix new problems/
With methods that's outdated, 
Feelins crept down the stairs/
Before they escalated,
Well **** it I'd rather slide/
No fun in the playground full of mood swings,
Felt like we hit the rock wall/
I cant stand the way you do things,
Mastered the art of storytelling/
She was the kubo to my two strings,
Now your carelessness/
can only lead to two things,
Times as hard as a brick clock/
And lies that get you ******* like shoe strings....©️

A mother’s limited knowledge of food choices,
You can hear the kids’ voices,
They want food,
Screaming are the broods,
They seek healthcare
The little scared children.
They could not afford to feed them properly as babies,
And cannot afford it now, the ladies.

“We are begging the government,”
The worried mothers say.

The widespread poverty,
Lack of public safety in the North,
Guns are everywhere,
And violence is getting worse,
All contribute to
The plight of mothers
Who want their children to be happy like others’.

“We are begging the government,”
The worried mothers say.

Poor infant development,
Premature death,
Babies gone before they took a breath.
Kids are not being vaccinated,
And bad conditions are created.
Malnutrition,
All affect mothers and their
Precious offspring.

“We are begging the government,”
The worried mothers say.

PforR,
The British government,
And PATH,
Put all of their efforts to make sure
Kids are being treated.

But still,
Healthcare providers the country leave,
And mothers are left with no relief,
With no regret of leaving millions of starving kids,
They fly to the beautiful turquoise skies,
In order to get one more dollar an hour,
They think it gives them power.

“We are begging the government,”
The worried mothers say.

The mothers don’t give up,
They want to be educated,
Money has to be donated.
With only technology, they can do it.
The access, the supplies, the needed budget, and commitment,
Will help children get the best treatment.

I'm a human of the contemporary times
A millennial, part of Generation Y
A digital native in shrink wrap
An open minded, wide eyed, big mouthed wind tunnel

A genetic, mathematical, anatomic error
I'm souped up and decked out
I'm high maintenance with low standards
My humor is low brow, my expectations are nonexistent
I see the negatives as positive
I see the positives as negative
I think in subjective and objectives
I'm on the web
But off the grid

My pockets full
But my wallets empty

I'm over educated
But underemployed
I'm overworked
But under paid

I'm a bisexual, bipolar by product of society
I'm a hardworking, dedicated procrastinator
I'm an inarticulate fat head who isn't afraid to speak his mind
I'm a cold hearted hothead
I can hear, some times I don't listen
I'm clean and polished to get my hands *****
I work my fingers to the bone
Then cross them in hope of better tomorrow
And knock on wood until my knuckles bleed

You can check my Facebook profile
Read my Tweets
Scroll through my Instagram
Send me a Snapchat
And you can kiss my ***
I'm non-toxic
I'm irreplaceable
I'm a rarity
I'm an oddity
I'm offbeat
Off centered
Off color
Off kilter
Out of tune
Out of my mind
Hypersensitive
Indifferent
Rude
Crude
And universally unacceptable

I'm wasting time
And taking up space
But I'm living it up
I won't die down
I'm two steps ahead
I'm left behind
Coasting on thin ice
Walking the edge
Pushing the limit
And taking a nap
I'm greedy
I'm *****
I'm lazy
I'm angry
I'm cocky
I'm envious
And I'm
Not sorry

I like laying low
I love being high
I don't want to be a stick in the mud so I get ******
I'm a street smart *******
I'm book smart dumb ****
I'm an eloquent gutter mouth
I speak in
****** vernacular
Passionate profanity
Cynical sarcasm
And choleric curses
I have criminal ties
And it suites me
I'm a ball hogging, showboating team player
I'm a devoted alcoholic
I'm a thrifty shopaholic
I'm in school
But out to lunch

I've got friends
I've got enemies
I've got my family
And I've got problems
I hear voices in my head
I see things that aren't there
I over look
Over analyze
And over think
I under cook
Under appreciate
And underestimate

I use my WiFi to listen to LoFi
I watch low quality television in Hi Def
I'm a bombastic contentious objector
Taken aback but forwardly thinking
In your face
Out of stock
Unisex
I get down
And get it up
I'm a low key middle man
Undeniable
Unlikable
But lovable
A grounded skyrocket
Detachable
Seasonal
Unflappable
An everlasting
Know nothing
Know it all
I'm a egg-headed basket case
I'm a real heel
A loafer
I got the boot
Because he couldn't afford to live in a shoe
Or the box it came in
I'm broke
I'm busted
Discussed
Disgusted
But I loved
I care
I help
I laugh
I try
I cry

I'm on the short bus for the long haul
I have no money but I always got my two cents
I'm good with secrets
I'm bad with numbers
And good with money
I'm bad with people
But yet they love me
I'm unbiased
Tolerant
And impatient
I'm abstract
I'm avant garde
I like violent ***
With volatile love
I like pornographic snapshots
******* ******* motion pictures
Live action lust
But nothing beats my meat like the real thing

I shop at second rate super markets
First rate second hand stores
I'm on cruise control in the fast lane
I'm double parked
I've been traumatized
Dramatized
Hospitalized
Ostracized
Demoralized
Desens­itized
Exorcised
And I've had my toes stepped on

I was a premeditated mistake
A failed abhorrent abortion
Vaccinated
Alienated
Regulated
And always medicated
I have a an attention span an inch wide
But, I'm real
I'm honest
I'm kind
I go hard
But  take it easy
I'm always slick
But never ******

Wheeling and dealing
Clipping and stealing
Lending and giving
Living and breathing

I think this one's a keeper
You've all dug me a little deeper
Hope you enjoyed my veracity
Because this poem is completely me

I wish I had a big ol' chunk of Covid. So creamy and buttery. I know that only my mind can unlock the gate to let covid through, and lock my cells in a cell. Have you ever been vaccinated? Have you ever been vaccinated while eating a big ol' chunk of covid? HEAVEN

It truly is heaven knowing that the vaccination can't hurt me. It's 2nd heaven to know that Covid can't hurt me either. How in the HELL do i get to 7th heaven?

I swear i would eat a chunk. I bet the AMA would charge an arm and a leg for that goodness! Or will they say there's a shortage? **** AMA

we all remember
where we were
watching the towers
burn and fall
knowing that things would
never be the same at all
disbelief at first, or
had an action movie
slipped into the news

no, it was real
and then twenty years
of vengeful repercussion
of military posturing
of suffering for many
we watched
the baddies being painted
good and evil
being redefined
virtue confused
impotence and power
conflated
lies and spin
consecrated
truth
alternated
idiot rich guys
promoted
tax for the poor
promulgated
democracy
desecrated
climate destruction
accelerated
by denialist
complacency
inequality
more concentrated
goodness and morality
infiltrated

by posturing political
pus weasels
venal vultures
of self interest
grasping for
short term dominance

and then ..
complacency pervaded
as absurdity
was accepted
as our new state of normal
and the height
of compassion
was owning a dog
and tut tutting
as refugees marched
across our news screens

and now we
bemoan being isolated
from being contaminated
we are mostly relegated
to stay in our mansions
while dinner is contemplated
have you been vaccinated?

my first steepest path of no return was just before a gorgeous mountain sunset.

a step by step ascending lesson of life and death executes a subconscious mantra in the head.

“let this trail cleanse the left!”
“oh you don’t even know what you wish for” a fallen rock said.

Dangers of naivety soon to become an inconvincible dance
arm in arm with a serpent deep down curling along a 50 minutes line.

What if it would be dark before reach?
No you don’t think that!
You don’t think anything there is not time for.
Make your each step the first full one and the last.
Questioning too is undone by each:
don’t look left, don’t look right, don’t look backs
stand upright, hurry not and move aheads.

He says stand upright ******
and I repeat
Every word that he says
I repeat.

Stand
I say,
I will,
will stand now again...
Making my sound a guide as if a movie or a dream but none,  
it’s for real this time.

Haven’t known sound could have such firing power,
it ‘s a conversion factor,
converts illusive threat jokingly to harsh reality.

Joking helps at moments as such of black and white,
brings in awareness by memorial color
and attention.
Oh If I have ever known have I dared to walk that path?
I presumably would have said: Hey you keep the faith, move ahead,
get slapped by the mountain for a chick tattoo on your forehead.”

or have I maybe known but hushed up by innocence?
... to be granted a new life as if a test!

Is that maybe why two horses heartily blessed me goodbye
after a cup of soup on a traveler’s inn and grounded my burning anxiety?

Life asks to shut the mind, switch off the emotion
Death requires the fantasy of the fright:
a slippery byproduct from the left or the right side.

maybe I play a trick on me

Unless he said ... unless you can cross the death.

but happy I am, happy now I did it I say, happy because I am alive I say
and these are mouthful of blubber just!

We both know it had to be done.
A prerequisite to undone a past is no choice and always comes in with a test.
Call it an initiation’s necessity – an immunization so blood knows how to fight
but also invites by incarnating the next - when once vaccinated ...

I say let the following be a goddess by the name of Grace
such as is a glimpse of a yellow flower on my thoughtless way  
78 degrees to the eye but perception marks its true coordinates
once a priceless confidence is granted through her sudden appearance
she says :
the mountain knows you
trust it so be it then you will see
without depending on your eyes
it is a curly, tunnel like track beneath the crown
light shines through on a straight line
illuminates sides of the caves
all at a moment of now
you shall see whichever path is the truth paved for you only

I am mute since then peacefully empty inside
silent, different, high
as if a part of me stayed at heavenly heights to endlessly be irrigated
I accept
without bringing in past emotions to fill the gap
no I fright not anymore not to have frights or ties  
a memory is lost and let me be empty inside

Even the pipilikas maybe
kept an ear to the ground
and heard the men on earth’s
news of the year: it works!
Pfizer-BioNTech jab is out.

Finally the Covid-19
vaccine is on our hand
life hopefully will soon be normal!

Along with everyone else me too
is absolutely over the moon
yet something I can’t forget.
Like how that came months ago
on 27 Ramadan 2020 in London.
I was still in sleep in the morning
in a dream but turned out to be real
indeed touched by lovely safest hands
promptly vaccinated me there and then.

Know not how that could key out
off the safe the trillion dollar vaccine at first!
All I know when that hands of love tie a knot
it becomes the undoable perfect circle.