Hepatitis A Vaccine

Generic Name: Hepatitis A Vaccine

The hepatitis A vaccine consists of an inactivated version of hepatitis A virus, or HAV.

There are two hepatitis A vaccines available: HAVRIX and VAQTA, which are produced by GlaxoSmithKline and Merck, respectively.

The first dose of the vaccine causes more than 95 percent of adults and more than 97 percent of children to develop protective antibodies, according to the CDC.

Nearly 100 percent of people will develop the antibodies after a second dose of the vaccine (given about six months after the first dose).

Research suggests the two vaccines are similarly effective at protecting against clinical hepatitis A.

HAVRIX, which first became available in 1995, was 94 percent effective in preventing hepatitis A in a study of 40,000 Thai children between one and 16 years of age who were living in villages with high HAV disease rates, according to the CDC.

Comparatively, VAQTA, which first became available in 1996, was 100 percent effective in preventing hepatitis A in a study of 1,000 New York City children between two and 16 years of age who were living in a community with a high HAV disease rate.

China and some areas of India use another type of hepatitis A vaccine that contains live, attenuated (weakened) strains of HAV.

This vaccine has also been shown to be safe and highly protective against hepatitis A, according to the World Health Organization (WHO).

No health feed found.

The hepatitis A virus belongs to the picornavirus family. It is one of several hepatitis viruses that cause systemic disease with pathology in the liver. The incubation period for hepatitis A averages 28 days (range: 15 to 50 days). The course of hepatitis A infection is extremely variable, ranging from asymptomatic infection to icteric hepatitis and death. The presence of antibodies to HAV confers protection against hepatitis A infection. However, the lowest titer needed to confer protection has not been determined.

Within the US, the vaccine was first phased in around 1996 for children living in high-risk areas. In 1999, it was spread to areas with elevating levels of infection. In the US today, the vaccine is strongly recommended for all children 12 to 23 months of age in an attempt to eradicate the virus nationwide. Although the original FDA license for Havrix by GlaxoSmithKline is dated in 1995, it has been in use in Europe since 1993.

According to the US Centers for Disease Control and Prevention, the following people should be vaccinated: all children over one year of age, people whose sexual activity puts them at risk, people with chronic liver disease, people who are being treated with clotting factor concentrates, people working within close proximity to the virus, and people who are living in communities where an outbreak is present. Hepatitis A is the most common vaccine-preventable virus acquired during travel, so people travelling to places where the virus is common like the Indian subcontinent, Africa, Central America, South America, the far East, and Eastern Europe should be vaccinated.

The vaccine should be given in the muscle of the upper arm and be given in two doses for the best protection. The initial dose of the vaccine should be followed up by a booster six to twelve months later. Protection against hepatitis A begins approximately two to four weeks after the initial vaccination. Protection last at least 15 years and is estimated to last at least 25 years if the full course is administered.

A Cochrane review found that both types of vaccines offer significant protection, for at least two years with the inactivated vaccine and at least five years with the attenuated vaccine. The review also found evidence to conclude that the inactivated vaccine was safe, but required more high quality evidence to assess the safety of the attenuated vaccine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  • Fever more than 99.5 degrees F
  • general feeling of discomfort or illness
  • unusual tiredness or weakness

Rare

  • Body aches or pain
  • chills
  • congestion
  • cough
  • difficulty with breathing or swallowing
  • dryness or soreness of the throat
  • ear congestion
  • headache
  • hives
  • hoarseness
  • itching, especially of the feet or hands
  • loss of voice
  • nasal congestion
  • reddening of the skin, especially around the ears
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • swelling of the eyes, face, or inside of the nose
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tender, swollen glands in the neck
  • tightness in the chest
  • unusual tiredness or weakness (sudden and severe)
  • voice changes
  • wheezing

Incidence not known

  • Abdominal or stomach pain
  • agitation
  • back pain
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
  • clay-colored stools
  • coma
  • confusion
  • dark urine
  • diarrhea
  • difficulty controlling your bladder or bowels
  • difficulty with walking
  • dizziness
  • drowsiness
  • fainting
  • fast heartbeat
  • feeling of discomfort
  • feeling sad or depressed
  • flu-like symptoms
  • forgetful
  • hallucinations
  • inability to move the arms and legs
  • increased sweating
  • inflammation of the joints
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle aches or cramps
  • nausea
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red, irritated eyes
  • seizures
  • sensation of pins and needles
  • shakiness and unsteady walk
  • slurred speech
  • sores, ulcers, or white spots in the mouth or on the lips
  • stabbing pain
  • stiff neck
  • sudden numbness and weakness in the arms and legs
  • swollen lymph glands
  • unpleasant breath odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • vomiting of blood
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Pain, redness, swelling, or lumps at the injection site
  • weight loss

Less common

  • Arm pain
  • bleeding between periods
  • change in the amount of bleeding during periods
  • change in the pattern of monthly periods
  • lack or loss of strength
  • tenderness or warmth at the injection site
  • unusual stopping of menstrual bleeding

Rare

  • Change in color vision
  • change in taste
  • collection of blood under the skin
  • deep, dark purple bruise
  • difficulty seeing at night
  • difficulty with moving
  • dizziness or lightheadedness
  • excessive muscle tone
  • feeling of constant movement of self or surroundings
  • increased sensitivity of the eyes to sunlight
  • loss of taste
  • muscle tension or tightness
  • sensation of spinning
  • sleeplessness
  • trouble with sleeping
  • unable to sleep
  • welts

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • sleepiness or unusual drowsiness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

For primary immunization (Havrix or Vaqta).

Intramuscular dosage

Adults >= 19 years of age

1 mL/dose IM followed by a 1 mL booster dose at least 6 months after the first dose. After the first dose, the ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. 

Adults 18 years of age, Adolescents, and Children

0.5 mL/dose IM ideally given at 12 to 23 months of age, followed by a 0.5 mL/dose booster dose at least 6 months after the first dose. After the first dose, the ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

For post-exposure hepatitis A prophylaxis†.

Intramuscular dosage

Adults older than 40 years

Immune globulin is preferred, although 1 mL IM of the vaccine may be used if immune globulin cannot be obtained. If needed, administer the second vaccine dose (1 mL IM) at a later time to complete the series. The efficacy of the vaccine for postexposure prophylaxis is unknown in patients older than 40 years. Also, more severe manifestations of hepatitis A may occur in older patients.

Healthy Adults 19 to 40 years of age who have not previously received the hepatitis A vaccine and who have been exposed to HAV

1 mL IM as soon as possible after HAV exposure. Efficacy when administered greater than 2 weeks after exposure is not established. If needed, administer a booster dose at least 6 months after the first dose to complete the series. The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, and anyone who cannot get the vaccine because of contraindications.

Healthy Adults 18 years of age, Adolescents, or Children who have not previously received the hepatitis A vaccine and who have been exposed to HAV

0.5 mL IM as soon as possible after HAV exposure. Efficacy when administered more than 2 weeks after exposure is not established. Administer a booster dose at least 6 months after the first dose to complete the series. The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Use immune globulin for postexposure prophylaxis in immunocompromised patients, chronic liver disease patients, and anyone who cannot get the vaccine because of contraindications.

For patients traveling to regions that have high or intermediate hepatitis A endemicity†.

Intramuscular dosage

Adults older than 18 years

1 mL IM at any time before departure. For most healthy persons, adequate protection is afforded from 1 dose. A booster dose can be given at least 6 months after the first dose to complete the series. The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Adults at least 40 years, immunosuppressed patients, or those with chronic liver disease planning to depart in 2 weeks or less should receive an initial dose of the vaccine plus immune globulin 0.02 mL/kg at a different injection site.

Adults 18 years of age, Adolescents, and Children

0.5 mL IM at any time before departure; ideally, administer as soon as travel is considered. For most healthy persons, adequate protection is afforded from 1 dose. For long-term protection, administer a 0.5 mL booster at least 6 months after the first dose to complete the series. The ACIP recommends series completion within 18 months; the manufacturer of Havrix recommends series completion within 1 year. Immunosuppressed patients or those with chronic liver disease planning to depart in less than 2 weeks should receive an initial dose of the vaccine plus immune globulin 0.02 mL/kg at a different injection site.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to neomycin—Should not be used in patients with this condition.
  • Bleeding problems (e.g., hemophilia)—Use with caution. May have an increased risk of bleeding at the injection site.
  • Liver disease or
  • Weak immune system from a disease or medicine—May not work as well in patients with these conditions.
  • Severe illness with fever—Your dose may need to be given at a later time.

A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of your muscles.

This vaccine is usually given as 2 doses. After the first dose, the Havrix® booster dose is given anytime between 6 to 12 months later, while the Vaqta® booster dose is given anytime between 6 to 18 months later, unless your doctor tells you otherwise.

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis A vaccine in children. However, safety and efficacy have not been established in infants younger than 12 months of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis A vaccine in the elderly.

Pregnancy

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Share Your Opinion

Please fill the details


Did you find this helpful?

Your feedback will help us improve the product

Disclaimer :

The texts and materials and any other information published on this site serve a purely informative purpose, and have no official or legal status in the form they are published here. We do not guarantee any authenticity to the information provided here, kindly confirm the exactness of the content published here from relevant sources before you act on any information provided on this site.

Check your area pincode

Sorry, right now we are not available in your area

Send Your Message


or

By signing up, I agree to terms