About
- Afluria: Influenza Virus Vaccine (2011-2012 Formula); Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- Comvax: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine; Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- M-M-R II: Measles, Mumps and Rubella Virus Vaccine Live; Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- Liquid PedvaxHIB: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate).
- Pneumovax 23: Pneumococcal vaccine polyvalent; Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- ProQuad: Combined, attenuated, live virus vaccine containing measles, mumps, rubella, and varicella viruses.
- Recombivax HB: Hepatitis B Vaccine (Recombinant).
- RotaTeq: Rotavirus vaccine, live, oral, pentavalent.
- Tetanus and Diphtheria Toxoids Adsorbed: Manufactured by MassBiologics (University of Massachusetts Medical School) & Distributed by Merck Sharp & Dohme Corp.
- Vaqta: Hepatitis A Vaccine Inactivated - Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- Varivax: Varicella Virus Vaccine Live - Manufactured by CSL Limited & Distributed by Merck Sharp & Dohme Corp.
- Zostavax: Zoster Vaccine Live.
Afluria
- Initial U.S. Approval: 2007.
- Not approved for use in children less than 5 years of age.
- Prepared from influenza virus propagated in the allantoic fluid of embryonated chicken eggs. Following harvest, the virus is purified in a sucrose density gradient using continuous flow zonal centrifugation. The purified virus is inactivated with beta-propiolactone, and the virus particles are disrupted using sodium taurodeoxycholate to produce a "split virion". The disrupted virus is further purified and suspended in a phosphate buffered isotonic solution.
- Formulated to contain 45 mcg hemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 mcg HA for each of the three influenza strains recommended for the 2011-2012 Northern Hemisphere influenza season: A/California/7/2009, NYMC X-181 (H1N1), A/Victoria/210/2009, NYMC X-187 (H3N2) (an A/Perth/16/2009-like strain), and B/Brisbane/60/2008.
- The multi-dose presentation contains thimerosal, added as a preservative; each 0.5 mL dose contains 24.5 mcg of mercury.
- A single 0.5 mL dose contains: sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (1.5 mcg).
- From the manufacturing process, each 0.5 mL dose may also contain: residual amounts of sodium taurodeoxycholate (≤10 ppm), ovalbumin (≤1 mcg), neomycin sulfate (≤3 nanograms), polymyxin B (≤0.5 ng), and beta-propiolactone (≤2 ng).
- Contraindicated in individuals with known severe allergic reactions to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine.
- Children 5 years through 8 years of age not previously vaccinated with an influenza vaccine, or vaccinated for the first time last season with only one dose: Two 0.5 mL doses, one on Day 1 and another approximately 4 weeks later.
- Children 5 years through 8 years of age given 2 doses last season, or at least one dose two or more years ago: Single 0.5 mL dose.
- Children 9 years of age and older: Single 0.5 mL dose.
- Adults: Single 0.5 mL dose.
- Effectiveness: Vaccination may not protect all individuals.
- Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Adverse Reactions: Neuralgia, paresthesia, convulsions (including febrile seizures), transverse myelitis, encephalopathy, optic neuritis/neuropathy, partial facial paralysis, brachial plexus neuropathy, Guillain-Barré Syndrome; Allergic reactions including anaphylactic shock and serum sickness; Microscopic polyangiitis (vasculitis), vasculitis with transient renal involvement; Transient thrombocytopenia; Pruritus, urticaria, rash; Upper respiratory tract infection, oropharyngeal pain, nasopharyngitis, pyrexia, headache, nasal congestion, cough, rhinorrea, pharyngolaryngeal pain, tenderness (pain on touching), pain (without touching), redness, induration, erythema, swelling, bruising, malaise or feeling generally unwell, muscle aches, nausea/vomiting, vomiting/diarrhea, chills/shivering, fever (≥102.2°F, ≥39°C), irritability, loss of appetite.
- No data to assess the concomitant administration with other vaccines.
- No adequate and well-controlled studies in pregnant women.
- Not evaluated in nursing mothers.
- Not known whether it is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
- Not evaluated for carcinogenic or mutagenic potential.
Comvax
- Sterile bivalent vaccine made of the antigenic components used in producing PedvaxHIB (Haemophilus B Conjugate Vaccine Meningococcal Protein Conjugate) and Recobivax HB (Hepatitis B Vaccine Recombinant).
- These components are the Haemophilus influenzae type B capsular polysaccharide (polyribosylribitol phosphate, PRP) that is covalently bound to an outer membrane protein complex (OMPC) of Neisseria meningitidis and hepatitis B surface antigen (HBsAg) from recombinant yeast cultures.
- Haemophilus influenzae type B and Neisseria meningitidis serogroup B are grown in complex fermentation media.
- The primary ingredients of the phenol-inactivated fermentation medium for Haemophilus influenzae include an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts and for Neisseria meningitidis include an extract of yeast, amino acids and mineral salts.
- The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration.
- The OMPC from Neisseria meningitidis is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration.
- The PRP-OMPC conjugate is prepared by the chemical coupling of the highly purified PRP (polyribosylribitol phosphate) of Haemophilus influenzae type b (Haemophilus b, Ross strain) to an OMPC of the B11 strain of Neisseria meningitidis serogroup B.
- The coupling of the PRP to the OMPC is necessary for enhanced immunogenicity of the PRP.
- This coupling is confirmed by analysis of the components of the conjugate following chemical treatment which yields a unique amino acid.
- After conjugation, the aqueous bulk is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant.
- HBsAg is produced in recombinant yeast cells.
- A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.
- The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg.
- The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts.
- The HBsAg protein is released from the yeast cells by mechanical cell disruption and detergent extraction, and purified by a series of physical and chemical methods, which includes ion and hydrophobic chromatography, and diafiltration.
- The purified protein is treated in phosphate buffer with formaldehyde (human carcinogen) and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
- The vaccine contains no detectable yeast DNA, and 1% or less of the protein is of yeast origin.
- The individual PRP-OMPC and HBsAg adjuvanted bulks are combined to produce Comvax.
- Each 0.5 mL dose is formulated to contain 7.5 mcg PRP conjugated to approximately 125 mcg OMPC, 5 mcg HBsAg, approximately 225 mcg aluminum as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg sodium borate (decahydrate) as a pH stabilizer, in 0.9% sodium chloride.
- The vaccine contains not more than 0.0004% (w/v) residual formaldehyde (human carcinogen).
- The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration by an HPLC method.
- The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay.
- Contraindications: Hypersensitivity to yeast or any component of the vaccine.
- Precautions: As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
- Not known whether antigenuria will occur after vaccination.
- Not evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Not recommended for use in women of childbearing age.
- Not recommended for use in adult populations.
- Should not be administered to any infant before the age of 6 weeks.
- Safety and effectiveness in infants below the age of 6 weeks and above the age of 15 months: Not established.
- Animal reproduction studies: Not conducted.
- Adverse Reactions: Anaphylaxis, angioedema, urticaria, erythema multiforme; Thrombocytopenia; Seizure, febrile seizures; Lymphadenopathy; Sterile injection-site abscess, pain at the injection site; Rash, pruritus, edema, arthralgia, dyspnea, hypotension, ecchymoses; Tachycardia, syncope; Elevation of liver enzymes; Increased erythrocyte sedimentation rate; Arthritis; Bell's Palsy, Guillain-Barré Syndrome; Agitation, somnolence, irritability; Stevens-Johnson Syndrome, alopecia; Conjunctivitis, visual disturbances; Pain/soreness, erythem, swelling/induration, crying (unusual, high pitched, prolonged >4 hours), anorexia, vomiting, otitis media, fever (101.0-102.9°F, ≥103.0°F), diarrhea, upper respiratory infection, rhinorrhea, respiratory congestion, cough, candidiasis.
M-M-R II
- Sterile lyophilized preparation of Attenuvax (Measles Virus Vaccine Live), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumpsvax (Mumps Virus Vaccine Live), the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and Meruvax II (Rubella Virus Vaccine Live), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts.
- Growth medium for measles and mumps: Medium 199 (buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as stabilizer and neomycin.
- Growth medium for rubella: Minimum Essential Medium (buffered salt solution containing vitamins and amino acids and supplemented with fetal bovine serum) containing recombinant human albumin and neomycin. Sorbitol and hydrolyzed gelatin stabilizer are added to the individual virus harvests.
- The cells, virus pools, and fetal bovine serum are all screened for the absence of adventitious agents.
- Each 0.5 mL dose contains not less than 1,000 TCID50 (tissue culture infectious doses) of measles virus, 12,500 TCID50 of mumps virus and 1,000 TCID50 of rubella virus; Calculated to contain sorbitol (14.5 mg), sodium phosphate, sucrose (1.9 mg), sodium chloride, hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (< 1 ppm), other buffer and media ingredients and approximately 25 mcg of neomycin.
- Contraindications: Hypersensitivity to any component of the vaccine, including gelatin; Anaphylactic or anaphylactoid reactions to neomycin; Febrile respiratory illness or other active febrile infection; Patients receiving immunosuppressive therapy; Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems; Primary and acquired immunodeficiency states, cellular immune deficiencies, and hypogammaglobulinemic and dysgammaglobulinemic states; Individuals with a family history of congenital or hereditary immunodeficiency.
- Precautions: Adequate treatment provisions including epinephrine injection (1:1000) should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
- Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving vaccines containing traces of
chick embryo antigen.
- Persons who have experienced anaphylactic reactions to topically or systemically administered neomycin should not receive measles vaccine.
- Reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
- Individuals with active untreated tuberculosis should not be vaccinated.
- Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-R II (or its component vaccines) may develop thrombocytopenia with repeat doses.
- As for any vaccine, may not protect everyone who gets the vaccine.
- Does not treat measles, mumps, or rubella once you or your child has them.
- Safety and effectiveness of measles vaccine in infants below the age of 6 months: Not established.
- Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age: Not established.
- Do not give to pregnant females.
- Possible effects on fetal development: Unknown.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Pregnancy should be avoided for 3 months following vaccination.
- Not known whether measles or mumps vaccine virus is secreted in human milk.
- Studies show that lactating postpartum women immunized with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants.
- Excretion of small amounts of the live attenuated rubella virus from the nose or throat has occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
- Vaccination should be deferred for 3 months or longer following blood or plasma transfusions, or administration of immune globulin (human).
- Not evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
- Animal reproduction studies: Not conducted.
- Adverse Reactions: Panniculitis, atypical measles, fever, syncope, headache, dizziness, malaise, irritability; Vasculitis; Pancreatitis, diarrhea, vomiting, parotitis, nausea; Diabetes mellitus; Thrombocytopenia, purpura, regional lymphadenopathy, leukocytosis; Anaphylaxis, anaphylactoid reactions, angioneurotic edema (including peripheral or facial edema), bronchial spasm; Arthritis, arthralgia, myalgia; Encephalitis, encephalopathy, measles inclusion body encephalitis, subacute sclerosing panencephalitis, Guillain-Barré Syndrome, febrile convulsions, afebrile convulsions or seizures, ataxia, polyneuritis, polyneuropathy, ocular palsies, paresthesia; Pneumonia, pneumonitis, sore throat, cough, rhinitis; Stevens-Johnson syndrome, erythema multiforme, urticaria, rash, measles-like rash, pruritis, local reactions including burning/stinging at injection site, wheal and flare, redness (erythema), swelling, induration, tenderness, vesiculation at injection site; Nerve deafness, otitis media; Retinitis, optic neuritis, papillitis, retrobulbar neuritis, conjunctivitis; Epididymitis, orchitis; Death.
- Caution: Protect the vaccine from light at all times, since such exposure may inactivate the viruses.
Liquid PedvaxHIB
- Highly purified capsular polysaccharide (polyribosylribitol phosphate) of Haemophilus influenzae type b (Haemophilus b, Ross strain) that is covalently bound to an outer membrane protein complex of the B11 strain of Neisseria meningitidis serogroup B.
- Each 0.5 mL dose is formulated to contain 7.5 mcg of Haemophilus b PRP, 125 mcg of Neisseria meningitidis OMPC and 225 mcg of aluminum as amorphous aluminum hydroxyphosphate sulfate in 0.9% sodium chloride.
- Indicated for routine vaccination against invasive disease caused by Haemophilus influenzae type b in infants and children 2 to 71 months of age.
- Revaccination: Infants completing the primary two-dose regimen before 12 months of age should receive a booster dose.
- Because of the potential for immune tolerance, it is not recommended for use in infants youger than 6 weeks of age.
- Not recommended for use in individuals 6 years of age and older.
- Not recommended for use in adult populations.
- Don't protect against disease caused by Haemophilus influenzae other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.
- As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.
- Contraindications: Hypersensitivity to any component of the vaccine or the diluent; Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine.
- As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.
- As with other vaccines, it not induce protective antibody levels immediately following vaccination.
- As reported with Haemophilus b Polysaccharide Vaccine and another Haemophilus b Conjugate Vaccine, cases of Hib disease may occur in the week after vaccination, prior to the onset of the protective effects of the vaccines.
- Not evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
- Animal reproduction studies: Not conducted.
- Adverse reactions: Fever (>38.3°C, ≥101°F rectal), irritability, sleepiness, injection site pain/soreness, injection site erythema, injection site swelling/induration, unusual high-pitched crying, prolonged crying (>4 hr), diarrhea, vomiting, crying, pain, otitis media, rash, upper respiratory infection, seizures; Urticaria, thrombocytopenia; Lymphadenopathy; Angioedema; Febrile seizures; Sterile injection site abscess.
- The use of Haemophilus b Polysaccharide Vaccines and another Haemophilus b Conjugate Vaccine has been associated with the following additional adverse effects: early onset Hib disease and Guillain-Barré syndrome.
Pneumovax 23
- Initial U.S. Approval: 1983.
- Active Ingredients: Bacterial sugars from 23 pneumococcal types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F).
- Inactive Ingredients: Phenol (preservative).
- Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.
- Does not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
- Approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
- Not approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine.
- Not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Animal reproduction studies: Not conducted.
- Immunocompromised Individuals: Response to vaccination may be diminished.
- Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine: Not recommended.
- Do not administer to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine.
- Use caution and appropriate care for individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
- Defer vaccination in persons with moderate or severe acute illness.
- Does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection. In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination.
- May not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
- Adverse reactions: Injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, myalgia; Angina pectoris, heart failure, chest pain, ulcerative colitis, depression, headache/tremor/stiffness/sweating; Ecchymosis, pruritus, chills, diarrhea, dyspepsia, back pain, neck pain, nausea, vomiting, upper respiratory infection, pharyngitis; Cellulitis, malaise, fever (>102°F), warmth at the injection site, decreased limb mobility, peripheral edema in the injected extremity; Lymphadenitis, lymphadenopathy, thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura, hemolytic anemia in patients who have had other hematologic disorders, leukocytosis; Anaphylactoid reactions, serum Sickness, angioneurotic edema; Arthralgia, arthritis; Paresthesia, radiculoneuropathy, Guillain-Barré syndrome, febrile convulsion; Rash, urticaria, cellulitis-like reactions; Increased serum C-reactive protein.
- Controlled studies: Male novice gold miners ranging in age from 16 to 58 years in South Africa.
- Immunogenicity: The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
ProQuad
- Initial U.S. Approval: 2005.
- Sterile lyophilized preparation of the components of M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl LynnTM (B level) strain of mumps virus propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells.
- Each 0.5-mL dose contains not less than 3.00 log10 TCID50 of measles virus; 4.30 log10 TCID50 of mumps virus; 3.00 log10 TCID50 of rubella virus; and a minimum of 3.99 log10 PFU of Oka/Merck varicella virus.
- Each 0.5-mL dose contains no more than 21 mg of sucrose, 11 mg of hydrolyzed gelatin, 2.4 mg of sodium chloride, 1.8 mg of sorbitol, 0.40 mg of monosodium L-glutamate, 0.34 mg of sodium phosphate dibasic, 0.31 mg of human albumin, 0.17 mg of sodium bicarbonate, 72 mcg of potassium phosphate monobasic, 60 mcg of potassium chloride; 36 mcg of potassium phosphate dibasic; residual components of MRC-5 cells including DNA and protein; < 16 mcg of neomycin, bovine calf serum (0.5 mcg), and other buffer and media ingredients.
- Indicated for children 12 months through 12 years of age.
- Not indicated for use in the geriatric population (≥age 65).
- Contraindications: History of anaphylactic reaction to neomycin or hypersensitivity to gelatin or any other component of the vaccine; Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system; Individuals on immunosuppressive therapy; Primary or acquired immunodeficiency states, cellular immune deficiencies, hypogammaglobulinemic or dysgammaglobulinemic states; Family history of congenital or hereditary immunodeficiency; Immunosuppressive therapy; Active untreated tuberculosis or febrile illness (>101.3°F, >38.5°C); Pregnancy.
- Disseminated varicella vaccine virus infection reported in children with underlying immunodeficiency disorders vaccinated with varicella-containing vaccine.
- Administration to children 12 to 23 months old who have not been previously vaccinated against measles, mumps, rubella, or varicella, nor had a history of the wild-type infections, is associated with higher rates of fever and febrile seizures at 5 to 12 days after vaccination.
- Exercise caution when administering to persons with a history of cerebral injury, individual or family history of convulsions, or any other condition in which stress due to fever should be avoided.
- Safety and efficacy for use after exposure to measles, mumps, rubella, or varicella: Not established.
- Safety and efficacy for use in children known to be infected with human immunodeficiency viruses: Not established.
- Formal studies to evaluate clinical efficacy: Not performed.
- Defer vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulins.
- Avoid close contact with high-risk individuals susceptible to varicella for up to 6 weeks following vaccination, since transmission of varicella vaccine virus may occur between vaccinees and susceptible contacts.
- Avoid pregnancy for 3 months following vaccination with measles, mumps, rubella, and/or varicella vaccines.
- Avoid using salicylates for 6 weeks after vaccination.
- Do not administer to infants younger than 12 months of age or to children 13 years and older.
- Do not administer to pregnant females.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Animal reproduction studies: Not conducted.
- Transmission of the rubella vaccine virus to infants via breast milk: Documented.
- Excretion of small amounts of the live, attenuated rubella virus from the nose or throat occurred in the majority of susceptible individuals 7 to 28 days after vaccination.
- Not evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility.
- Adverse Reactions: Pain/tenderness/soreness, erythema, swelling, fever (≥102°F, ≥38.9°C oral equivalent or abnormal), irritability, measles-like rash, viral exanthema, diarrhea, ecchymosis, herpes zoster, febrile seizures, rhinorrhea, cough, headache, nasopharyngitis, vomiting, pain, bruising, pruritus, somnolence; Atypical measles, candidiasis, cellulitis, herpes zoster, infection, influenza, measles, orchitis, parotitis, respiratory infection, skin infection, varicella (vaccine strain); Aplastic anemia, lymphadenitis, regional lymphadenopathy, thrombocytopenia; Anaphylactoid reaction, anaphylaxis and related phenomena such as angioneurotic edema, facial edema, peripheral edema, anaphylaxis in individuals with or without an allergic history; Agitation, apathy, nervousness; Afebrile convulsions or seizures, aseptic meningitis, ataxia, Bell's palsy, cerebrovascular accident, convulsion, dizziness, dream abnormality, encephalitis, encephalopathy, febrile seizure, Guillain-Barré syndrome, headache, hypersomnia, measles inclusion body encephalitis, ocular palsies, paraesthesia, polyneuritis, polyneuropathy, subacute sclerosing panencephalitis, syncope, transverse myelitis, tremor; Edema of the eyelid, irritation, optic neuritis, retinitis, retrobulbar neuritis; Ear pain, nerve deafness; Extravasation; Bronchial spasm, bronchitis, epistaxis, pneumonitis, pneumonia, pulmonary congestion, rhinitis, sinusitis, sneezing, sore throat, wheezing; Abdominal pain, flatulence, hematochezia, mouth ulcer; Erythema multiforme, Henoch-Schönlein purpura, herpes simplex, impetigo, panniculitis, pruritus, purpura, skin induration, Stevens-Johnson syndrome, sunburn; Arthritis and/or arthralgia, musculoskeletal pain, myalgia, pain of the hip/leg/neck, swelling; Epididymitis; Injection-site complaints (burning and/or stinging of short duration, eczema, edema/swelling, hive-like rash, discoloration, hematoma, induration, lump, vesicles, wheal and flare), inflammation, lip abnormality, papillitis, roughness/dryness, stiffness, trauma, varicella-like rash, venipuncture site hemorrhage, warm sensation, warm to touch.
- Live, attenuated measles, mumps, and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity.
- Chronic joint symptoms: Reported (rubella vaccination).
- Subacute sclerosing panencephalitis in children: Reported (measles vaccination).
- Aseptic meningitis: Reported (measles, mumps, and rubella vaccination).
- Thrombocytopenia: Reported (measles, mumps, and rubella vaccination; varicella vaccination).
- Deaths: Reported (measles, mumps, and rubella vaccination).
- This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases.
- Protect the vaccine from light at all times since such exposure may inactivate the vaccine viruses.
Recombivax HB
- Adw subtype.
- Non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells.
- A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain.
- The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg.
- The fermentation process involves growth of Saccharomyces cerevisiae on a complex fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids and mineral salts.
- The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods.
- The purified protein is treated in phosphate buffer with formaldehyde (human carcinogen) and then coprecipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate.
- Each dose contains less than 1% yeast protein.
- Pediatric/Adolescent Formulation, 10 mcg/mL: Each 0.5 mL dose contains 5 mcg of hepatitis B surface antigen.
- Adult Formulation, 10 mcg/mL: Each 1 mL dose contains 10 mcg of hepatitis B surface antigen.
- Dialysis Formulation, 40 mcg/mL: Each 1 mL dose contains 40 mcg of hepatitis B surface antigen.
- All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine.
- The vaccine contains <15 mcg/mL residual formaldehyde (human carcinogen).
- Contraindications: Hypersensitivity to yeast or any component of the vaccine.
- Warnings: Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine; Because of the long incubation period for hepatitis B, it is possible for unrecognized infection to be present at the time the vaccine is given, the vaccine may not prevent hepatitis B in such patients.
- Precautions: As with any percutaneous vaccine, epinephrine (1:1000) should be available for immediate use should an anaphylactoid reaction occur.
- Not evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.
- Animal reproduction studies: Not conducted.
- Adverse Reactions: Soreness, pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation, nausea, diarrhea, pharyngitis, upper respiratory infection; Sweating, achiness, sensation of warmth, lightheadedness, chills, flushing, vomiting, abdominal pains/cramps, dyspepsia, diminished appetite, rhinitis, influenza, cough, vertigo/dizziness, paresthesia, rash, angioedema, urticaria, arthralgia including monoarticular, myalgia, back pain, neck pain, shoulder pain, neck stiffness, lymphadenopathy, insomnia/disturbed sleep, earache, dysuria, hypotension; Anaphylaxis and symptoms of immediate hypersensitivity reactions including rash, pruritus, urticaria, edema, angioedema, dyspnea, chest discomfort, bronchial spasm, palpitation, symptoms consistent with a hypotensive episode, hypersensitivity syndrome (serum-sickness-like) of delayed onset, arthralgia/arthritis (usually transient), fever, dermatologic reactions such as urticaria, erythema multiforme, ecchymoses, erythema nodosum; Elevation of liver enzymes, constipation; Guillain-Barré Syndrome, multiple sclerosis, exacerbation of multiple sclerosis, myelitis including transverse myelitis, seizure, febrile seizure, peripheral neuropathy including Bell's Palsy, radiculopathy, herpes zoster, migraine, muscle weakness, hypesthesia, encephalitis; Stevens-Johnson Syndrome, alopecia, petechiae, eczema; Arthritis, pain in extremity; Increased erythrocyte sedimentation rate, thrombocytopenia; Systemic lupus erythematosus, lupus-like syndrome, vasculitis, polyarteritis nodosa; Irritability, agitation, somnolence; Optic neuritis, tinnitus, conjunctivitis, visual disturbances, uveitis; Syncope, tachycardia.
- The duration of the protective effect in healthy vaccinees is unknown and the need for booster doses is not yet defined.
RotaTeq
- Initial U.S. and Canada Approval: 2006.
- Live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses.
- Rotavirus parent strains of the reassortants: Isolated from human and bovine hosts.
- Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (serotype P7) from the bovine rotavirus parent strain.
- The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as serotype P1A[8], from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain.
- The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents, and are suspended in a buffered stabilizer solution.
- Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum.
- In the manufacturing process, a porcine-derived material is used; DNA from porcine circoviruses 1 and 2 is detected in the vaccine.
- Approved for use in infants 6 weeks to 32 weeks of age.
- Vaccination series: 3 ready-to-use liquid doses administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4 to 10 week intervals; The third dose should not be given after 32 weeks of age.
- Contraindications: History of hypersensitivity to the vaccine or any component; Severe Combined Immunodeficiency Disease; History of intussusception (form of blockage of the intestines).
- Dosage Form: 2 mL solution for oral administration of 5 live human-bovine reassortant rotaviruses which contains a minimum of 2.0-2.8x10 infectious units (IU) per reassortant dose, depending on the serotype, and not greater than 116x10 IU per aggregate dose.
- No safety or efficacy established in infants: Less than 6 weeks or greater than 32 weeks of age; Potentially immunocompromised; History of gastrointestinal disorders.
- Caution advised: Reported vaccine virus transmission from vaccine recipient to non-vaccinated contacts, the potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.
- May not protect all vaccine recipients against rotavirus.
- No clinical data available when administered after exposure to rotavirus.
- The clinical studies were not designed to assess the level of protection provided by only one or two doses.
- Pre-Term Infants Clinical Studies Experience: RotaTeq or placebo was administered to 2,070 pre-term infants (25 to 36 weeks gestational age, median 34 weeks) according to their age in weeks since birth in REST; All pre-term infants were followed for serious adverse experiences.
- Adverse Reactions: Bronchiolitis, gastroenteritis, pneumonia, fever, urinary tract infection; Hematochezia; Seizures; Kawasaki disease (serious condition that can affect the heart, symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet and, if not treated, death can occur); Vomiting, diarrhea, irritability, runny nose and sore throat, wheezing or coughing, otitis media, nasopharyngitis, bronchospasm, hives; Intussusception (including death), Hematochezia, Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease; Urticaria; Transmission of vaccine virus strains from vaccine recipient to non-vaccinated contacts.
- Deaths: Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was sudden infant death syndrome, which was observed in 8 recipients of RotaTeq and 9 placebo recipients.
- Animal reproduction studies: Not conducted.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Not indicated in women of child-bearing age and should not be administered to pregnant females.
- Not evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
Tetanus and Diphtheria Toxoids Adsorbed
- Approved for use in persons 7 years of age and older.
- Vaccination may not protect all individuals.
- Each 0.5 ml dose is formulated to contain: 2 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid, aluminum adjuvant (not more than 0.53 mg aluminum by assay), < 100 mcg (0.02%) of residual formaldehyde (human carcinogen), and a trace amount of thimerosal (mercury derivative, < 0.3 mcg mercury/dose).
- The Corynebacterium diphtheriae and Clostridium tetani organisms are grown on modified Mueller's media1 which contains bovine extracts.
- Tetanus and diphtheria toxins produced during growth of the cultures are detoxified with formaldehyde (human carcinogen). The detoxified materials are then separately purified by ammonium sulfate fractionation. The diphtheria toxoid is further purified by column chromatography.
- The tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.
- The tetanus and diphtheria toxoids induce at least 2 units and 1 unit of antitoxin per ml of serum, respectively, in the guinea pig potency test.
- A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome.
- Precautions: Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.
- Safety and immunogenicity data on concomitant administration with other vaccines: No available.
- Carcinogenicity, mutagenic potential, or impairment of fertility evaluation: No studies performed.
- Animal reproduction studies: Not conducted.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Not known whether it is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman.
- Safety and effectiveness for use in infants and children younger than 7 years of age: Not established.
- No studies performed in adults aged 65 years and older in order to determine whether they respond differently than younger subjects.
- Adverse Reactions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth, peripheral oedema, pyrexia, malaise; Dizziness, headache, convulsions; Myalgia, musculoskeletal stiffness or pain, arthralgia; Rash; Nausea; Cellulitis.
Vaqta
- Initial U.S. Approval: 1996.
- Inactivated whole virus vaccine derived from hepatitis A virus grown in cell culture in human MRC-5 diploid fibroblasts.
- Children/Adolescents: 0.5-mL primary dose administered intramuscularly, and a 0.5-mL booster dose administered intramuscularly 6 to 18 months later.
- Each 0.5-mL pediatric dose contains 25U of hepatitis A virus antigen and adsorbed onto approximately 0.225 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 35 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.
- Adults: 1.0-mL primary dose administered intramuscularly, and a 1.0-mL booster dose administered intramuscularly 6 to 18 months later.
- Each 1.0-mL adult dose contains 50U of hepatitis A virus antigen and adsorbed onto approximately 0.45 mg of aluminum provided as amorphous aluminum hydroxyphosphate sulfate, and 70 mcg of sodium borate as a pH stabilizer, in 0.9% sodium chloride.
- Within the limits of current assay variability, the 50U dose contains less than 0.1 mcg of non-viral protein, less than 4 x 10–6 mcg of DNA, less than 10–4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde (human carcinogen); Other process chemical residuals are less than 10 parts per billion, including neomycin.
- Vaccination may not result in a protective response in all susceptible vaccinees.
- Immunocompromised persons may have a diminished immune response and may not be protected against HAV infection.
- Do not administer to individuals with a history of immediate allergic or hypersensitivity reactions (anaphylaxis...) after a previous dose of any hepatitis A vaccine, or to individuals who have had an anaphylactic reaction to any component, including neomycin.
- Adverse reactions: Diarrhea/gastroenteritis; Injection-site pruritus and/or rash; Bronchial constriction, asthma, wheezing, edema/swelling, rash, generalized erythema, urticaria, pruritus, eye irritation/itching, dermatitis; Thrombocytopenia; Guillain-Barré syndrome, cerebellar ataxia, encephalitis.
- Safety and effectiveness: Not established in children less than 12 months of age, pregnant women, and nursing mothers.
- Not evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
- Not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- Not known whether it is excreted in human milk, because many drugs are excreted in human milk, caution should be exercised when administered to a woman who is breast-feeding.
- Animal reproduction studies: Not conducted.
Varivax
- Preparation of the Oka/Merck strain of live, attenuated varicella virus initially obtained from a child with natural varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures (WI-38).
- Further passage of the virus for varicella vaccine performed at Merck Research Laboratories in human diploid cell cultures (MRC-5) that were free of adventitious agents.
- Live, attenuated varicella vaccine: Lyophilized preparation containing sucrose, phosphate, glutamate, and processed gelatin as stabilizers.
- Each 0.5 mL dose contains the following: a minimum of 1350 PFU (plaque forming units) of Oka/Merck varicella virus when reconstituted and stored at room temperature for 30 minutes, approximately 25 mg of sucrose, 12.5 mg hydrolyzed gelatin, 3.2 mg sodium chloride, 0.5 mg monosodium L-glutamate, 0.45 mg of sodium phosphate dibasic, 0.08 mg of potassium phosphate monobasic, 0.08 mg of potassium chloride; Residual components of MRC-5 cells including DNA and protein; Trace quantities of sodium phosphate monobasic, EDTA, neomycin, and fetal bovine serum.
- Indicated for vaccination against varicella in individuals 12 months of age and older.
- Duration of protection: Unknown.
- May not result in protection of all healthy, susceptible children, adolescents, and adults.
- Not evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
- Animal reproduction studies: Not conducted.
- Possible effects on fetal development: Unknown.
- Pregnancy should be avoided for 3 months following vaccination.
- Not known whether varicella vaccine virus is secreted in human milk, therefore, because some viruses are secreted in human milk, caution should be exercised if administered to a nursing woman.
- No clinical data available on safety or efficacy in children less than one year of age, administration is not recommended.
- Vaccination should be deferred for at least 5 months following blood or plasma transfusions, or administration of immune globulin or varicella zoster immune globulin.
- Safety and efficacy have not been established in children and young adults who are known to be infected with human immunodeficiency viruses with and without evidence of immunosuppression.
- Vaccination should be deferred in patients with a family history of congenital or hereditary immunodeficiency until the patient's own immune system has been evaluated.
- Adverse Reactions: Fever (≥102°F, 39°C) oral; Upper respiratory illness, cough, irritability/nervousness, fatigue, disturbed sleep, diarrhea, loss of appetite, vomiting, otitis, diaper rash/contact rash, headache, teething, malaise, abdominal pain, other rash, nausea, eye complaints, chills, lymphadenopathy, myalgia, lower respiratory illness, allergic reactions (including allergic rash, hives), stiff neck, heat rash/prickly heat, arthralgia, eczema/dry skin/dermatitis, constipation, itching; Pneumonitis; Febrile seizures; Anaphylaxis (including anaphylactic shock) and related phenomena such as angioneurotic edema, facial edema, and peripheral edema; Aplastic anemia, thrombocytopenia (including idiopathic thrombocytopenic purpura); Varicella (vaccine strain); Encephalitis, cerebrovascular accident, transverse myelitis, Guillain-Barré syndrome, Bell's palsy, ataxia, non-febrile seizures, aseptic meningitis, dizziness, paresthesia; Pharyngitis, pneumonia/pneumonitis; Stevens-Johnson syndrome, erythema multiforme, Henoch-Schönlein purpura, secondary bacterial infections of skin and soft tissue, including impetigo and cellulitis, herpes zoster.
Zostavax
- Single 0.65 mL subcutaneous injection used for adults 50 years of age or older to prevent shingles (zoster).
- Lyophilized preparation of live, attenuated varicella-zoster virus (Oka/Merck) to be reconstituted with sterile diluent to give a single dose suspension with a minimum of 19,400 PFU (plaque forming units) when stored at room temperature for up to 30 minutes.
- Each dose contains 31.16 mg of sucrose, 15.58 mg of hydrolyzed porcine gelatin, 3.99 mg of sodium chloride, 0.62 mg of monosodium L-glutamate, 0.57 mg of sodium phosphate dibasic, 0.10 mg of potassium phosphate monobasic, 0.10 mg of potassium chloride; Residual components of MRC-5 cells including DNA and protein; Trace quantities of neomycin and bovine calf serum.
- Should not be used in pregnant or plan to get pregnant women, children and adolescents.
- Not indicated in women who are nursing. Not known whether Varicella zoster virus is secreted in human milk, therefore, because some viruses are secreted in human milk, caution should be exercised.
- Not indicated for treatment of zoster or postherpetic neuralgia and for prevention of primary varicella infection (chickenpox).
- Does not protect everyone, so some people who get the vaccine may still get shingles. The duration of protection beyond 4 years after vaccination is unknown. The need for revaccination has not been defined.
- Not evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
- Not known whether it can cause fetal harm.
- Animal reproduction studies have not been conducted.
- Do not administer to individuals with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin or any other component of the vaccine, and to immunosuppressed or immunodeficient individuals including those with a history of primary or acquired immunodeficiency states, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Warnings & Precautions: Hypersensitivity reactions including anaphylaxis; Transmission of vaccine virus may occur between vaccinees and susceptible contacts; Avoid pregnancy for 3 months following vaccination; Deferral should be considered in acute illness (for example, in the presence of fever) or in patients with active untreated tuberculosis.
- Side effects: Redness, pain, itching, swelling, hard lump, warmth, or bruising where the shot was given; Headache; Allergic reactions, which may be serious and may include difficulty in breathing or swallowing; Hypersensitivity reactions including anaphylactic reactions; Respiratory infection, fever, flu syndrome, diarrhea, rhinitis, skin disorder, respiratory disorder, asthenia; Arthralgia, myalgia; Chickenpox; Hives at the injection site; Joint pain; Muscle pain; Nausea; Rash, pyrexia, injection-site urticaria, transient injection-site lymphadenopathy; Swollen glands near the injection site (that may last a few days to a few weeks); Serious cardiovascular events, congestive heart failure, pulmonary edema; Asthma exacerbation, polymyalgia rheumatica; Death.
- "For a complete list of side effects, ask your health care provider".
- Patient Information: "You should read this summary of information about Zostavax before you are vaccinated. [...] Only your health care provider can decide if Zostavax is right for you. [...] Tell your health care provider if you expect to be in close contact (including household contact) with newborn infants, someone who may be pregnant and has not had chickenpox or been vaccinated against chickenpox, or someone who has problems with their immune system. Your health care provider can tell you what situations you may need to avoid."
Joseph Mercola and Barbara Loe Fisher