Havrix

Hepatitis Vaccines

 
NOTE: According to U.S. federal laws, the health care provider must record the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine in the patient's permanent record.
Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986. As of July 1, 2006, health care providers who administer any hepatitis A vaccine to a child or adult must provide copies of the vaccine information statement developed by the Centers for Disease Control and Prevention.
Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. The health care professional should have immediate availability of epinephrine (1 mg/mL) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
If a prior hepatitis A vaccine dose has been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1-800-822-7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.

Inactivated hepatitis A vaccine is administered intramuscularly; do not inject intravenously, intradermally, or subcutaneously.
Visually inspect parenteral products for particulate matter and discoloration prior to administration. After agitation, the injection should appear as an opaque, white, homogenous suspension. Discard if it appears otherwise.

Preparation
The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Shake vigorously just prior to administration. With through agitation, Harvix is a homogenous, turbid white suspension, and Vaqta is a slightly opaque, white suspension. If the vaccine cannot be resuspended or the appearance is not as described, discard it.
Do not mix with any other vaccine or immune globulin.
Storage of unopened vials and prefilled syringes:
Manufacturer recommendations: Store refrigerated at 2 to 8 degrees C (36 to 46 degrees F); do not freeze.
Off-label storage information: According to a 2007 published article, storage of Havrix (GlaxoSmithKline) at room temperature for up to 72 hours is acceptable, and Vaqta (Merck) can be stored at 37 degrees C (98.6 degrees F) for up to 12 months. Other sources suggest that Havrix (GlaxoSmithKline) may maintain stability for up to 3 weeks at 37 degrees C. NOTE: Because changes in vaccine formulation can affect stability and effectiveness, confirmation of acceptable duration of storage at room temperature directly from the manufacturer for the specific vaccine being administered is recommended.
 
Intramuscular (IM) injection
A separate syringe and needle should be used for each person receiving hepatitis A vaccine, inactivated.
Aspirate prior to injection to avoid injection into a blood vessel. Inject into the deltoid muscle of the upper arm. Do not inject into the gluteal region as this may result in a suboptimal response.
When concomitant administration of other vaccines or immunoglobulin is required, they should be given with different syringes and at different injection sites.

seizures / Delayed / 0-1.0
Guillain-Barre syndrome / Delayed / Incidence not known
myelitis / Delayed / Incidence not known
anaphylactic shock / Rapid / Incidence not known
vasculitis / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
serum sickness / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
erythema multiforme / Delayed / Incidence not known

erythema / Early / 21.2-21.2
constipation / Delayed / 0-10.0
lymphadenopathy / Delayed / 0-1.0
hypertonia / Delayed / 0-1.0
photophobia / Early / 0-1.0
wheezing / Rapid / 0-1.0
encephalopathy / Delayed / Incidence not known
peripheral neuropathy / Delayed / Incidence not known
dyspnea / Early / Incidence not known
thrombocytopenia / Delayed / Incidence not known

injection site reaction / Rapid / 18.2-67.0
irritability / Delayed / 2.8-33.3
drowsiness / Early / 20.8-22.3
headache / Early / 0-16.1
fever / Early / 1.0-12.4
fatigue / Early / 1.0-10.0
malaise / Early / 1.0-10.0
vomiting / Early / 0-10.0
anorexia / Delayed / 1.0-10.0
nausea / Early / 1.0-10.0
insomnia / Early / 0-10.0
myalgia / Early / 0-5.0
diarrhea / Early / 0-4.6
chills / Rapid / 0-1.3
abdominal pain / Early / 0-1.2
arthralgia / Delayed / 0-1.0
dysgeusia / Early / 0-1.0
vertigo / Early / 0-1.0
pruritus / Rapid / 0-1.0
ocular irritation / Rapid / 0-1.0
urticaria / Rapid / 0-1.0
rash / Early / 0-1.0
paresthesias / Delayed / Incidence not known
dizziness / Early / Incidence not known
hypoesthesia / Delayed / Incidence not known
ocular pruritus / Rapid / Incidence not known
syncope / Early / Incidence not known

Havrix, Havrix Pediatric, Vaqta

Rx

Intramuscular vaccine
Used for protection against hepatitis A
Ideally, immunization should occur between 12 to 23 months of age

1 mL IM followed by a 1 mL booster dose at least 6 months after the first dose. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.

0.5 mL IM followed by a 0.5 mL booster dose at least 6 months after the first dose. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

0.5 mL IM ideally given at 12 to 23 months of age followed by a 0.5 mL booster dose at least 6 months after the first dose. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart. Catch-up vaccination may occur in patients 2 years and older, with doses separated by 6 to 18 months.

1 mL IM as soon as possible after exposure. Efficacy when administered more than 2 weeks after exposure is not established. A second dose is not necessary for postexposure prophylaxis; however, a 1 mL booster dose can be administered at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

0.5 mL IM as soon as possible after exposure. Efficacy when administered more than 2 weeks after exposure is not established. A second dose is not necessary for postexposure prophylaxis; however, a 0.5 mL booster dose can be administered at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

0.5 mL IM as soon as possible after exposure. Efficacy when administered more than 2 weeks after exposure is not established. A second dose is not necessary for postexposure prophylaxis; however, a 0.5 mL booster dose can be administered at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

1 mL IM at any time before departure; ideally, administer as soon as travel is considered.[65007] Administer a 1 mL booster at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

0.5 mL IM at any time before departure; ideally, administer as soon as travel is considered.[65007] Administer a 0.5 mL booster at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

0.5 mL IM at any time before departure; ideally, administer as soon as travel is considered.[65007] Administer a 0.5 mL booster at least 6 months after the first dose to complete the series. Complete the Havrix series 6 to 12 months apart or Vaqta series 6 to 18 months apart.[31413] [40356] [53026] [65007]

0.5 mL IM before departure; revaccinate with 2 doses, separated by 6 to 18 months, between 12 to 23 months of age.[53026]

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.

Havrix/Vaqta Intramuscular Inj Susp: 0.5mL, 1mL, 25IU, 50IU, 720ELU, 1440ELU

Adults 19 years and older: 1 mL/dose IM.
Adults 18 years: 0.5 mL/dose IM.

1 mL/dose IM.

0.5 mL/dose IM.

0.5 mL/dose IM.

Infants 6 to 11 months: 0.5 mL/dose IM is recommended by ACIP for international travel; not FDA-approved.
Infants 5 months and younger: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Injection of hepatitis A vaccine produces antibodies that confer protection against hepatitis A infection. Stimulation of specific antibodies takes place without producing any disease symptoms. During the course of natural infection with the hepatitis A virus, the initial antibody response is predominantly of the IgM class. This response lasts for several months, but during convalescence antibodies of the IgG class become dominant. Patients with anti-HAV of the IgG class are immune to reinfection. The IgG antibodies remain detectable indefinitely. Two years after immunization with hepatitis A vaccine IgG levels remained relatively high in the serum of immunized patients. The duration of protection from a course of hepatitis A vaccine is as yet unknown. Long term follow-up studies will determine the necessity for booster doses of HAV.

Hepatitis A vaccine, inactivated is administered intramuscularly. Rapid seroconversion from a single-dose can provide protection against hepatitis A for at least 12 months. Increasing the dose of viral antigen directly affects the speed at which seroconversion occurs. However, a primary response to the vaccine can be expected 8 to 10 days after administration. To maintain the highest antibody titers a booster dose is recommended between 6 and 18 months after the initial dose. The response to this booster dose is vigorous and increases the protection time against hepatitis A. Some investigators have postulated a minimum level of protective antibody concentration at 10 milliunits/mL.[24197] However, a concentration of 20 milliunits/mL of anti-HAV antibodies was recognized as the definition of seroconversion in clinical trials. Clinical data reveal Havrix induced an immune response in 97% of those immunized after a single dose of 720 EL.U. After a second dose, there was a 100% seroconversion rate.[24196] The lowest antibody titer needed to confer protection is unknown. Although the total duration of protection is also unknown, 100% of children at least 2 years of age and adolescents had anti-HAV antibody titers of at least 10 milliunits/mL for at least 10 years after 2 doses of VAQTA separated by 6 months. The geometric mean titers ranged from 505 milliunits/mL to 819 milliunits/mL. Among adults who got 2 doses of VAQTA separated by 6 months, the hepatitis A antibody response persisted at least 6 years; more than 99% of adults had anti-HAV antibody titers of at least 10 milliunits/mL, and the geometric mean titers ranged from 605 milliunits/mL to 1,734 milliunits/mL.

No adequate and well-controlled studies have been conducted with the hepatitis A vaccine, inactivated during pregnancy. In pre- and post-licensure clinical studies and post-approval reports, pregnant women who were administered hepatitis A vaccine, inactivated had rates of miscarriage and major birth defects that were consistent with estimated background rates.[31413] [40356] According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus vaccines to pregnant women has not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm.[43236]

There is no information regarding the presence of hepatitis A vaccine, inactivated in human milk, its effects on the breast-fed infant, or its effects on milk production.[31413] [40356] According to the Advisory Committee on Immunization Practices (ACIP), inactivated vaccines pose no risk to breast-feeding mothers or their infants. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for hepatitis A vaccine, inactivated and any potential adverse effects on the breast-fed child from hepatitis A vaccine, inactivated or the underlying maternal condition.[43236] If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.