Updated on 11/08/2010

H1N1 (Swine) flu Vaccination
Frequently ask questions

  1. Who can be vaccinated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
  2. How often should the nasal-spray flu vaccine LAIV (NASOVAC) be given ?

  3. Is the nasal-spray flu vaccine LAIV (NASOVAC) effective ?
  4. Can the nasal spray flu vaccine give you the swine flu ?
  5. What are the advantages of the nasal-spray flu vaccines LAIV ?
  6. Is the nasal-spray flu vaccine LAIV (NASOVAC) safe ?
  7. What side effects are associated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
  8. Who should not be vaccinated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
  9. Are there any precautions and warnings before use of NASOVAC ?
  10. Are there any contraindications to give LAIV (NASOVAC) to breastfeeding mothers ?
  11. Can the nasal spray flu vaccine cause Guillain-Barré syndrome (GBS) ?
  12. Can the nasal-spray flu vaccine LAIV (NASOVAC) be given to patients when they are ill ?
  13. Can people receiving the nasal-spray flu vaccine LAIV (NASOVAC) pass the vaccine viruses to others ?
  14. Can people who are in close contact with patients having weakened immune systems get the nasal-spray flu vaccine LAIV (NASOVAC) ?
  15. Can people who received inactivated influenza vaccine (the flu shot) last year get the nasal-spray flu vaccine LAIV (NASOVAC) this year ?
  16. How long does it take for the vaccine to give protection ?
  17. Can a person get swine flu infection within 3 weeks after being vaccinated with nasal spray LAIV ?
  18. If a person gets severe flu-like symptoms within 3 weeks of vaccination, is it a vaccine reaction or swine flu/seasonal flu infection ? What should we do ?
  19. Can a person use antiviral drugs like Tamiflu / Fluvir if she/he is confirmed to have swine flu ?
  20. Can a person take the nasal-spray flu vaccine LAIV (NASOVAC) if she/he is already taking influenza antiviral medications ?
  21. Can other medicines and vaccines be used together with the nasal- spray flu vaccine LAIV (NASOVAC) ?
  22. If adults and elderly are taking aspirin therapy, can they take the vaccine ?
  23. How long does the nasal-spray flu vaccine LAIV give protection ?
  24. How is the nasal-spray flu vaccine LAIV (NASOVAC) stored ?
  25. What personal protective equipment is recommended for those who are administering LAIV (NASOVAC) ?
  26. Does the nasal-spray flu vaccine LAIV (NASOVAC) contain thimerosal ?


MEASLES
Frequently ask questions

  1. What is Measles ?
  2. Who are susceptible of Measles ?
  3. How does Measles spread ?
  4. What is the prevalence of Measles in India and the world over ? 
  5. What are the symptoms and adverse effects of Measles ?
  6. What is the treatment for Measles ?
  7. When should the vaccine be taken ?
  8. What is the vaccination schedule if the above doses are missed ?
  9. How long does this vaccine offer protection against Measles ?
  10. What are the side effects of this vaccine ?

MUMPS
Frequently ask questions

  1. What is Mumps?
  2. Who are susceptible of Mumps?
  3. How Mumps spreads?
  4. What is the prevalence of Mumps in India and the world over?
  5. What are the symptoms and adverse effects of Mumps?
  6. What is the treatment for Mumps?
  7. When should the vaccine be taken and what is the vaccine schedule for missed doses?
  8. What are the side effects of this vaccine?

RUBELLA
Frequently ask questions

  1. What is Rubella?
  2. Who are susceptible of Rubella?
  3. How Rubella spreads?
  4. What is the prevalence of Rubella in India?
  5. What are the symptoms and adverse effects of Rubella?
  6. What is the incidence of deformities in the various stages of pregnancy?
  7. What is the treatment for Rubella?
  8. When should the vaccine be taken and what is the vaccine schedule for missed doses?
  9. Can a pregnant woman take the vaccine?
  10. How long does this vaccination offer protection against Rubella?
  11. What are the side effects of this vaccine?

DIPHTHERIA, TETANUS AND PERTUSSIS (DTP)
Frequently ask questions

  1. What is DTP?
  2. What are the symptoms and harmful effects of DTP?
  3. Who are susceptible of DTP?
  4. Who should get DTP vaccine and when?
  5. Can DTP vaccine be taken during illness?
  6. What is the importance of booster doses?
  7. Can DTP vaccine be given to older children and adults?
  8. What are the risks from DTP vaccine?

HEPATITIS-B
Frequently ask questions



Who can be vaccinated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
LAIV (NASOVAC) is approved for use in healthy people of the age 3 years and above. There is no upper age limit.

How often should the nasal-spray flu vaccine LAIV (NASOVAC) be given ?
A single dose of 0.5 ml of LAIV should be given intra-nasally to children of age 3 years & above, to adults and elderly 0.25 ml is to be sprayed in each nostril.
Under no circumstances NASOVAC should be injected.

Is the nasal-spray flu vaccine LAIV (NASOVAC) effective ?
Yes, it is a very effective vaccine as observed in our studies . There have been various other studies on live attenuated nasal-spray flu vaccines in the world which have shown that they give protection to the majority of the people.
Their use in USA and Russia for the last many years has also shown similar results .

Can the nasal spray flu vaccine give you the swine flu ?
No, the nasal spray flu vaccine cannot give you swine flu. The nasal spray flu vaccine contains attenuated (weakened) live viruses. The weakened viruses are temperature sensitive and cold-adapted, which means they can grow only at the cooler temperatures found within the nose and will not cause an infection in the lungs .

What are the advantages of the nasal-spray flu vaccines LAIV ?
The nasal spray flu vaccines are highly safe and offer protection against influenza viruses. Since they mimic the natural route of infection, they also give protection against slightly changed viruses.
LAIVs have been shown to exhibit a phenomenon called ‘herd immunity’, which means, even the unvaccinated people who come in contact with vaccinated people may also get some protection. This has been seen especially with school children who have received vaccines. Their family members were also protected.
Since the vaccines induce immunity in the nose, apart from immunity in blood, the protection is by two way defense.  Moreover, it is a painless administration.

Is the nasal-spray flu vaccine LAIV (NASOVAC) safe ?
Yes, it is a very safe vaccine. It does not cause any serious reactions or any long-lasting reactions / side effects. Such vaccines have been in use in Russia and USA for last many years, where millions of people have received them without any safety concerns.

What side effects are associated with the nasal-spray flu vaccine LAIV (NASOVAC) ?

Some children & young adults between 3-17 years of age and adults have reported experiencing mild reactions after receiving nasal spray flu vaccine such as sneezing, runny nose, nasal congestion or cough, chills, tiredness/weakness, sore throat and headache.
These side effects are mild and short-lasting (1 to 2 days), especially when compared to symptoms of influenza infection. They usually require no medication. There are no serious side effects.

Who should not be vaccinated with the nasal-spray flu vaccine LAIV (NASOVAC) ?
• Children less than 3 years of age
• Children less than 5 years who have a history of recurrent wheezing
• Children or adolescents receiving aspirin
• People who have previous history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
• Pregnant women
• People who have a history of allergy to chicken eggs or who are allergic to any of the nasal spray vaccine ingredients like gelatin.

Are there any precautions and warnings before use of NASOVAC ?
Caution should be exercised in people with a medical conditions like -
• chronic heart or lung disease, such as asthma or reactive airways disease
• uncontrolled diabetes or kidney failure
• illnesses that weaken the immune system.
Administration of NASOVAC to such persons should be based on careful consideration of potential benefits and risks.
• There is no clinical data available on the use of this vaccine in immunocompromised persons or people who take medications that can weaken the immune system [ for example chronic corticosteroid therapy ] .
Antibody response in such patients may be insufficient.

Are there any contraindications to give LAIV (NASOVAC) to breastfeeding mothers ?
It is not known whether vaccine virus is released in mother’s milk. Therefore, administration of NASOVAC should be based on careful consideration of potential benefits and risks. Besides, a close proximity of mother and child also needs consideration.

Can the nasal spray flu vaccine cause Guillain-Barré syndrome (GBS) ?
No GBS is reported after immunization with intra nasal LAIV.

Can the nasal-spray flu vaccine LAIV (NASOVAC) be given to patients when they are ill ?
The nasal-spray flu vaccine LAIV (NASOVAC) can be given to people with minor illnesses (e.g., diarrhea or mild upper respiratory tract infection without fever). However, if nasal congestion is present that might limit delivery of the vaccine to the nasal lining, in which case delaying of vaccination until the nasal congestion is reduced, should be considered.
If the pandemic situation allows, immunisation should be postponed in patients with severe febrile illness or any acute infection.

Can people receiving the nasal-spray flu vaccine LAIV (NASOVAC) pass the vaccine viruses to others ?
In clinical studies, transmission of vaccine virus to close contacts has occurred in extremely rare cases and it was seen to be completely harmless.

Can people who are in close contact with patients having weakened immune systems get the nasal-spray flu vaccine LAIV (NASOVAC)?
• People who are in contact with persons with severely weakened immune systems ( those being cared for in a protective environment for example, people with hematopoietic stem cell transplants ) should not get LAIV (NASOVAC). It is an extreme precaution only.
• People who have contact with persons with low degree of immunosuppression for example, people with diabetes, people with asthma taking corticosteroids, or people infected with HIV can get LAIV (NASOVAC).

Can people who received inactivated influenza vaccine (the flu shot) last year get the nasal-spray flu vaccine LAIV (NASOVAC) this year ?
Yes, people who have taken inactivated influenza vaccine (the flu shot) last year can get the nasal-spray flu vaccine LAIV (NASOVAC) this year.

How long does it take for the vaccine to give protection ?
Any vaccine requires approximately 3 weeks to produce antibodies against the disease for which the said vaccine is administered. Similarly nasal spray flu vaccines also require approximately 3 weeks to offer optimum protection.

Can a person get swine flu infection within 3 weeks after being vaccinated with nasal spray LAIV ?
Like any other vaccine, during 3 weeks after vaccination, you remain vulnerable to swine flu infection.

If a person gets severe flu-like symptoms within 3 weeks of vaccination, is it a vaccine reaction or swine flu/seasonal flu infection? What should we do ?
The vaccine does not cause severe flu-like symptoms. If you get severe flu like symptoms immediately or within three weeks from vaccination , it could be either because of already acquired natural infection before vaccination or natural infection occurring during the three week period after vaccination.
Please consult your doctor Immediately because it could be influenza (either swine or seasonal infection). Don’t ignore it thinking that it is a reaction to the vaccine taken. As you know, swine flu can be fatal.

Can a person use antiviral drugs like Tamiflu / Fluvir if he is confirmed to have swine flu ?
You must take antiviral drugs if you are diagnosed with swine flu, as prescribed by your doctor. If the antiviral drugs are used within two weeks of getting the nasal spray flu vaccine, such person should get revaccinated.
( Please note that the antiviral drugs will kill the vaccine viruses that were administered to give protection against the real swine flu virus.)

Can a person take the nasal-spray flu vaccine LAIV (NASOVAC) if he is already taking influenza antiviral medications ?
If a person is taking an influenza antiviral drug (including Tamiflu , Fluvir, Relenza etc. ), then the nasal spray flu vaccine should not be given until 48 hours after the last dose of the influenza antiviral medication was given.

Can other medicines and vaccines be used together with the nasal- spray flu vaccine LAIV (NASOVAC) ?
As said above, children and adolescents taking aspirin therapy should not get the vaccine.
There is no data on co-administration of NASOVAC with other vaccines or intra nasal medicines. However, if co-administration with another vaccine is necessary, vaccination may be carried out. The immunological response to the vaccine may be lower if the patient is undergoing immunosuppressant treatment.

If adults and elderly are taking aspirin therapy, can they take the vaccine ?
The restriction of aspirin use is only for children and adolescents.

How long does the nasal-spray flu vaccine LAIV give protection ?
This vaccine gives protection at least for a year.

How is the nasal-spray flu vaccine LAIV (NASOVAC) stored ?
The nasal-spray flu vaccine LAIV (NASOVAC) must be stored in a refrigerator at 2-8°C (35-46°F).

What personal protective equipment is recommended for those who are administering LAIV (NASOVAC) ?
Personal protective equipment like gloves and masks are not required.

Does the nasal-spray flu vaccine LAIV (NASOVAC) contain  thimerosal ?
No, the nasal-spray flu vaccine LAIV (NASOVAC) does not contain  thimerosal or any other preservative, including Mercury based preservatives.
 



MEASLES

What is Measles?
Measles is a viral disease. Not everyone recognizes measles as a serious disease, which it really is. Measles can be deadly. The 10th Century Persian physician, Rhazes considered measles "to be dreaded more than smallpox." Measles still kills about a million people a year around the world.

Who are susceptible of Measles?
All unvaccinated newborns are at danger from Measles. Usually children become susceptible to Measles around the age of nine months, probably because they are protected up to this period by the antibodies (proteins that protect against a disease) against Measles, received from their mothers.

How does Measles spread?
Measles is a highly contagious disease, which spreads through air. Mere sneezing by an infected child in a group of children can easily spread this virus. It spreads so easily that any child who is exposed to it and is not immune will probably get it. One can get measles from an infected person who coughs or sneezes around you or even talks to you.

What is the prevalence of Measles in India and the world over?
Measles is a leading cause of childhood deaths. Every year around 3 million cases of Measles are seen and about 900,000 children die because of Measles around the world. In India everyday, 500 children die because of Measles. The most worrying part is that the vaccine coverage against Measles in India is only 66% and even below 50% in many states.

What are the symptoms and adverse effects of Measles?
The symptoms of Measles start about 10 days after the infection and include high fever (103oF - 105o F), running nose, cough, and redness of eyes (pin head sized bluish white spots on a red base occur in the mouth. The child loses weight and remains weak for several days). Rash appears behind the ears and spreads rapidly over the face and the neck extending downwards reaching the hands and feet over the next three days. The rash fades in the same order leaving a brownish discolouration, which persists for two months or more. In general the disease is very trouble some for the child. In fact, the term "measles" probably comes from a Latin word meaning "miserable."
Complications of measles:
For most children, measles means a rash and cold, and missing a few days of school. But there are several complications caused by measles. These are:
· About 1 out of every 10 children who get measles also get an ear infection (Otitis media).
· Upto 1 out of 20 of them get pneumonia.
· About 1 child in every 1,000 who get measles get encephalitis. (Encephalitis is an inflammation of the brain that can lead to convulsions, and can leave your child deaf or mentally retarded.)
· Out of every 1,000 children who get measles, 1 or 2 die from it. In developing countries (like India), where malnutrition and vitamin A deficiency is prevalent, measles has been known to kill as many as one out of four children.
· Diarhoea and pneumonia are other complications of measles which can cause death
· Measles can also cause permanent brain damage
· In some countries measles causes blindness
· Measles can also lead to degenerative disease of nervous system named as SSPE (Subacute Sclerosing Pan Encephalitis). SSPE can further cause paralysis.
These complications are more common among children under 5 years of age and adults over 20 years old.

What is the treatment for Measles?
Few drugs like Interferon, Vitamin A, may be used for the treatment of Measles. Moreover, certain antibodies are required to treat ear and chest complications as well as chemotherapeutic agents have been tried for the treatment of Measles (SSPE) but unfortunately these remedies are not very effective and hence vaccination is a better way to prevent complications of Measles. Measles is a completely preventable disease.

When should the vaccine be taken?
The first dose of Measles should be given at the age of 9 months (M-Vac). However, it has been observed that a single dose of Measles is not enough for effective eradication of this disease. Therefore, a second dose against Measles as MMR (Tresivac) should be administered at the age of 12-15 months.

What is the vaccination schedule if the above doses are missed?
If both of these doses are missed, then a child can still be given the vaccine. This should be done at the earliest possible stage. If the child is below one year, he must be given the measles vaccine (M-Vac) and if the child is above one year he must be vaccinated by administering a dose of MMR (Tresivac) at the earliest, up to the age of 12-13 years.

How long does this vaccine offer protection against Measles?
Usually two doses against Measles (first M-Vac at 9 months and Tresivac at 12-15 months) offer long term protection. Clinical data is available showing antibody titers well above the minimal limits up to 16 years after vaccination.

What are the side effects of this vaccine?
Usually both M-Vac as well as MMR (Tresivac) are well tolerated. However, in rare cases there are some chances of mild reactions, usually low/mild fever and slight rash.


MUMPS

What is Mumps?
Mumps is a common childhood viral disease mainly involving the parotid glands and other important organs of the body.

Who is at danger because of Mumps?
All un-immunized children in late age group 5-15 years of age and un-immunized adults.

How Mumps spreads?
Mumps spreads through air. Children get mumps through contact with others who are already infected with the mumps virus. The virus is spread through the air by coughing, sneezing, or simply talking.

What is the prevalence of Mumps in India and the world over?
Though Mumps is less severe as compared to Measles, it has been observed that 10-15% children are susceptible to this disease. The real problems are the serious complications it can cause

What are the symptoms and adverse effects of Mumps?
The most obvious sign of mumps is swelling of the cheeks and jaw, which is caused by inflammation in the salivary glands. This swelling usually lasts for 10 days associated with fever for 1-6 days. It affects various organs like salivary glands (Parotid glands), testicles (in boys) and ovary (in females), pancreas, and joints.
Mumps can cause severe complications in children like Orchitis in boys (inflammation of testicles), which may lead to infertility. Mumps can also affect reproductive organs in females. Moreover, Mumps can also cause permanent brain damage, deafness, joint pain and even diabetes.
· About 1 child in every 10 who get mumps also gets meningitis (an inflammation of the covering of the brain and spinal cord)
· Occasionally mumps also causes encephalitis. Mumps is a disease, which causes high morbidity but low mortality. The symptoms are troublesome, which is inflammation of the brain itself.
· About 38% teenage or adult men who get mumps develop a painful swelling of the testicles.
· Mumps is a major cause of sensorineural deafness, which is usually permanent
· Studies have also indicated that Mumps can cause diabetes mellitus that rarely causes death (about 1 in 10,000 cases).

What is the treatment for Mumps?
Unfortunately, there is no sure treatment available for Mumps. Vaccination is the only way to prevent Mumps.

When should the vaccine be taken and what is the vaccine schedule for missed doses?
Usually MMR (Tresivac) vaccine is given to protect against Mumps. Tresivac should be administered at the age of 12-15 months, if missed anytime up to the age of 12-13 years.

What are the side effects of this vaccine?
Usually MMR (Tresivac) is well tolerated. However, in rare cases there are some chances of mild reactions like low/mild fever and parotitis.


RUBELLA

What is Rubella?
Rubella is a viral disease, which mainly affects the foetus. If a woman is infected with this virus during the first three months of pregnancy.

Who are susceptible of Rubella?
Rubella affects the foetus, if the mother is infected in the early months of her pregnancy. All girls aged 11 to 19 years and women in the childbearing age are at risk of developing Rubella.

How Rubella spreads?
Rubella is a contagious disease and spreads through air by coughing, sneezing, or simply talking.

What is the prevalence of Rubella in India?
It has been observed that around 40-45% of women in the childbearing age are susceptible to Rubella. Moreover it is surprising to know that over 2 lakh babies are born with birth defects because of Rubella infection during pregnancy in the Indian sub-continent.

What are the symptoms and adverse effects of Rubella?
Rubella infection during the early months of pregnancy may lead to congenital deformities (birth defects). These birth defects include deafness, cataract, heart defects and mental retardation in the newborns. Such children become social and economic burden for parents. Rubella can also lead to abortions. The chances of developing these deformities are very high if the infection occurs in the first three months of pregnancy. The following table gives the chances of a particular deformity developing:

Hearing loss
92%
Congenital Heart Disease
65%
Impaired vision
56%
Behaviour disorders
32%
Neurological deficit residual
26%
Hearing and visual defect
19%
Diabetes mellitus
01%


What is the incidence of deformities in the various stages of pregnancy?
The Rubella virus interferes with the development of organs in the foetus. Therefore, depending on the time of pregnancy and the organs developing during that time, the type and the chances of deformities developing in the child varies. The risk of deformities developing is as follows:

Time of maternal infection
Result
1-2 weeks
Harmless
3-11 weeks
100% infected fetus
12 weeks
80% infected fetus
13-14 weeks
54% infected fetus
15-16 weeks
35% infected fetus
23-26 weeks
25% infected fetus

What is the treatment for Rubella?
Unfortunately there is no treatment for Rubella. Vaccination is the only way to prevent all these complications.

When should the vaccine be taken and what is the vaccine schedule for missed doses?
Children can be protected against Rubella with a dose of MMR at 12-15 months. If missed anytime up to the age of 12-13 years. Moreover, a separate vaccine against Rubella is also available (R-Vac).
R-Vac should be given to:
· all girls at puberty (12 years and above)
· all women of child bearing age and if missed
· Post delivery.
Even males should be vaccinated against Rubella because infected males can transmit this virus to the females of their family.

Can a pregnant woman take the vaccine?
No, rubella vaccine is not to be taken by a pregnant woman. Pregnancy must be avoided for 28 days following R-Vac. This is a precaution that must be taken.

How long does this vaccination offer protection against Rubella?
Vaccine against Rubella offers long-term protection. Clinical reports state that sufficient antibodies are present in the blood even after 21 years of vaccination.

What are the side effects of this vaccine?
Usually both R-Vac as well as MMR (Tresivac) is well tolerated. However, in rare cases there are some chances of mild reactions like low fever.


DIPHTHERIA, TETANUS AND PERTUSSIS (DTP)

What is DTP?
'D' stands for Diphtheria, 'T' stands for Tetanus and 'P' stands for Pertussis. These three are serious diseases caused by bacteria. Diphtheria and Pertussis are spread from one person to another while Tetanus enters the body through cuts and wounds, which may not appear dangerous and are often unnoticed or neglected.

What are the symptoms and harmful effects of DTP?
Diphtheria: It causes a thick covering in the back of the throat. It can lead to breathing problems, paralysis, heart failure and even death in severe cases.
Tetanus: It causes painful tightening of the muscles usually all over the body. Tetanus can lead to locking of the jaw as a result the victim cannot open his mouth or swallow. Deaths because of Tetanus are around 10%.
Pertussis (whooping cough or black cough): It causes severe coughing spells that it is hard for infants to eat, drink or even breathe. These spells can last for weeks. Pertussis can lead to Pneumonia, convulsions, Brain Damage and Death.

Who is at danger because of DTP?
All un-protected children are at danger of these three serious diseases. DTP can be prevented by vaccinating children.

Who should get DTP vaccine and when?
All children should get five doses of DTP vaccine as per the schedule mentioned below:
6 weeks, 10 weeks, 14 weeks,
1st booster - 16-18 months,
2nd booster - 5 years

Can DTP vaccine be taken during illness?
· Children with minor illness such as cold may be vaccinated but children who are moderately or severely ill should wait until they recover
· A child who had a life threatening allergic reaction after a dose of DTP vaccination should not get another dose.
· A child who had encephalopathy (brain illness) or nervous system disease within 7 days after a dose of DTP should not get another dose.
· A child who had a temperature of 105oF within 48 hours after a dose of DTP should probably not get another dose of Pertussis-containing vaccine.
· A child who collapses or goes into a "shock-like" state within 48 hours after a dose of DTP should probably not get another dose of Pertussis-containing vaccine.
· A child who cries continuously for 3 or more hours within 48 hours after a dose of DTP should probably not get another dose of Pertussis-containing vaccine.
· A child who has convulsions within 3 days after a dose of DTP should probably not get another dose of Pertussis-containing vaccine.

What is the importance of booster doses?
It has been observed that even after 3 doses of DTP vaccine. The protection level is only 80% hence it is prudent to administer 2 boosters for better protection against DTP.

Can DTP vaccine be given to older children and adults?
DTP should not be given to anyone of age 7 years and above because Pertussis vaccine is only licensed for children under 7 years but if older children, adolescents and adults still need a protection from Tetanus and Diphtheria, a booster dose of DT is recommended at 11-12 years of age and then every 10 years.

What are the risks from DTP vaccine?
A vaccine, like any medicine, is capable of causing serious problems, such as severe allergic reactions. The risk of DTP vaccine causing serious harm, or death, is extremely small.
Mild Problems (Common)
· Fever
· Redness or swelling
· Soreness or tenderness at the site of injection.
Other mild problems include:
· Irritability Fussiness (up to about 1 child in 3)
· Tiredness or poor appetite (up to about 1 child in 10)
· Nausea (up to about 1 child in 50)
These problems generally occur 1-3 days after the injection.
Moderate Problems (Uncommon)
· Seizure (about 1 child out of 14,000)
· Non-stop crying, for 3 hours or more (up to about 1 child out of 1,000)
· High fever, over 105oF (about 1 child out of 16,000).
Severe Problems (Very Rare)
· Serious allergic reaction (less than 1 out of million doses.


Hepatitis-B

What is Hepatitis B?
Hepatitis B is a disease of the liver caused by a virus infection. The virus causes destruction of the liver tissue and may lead to liver cancer later in life. In our country eight in every ten cases of liver cancer is due to Hepatitis B virus infection. Humans are the only known reservoir of this infection.
The threat to the community posed by hepatitis B is much more in comparison to HIV - the virus that causes AIDS. In fact, Hepatitis B is 100 times more infectious than AIDS and kills more people in a day than AIDS kills in a year.
Liver disease due to Hepatitis B infection is considered to be the fourth or fifth important cause of mortality in the most productive years of life. In fact, it is regarded as the second most important cancer-causing agent - next only to tobacco.

How does one get infected with Hepatitis B virus?
There are a millions of 'carriers' of the Hepatitis B virus, who appear to be normal and healthy but can transmit the virus to others. Various instruments contaminated with the infected blood or body fluids of such 'carriers' can transmit the virus to a healthy person. Thus the use of unsterilised needles for injections, ear piercing and tattooing, unsterilised instruments during operation or wound suturing and infected blood used during transfusion can put an individual at high risk of acquiring the Hepatitis B virus.

Is Hepatitis B infection a serious problem in India?
In India it is found that one in every twenty persons in our population is a Hepatitis B virus 'carrier'. Accidental contacts with such 'carriers', who are unaware about the virus they are harbouring, can transmit the virus to others. Hence a constant risk of acquiring this infection exists in our country.
But there is a definite group of individuals who are at high-risk. They are:
At high-risk due to daily practice:
· All Medical Personnel.
· All Para-medical personnel such as Nurses, Staff members of pathological labs, Blood banks, Dialysis units and Cancer units.
At high-risk due to sexual and social habits:
· Heterosexuals with multiple sex partners, homosexuals and prostitutes.
· Intravenous drug users.
· People whom have themselves tattooed.
· People who play contact sports.
At high-risk due to illness:
· Patients like Thalassemics and Haemophiliacs who receive blood or blood related products.
· Patients on dialysis.
Others
· Infants born to Hepatitis B infected mothers.
· Family members of Hepatitis B virus 'carriers'.

What are the signs and symptoms of Hepatitis B infection?
Majority of infants and children infected with Hepatitis B do not show any signs and symptoms of Hepatitis B infection.
In the case of adults, a small number of individuals may not show any signs and symptoms. Others initially develop flu like symptoms such as:
· Loss of appetite
· Tiredness
· Chills and mild fever
· Body ache
· And later Jaundice - yellowness of skin and eyes, Pale feces, Dark urine.

What test needs to be conducted to determine Hepatitis B status?
A simple blood test called the Australia antigen test will help determine whether one is infected with the Hepatitis B virus.

Is any treatment available for this infection?
Unfortunately no. Only vaccination against the Hepatitis B virus can prevent this infection. Recently interferons have been tried in certain selected patients of Hepatitis B and found to have variable results.

What is Hepatitis B vaccination?
The Hepatitis B vaccination course comprises of 3 injections to be given at definite intervals over a period of 6 months. After vaccination, the body will be able to produce substances called antibodies, which will protect against Hepatitis B infection.

What are the different Hepatitis B vaccines available in our country?
There are two types of Hepatitis B vaccines available:
Plasma derived- Manufactured using blood and blood-products and
Genetically engineered - where no blood and blood-products are used to manufacture this vaccine. ('GeneVac-B', is manufactured using third generation recombinant DNA technology).

Is 'GeneVac-B' safe?
'GeneVac-B', is a genetically engineered Hepatitis B vaccine and is found to be safe.

How effective is 'GeneVac-B'?
Extensive clinical studies conducted have shown 'GeneVac-B' to be effective in protecting healthy individuals.
However, the vaccine efficacy varies in elderly subjects, chronic alcoholics, and smokers, obese individuals and immunocompromised subjects where the body defense response is found to be varying.

Does 'GeneVac-B' vaccination produce any side effects?
'GeneVac-B' recipients may experience mild and transient side effects such as soreness, redness and swelling at the injection site, as seen with all vaccines. These reactions generally subside within two days of vaccination.
'GeneVac-B' is contra-indicated in individuals who are hypersensitive to yeast or any other component of the vaccine.
In fact clinical trials conducted have shown low reactogenicity, low incidence of pain and swelling.
The recipients neither experienced systemic reactions nor GI disturbances.

What is the vaccination course of 'GeneVac-B'?
Recommended Schedules for Immunization
Primary Immunization
Dose:
Neonates / infants and Children under 10 years - A dose of 10 mcg
Adults and Children of 10 years and above-A dose of 20 mcg
I) Recommended Schedule for
*
Standard Immunization

0-1-6 months

Dose
Time
Adults and Children over 10 yr.
Children under 10 years
1st dose
0 month
20 mcg
10 mcg
2nd dose
1 month
20 mcg
10 mcg
3rd dose
6 month
20 mcg
10 mcg

II) Recommended Schedule for
· Neonates born of Hepatitis B infected mothers,
· Recently exposure to the virus
· Travelers to high-risk areas

0-1-2-12 months

Dose
Time
Adults and Children over 10 yr.
Children under 10 years
1st dose
0 month
20 mcg
10 mcg
2nd dose
1 month
20 mcg
10 mcg
3rd dose
2 month
20 mcg
10 mcg
1st Booster
12 month
20 mcg
10 mcg

III) Recommended Schedules for Boosters

IV) Recommended Schedules for Special Populations
· Immunocompromised patients
· Chronic renal failure

High Dose
0-1-2-6-12 months
Dose Timings
Time
Dose
1st dose
0 month
40 mcg
2nd dose
1 month
40 mcg
3rd dose
2 month
40 mcg
4th dose
6 month
40 mcg
5th dose
12 month
40 mcg

The immunization schedule should be adapted in order to ensure that the anti-HBs antibody titre remains above the accepted protective levels of 10 IU/L.

In which packs are 'GeneVac-B' available?
'GeneVac-B' is available in four packs:
· 10 ml MD Vial:- Contains 20 micrograms of the Hepatitis B surface antigen per ml. (10 Adult doses)
· 5 ml MD Vial: - Contains 20 micrograms of the Hepatitis B surface antigen per ml. (10 Paediatric doses / 5 Adult doses)
· 1 ml SD Vial:- Contains 20 micrograms of the Hepatitis B surface antigen per ml. (1 Adult dose).
· 0.5 ml Paediatric SD Vial:- Contains 10 micrograms of Hepatitis B surface antigen in 0.5 ml. (1 Paediatric dose)
SD - Single Dose, MD - Multi dose

How is 'GeneVac-B' vaccine to be stored?
Like other vaccines, 'GeneVac-B' also needs to be stored between +20C to +80C in the refrigerator. The vaccine should not be frozen. Once frozen, the vaccine should be discarded. The vaccine vial should be shaken well before use.
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