What Are the Risks of Measles during Pregnancy?
Live attenuated measles, mumps and rubella vaccine is indicated for the prevention of measles, mumps and rubella.
- Drug Name
- Live measles mumps rubella attenuated live vaccine
- Drug type
- Prescription drugs, essential drugs
- Live attenuated measles, mumps and rubella vaccine is indicated for the prevention of measles, mumps and rubella.
Components and traits of live attenuated measles and mumps rubella vaccine
- This product is a triple attenuated live vaccine, and its main components are: live measles, mumps, rubella live virus.
This product includes ATTENUVAX * (live measles virus vaccine), a further attenuated measles virus strain derived from Enders attenuated Edmonston strain, which is propagated in chicken embryo cell culture; MUMPSVAX * (mumps virus live vaccine) The mumps virus of Jeryl Lynn TM (level B) strain proliferated in chicken embryo cell culture; MERUVAX * II (live rubella virus vaccine), Wistar RA 27/3 live rubella virus attenuated strain in human diploid in WI-38 Proliferation in lung fibroblasts.
Each dose of this vaccine contains inactive ingredients: sodium phosphate (3.1 mg single base, 2.2 mg double base), sodium bicarbonate (0.5 mg), medium 199 (3.3 mg), Iggler's medium (0.1 mg) , Neomycin (25.0 g), phenol red (3.4 g), sorbitol (14.5 mg), potassium phosphate (single base 20.0 g, double base 30.0 g), porcine hydrolyzed gelatin (14.5 mg), recombinant human white Protein ( 0.3mg), sucrose (1.9mg), L-glutamic acid monosodium salt (20.0 g). This product contains no preservatives.
* Registered trademark of Merck & Co. Inc.
Measles Mumps Rubella Live Attenuated Vaccine Traits
- The vaccine is a lyophilized preparation. It is a pale yellow dense crystal before preparation and a clear yellow liquid after reconstitution.
- Measles Mumps Rubella Live Attenuated Vaccine -Prophylactic Biologics
- Suitable for susceptible people aged 12 months and over.
- Effect and use of live attenuated measles mumps and rubella vaccine -preventive biological agents
- The vaccine can stimulate the body to produce immunity to measles virus, mumps virus and rubella virus at the same time. This product is used to prevent measles, mumps and rubella.
Measles Mumps Rubella Live Attenuated Vaccine Specifications
- 0.5 ml / bottle. Each injection is 0.5ml and contains not less than 1000 CCID 5O (50% of the cell infection dose) of measles virus, 20,000 CCID 5O mumps virus, and 1000 CCID 5O rubella virus.
Immune procedures and doses of live attenuated measles and mumps rubella vaccine
- This product is inoculated with a single dose of 0.5ml and injected subcutaneously (the outer part of the upper arm is recommended).
[u] Recommended vaccination procedures for children: [/ u]: Those who are vaccinated for the first time at 12 months or older should be vaccinated again at the age of 4-6 years. Re-vaccination can lead to seroconversion in children who do not develop an immune response in the first vaccination.
[u] Preparation guidance [/ u]:
The vaccine must be prepared by dissolving it with the special dilution solution (without preservatives or other antiviral substances that can inactivate the vaccine). After adding the dilution solution, shake it until it is completely mixed before use.
Each time this product is injected and / or formulated, a sterile syringe without preservatives, bactericides and detergents should be used, as these substances can inactivate the live virus vaccine contained in this product.
When the solution and container meet the conditions, the injected vaccine should be visually observed before use. If it contains visible particles and discoloration, or the lyophilized vaccine cannot be dissolved, discard it.
Adverse reactions to live attenuated measles, mumps, rubella vaccine
- The following adverse reactions of this product are listed in descending order of severity in each body system classification, regardless of the degree of its relevance to the vaccine. They come from reports of clinical trials, post-marketing vaccine use, or application of monovalent or bivalent vaccines containing measles, mumps or rubella.
Systemic <br /> lipodenitis; atypical measles; fever; syncope; headache; dizziness; discomfort; irritability.
Cardiovascular system < br angiitis.
Digestive System < br Pancreatitis; diarrhea; vomiting; mumps; nausea.
Endocrine system <br /> Diabetes.
Blood and Lymphatic System < br Thrombocytopenia (see [Notes]); Purpura; Local lymphadenopathy; Leukopenia.
Immune system < br Allergies, allergic reactions and other related symptoms such as angioedema (peripheral or facial), bronchospasm and urticaria. The above allergic reactions have nothing to do with whether the vaccinator has a history of allergies.
Musculoskeletal system <br /> arthritis; joint pain; myalgia.
Arthralgia and / or arthritis (often transient and chronically rare) and polyneuritis are characteristic manifestations of wild-type rubella virus infection, and their incidence and severity vary with age and gender, and in adulthood Symptoms are most severe in women, and are mildest in prepubertal children. This type of paresthesia and myalgia has been reported after MERUVAX II inoculation.
Chronic arthritis is associated with wild-type rubella virus infection and the persistence of viruses and / or viral antigens isolated from body tissues. Chronic joint symptoms are rare in vaccinated individuals.
Joint reactions in children vaccinated against this vaccine are uncommon and usually short in duration. The incidence of arthritis and joint pain is usually higher in women who are vaccinated than in children (children: 0-3%, women: 12-26%), and joint reactions tend to be more pronounced and last longer. Symptoms can persist for months or in rare cases to years. The incidence among young women after vaccination is between children and adult women. In women over 35 years of age, these reactions are usually well tolerated and rarely affect daily life.
Nervous system <br /> encephalitis; encephalopathy; measles inclusion encephalitis (MIBE) (see [taboo]); subacute sclerosing panencephalitis (SSPE); Guillain-Barre syndrome (GBS); ; No febrile seizures or seizures; ataxia; polyneuritis; polyneuropathy; ocular paralysis; paresthesia.
Post-marketing data show that within 30 days of vaccination, there is rarely a noticeable central system response in time related to vaccination, such as encephalitis and encephalopathy. But it suggests that some of the above cases may be caused by measles vaccine. The risk of such severe neurological conditions following live measles virus vaccine is much lower than encephalitis and encephalopathy caused by wild-type measles virus (1/2000).
In the past 25 years (1971-1996), post-market surveillance of more than 200 million MMR and this product have been used worldwide, and the results show that serious adverse events such as encephalitis and encephalopathy have been rarely reported.
Subacute sclerosing panencephalitis (SSPE) has been reported in children who have never been infected with wild-type measles but who have received the measles vaccine, and some of these cases may be due to being undiagnosed in the first year after birth Of measles infections or vaccination. According to the estimated distribution of measles vaccine in the local area, the incidence of SSPE-related cases caused by measles vaccination is about 1 in 1 million. It is much lower than SSPE caused by wild-type measles (incidence rate 6-22 / 1 million). According to the results of a retrospective case-control study conducted by the CDC, it is believed that the overall effect of measles vaccine is to prevent SSPE by preventing inherently high-risk measles.
Cases of aseptic meningitis have been reported after vaccination against measles, mumps and rubella. Although the causal relationship between the mumps vaccine Urab strain and aseptic meningitis has been confirmed, there is no evidence to show the correlation between Jeryl Lynn mumps vaccine and aseptic meningitis in this product.
Respiratory system < br Pneumonia; localized pneumonia; sore throat; cough; rhinitis.
Skin Stevens-Johnson syndrome; erythema polymorpha; urticaria; rash; measles-like rash; itching.
Local reactions at the injection site, including burning sensations / itchiness; wind and flushing; redness (erythema); swelling; induration; tenderness; blisters at the injection site.
Special sensationear <br /> sacral deafness; otitis media.
Special sensationseye <br /> retinitis; optic neuritis; optic papillitis; retrobulbar optic neuritis; conjunctivitis.
Urogenital system <br /> Epididymitis, orchitis.
Others < br Deaths caused by vaccination against measles, mumps, and rubella are rare. The causes of death are diverse and some of the causes are unknown; however, the causal relationship in healthy individuals is still unclear (see [Contraindications]). Post-marketing surveillance studies were performed on 1.5 million children and adults who were vaccinated in Finland between 1982 and 1993, and published studies have shown that no deaths or permanent sequelae have been reported.
Measles Mumps Rubella Live Attenuated Vaccine Contraindications
- 1. People who are allergic to any vaccine component, including gelatin.
2. Allergic or allergic reactions to neomycin (each vaccine contains about 25 g neomycin).
3 Any person with a fever that is infected with respiratory disease and other active fevers; patients with active untreated tuberculosis.
4 Pregnant women should not be vaccinated with this product, and it is unclear how the vaccine may affect fetal development. If post-pubertal women are vaccinated, pregnancy should be avoided 3 months after vaccination.
5. Patients receiving immunosuppressive therapy. This contraindication does not apply to patients receiving corticosteroids as an alternative treatment, such as Addison's disease.
6. Patients with blood cachexia, leukemia, any type of lymphoid tissue tumor, or other malignant tumors affecting the bone marrow or lymphatic system.
7. Patients with primary and acquired immunodeficiency, including patients with AIDS-related immunosuppression or other clinically multiple infections caused by human immunodeficiency virus, patients with cellular immunodeficiency, and hypogammaglobulin and hypogammaglobulin abnormal blood Patients. In patients with severe immune dysfunction, measles inclusion body encephalitis (MIBE), pneumonia, and deaths directly due to measles vaccine virus infection have been reported as a result of negligence of a vaccine containing a measles component.
8. Individuals with a family history of congenital or inherited immunodeficiency can be vaccinated only if the vaccine recipient is proven to be immune.
Precautions for live attenuated measles and mumps rubella vaccine
- 1. If an allergic or allergic reaction occurs after vaccination with this product, appropriate treatment and rescue measures should be taken immediately, including injection (1: 1000) of epinephrine.
2. This product is prohibited from intravascular injection.
3 The following people should pay special attention when using this product:
(1) People who have a history of brain trauma, personal or family convulsions, or other symptoms caused by fever should avoid vaccination with this product. Physicians should be aware of the possible increase in body temperature after vaccination.
(2) Allergic reaction to eggs: The live measles and mumps vaccine in this product is prepared by chicken embryo cell culture. If allergies, allergies, and other rapid reactions (such as urticaria, swelling of the mouth and throat, dyspnea, hypotension, or shock) occur after eating eggs, the rapid development may be worsened after vaccination with chicken embryo antigens Allergic reactions. Therefore, the pros and cons should be carefully weighed for this group of people, and rescue measures should be prepared at any time when inoculating this product.
(3) Thrombocytopenia: Patients with thrombocytopenia may get worse after receiving this vaccine. Individuals with thrombocytopenia after the first vaccination can cause thrombocytopenia after re-vaccination, so the serological status should be checked before re-vaccination. Before immunizing such people, carefully weigh the pros and cons.
4 Immunization of susceptible women of childbearing age with this product can prevent rubella infection during pregnancy, and can prevent fetal infections and congenital rubella disease. However, pregnancy should be avoided within 3 months of vaccination and prior informed consent should be obtained. You should also be advised that self-limiting joint pain and / or arthritis will often occur 2 to 4 weeks after receiving this vaccine (see [Adverse Reactions] for details).
5. Children and young people who are known to be HIV-infected but not immunodeficiency can be vaccinated. However, the protective effects of such vaccinators should be closely monitored, as their immune efficacy may be lower than that of healthy people (see [Contraindications]).
6. Most susceptible persons will secrete a small amount of live attenuated rubella virus from the nose or throat within 7 to 28 days after vaccination. There is no definitive evidence that general exposure will allow transmission of this live attenuated rubella virus to susceptible people through vaccinators. However, there are reports in the literature that rubella vaccine virus can be transmitted to babies through breastfeeding (see [Medication for Pregnant Women and Lactating Women] for details).
No literature has reported that live attenuated measles or mumps virus can be transmitted to susceptible populations by vaccinators.
7. It has been reported that inoculation with live attenuated live virus monovalent vaccines for measles, mumps and rubella can temporarily inhibit the skin sensitivity of the tuberculin test. Therefore, if the tuberculin test is to be performed, it should be performed before or at the same time as the inoculation of this product.
8. As with any vaccine, not all people who get it will get protection.
Measles and mumps rubella attenuated live vaccine for pregnant and lactating women
- [u] pregnancy [/ u]
It is unknown at this time whether pregnant women will cause harm to the fetus or affect women's reproductive ability after vaccination with this product. Therefore, pregnant women should not be vaccinated with this vaccine, and women who have received this vaccine should avoid pregnancy for three months after vaccination.
If you are unintentionally vaccinated during this pregnancy or are pregnant within three months of being vaccinated, your doctor should pay attention to the following information: (1) Pass 10 years to more than 700 pregnant women within three months before conception or three years after conception The rubella vaccine (including 189 Wistar RA 27/3 strains) was vaccinated within one month for investigation. None of the newborns had abnormal symptoms similar to congenital rubella syndrome; (2) possible mumps infection during the first three months of pregnancy Improve natural abortion rate. Although mumps virus can cause placental and fetal infections, there is no evidence that it can cause congenital malformations in humans; (3) Natural infection with measles during pregnancy has been reported to increase the harm to the fetus. Natural measles infection during pregnancy increases the incidence of spontaneous abortions, stillbirths, birth defects, and preterm births. As the effects of attenuated measles virus strains on pregnancy have not been fully studied, care should be taken to assume the possibility of adverse reactions to the fetus.
[u] lactating women [/ u]
It is not known whether measles or mumps virus can be secreted from breast milk. Recent studies have shown that after postpartum feeding women are vaccinated against live rubella vaccine, the virus can be detected in breast milk and transmitted to nursing infants. Serological tests have confirmed that no serious disease is present in infants infected with rubella virus, but one case has mild clinical symptoms typical of rubella infection. Therefore, caution should be taken when inoculating this product to nursing women.
Measles Mumps Rubella Live Attenuated Vaccine for Children
- The safety and effectiveness of mumps and rubella vaccines in infants under 12 months of age have not been determined.
Measles Mumps Rubella Live Attenuated Vaccine
- still uncertain.
Measles Mumps Rubella Live Attenuated Vaccine Drug Interactions
- 1. Do not use immunoglobulin (IG) with this vaccine
The simultaneous use of immunoglobulin and this product may interfere with the immune response. If human immunoglobulins have been used or blood or plasma transfusions have been given, vaccination should be postponed until three months or more.
2. Combination with other vaccines This product should be used before or one month after other live virus vaccines.
This product has been used with attenuated live chickenpox vaccine and inactivated Haemophilus influenzae type b vaccine at the same time, but using different injection sites and different syringes. Experiments have shown that simultaneous use of these vaccines has no effect on the immune response of a single vaccine antigen. The type, frequency, and severity of the adverse reactions produced by this product when used in combination are similar to those of any of the vaccines used alone.
At present, due to limited information on the concurrent use of the following vaccines, DTP (diphtheria, pertussis, tetanus vaccine) and / or OPV (oral polio vaccine) is not recommended for routine concurrent use with this product.
However, other vaccination programs are currently in use. Published research data indicate that a full set of recommended vaccine series (ie: DTaP [or DTwP], IPV [or OPV], Haemophilus influenzae vaccine type B), and the simultaneous or non-use of hepatitis B vaccine, And chickenpox vaccine) have confirmed that there is no interference between the recommended routine vaccination of children (whether live, attenuated or inactivated).
Measles mumps rubella live attenuated vaccine overdose
- Rarely reported overdose of this product, and overdose has no correlation with the occurrence of any serious adverse reactions.
Clinical trial of live attenuated measles and mumps rubella vaccine
- Clinical pharmacological and toxicological measles, mumps, and rubella are three common childhood diseases caused by measles virus, mumps virus (paramyxovirus), and rubella virus (mantle virus), which can cause serious complications and / Or death. For example, measles causes pneumonia and encephalitis; mumps can cause aseptic meningitis, deafness, and orchitis; pregnant women with rubella can transmit the virus to their newborns to cause congenital rubella syndrome.
Clinical studies of 284 children aged 11 months to 7 years old and all three virus sera negative showed that this product is highly immunogenic and generally well tolerated. After a single vaccination, 95% of the susceptible population in the study produced measles erythrocyte aggregation inhibitory (HI) antibodies, 96% produced mumps neutralizing antibodies, and 99% produced rubella HI antibodies. However, 1-5% of vaccinated patients have failed seroconversion after the initial vaccination.
A study of 6-15 month old infants whose mothers have been immunized with vaccines has shown that 74% of 6 month old infants can reach the level of detection of neutralizing antibody (NT) after receiving live measles virus vaccine (ATTENUVAX *). Level, 100% of 15-month-old children reach NT detection titer level. This positive rate is higher than previously reported 6-month-old babies born to naturally immunized mothers using the HI method. At the age of 15 months, re-vaccination of 6-month-old children born to the mothers after the immunization, their antibody titers were comparable to those of 15-month-old children. There are two possible explanations for the low seroconversion rate in 6-month-old children: The detection level of the measurement method is limited [NT method and enzyme immunoassay method (EIA method)]. Due to the presence of undetected trace mother-derived antibodies, May interfere with infant seroconversion. Judging by two methods of antibody analysis, the immune system of 6-month-old children is not always capable of responding to measles vaccine.
A series of double-blind controlled trials evaluating the efficacy of measles, mumps and rubella vaccines have shown that each monovalent vaccine component can produce a high degree of protective efficacy. These studies have also confirmed that seropositive responses following vaccination can have parallel protective effects on measles, mumps and rubella diseases.
After inoculation, the relevant protective antibodies can be determined by neutralization test, HI or ELISA (enzyme-linked immunosorbent assay) method. Most of the vaccinated persons, 11-13 years after the initial immunization, can still detect antibodies to measles, mumps and rubella virus in vivo through neutralization tests and ELISA methods.
There is no research data on the reproductive toxicity of this product to animals. This product has not been evaluated for carcinogenicity, mutagenicity or damage to fertility.
Storage of live attenuated measles and mumps rubella vaccine
- During the transportation of the vaccine, to ensure that the efficacy of the vaccine is not reduced, the vaccine should be stored at 10 ° C or lower. Freezing the vaccine during transport has no effect on vaccine titer. This product should be stored away from light, as light may inactivate the virus.
Prior to preparation, freeze-dried vaccine vials are stored at 2-8 ° C or lower. The diluent can be stored in the refrigerator with the lyophilized vaccine or separately at room temperature. Do not freeze the dilution.
Joint packages containing lyophilized vaccine and diluent should be stored at 2-8 ° C.
It is recommended that the vaccine should be used immediately after preparation. The prepared vaccine should be stored in a vaccine bottle and stored at 2-8 ° C in the dark. If it is not used within 8 hours, it should be discarded.
Measles Mumps Rubella Attenuated Live Vaccine Packaging
- 1 bottle / box: Contains 1 single dose of lyophilized vaccine and 1 bottle of dilution.
5 bottles / box: contains 5 single doses of lyophilized vaccine and 5 bottles of dilution.
10 bottles / box: Contains 10 bottles of lyophilized vaccine in a single dose and 10 bottles of diluent.
Validity of live attenuated measles mumps rubella vaccine
- 24 months (from the date of packaging and transfer to 2-8 ° C for storage)
The product can be stored for 18 months at -20 ° C before packaging. If the storage time of -20 ° C exceeds 18 months, the storage time of 2-8 ° C will be reduced accordingly.
Implementation standard of live attenuated measles and mumps rubella vaccine
- Import Drug Registration Standard JS20070017 [1]