HomeMy WebLinkAboutMerck MMRM-M-R® II Vaccine Agent Summary Sheet (VASS)
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
M-M-R® II vaccine 8/10/2010
Health and Safety Summary Information for Employees Working with:
Attenuated Measles, Mumps and Rubella Virus
SECTION I-IDENTIFICATION
Organism: The vaccine contains: Enders' attenuated Edmonston strain of measles virus; Jeryl Lynn** (B
level) strain of mumps virus; and Wistar RA 27/3 strain of live attenuated rubella virus
Characteristics: All three virus strains are genetically weakened so it is not capable of causing disease in
humans (1).
Company Information: MERCK & CO., INC.
One Merck Drive
Whitehouse Station, NJ 08889-0100
(908) 423-1000 (General Information Only)
Emergency Telephone Number:
1-908-423-6000 (24/7/365) English Only
SECTION II-HAZARD IDENTIFICATION
Vaccine protects against: Measles infection. Transmission of the wild type virus is via droplet spread or
direct contact with nasal or throat secretions of infectious persons; less commonly by airborne spread or
indirect contact with freshly infected articles. Measles is one of the most readily transmitted diseases. The
infection is characterized usually by a mild fever (in children; in adults the fever may be severe), cough and
a red, blotchy rash. The rash usually appears on the face 3-7 days after the fever starts and becomes
generalized over the next 4-7 days. The affected person is infectious from the start of the fever until
approximately 4 days after the rash appears. Incubation period is approximately 10 days (2).
Mumps infection. Transmission of the wild type virus is via droplet spread and direct contact with the
saliva of an infected person. The infection is characterized by fever and swelling in the salivary glands. In
adults, inflammation of the reproductive organs is not uncommon (20-30% of males, 5% of women).
Neurologic involvement is rare, but can result in deafness. Pancreatitis occurs in 4% of cases. Affected
persons are infectious from 7 days prior to symptoms to approximately 9 days after. Incubation period is
12-25 days (3).
Rubella infection. Transmission of the wild type virus is via contact with nasopharyngeal secretions of
infected persons; droplet spread or direct contact with patients; indirect contact with freshly infected
articles; in closed environments (4). All exposed, susceptible individuals may be infected and infected
infants shed large quantities of virus (5). The manifestations of the illness includes a rash, slight fever,
headache, malaise, conjunctivitis, swollen lymph nodes, runny nose, leukopenia (abnormal decrease in
white blood cell count), thrombocytopenia (abnormal bleeding of blood vessels in the skin caused by a
decrease in platelet number), joint pain, and arthritis (6).
SECTION III-HEALTH HAZARDS
Special circumstances for workers handling vaccine:
Immune Status: Changes in the immune system due to cancer or cancer therapy (radiation or
chemotherapy), steroid use, tuberculosis, organ transplant or diseases of the immune system
(including HIV/AIDS) must be reported immediately to their occupational health group or
M-M-R® II Vaccine Agent Summary Sheet (VASS)
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
M-M-R® II vaccine 8/10/2010
personal physician, as appropriate. The US Advisory Committee on Immunizations Practices
(ACIP) has recommended severely immunocompromised individuals not be exposed to live virus
vaccines, as there is a risk of severe complications. However, administration of -measles-mumps-
rubella vaccines to HIV patients without titers is recommended, as no unusual adverse effects
have been found (7).
Pregnancy: (Measles) Women who are considering pregnancy should consult with their
occupational health group or personal physician, as appropriate, prior to conception. The wild
type virus has been associated with low birth weight infants and premature labor, but there is no
congenital syndrome associated with exposure to the wild type virus (8). Exposure to the vaccine,
in the unlikely event it occurred, would be to the highly attenuated virus which is not capable of
causing disease in humans and has not been associated with causing birth defects in women
inadvertently receiving the vaccine while pregnant (9). Fetuses of women with known immunity
(i.e., titers) are not considered to be at risk.
(Mumps) Women who are considering pregnancy should consult with their occupational health
group or personal physician, as appropriate, prior to conception. The wild type virus is not known
to cause congenital birth defects, but has been associated with an increased risk of spontaneous
abortions after a first trimester infection (10). There is one report that the vaccine strain can infect
the placenta and fetus, but there have been no reports of congenital birth defects after exposure to
the attenuated virus (11, 12). Fetuses of women with known immunity are not considered to be at
risk.
(Rubella) Women who are considering pregnancy should consult with their occupational health
group or personal physician, as appropriate, prior to conception. The wild type virus has been
associated with congenital rubella syndrome (13). Defects include deafness, eye problems,
congenital heart disease, and mental retardation. Infection in early pregnancy increases the risk of
spontaneous abortion and stillbirth. However, when infection occurs late in pregnancy, birth
defects are less likely to occur. In a 10 year survey involving over 700 pregnant women who
received rubella vaccine within 3 months before or after conception, none of the newborns had
abnormalities compatible with congenital rubella syndrome (14).
SECTION IV-MEDICAL
• Workers in areas responsible for seed growth, propagation and storage and vaccine growth and
propagation are required to have proof of titers or vaccination. This is consistent with national
guidelines and World Health Organization regulations for product protection.
• All others are recommended to have titers as part of a good public health philosophy.
Medical Surveillance: There is no routine medical surveillance for persons with a healthy immune system
working with the vaccine strains of measles, mumps and rubella virus. Changes in immune status or
pregnancy must be communicated to their occupational health group or personal physician, as appropriate,
immediately.
Medical risk for laboratory/production workers with measles, mumps and rubella titers (circulating
antibodies to virus): None. There are no known cases of infection of a person with a titer and a
functioning immune system.
Medical risk for laboratory/production workers without measles, mumps or rubella titers: The risk
from exposure to the live vaccine virus to a healthy employee appears to be low to no risk, the same as
M-M-R® II Vaccine Agent Summary Sheet (VASS)
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
M-M-R® II vaccine 8/10/2010
being given the vaccine (15). For a pregnant employee, the risk to her and her unborn child appears to be
low to no risk, but the risk cannot be quantified precisely (16).
SECTION V-RECOMMENDED PRECAUTIONS
Containment/Vaccination Policy regarding this agent: Containment for attenuated measles, mumps and
rubella virus is BSL1 (BSL1 containment is for organisms not considered to cause disease in healthy adult
humans). Containment for chicken embryo and WI-38 cells is BSL1 (BSL1 containment is for organisms
not considered to cause disease in healthy adult humans).
SECTION VI-HANDLING INFORMATION
Spills: A spill clean-up SOP should be developed. In the event it is not available, the measles, mumps and
rubella virus is easily inactivated. 70% ethanol, Vesphene and LpH are all capable of destroying the virus.
A freshly made 10% bleach solution will also inactivate the virus, but can damage stainless steel. The
standard procedure for any large spill in an open area is to leave the area for 30 min prior to returning to
disinfect the area. Wear gloves, safety glasses, face mask or respirator (as allowed by national regulation),
“bunny” suit, and shoe covers.
References
1. Prescribing Information, MMR-II. Merck & Co., Inc. Dec 2007.
2. Benenson, A, Ed. Measles. In: Control of Communicable Diseases Manual, 18th Ed. Am. Public
Health Assoc., 2008.
3. Heymann, DL, Ed. Mumps. In: Control of Communicable Diseases Manual, 18th Ed. Am.
Public Health Assoc., 1995.
4. Heymann, D, Ed. Rubella. In: Control of Communicable Diseases Manual, 18th Ed. Am. Public
Health Assoc., 2008.
5. Chernesky, MA and Mahony, JB. Rubella virus. In: Manual of Clinical Microbiology, 6th Ed.
Murray, P et al., Ed. ASM Press, 1995.
6. Jantausch, B; and Sever, J. Viral Infections. In; Occupational and Environmental Reproductive
Hazards. (M Paul, ed.) Williams & Williams, Maryland, 1993.
7. Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on
Immunization Practices (ACIP): User of vaccines and immune globulins in persons with altered
immunocompetence. MMWR 42(No. RR-4). 1993.
8. Glick M, Goldman HS. Viral infections in the dental setting. JADA 124:79-86, 1993.
9. Centers for Disease Control and Prevention. Update: Vaccine Side Effects, Adverse Reactions,
Contraindications, and Precautions. Recommendations of the Advisory Committee on
Immunization Practices. MMWR 45(No RR-12). 1996.
10. Glick M, Goldman HS. Viral infections in the dental setting. JADA 124:79-86, 1993.
M-M-R® II Vaccine Agent Summary Sheet (VASS)
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
M-M-R® II vaccine 8/10/2010
11. Centers for Disease Control and Prevention. Update: Vaccine Side Effects, Adverse Reactions,
Contraindications, and Precautions. Recommendations of the Advisory Committee on
Immunization Practices. MMWR 45(No RR-12). 1996.
12. Yamauchi, T, Wilson, C, and St Geme, JW. Transmission of live, attenuated mumps virus to the
human placenta. N. Engl. J. Med. 290(13):710-712, 1974.
13. Robertson, SE, Cutts, FT, Samuel, R, and Diaz-Ortega, J-L. Control of rubella and congenital
rubella syndrome (CRS) in developing countries, part 2: vaccination against rubella. Bulletin of
the WHO 75(1): 69-80, 1997.
14. Prescribing Information, MMR-II. Merck & Co., Inc. Dec 2007.
15. Centers for Disease Control and Prevention. Measles, Mumps, and Rubella-Vaccine use and
Strategies for Elimination of Measles, Rubella, and Congenital Rubella syndrome and control of
Mumps: Recommendations of the Advisory Committee on Immunization Practices. MMWR
47(No. RR-8). 1998.
16. Centers for Disease Control and Prevention. Recommendations of the Advisiory Committee on
Immunization Practices (ACIP): User of vaccines and immune globulins in persons with altered
immunocompetence. MMWR 42(No. RR-4). 1993.
Disclaimer
While this information and recommendations are believed to be accurate as of the date hereof, MERCK &
CO, INC. makes no warranty with respect hereto and disclaims all liability from reliance thereon.
M-M-R® II Vaccine Agent Summary Sheet (VASS)
(MEASLES, MUMPS, and
RUBELLA VIRUS VACCINE LIVE)
M-M-R® II vaccine 8/10/2010
Approvals
Signature Name Date
Secretary, Merck Biosafety Advisory
Committee
Chair, Merck Biosafety Advisory
Committee
Integrated Health Management