Wednesday, September 20, 2023

Is Heplisav B Live Vaccine

Guidance On Reporting Adverse Events Following Immunization

Update on BC’s Vaccine Card, September 7, 2021 (Edited)

Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.

Refer to Reporting Adverse Events Following Immunization in Canada and Adverse events following immunization in Part 2 for additional information about AEFI reporting.

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.

Apnea In Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including RECOMBIVAX HB, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination. For RECOMBIVAX HB, this assessment should include consideration of the mother’s hepatitis B antigen status and the high probability of maternal transmission of hepatitis B virus to infants born to mothers who are HBsAg positive if vaccination is delayed.

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Efficacy And Immunogenicity In Specific Populations

Chronic Hepatitis C Infection

In one published study, the seroprotection rates in individuals with chronic hepatitis C virus infection given the standard regimen of RECOMBIVAX HB was approximately 70%. In a second published study of intravenous drug users given an accelerated schedule of RECOMBIVAX HB, infection with HCV did not affect the response to RECOMBIVAX HB.

Predialysis and Dialysis Adult Patients

Predialysis and dialysis adult patients respond less well to hepatitis B vaccines than do healthy individuals however, vaccination of adult patients early in the course of their renal disease produces higher seroconversion rates than vaccination after dialysis has been initiated. In addition, the responses to these vaccines may be lower if the vaccine is administered as a buttock injection. When 40 mcg of Hepatitis B Vaccine , was administered in the deltoid muscle, 89% of 28 participants developed anti-HBs with 86% achieving levels 10 mIU/mL. However, when the same dosage of this vaccine was administered inappropriately either in the buttock or a combination of buttock and deltoid, 62% of 47 participants developed anti-HBs with 55% achieving levels of 10 mIU/mL.

Screen For Contraindications And Precautions

Merck Once PMH IN Cattle Vaccine, Avirulent Live Culture ...
  • Do not administer Heplisav-B to individuals with a history of severe allergic reaction after a previous dose of any hepatitis B vaccine or to any component of Heplisav-B, including yeast.
  • Consult the package insert for precautions, warnings, and contraindications and Hepatitis B Vaccine Safety for additional information and possible side effects.
  • See Vaccine Administration and SIRVA infographic pdf icon for more information about proper IM vaccine administration.
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    More Information On Side Effects

    Reactions listed under âpossible side effectsâ or âadverse eventsâ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.

    If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency through the Yellow Card Scheme

    Adverse Reactions6 Adverse Reactions

    In healthy infants and children , the most frequently reported systemic adverse reactions , in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In healthy adults, injection site reactions and systemic adverse reactions were reported following 17% and 15% of the injections, respectively.

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    Infants Weighing Less Than 2000 G

    Hepatitis B vaccination should be delayed until 1 month of age or hospital discharge in infants weighing < 2000 g if the mother is documented to be HBsAg negative at the time of the infant’s birth. Infants weighing < 2000 g born to HBsAg positive or HBsAg unknown mothers should receive vaccine and hepatitis B immune globulin in accordance with ACIP recommendations if HBsAg status cannot be determined .

    Us Children And Adult Hepatitis B Vaccine Schedules

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    *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 Children and Adults

    The hepatitis B vaccine is an injection that is generally given in the arm as a three-dose series on a 0, 1, and 6-month schedule. Alternative schedules may be considered, noting that a third dose at 6 months, meeting minimum intervals between doses, is needed for maximum, long-term protection. Completing the hepatitis B vaccine series, preferably beginning at birth, will ensure protection against hepatitis B, hepatitis delta and lower the lifetime risk of liver cancer. Greater than 90% of babies and up to 50% of young children who are not vaccinated and are infected with hepatitis B will have lifelong infection, which makes the birth dose essential to their protection.

    There are four, 3-dose vaccine brands approved in the U.S.

    • PreHevbrio PreHevbrio is only approved for adults age 18 and over.

    2-Dose Vaccine Series

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    Disruptions In The City Of Ottawa

    Many local businesses in downtown Ottawa closed for the day in anticipation of the crowds. The Rideau Centre, which is the largest mall in downtown Ottawa, was closed after being overwhelmed with protest attendees who refused to wear masks.

    Ottawa Mayor Jim Watson called this behaviour “unacceptable.”

    “We want to make sure those businesses can open safely and not have the idiocy of people coming into their establishments refusing to wear a mask,” he told CTV News Channel on Saturday.

    A protester was also filmed dancing and yelling on top of the Tomb of the Unknown Soldier at the national cenotaph, drawing widespread condemnation. Defence Minister Anita Anand called it “beyond reprehensible,” while Chief of the Defence Staff Gen. Wayne Eyre said he was “sickened.”

    “Generations of Canadians have fought and died for our rights, including free speech, but not this. Those involved should hang their heads in shame,” Eyre tweeted.

    Photos taken on Saturday morning showed several vehicles illegally parked on the grounds of the national cenotaph. that the vehicles have been removed by police, calling the act “a sign of complete disrespect.”

    Someone placed an upside-down Canadian flag and a “Mandate Freedom” sign on the statue of Terry Fox, sparking outrage online. Watson called the move “completely unacceptable” on Twitter and said he ordered staff to remove the items placed on the statue.

    Immunogenicity In Children And Adults

    Persons Aged 6 Months through 10 Years

    In clinical trials, children aged 6 months through 10 years were given ENGERIX-B at 0, 1, and 6 months. One to 2 months after the third dose, the seroprotection rate was 98% and the GMT of seroconverters was 4,023 mIU/mL.

    Persons Aged 5 through 16 Years

    In a separate clinical trial including both children and adolescents aged 5 through 16 years, ENGERIX-B was administered at 0, 1, and 6 months or 0, 12, and 24 months . Immediately before the third dose of vaccine, seroprotection was achieved in 92.3% of subjects vaccinated on the 0-, 1-, and 6-month schedule and 88.8% of subjects on the 0-, 12-, and 24-month schedule . One month following the third dose, seroprotection was achieved in 99.5% of children vaccinated on the 0-, 1-, and 6-month schedule compared with 98.1% of those on the 0-, 12-, and 24-month schedule. GMTs were higher for children receiving vaccine on the 0-, 1-, and 6-month schedule compared with those on the 0-, 12-, and 24-month schedule .

    Persons Aged 11 through 19 Years

    In clinical trials with healthy adolescent subjects aged 11 through 19 years, ENGERIX-B given at 0, 1, and 6 months produced a seroprotection rate of 97% at Month 8 with a GMT of 1,989 mIU/mL . Immunization with ENGERIX-B at 0, 1, and 6 months produced a seroprotection rate of 99% at Month 8 with a GMT of 7,672 mIU/mL .

    Persons Aged 16 through 65 Years

    Persons Aged 40 Years and Older

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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.

    Known Or Presumed Exposure To Hepatitis B Virus

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    Known or Presumed Exposure to HBsAg

    Refer to recommendations of the Advisory Committee on Immunization Practices and to the package insert for hepatitis B immune globulin for management of persons with known or presumed exposure to the hepatitis B virus . When recommended, administer RECOMBIVAX HB and HBIG intramuscularly at separate sites as soon as possible after exposure. Administer additional doses of RECOMBIVAX HB in accordance with ACIP recommendations.

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    Dosage Forms & Strengths


    • belimumab

      belimumab decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. Contraindicated. Do not administer live vaccines 30 days before or concurrently with belimumab.

    Serious – Use Alternative

    Monitor Closely


    • chloroquine decreases effects of hepatitis b vaccine by pharmacodynamic antagonism. Minor/Significance Unknown.

    • ozanimod

      ozanimod decreases effects of hepatitis b vaccine by immunosuppressive effects risk of infection. Minor/Significance Unknown. No clinical data are available on the efficacy and safety of vaccinations in patients taking ozanimod. Vaccinations may be less effective if coadministered with ozanimod.

    General Information About Vaccination Outside The Us

    In developing countries, the pentavalent vaccine, a combination 5-in-one vaccine that protects against five diseases, diphtheria, pertussis, tetanus, Hib and hepatitis B, may be given to babies more than 6 weeks of age, and can be given up to 1 year of age. The first dose is given at 6 weeks, and the second and third doses are given at 10 and 14 weeks of age. The pentavalent vaccine may be made available free of charge with the support of GAVI, the vaccine alliance. Check the GAVI country hub to see the resources and immunizations that may be available:

    For babies born to mothers with hepatitis B, waiting for the first dose of the pentavalent vaccine is too late and will NOT protect the baby from vertical or horizontal transmission of hepatitis B. Babies born to a mother with hepatitis B have a greater than 90% chance of developing chronic hepatitis B if they are not properly treated at birth.

    WHO recommends the hepatitis B vaccine within 24 hours of birth for ALL babies. Plan ahead and inquire about the availability and cost of the monovalent , birth dose of the vaccine, as it is not a GAVI provided immunization. This is particularly important to women who are positive for hepatitis B.

    If you are unsure of your hepatitis B status, please be sure your doctor tests you for hepatitis B!

    *WHO does not recommend a birth dose of HBIG, which may not be available in all countries. Talk to your doctor if you have questions.

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    Immunogenicity In Healthy Adults

    Clinical studies have shown that RECOMBIVAX HB when injected into the deltoid muscle induced protective levels of antibody in 96% of 1213 healthy adults who received the recommended three-dose regimen. Antibody responses varied with age a protective level of antibody was induced in 98% of 787 young adults 20-29 years of age, 94% of 249 adults 30-39 years of age and in 89% of 177 adults 40 years of age.

    Concomitant Administration With Other Vaccines

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    Do not mix RECOMBIVAX HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.

    In clinical trials in children, RECOMBIVAX HB was concomitantly administered with one or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis oral Poliomyelitis vaccine Measles, Mumps, and Rubella Virus Vaccine, Live Haemophilus b Conjugate Vaccine ] or a booster dose of Diphtheria, Tetanus, acellular Pertussis. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

    In another clinical trial, a related HBsAg-containing product, Haemophilus b Conjugate and Hepatitis B combination product , was given concomitantly with eIPV or VARIVAX® , using separate sites and syringes for injectable vaccines. No serious vaccine-related adverse events were reported, and no impairment of immune response to these individually tested vaccine antigens was demonstrated.

    The Haemophilus b Conjugate and Hepatitis B combination product has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.

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    Persons New To Canada

    Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals, as necessary. In many countries outside of Canada, HB vaccine is in limited use.

    All persons from a country that is endemic for HB should be assessed and vaccinated against HB if not immune and not infected. Individuals born in developing countries are more likely to be carriers of HB, necessitating vaccination of their sexual and household contacts based on review of their serologic test results. HB vaccine is recommended for all household contacts whose families have immigrated to Canada from areas in which there is a high prevalence of HB and who may be exposed to HB carriers through their extended families or when visiting their country of origin.

    Children adopted from countries in which there is a high prevalence of HB infection should be screened for HBsAg and, if positive, household or close contacts in the adopting family should be immunized before adoption or as soon as possible thereafter. Adults going to pick-up children from these countries should be vaccinated before departure. Refer to Immunization of Persons New to Canada in Part 3 for additional information.

    How Sweet It Is: Dynavax Finally Wins Fda Ok For Hep B Vaccine Heplisav

    The U.S. Food and Drug Administration approved Dynavax Technologies Corporations Heplisav-B, a hepatitis B vaccine. It is the first new hepatitis B vaccine in the U.S. in more than 25 years. The FDA turned down the drug twice before, in February 2013, and in November 2016.

    The approval process came with some hiccups. On August 4, 2017, only days after the FDA panel voted 12 to 1 to recommend Heplisav-B, the agency requested more information about the companys post-marketing plans. This caused the company stock to drop 11 percent.

    The sticking point was the companys design for a proposed post-marketing pharmacovigilance plan for the vaccine. There was never much concern about the vaccines efficacy, but the panel and the agency had some concerns over the vaccines safety profile. Regulators noted an imbalance of fatalities and cardiac events that had never been explained.

    The original post-marketing plan was to conduct observational electronic medical record review at Kaiser Permanente Northern California to compare 3-point MACE as well as pre-specified immune-mediated events. The evaluation would look at 20,000 patients who received Heplisav-B compared to 20,000 more who received a different hepatitis B vaccine.

    The advisory panel had also suggested that full safety data should be in Heplisavs label. This is typically undesirable, because doctors may choose against using the vaccine in high-risk patients as a result.

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    Important Information About Vaccine And Hepatitis B Immunoglobulin Shot Administration

    Where available, the hepatitis B birth-dose and HBIG should be administered within 24 hours of birth in order to prevent the transmission of hepatitis B from mother to child. It is very important that the shots be given in opposite limbs, to ensure the highest effectiveness. Please see chart above for more information.

    Other Hepatitis B Vaccines

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    There are two other hepatitis B vaccines, both of which are approved for people of all ages and delivered in three intramuscular injections:

    • Engerix-B
    • Recombivax HB

    There is also a combination vaccine called Twinrix that protects against both hepatitis A and hepatitis B. It is only approved for use in adults 18 and over and is delivered in a series of three or four injections.

    A non-vaccine option called HepaGam B is sometimes used to protect against infection in people who have been exposed to HBV through sex or contact with infected blood . It is a form of immunoglobulin therapy in which protective antibodies are harvested from donated blood. It is not used for primary immunization.

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