Content
Available Vaccines
Rubella
Introduction
Rubella, also known as German measles, is a common febrile exanthema of children and young adults. The causative agent, rubella virus (genus Rubivirus family Togaviridae) is transmitted from person-to-person through respiratory droplets. Humans are the only known natural hosts to the virus. The incubation period of the disease is 2-3 weeks. The infected individuals become infectious a week before, through 2 weeks after the onset of maculopapular rash. Apart from the fever and often pruritic skin rash, the disease is characterised by malaise, conjunctivitis and arthralgia or arthritis, which is most commonly observed in adult women. Lymph node enlargement involving post-auricular, occipital and posterior cervical groups is characteristic and precedes the rash onset by 5 to 10 days. Up to 50% of rubella infection may occur without skin rash. While rubella is a mild self-limiting illness during childhood, it poses a special risk to women of child-bearing age due primarily to the virus teratogenicity, which forms the primary basis for universal rubella vaccination. Infection that occurs just before conception and during the first trimester of the pregnancy may result in foetal loss or congenital rubella syndrome. Beyond this period, foetal malformation is rare although isolated sensorineural hearing loss may occur up to 20 weeks of gestation. Congenital rubella syndrome comprises a broad range of multi-systemic defects, including abnormalities affecting eyes (cataracts, chorioretinitis, microphthalmia, glaucoma), sensorineural deafness, heart (patent ductus arteriosus, peripheral pulmonic artery stenosis, ventricular septal defects), brain (encephalitis, microcephaly, cognitive impairment), intrauterine growth retardation, hepatitis, hepatosplenomegaly, thrombocytopenic purpura, pneumonitis, endocrine disorders (diabetes, hypothyroidism) and autism in later life. Infants with congenital rubella may have prolonged viral shedding for a year or longer in throat secretions and urine.
Vaccines
A number of live-attenuated rubella vaccines are available, either as monovalent or rubella-containing vaccine, in combination with measles (MR), measles and mumps (MMR) or measles, mumps and varicella (MMRV). The protective immune responses to each individual vaccine antigen as well as vaccine associated adverse events, remain largely unchanged. They are safe, effective and provide long-lasting immunity.
Vaccines Available in Malaysia
1. Rubella®
(Live attenuated rubella vaccine)
SM Pharmaceuticals Sdn Bhd/Serum Institute of India
2. Measles and Rubella®
(Live attenuated measles and rubella vaccine)
SM Pharmaceuticals Sdn Bhd/Serum Institute of India
3. MMR II®
(Live attenuated measles, mumps and rubella vaccine)
Merck Sharp & Dohme (Malaysia) Sdn Bhd/Merck Sharp & Dohme Corp. USA
4. Proquad®
(Live attenuated measles, mumps and rubella plus varicella vaccine)
Merck Sharp & Dohme (Malaysia) Sdn Bhd/Merck Sharp & Dohme Corp. USA
5. Priorix®
(Live attenuated measles, mumps and rubella vaccine)
GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium
6. Priorix Tetra®
(Live attenuated measles, mumps and rubella plus varicella vaccine)
GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium
7. SII Measles and Rubella Virus Vaccine®
(Live attenuated measles and rubella vaccine, single or 10 doses)
SM Pharmaceuticals Sdn Bhd/Serum Institute of India
Mode of Administration
- Rubella containing vaccine is normally administered subcutaneously, but it is also effective when administered intramuscularly.
- A single dose of rubella vaccine provides high response rate (≥95%) and long-term persistence of immunity. While in theory a second dose of rubella vaccine is not required, it is nonetheless routinely given based on the indications for a second dose of measles and mumps-containing vaccines in most settings.
Co-administration with Other Vaccines
Rubella or rubella-containing vaccine can be given simultaneously, but at a separate site, with diphtheria and tetanus toxoids and pertussis vaccine, H. influenzae vaccine, IPV, hepatitis B vaccine, OPV and varicella vaccine.
Contraindications and Adverse Effects
Blood Products: Rubella containing vaccines should be given at least 2 weeks before the administration of blood products or deferred until 3 -11 months after such administration, depending on the nature of the blood product as passively acquired antibodies can interfere with response to the vaccine (refer to Table 10.1). However, anti-Rho(D) globulin does not interfere with vaccination of postpartum women. Women who are vaccinated after receiving anti-Rho (D) globulin should be tested 6 weeks later for rubella antibodies.
Pregnancy: Based on a theoretical, yet never proven, risk of teratogenicity, pregnant women should not receive rubella vaccination. Women who plan to conceive should be advised to delay the pregnancy for 1 month following rubella vaccination. However, inadvertent rubella vaccination of unknowingly pregnant women is not an indication for termination of pregnancy.
Common side effects: vaccinees sometimes develop mild rubella, including rash, lymphadenopathy, fever, sore throat and headache as well as mild local reactions (pain, redness and induration). The incidence varies directly with age, being almost absent in infants but present in up to 50% of women. While joint-related symptoms are rarely reported in children and in men, arthralgia and arthritis may occur 7–21 days post-vaccination and last up to 2 weeks in adult women. Epidemiological studies have not demonstrated an association between rubella vaccine and chronic joint disease. There is an increased, albeit small, risk of febrile seizures following tetravalent measles-mumps-rubella-varicella vaccine when compared to concomitant administration of MMR and varicella vaccine in children aged 12-23 months when the vaccines are given for the first time. There was no increase in febrile seizures after the second dose of MMRV.
Individuals with a history of an anaphylactic reaction to neomycin, gelatin or other components of the vaccine should not be vaccinated. Rubella vaccines should not be given to immunocompromised or immunosuppressed individuals including advanced HIV infection and AIDS, primary immunodeficiency, malignancies and aggressive immunosuppressive therapy.
To date, the most frequently reported adverse events for rubella vaccines received by the National Pharmaceutical Regulatory Agency (NPRA) include malaise, vomiting and rash.
Target Groups in Malaysia
- All adult females especially of childbearing age
- College and university students
- Healthcare workers
Evidence for Effectiveness
Internationally licensed rubella vaccines, either single or in combinations, have proven highly efficacious in the prevention of rubella and congenital rubella syndrome worldwide. In outbreak situations the effectiveness of different rubella vaccines has been found to be 90–100% effective. The vaccine provides life-long immunity against rubella virus.
References
- The Malaysian National Centre of Adverse Drug Reactions Database. Accessed October 10, 2019
- National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. Senarai Produk Vaksin Berdaftar Dengan Pihak Berkuasa Kawalan Dadah. Updated September 5, 2019.
- Plotkin, S.A. & Reed, S.E. (2018). Rubella vaccine in Stanley Plotkin, Walter Orenstein and Paul Offit. (7th Ed) Vaccines. PA: Elsevier
- Rubella vaccine: WHO position paper (2011). WHO Weekly Epidemiological Record No 29, 86:301-316