.png?width=200&height=94&name=PDR_stacked_purple%20(002).png)
Comvax
Classes
All Other Vaccine Combinations
Administration
NOTE: According to U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine.
Inform the parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the parent or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
If a Haemophilus influenzae type b conjugate vaccine; hepatitis B recombinant vaccine has been previously given, question the parent or guardian about any symptoms or signs of an adverse reaction.
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.
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 (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.
Administer intramuscularly (IM) only; do not inject intravenously, subcutaneously, or intradermally.
Visually inspect parenteral products for particulate matter and discoloration prior to administration. Haemophilus influenzae type b conjugated vaccine; hepatitis B recombinant vaccine is a slightly opaque, white suspension.
Use vaccine as supplied; reconstitution is not necessary.
Shake vial well prior to use.
Using a sterile syringe and needle (7/8th to 1 inch in length), withdrawal suspension from vial. A separate syringe and needle MUST be used for each patient.
Inject the suspension intramuscularly into the anterolateral thigh. Administering in the buttocks has resulted in lower hepatitis B seroconversion rates.
Adverse Reactions
Stevens-Johnson syndrome / Delayed / 0-1.0
anaphylactoid reactions / Rapid / 0-1.0
erythema multiforme / Delayed / 0-1.0
angioedema / Rapid / 0-1.0
Guillain-Barre syndrome / Delayed / 0-1.0
seizures / Delayed / 0-1.0
erythema / Early / 22.4-27.2
candidiasis / Delayed / 0.2-0.8
thrombocytopenia / Delayed / Incidence not known
irritability / Delayed / 32.2-57.0
drowsiness / Early / 21.1-49.5
injection site reaction / Rapid / 22.4-34.5
fever / Early / 10.5-14.2
anorexia / Delayed / 0.8-3.9
infection / Delayed / 0.5-2.7
vomiting / Early / 1.0-2.5
inconsolable crying / Delayed / 0.2-2.4
diarrhea / Early / 0.8-2.2
rhinorrhea / Early / 0.2-1.3
nasal congestion / Early / 0.3-1.2
rash / Early / 0.8-0.9
cough / Delayed / 0.2-0.9
urticaria / Rapid / Incidence not known
Common Brand Names
Comvax
Dea Class
Rx
Description
Bivalent vaccine made up of the antigenic components present in PedvaxHIB and Recombivax HB
For vaccination against Haemophilus influenzae type b and hepatitis B virus infections in infants born to HBsAg negative mothers, age 6 weeks to 15 months
3-dose primary immunization series required for immunity
Dosage And Indications
0.5 mL IM ideally given at 2, 4, and 12 to 15 months of age. Infants who receive a dose of Hepatitis B vaccine at birth may also receive this same schedule at 2, 4, and 12 to 15 months of age, which results in a total of 4 doses of Hepatitis B vaccination. No data support this series in infants who have previously received more than 1 dose of hepatitis B vaccine. If the recommended 3-dose schedule cannot be followed, the interval between the first 2 doses should be at least 6 weeks, and the interval between the second and third dose should be as close as possible to 8 to 11 months. If the vaccine schedule is not initiated prior to 11 months of age, administration of the 3-dose series is not required for immunity development to Haemophilus influenzae type b; an infant 11 to 14 months of age should receive 2 doses and a child 15 to 71 months of age should receive 1 dose. Infants and children, regardless of age, should still receive 3 doses of a HBsAg-containing vaccine.
Dosing Considerations
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. However, consult current immunization schedules for recommended vaccines for use in young dialysis patients; the ACIP states that all routine vaccinations are likely effective in patients with chronic renal disease.
Drug Interactions
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.
Hepatitis B Immune Globulin, HBIG: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B 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.
How Supplied
Comvax Intramuscular Inj Susp: 0.5mL, 5-7.5mcg
Maximum Dosage
Use not recommended.
Use not recommended.
Use not recommended.
> 15 months: Use not recommended.
<= 15 months: 0.5 mL/dose IM.
>= 6 weeks: 0.5 mL/dose IM.
< 6 weeks: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Mechanism Of Action
Haemophilus influenzae type b conjugate vaccine: The high virulence of Haemophilus influenzae type b (Hib) is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. The Haemophilus influenzae type b conjugate vaccine contains the capsule polysaccharides from Hib bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis. Haemophilus b conjugate vaccine exposure stimulates the immune system to produce Hib capsule-specific antibodies (anti-PRP) that makes the organism vulnerable to antibody and cell-mediated immunity. Unconjugated capsule polysaccharide vaccines cause B-cell stimulation only; conjugation of the capsule polysaccharide results in T-cell stimulation as well, which makes antibodies more persistent and more likely to be stimulated with subsequent exposure to Hib antigens.
Hepatitis B recombinant vaccine: Patients who develop anti-hepatitis B surface antigen antibodies (anti-HBs) following infection with hepatitis B are immune to the virus upon reexposure. Active immunization with hepatitis B vaccine stimulates the immune system to produce anti-HBs without exposing the patient to the risks of active infection. Infection with hepatitis D can occur only with concurrent hepatitis B infection, so vaccination with recombinant hepatitis B vaccine provides protection against hepatitis D as well. The recombinant hepatitis B vaccine is produced by introducing the gene that codes for the adw subtype of HBsAg into Saccharomyces cerevisiae (yeast). The genetically altered yeast produce significant quantities of HBsAg, which are released during cell disruption, collected, and purified. The HBsAg contained within the hepatitis B recombinant vaccine causes an immune response resulting in the formation of anti-HBs.
Pharmacokinetics
The Haemophilus influenzae type b conjugate vaccine; hepatitis B recombinant vaccine is administered intramuscularly. Protective antibody levels may not occur for several weeks after administration of the vaccine. In some individuals, immune response to the vaccine may not be sufficient to provide protection against Haemophilus influenzae type b and/or hepatitis B infections. The distrubution, metabolism, and excretion of the vaccine has not been defined.
Pregnancy And Lactation
The Haemophilus influenzae type b conjugate vaccine; hepatitis B recombinant vaccine is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial vaccines to pregnant women have 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. According to the manufacturer, use of this vaccine is not recommended in women of childbearing age.
According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as Haemophilus influenzae type b conjugate vaccine; hepatitis B recombinant vaccine, pose no risk for nursing mothers or their infants. Similarly, breast-feeding does not adversely affect immunization of the mother or infant; limited data suggest breast-feeding can enhance the immune response to certain vaccine antigens. This particular vaccine is only approved for use in infants and children 6 weeks to 15 months of age. If a woman who is nursing her child requires vaccination, the individual vaccines are and may be potential alternatives to consider during breast-feeding (see the individual monographs for more information). Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. 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.