What Is The Proquad Vaccine

How Does Proquad Work

ProQuad is a vaccine. Vaccines work by teaching the immune system how to defend itself against a disease. ProQuad contains weakened forms of the viruses that cause measles, mumps, rubella and chickenpox. When a person is given the vaccine, the immune system recognises the weakened viruses as foreign and makes defences against them. In the future, the immune system will be able to respond more quickly when it is exposed to the viruses again. This will help to protect against the diseases caused by these viruses.

Less Common And Serious Or Severe Adverse Events

Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. Anaphylaxis following vaccination with varicella-containing vaccine may occur but is very rare.

Univalent varicella vaccine

Most reported serious adverse events have not been proven to be caused by the vaccine, with the exception of rare events linked to the varicella vaccine strain among immunocompromised individuals or those with other serious medical conditions.

Measles-Mumps-Rubella-Vaccine vaccine

Immune Thrombocytopenic Purpura

Rarely, ITP occurs within 6 weeks after immunization with MMRV vaccine. In most children, post-immunization thrombocytopenia resolves within 3 months without serious complications. In individuals who experienced ITP with the first dose of MMRV vaccine, serologic status may be evaluated to determine whether an additional dose of vaccine is needed for protection. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases.

Encephalitis

Encephalitis has been reported in association with administration of measles vaccine in approximately 1 per million doses distributed in North America, which is much lower than the incidence observed with natural measles disease .

Varicella zoster immunoglobulin

There is a remote risk of an anaphylactic reaction to VarIg in individuals with hypersensitivity to blood products.

How Does The Measles Vaccine Work

After two doses, the MMR and MMRV vaccines are about 97% effective against measles, 88% effective against mumps, and 97% effective against rubella. Additionally, the MMRV vaccine is about 95% effective against chickenpox. It can take up to 14 days after vaccination with either vaccine to be fully protected.

The MMR and MMRV vaccines have several benefits. They prevent serious measles-related complications, like pneumonia and death. Also, according to the CDC, Measles is so contagious that if one person has it, 90% of the people close to that person who are not immune will also become infected. So, by getting your children and yourself vaccinated, youre helping to keep measles out of our daycares, schools, colleges, amusement parks and other community areas.

Whats in them?

Both vaccines contain live, attenuated viruses. Live viruses are much weaker versions of the natural germ. They dont have enough strength to cause the actual disease.

Because live, weakened viruses are so similar to natural viruses, your immune system has a strong response to them. That means two things:

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What Should I Discuss With My Healthcare Provider Before Receiving This Vaccine

Your child should not receive this vaccine if he or she:

• is allergic to gelatin or
• has had a severe allergic reaction to neomycin.

Your child should also not receive this vaccine if he or she has:

• untreated tuberculosis
• a history of severe allergic reaction to eggs or
• severe immune suppression caused by disease , or by receiving medicines such as certain steroids, chemotherapy or radiation.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

• active tuberculosis infection
• a history of brain injury or seizures
• thrombocytopenia purpura or
• if you have received an immune globulin or a blood or plasma transfusion within the past 3 months.

Although MMRV vaccine is normally given only to children, a pregnant women should not receive this vaccine. Chickenpox can cause birth defects, low birth weight, or a serious infection in the newborn, and this vaccine exposes you to a small amount of this virus. Any female receiving MMRV vaccine should not get pregnant for 3 months after getting the vaccine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How Is Proquad Given

ProQuad is given as an injection in the arm or thigh. Your child receive this injection in a doctor’s office or clinic setting.

ProQuad vaccine is usually given only once when the child is 12 to 15 month old. A booster dose may be given between 4 and 6 years of age.

If your child has received any other measles vaccine, at least 1 month should pass between that vaccine and the ProQuad vaccine.

If your child has received any other varicella vaccine, at least 3 months should pass between that vaccine and the ProQuad vaccine.

Your child’s booster schedule may be different from these guidelines. Follow the doctor’s instructions or the schedule recommended by your local health department.

ProQuad can cause false results on a skin test for tuberculosis for up to 6 weeks. Tell any doctor who treats your child if he or she has received an MMRV vaccine within the past 4 to 6 weeks..

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What Benefit Has Proquad Shown During The Studies

The response rates in children above 12 months of age were: 98% for measles, 96% to 99% for mumps, 96% for rubella and 91% for chickenpox. After the second dose, the rates were around 99% for measles, 100% for mumps, 98% for rubella, and 99% for chickenpox.

The study in children from nine to 12 months of age showed that, after two doses of ProQuad, the immune response against mumps, rubella and chickenpox in children who received the first dose at nine months of age was comparable with those who received the first dose at 12 months of age. However, children who received the first dose at nine months of age had a lower immune response against measles.

Proquad Vaccine News For 2005

– The U.S. CDC published the Top 10 Countries with Global Measles Outbreaks in 2021.

– The CDC published: Notes from the Field: Congenital Varicella Syndrome Case Illinois, 2021. This case reaffirms current Advisory Committee on Immunization Practices recommendations for preventing varicella that all adults be assessed for varicella immunity and that those who do not have evidence of immunity should receive 2 doses of varicella vaccine, with special emphasis for adult groups at high risk, including nonpregnant women of childbearing age.

– The U.S. CDC’s MMWR confirmed 173 of 194 countries had introduced RCVs by 2020, and 93 had been verified as having eliminated rubella transmission.

– The Lancet published an article that stated: Disrupted vaccination activities during the pandemic increase the potential for another resurgence of measles in the near future.

January 3, 2022 – The CDC confirmed a total of 49 measles cases were reported by 5 jurisdictions in the U.S. during 2021. This data compares with 2020, when13 individual cases of measles were confirmed in 8 jurisdictions.

– A total of 42 measles cases were reported by three jurisdictions this year. In 2020, the U.S. CDC confirmed 13 individual cases of measles were established in 8 jurisdictions.

– GSK reported financial results. MMRV vaccines sales were flat at AER but grew 6% CER to £54 million, largely driven by favorable phasing in International.

– The U.S. CDC reconfirmed various measles outbreaks in Africa.

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Listing Requested And Pbacs View

The submission sought inclusion on the NIP for the vaccination of children at the age of 18 months. The submission noted that from July 2013, the 18 month dose of varicella vaccine and the 4 year old dose of measles, mumps and rubella will be replaced by a single dose of measles, mumps, rubella and varicella at 18 months of age, bringing forward the second dose of MMR.

How To Use Proquad Vial

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by injection by a health care professional. Depending on the brand of vaccine your child receives, it will be given either under the skin or into the muscle of the upper arm.

Vaccines are usually given in a series of doses to provide the best protection. Closely follow the vaccination schedule provided by the health care professional. Keep all scheduled medical appointments. It may be helpful to mark a calendar as a reminder.

This combination of vaccines may be given at the same time as other childhood vaccines using a separate needle and injection site.

There are various combinations of vaccines available. Based on your child’s age, vaccination history, and previous reaction to vaccines, the health care professional will decide which vaccines are best for your child. Discuss the risks and benefits of vaccination with the health care professional.

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What Are The Side Effects Of Proquad

Get emergency medical help if your child has signs of an allergic reaction or a severe skin reaction .

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child’s health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

• a high fever
• nervous system problems–numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Common side effects may include:

• redness, pain, or swelling where the shot was given
• fever
• rash or
• feeling irritable .

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

How Supplied/storage And Handling

No. 4171 ProQuad is supplied as follows:

a package of 10 single-dose vials of lyophilized vaccine, NDC 0006-4171-00

a separate package of 10 vials of sterile water diluent .

Storage

To maintain potency, ProQuad must be stored frozen between -58°F and +5°F . Use of dry ice may subject ProQuad to temperatures colder than -58°F .

Before reconstitution, store the lyophilized vaccine in a freezer at a temperature between58°F and +5°F for up to 18 months. Any freezer that reliably maintains an average temperature between58°F and +5°F and has a separate sealed freezer door is acceptable for storing ProQuad. Routine defrost cycling of a frost-free freezer is acceptable.

ProQuad may be stored at refrigerator temperature for up to 72 hours prior to reconstitution. Discard any ProQuad vaccine stored at 36° to 46°F which is not used within 72 hours of removal from 5°F storage.

Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.

IF NOT USED IMMEDIATELY, THE RECONSTITUTED VACCINE MAY BE STORED AT ROOM TEMPERATURE, PROTECTED FROM LIGHT, FOR UP TO 30 MINUTES.

DISCARD RECONSTITUTED VACCINE IF IT IS NOT USED WITHIN 30 MINUTES.

DO NOT FREEZE RECONSTITUTED VACCINE.

Diluent should be stored separately at room temperature , or in a refrigerator .

For information regarding the product or questions regarding storage conditions, call 1-800-MERCK-90.

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What Are The Possible Side Effects Of This Vaccine

Get emergency medical help if you have signs of an allergic reaction or a severe skin reaction .

Your child should not receive a booster vaccine if he or she had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving this vaccine. If the child ever needs to receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.

Becoming infected with measles, mumps, rubella, or varicella is much more dangerous to your child’s health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

• a high fever
• nervous system problems–numbness, pain, tingling, weakness, burning or prickly feeling, vision or hearing problems, trouble breathing.

Common side effects may include:

• redness, pain, or swelling where the shot was given
• fever
• rash or
• feeling irritable .

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

What Other Drugs Will Affect Measles Mumps Rubella And Varicella Virus Vaccine

MMRV vaccine is sometimes given at the same time as other vaccines. Before receiving this vaccine, tell the doctor about all other vaccines your child has recently received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

• an oral, nasal, inhaled, or injectable steroid medicine
• chemotherapy or radiation cancer treatments
• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders or
• medicines to treat or prevent organ transplant rejection.

If your child is receiving any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

Other drugs may affect MMR vaccine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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Is The Mmrv Vaccine Safe

The MMRV vaccine is safe and effective most children will have no reaction. Some common side effects from the MMRV include redness, swelling and tenderness in the area where the needle is given. Fever, and/or a rash can occur four to 12 days after getting the vaccine. The rash can be a blotchy red rash and/or spots that look like blisters . Severe reactions are rare.

There have been studies that showed a possible increased risk of febrile seizures in children who received the MMRV vaccine as a first dose when younger than two years of age. These studies were conducted in the United States for the MMRV vaccine ProQuad. The rate of febrile seizures in Priorix-Tetra has not been reported to be higher than if MMR and varicella vaccines are given separately. As children get older their risk for febrile seizures lessens. Children who are four to six years of age do not experience febrile seizures as often as children less than four years of age.

Please report any side effects or severe vaccine reaction to your health care provider or local public health unit.

Acip Preference For 2nd Dose 1

• The ACIP generally prefers the combination vaccine MMRV for the 2nd dose at any age .1
• In a postmarketing observational study, no cases of febrile seizure were observed during the 5- to 12-day postvaccination period among children who received ProQuad as a 2nd dose.
• A personal or family history of seizures of any etiology is a precaution for vaccination with ProQuad.1

Reference

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Schedule : Controlled Drug

Schedule 8 drugs and poisons, otherwise known as Controlled Drugs, are substances and preparations for therapeutic use which have high potential for and . The possession of these medications without authority is an offence.

Like schedule 4 substances, the price of many Schedule substances are subsidized through the , some of which may require an authority. In addition, in some states, all drugs on schedule 8 require a doctor to have an S8 permit before prescribing treatment. For example, in the prescribing of Schedule 8 CNS stimulant medication requires authorisation from the NSW Ministry of Health and is generally restricted to specialists, such as paediatricians and psychiatrists. A GP cannot initiate the treatment, although they can prescribe in very limited circumstances, e.g. co-prescribing on behalf of the specialist and in rural areas, if the patient has been diagnosed with , a GP may apply for the authority to prescribe. Patients who may require Schedule 8 CNS stimulant medication should be referred to a specialist for assessment.

Examples:

Which Vaccine Is Used And What Does It Contain

The product used in the vaccination programme is called ProQuad.

• The MMRV vaccine contains live, attenuated measles, mumps, rubella and chickenpox viruses cultivated in chicken embryo and human cells.
• The auxiliary agents are sugar, sorbitol, gelatine, urea, salts, sodium glutamate, pH indicator dye and purified water.
• The vaccine does not contain significant amounts of egg protein .
• The vaccine only contains traces of neomycin.
• The vaccine does not contain adjuvants.

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Carcinogenesis Mutagenesis Impairment Of Fertility

ProQuad has not been evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility.