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When Was Hepatitis B Vaccine Developed

Who Should Be Immunised Against Hepatitis B

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Hepatitis B immunisation is recommended and funded for the following groups:

  • all children up to their 18th birthday
  • babies born to mothers with hepatitis B infection
  • people who live in close contact with someone infected with hepatitis B
  • anyone undergoing renal dialysis
  • people who have hepatitis C infection, or who are HIV positive, or who have had a needle stick injury.
  • anyone who has received immunosuppression therapy of at least 28 days or has had solid organ or bone marrow transplant.

Hepatitis B immunisation is also recommended, but not funded, for:

  • workers who are likely to come into contact with blood products, or who are at increased risk of needlestick injuries, assault, etc.
  • people who change sex partners frequently such as sex workers
  • people who regularly receive blood transfusions such as people with haemophilia
  • current or recent injecting drug users
  • migrants and travellers from or to areas with intermediate or high rates of hepatitis B such as the Asia and Pacific region.

What Is Hepatitis B Virus

Hepatitis B virus attacks the liver. Hepatitis B virus infections are known as the “silent epidemic” because many infected people don’t experience symptoms until decades later when they develop hepatitis , cirrhosis , or cancer of the liver . Every year in the United States about 22,000 new hepatitis B infections occur and about 2,000 people die from their infections.

Paho’s Technical Cooperation Aims To:

  • Provide guidance to national immunization programs for the introduction of universal hepatitis B birth dose and for maintenance of high infant vaccination coverage.
  • Provide access to affordable monovalent hepatitis B and combined vaccines containing hepatitis B for countries in the Americas through the Revolving Fund.
  • Monitor and reports progress towards hepatitis B regional elimination targets.
  • In coordination with WHO, contribute to developing methodologies, guidance and a process for the validation of mother-to-child and early childhood horizontal hepatitis B elimination in the countries in the Americas.

Infant Hep B vaccination

  • travelers to countries where the virus is endemic
  • men who have sex with men and
  • people with chronic liver disease .

In countries with high endemicity, the use of vaccines is limited as most adults are naturally immune.

While the 2-dose regimen of inactivated hepatitis A vaccine is used in many countries, other countries may consider the inclusion of a single-dose inactivated hepatitis A vaccine in their immunization schedules.

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Vaccines For Adults Increasing Opportunities For Health

Historically, vaccines were deemed to be only for children. However, vaccines for adults are becoming increasingly common and necessary. Most adults think only of the tetanus booster recommended every 10 years and even then, many adults only get the vaccine if they injure themselves. In 2005, the Tdap vaccine was licensed as an improved version of the typical tetanus booster, Td. The newer version also contains a component to protect against pertussis . All adults, especially those who are going to be around young infants, should get the Tdap vaccine. Adults often unwittingly pass pertussis to young infants for whom the disease can be fatal. In 2012, the CDC recommended that pregnant women get a dose of Tdap during each pregnancy between 27 and 36 weeks gestation. In 2019, the CDC recommended that Tdap or Td vaccine could be used for booster dosing every 10 years.

Influenza vaccines, available since the 1940s, are now recommended for most adults. Vaccines like MMR and chickenpox are recommended for adults who have not had the diseases, and vaccines including hepatitis A, hepatitis B, pneumococcus, and meningococcus are recommended for sub-groups of the adult population. The HPV vaccine became available in 2006. In 2018, the license was expanded to include people up to 45 years of age.

The first formal adult immunization schedule was published in 2002 and is updated annually.

Hepatitis A And B: Diseases Of The Liver

Bevac Hepatitis B Vaccine, 10 Ml, Rs 58.56/piece Shruthi Biotech

Hepatitis is an inflammation of the liver, most often caused by a viral infection. There are three common types of hepatitis caused by viruses: hepatitis A, hepatitis B, and hepatitis C. Vaccines have been developed that protect people from contracting hepatitis A and B. There is no vaccine for hepatitis C.

Hepatitis A and hepatitis B can be spread from person to person, although in different ways. They have similar symptoms, which include abdominal pain, fever, fatigue, joint pain, and jaundice .

Over the last 20 years, there has been a 90% decrease in cases of hepatitis A and an 80% decrease in hepatitis B cases in the U.S. Health experts believe that immunization efforts have led to this drop in rates of infection.

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Babies And Children Can Develop Chronic Hbv

You may be wondering why the recommendations for the HBV vaccine start on the first day of life.

Adults who contract HBV will likely not experience long-term complications from hepatitis B. But the same is not the case for babies. As many as of babies who contract an HBV infection at birth from their mothers become chronically infected with HBV.

Children between the ages of 1 and 5 who get an HBV infection have a 25 percent of people who become chronically infected during childhood will develop liver cancer or cirrhosis. Thats why pediatricians want children to have immunity from HBV from the earliest possible age. Many babies and children exposed to HBV receive post-exposure prophylaxis, which decreases chance of infection.

If youre pregnant, youll most likely have a blood test to see if youre positive for hepatitis B. This allows doctors to find out if theres a chance that you could pass on the virus. These tests are highly sensitive and have a good accuracy rate, but they arent perfect. Additionally, a pregnant person may become infected between the time of the test and giving birth. The first dose of the vaccine given at birth lowers the risk of a newborn baby contracting hepatitis B.

How Is The Hepatitis B Vaccine Made

People are protected against hepatitis B virus infection by making an immune response to a protein that sits on the surface of the virus. When hepatitis B virus grows in the liver, an excess amount of this surface protein is made. The hepatitis B vaccine is made by taking the part of the virus that makes surface protein and putting it into yeast cells. The yeast cells then produce many copies of the protein that are subsequently used to make the vaccine. When the surface protein is given to children in the vaccine, their immune systems make an immune response that provides protection against infection with the hepatitis B virus.

The first hepatitis B vaccine was made in the 1980s by taking blood from people infected with hepatitis B virus and separating or purifying the surface protein from the infectious virus. Because blood was used, there was a risk of contaminating the vaccine with other viruses that might be found in blood, such as HIV. Although contamination with HIV was a theoretical risk of the early, blood-derived hepatitis B vaccine, no one ever got HIV from the hepatitis B vaccine. That is because the blood used to make vaccine was submitted to a series of chemical treatments that inactivated any possible contaminating viruses. Today, there is no risk of contaminating the vaccine with other viruses because the surface protein is manufactured in the laboratory.

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Us Infant Hepatitis B Vaccine Schedules

*Please note that the first dose should be given as soon as possible. Additional doses require minimum time intervals between doses in order for the vaccine to be effective.
3-Dose Vaccine Series for Infants

Since 1991, ALL medically stable infants with a birth weight of at least 2,000 g in the U.S. are recommended to receive the first dose of hepatitis B vaccine within 24 hours of birth. The additional 2 doses are given at 1 month and 6 months of age.

4-Dose Vaccine Combination Series for Infants

Combination vaccines, such as the pentavalent and hexavalent vaccines, include protection against 5 or 6 diseases, including hepatitis B. The first shot is usually given at 6 weeks of age, but in order to protect infants from hepatitis B beginning at birth, a monovalent or single dose of the hepatitis B vaccine is also recommended within 24 hours of birth. The hepatitis B vaccine series can then be completed with the pentavalent or hexavalent vaccine with the recommended schedule.

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Symptoms And Causative Agent

Addressing Adult Patientsâ Hepatitis B Vaccine Concerns with Dr. Sandra Leal

Hepatitis is a general term for inflammation of the liver, which may result from infectious or non-infectious causes. Viruses responsible for many cases of infectious hepatitis include hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E. Hepatitis A and B are the only hepatitis viruses for which vaccines are currently available in the United States .

The hepatitis B virus is a partly double-stranded DNA virus in the hepadnavirus family. The hepatitis A virus is a single-stranded RNA virus in the Picornavirus family. Both viruses, though structurally unrelated, infect and replicate primarily in liver cells.

The symptoms of acute hepatitis A infection are identical to those of hepatitis B infection. Early symptoms are headache, nausea, vomiting, abdominal pain, fever, rash, body aches and pains, and dark colored urine. Following this phase, jaundice , light stools, and liver pain may appear.

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Hepatitis B Prevention Strategies

HepB vaccination is the mainstay of hepatitis B prevention efforts. A comprehensive strategy to eliminate HBV transmission includes universal vaccination of infants beginning at birth, routine vaccination of previously unvaccinated children less than age 19 years, and vaccination of adults at risk for HBV infection, including those requesting protection from HBV without acknowledgement of a specific risk factor. It also includes universal testing of pregnant women for HBsAg to identify newborns who require immunoprophylaxis for prevention of perinatal infection and to pregnant women who can benefit from antiviral therapy to reduce perinatal transmission.

Newly Licensed Hepatitis B Vaccine

A new hepatitis B vaccine, named HEPLISAV-B®, was licensed for adults 18y old in 2018, and the new vaccine requires just two doses at 1 month interval,29 instead of three doses during a 6-month period. The HEPLISAV-B, which had been named HBsAg-1018 ISS before it was approved, contains recombinant HBsAg combined with a novel, Toll-like receptor 9 agonist adjuvant, an oligodeoxynucleotide that contains immunostimulatory CpG motifs, which can stimulate B cells and plasmacytoid dendritic cells by binding to Toll-like receptor 9.30

The newly licensed hepatitis B vaccine can elicit higher anti-HBs response more rapidly, which can provide earlier protection. The two-dose schedule at 1 month interval can increase the adherence of full vaccination. While the new vaccine does not have additional side effects in clinical trials, the long-term safety data remain further observation.

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Emergency Hepatitis B Vaccination

If you have been exposed to the hepatitis B virus and have not been vaccinated before, you should get immediate medical advice, as you may benefit from having the hepatitis B vaccine.

In some situations, you may also need to have an injection of antibodies, called specific hepatitis B immunoglobulin , along with the hepatitis B vaccine.

HBIG should ideally be given within 48 hours, but you can still have it up to a week after exposure.

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Why A Variety Of Hepatitis B Vaccine Schedules Have Been Used

Hepatitis B Vaccine

Generally, the recommended number of doses of hepatitis B vaccine required to induce protective immunity varies by product and with the age of the recipient. Historically, the standard 3-dose hepatitis B vaccine series has consisted of 2 priming doses administered 1 month apart and a third dose administered 6 months after the first dose. Today, the WHO recommends multiple options for adding hepatitis B vaccine to existing infant immunization schedules. Several options are considered to be appropriate for infants: 1 birth dose followed by either 2 doses of monovalent or hepatitis B containing combination vaccine at 1 and 6 months of age or at 2, 4, and 6 months of age or at 3, 5, and 11 months of age or at 8, 12, 16 weeks and 12 or 15 months or at 6, 10, and 14 weeks of age, according to the WHOs Expanded Programme on Immunization schedule . Currently, a variety of hepatitis B vaccine schedules have been used successfully worldwide. In general, preference is given to effective options that require minimal additional visits for immunization, to increase compliance and to reduce the logistics burden.

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Universal Hepatitis B Vaccination

Since the recombinant DNA technology can produce unlimited supplies of hepatitis B vaccine, it becomes feasible to prepare sufficient hepatitis B vaccine for the worldwide use. The World Health Organization recommended in 1991 that all countries implement universal hepatitis B vaccination by 1997 to prevent and control on a global scale HBV infection.74 This recommendation promoted all countries to incorporate hepatitis B vaccine into their national immunization program. However, worldwide implementation of universal vaccination is not an easy task. By 2000, only 116 of 215 countries adopted this policy, representing 31% of the global birth cohort.75 In hepatitis B endemic regions, where economics is usually less developed, lack of funds is the main reason, whereas in the low-endemic regions, universal infant vaccination appears to be less importance, leading to reluctant to adopt this policy. Japan and UK did not take the universal vaccination policy until 2016 and 2017, respectively.7678

Safety Of Hepatitis Vaccines

Hepatitis vaccines have been given to millions of people all across the world without any evidence of serious side effects. “They’re very safe, and they’re extremely effective,” says Poland.

If you are not sure whether you should have hepatitis vaccines, talk with your doctor about your specific concerns.

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British Columbia Specific Information

Hepatitis B is a virus that attacks the liver. It can cause serious disease, including permanent liver damage , and is also the main cause of liver cancer.

The hepatitis B vaccine provides immunity for at least 10 years and likely for a lifetime when completing the full series. There are currently no recommendations for a healthy person to receive a booster for this vaccine if they have completed the full series.

For more information on hepatitis B and the hepatitis B vaccine, visit our Hepatitis page.

You may also call 8-1-1 to speak to a registered nurse or pharmacist. Our nurses are available 24 hours a day, 7 days a week and our pharmacists are available every night from 5:00 p.m. to 9:00 a.m.

Hepatitis Research Under The Fda

Hepatitis A and B

Hepatitis was a major focus of the Bureau of Biologics blood regulatory program early on, from checking the proficiency of blood banks to conduct hepatitis tests, to collaborative research on the virus using animal models with NIH’s National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention , to further study of donor selection criteria.

Following two meetings of its external advisory Panel on Safety and Effectiveness, which considered published and unpublished data on coordinated clinical trials conducted across the nation, the advisors broadly concurred with the Bureau that hepatitis B immune globulin was safe and effective for hepatitis B prophylaxis. Thus, in 1977 the Bureau issued the first license for this product in post-exposure prophylaxis in the event of accidental encounters such as needle sticks, laboratory accidents, and similar situations.

In 1978, and following efforts over several years, FDA finalized regulations to help lessen the likelihood of hepatitis contamination of blood through labeling. Research suggested a significant difference in likelihood of such contamination from paid blood donors rather than volunteers. Henceforth, blood intended for transfusion had to be labeled as either paid or volunteer sourced.

In July 1986, OBRR licensed the first recombinant viral vaccine, for hepatitis B. The same manufacturer, Merck, Sharp & Dohme, had received a license for a hepatitis B vaccine some years earlier.

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Albert Lasker Public Service Award

Maurice R. Hilleman

Merck Sharp & Dohme Research Laboratories

For discovering the causes of certain viral diseases and for pioneering breakthroughs in vaccine, especially hepatitis B vaccine development throughout the world.

Maurice R. Hilleman has created effective vaccines which have saved millions of people from illness and death from viral, rickettsial, and bacterial infections.

Dr. Hillemans career in science has been dedicated to putting the power of basic science at the service of preventive medicine, consistently linking the laboratory, the clinic and the scientific resources of the pharmaceutical community.

Dr. Hilleman and his team developed the first live vaccines against measles, mumps, and rubella, and then produced the combined measles-mumps-rubella live virus vaccine now used routinely, worldwide, to immunize children with a single injection. He prepared the first purified poliomyelitis vaccine and the first vaccines against chicken pox, bacterial pneumonias, and meningitis.

Dr. Hilleman also participated in the discovery of many viruses, including the adenoviruses that cause severe respiratory infections, the rhinoviruses which cause the common cold, and the oncogenic SV40 virus. He performed the first substantial purification and definition of interferon, and discovered that it is induced by double-stranded RNA.

Who Should Get Hepatitis B Vaccine

All infants should get their first dose of hepatitis B vaccine within 24 hours of birth and will usually complete the series at 6 months of age.

All unvaccinated children and adolescents younger than 19 years of age should also get vaccinated.

All adults 19 through 59 years of age are recommended to get vaccinated.

Adults 60 years and older with risk factors should get vaccinated. Risk factors include:

  • People whose sex partners have hepatitis B
  • People who live with someone with hepatitis B
  • Sexually active people who are not in a long-term relationship
  • People getting evaluated or treated for a sexually transmitted infection
  • Men who have sex with men
  • People who share needles, syringes, or other drug-injection equipment
  • Health care and public safety workers at risk for exposure to blood or body fluids
  • People with chronic liver disease, who are on dialysis, have HIV infection, or hepatitis C infection
  • People with diabetes
  • Developmentally disabled persons in long-term care facilities
  • People in prison or jail
  • Travelers to areas with high rates of hepatitis B
  • Anyone who wants to be protected from hepatitis B
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