GlaxoSmithKline – Vaccines (2009)

About

ACWY Vax: Meningococcal polysaccharides serogroups A, C, W135 and Y.
Ambirix: Hepatitis A (inactivated) and hepatitis B (rDNA) (HAB) vaccine (adsorbed).
Arepanrix: AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine.
Boostrix: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed.
Cervarix: Human Papillomavirus vaccine (types 16, 18), recombinant, adjuvanted, adsorbed.
Engerix-B: Hepatitis B Vaccine (Recombinant).
Fendrix: Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).
Fluarix: Influenza vaccine.
FluLaval: Influenza vaccine.
Havrix: Hepatitis A vaccine, inactivated.
Hepatyrix: Hepatitis A (inactivated, adsorbed) and Typhoid Polysaccharide vaccine.
Hiberix: Haemophilus B conjugate vaccine (tetanus toxoid conjugate).
Infanrix: Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed.
– Infanrix IPV: Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed).
– Infanrix IPV + HIB: Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) and Haemophilus influenzae serotype b conjugate vaccine (adsorbed).
Kinrix: Diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine.
Menitorix: Combined Haemophilus influenzae type b and Neisseria meningitidis group C (Hib-MenC) conjugate vaccines.
Pandemrix: AS03-Adjuvanted H1N1 Pandemic Influenza Vaccine.
Pediarix: Diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine combined.
Poliomyelitis: Poliomyelitis monodose vaccine live (oral).
Priorix: Measles, mumps and rubella vaccine (live attenuated virus).
Rotarix: Human rotavirus vaccine, live attenuated.
Twinrix: Combined hepatitis A (inactivated virus) and hepatitis B vaccine (genetically derived surface antigen).
Typherix: Typhoid vaccine (purified polysaccharide antigen).
Varilrix: Varicella in healthy adults and adolescents.

Influenza

FluLaval
– Initial U.S. Approval: 2006.
– Each 0.5 mL dose contains 15 micrograms (mcg) of influenza virus hemagglutinin (HA) of each of the following 3 strains: A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus), and B/Brisbane/60/2008.
– Each dose may also contain residual amounts of egg proteins (≤1 mcg ovalbumin), formaldehyde (≤25 mcg), and sodium deoxycholate (≤50 mcg).
– Culture media: Chicken embryo.
– Excipients: Egg Albumin (Ovalbumin), Egg Protein, Formaldehyde or Formalin, Sodium Deoxycholate, Phosphate Buffers, Thimerosal (each 0.5 mL dose contains 25 mcg mercury).
– Randomized controlled clinical trials: United States + Canada = 1,049 adults.
– No controlled trials demonstrating a decrease in influenza disease after vaccination performed.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
– Safety and effectiveness not established in pregnant women, nursing mothers, and children.
– Appropriate medical treatment, including epinephrine, and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
– If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior influenza vaccine, the decision should be based on careful consideration of the potential benefits and risks.
– Vaccination may not protect all susceptible individuals.
– As with any vaccine, broad use could reveal adverse events not observed in clinical trials.
– Postmarketing Experience: Lymphadenopathy; Conjunctivitis, eye pain, photophobia; Dysphagia, vomiting; Chest pain, injection site inflammation, rigors, asthenia, injection site rash, influenza-like symptoms, abnormal gait, injection site bruising, injection site sterile abscess; Allergic edema of the face, allergic edema of the mouth, anaphylaxis, allergic edema of the throat; Pharyngitis, rhinitis, laryngitis, cellulitis; Muscle weakness, back pain, arthritis; Dizziness, paresthesia, hypoesthesia, hypokinesia, tremor, somnolence, syncope, Guillain-Barré syndrome, convulsions/seizures, facial or cranial nerve paralysis, encephalopathy, limb paralysis; Insomnia; Dyspnea, dysphonia, bronchospasm, throat tightness; Urticaria, localized or generalized rash, pruritus, periorbital edema, sweating; Flushing, pallor.

Fluarix
– Initial U.S. Approval: 2005.
– Influenza virus subtypes A and type B contained in the vaccine, for use in persons 3 years of age and older.
– Culture media: Chicken embryo.
– Excipients: Egg Albumin (Ovalbumin), Egg Protein, Formaldehyde or Formalin, Gentamicin, Hydrocortisone, Octoxynol-10, á-Tocopheryl Hydrogen Succinate, Polysorbate 80, Sodium Deoxycholate, Sodium Phosphate, Thimerosal.
– 45 micrograms (mcg) hemagglutinin (HA) per 0.5-mL dose, in the recommended ratio of 15 mcg HA of each of the following 3 strains: A/Brisbane/59/2007, IVR-148 (H1N1), A/Uruguay/716/2007, NYMC X-175C (H3N2) (an A/Brisbane/10/2007-like virus), and B/Brisbane/60/2008.
– Each 0.5-mL dose also contains octoxynol-10 (TRITON X-100) ≤0.085 mg, α-tocopheryl hydrogen succinate ≤0.1 mg, and polysorbate 80 (Tween 80) ≤0.415 mg.
– Each dose may also contain residual amounts of hydrocortisone ≤0.0016 mcg, gentamicin sulfate ≤0.15 mcg, ovalbumin ≤1 mcg, formaldehyde ≤50 mcg, and sodium deoxycholate ≤50 mcg from the manufacturing process.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
– Not known whether is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when is administered to a nursing woman.
– No adequate and well-controlled studies in pregnant women.
– Do not administer to anyone with known systemic hypersensitivity reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous administration of any influenza vaccine.
– If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior influenza vaccine, the decision should be based on careful consideration of the potential benefits and risks.
– Vaccination may not protect all susceptible individuals.
– There is the possibility that broad use could reveal adverse reactions not observed in clinical trials.
– Postmarketing Experience: Lymphadenopathy; Tachycardia; Vertigo; Conjunctivitis, eye irritation, eye pain, eye redness, eye swelling, eyelid swelling; Abdominal pain or discomfort, nausea, swelling of the mouth, throat, and/or tongue; Asthenia, chest pain, chills, feeling hot, injection site mass, injection site reaction, injection site warmth, body aches; Anaphylactic reaction including shock, anaphylactoid reaction, hypersensitivity, serum sickness; Injection site abscess, injection site cellulitis, pharyngitis, rhinitis, tonsillitis; Pain in extremity; Convulsion, dizziness, encephalomyelitis, facial palsy, facial paresis, Guillain-Barré syndrome, hypoesthesia, myelitis, neuritis, neuropathy, paresthesia; Asthma, bronchospasm, cough, dyspnea, respiratory distress, stridor; Angioedema, erythema, erythema multiforme, facial swelling, pruritus, rash, Stevens-Johnson syndrome, urticaria; Henoch-Schönlein purpura, vasculitis.

Arepanrix & Pandemrix
Nano vaccine: Particle size of AS03 adjuvant is 150-155 nm, side effects even on the DNA level.
– Arepanrix: Authorized by Health Canada based on limited clinical testing in humans under the provision of an Interim Order issued on October 2009.
– Pandemrix: Approved for use by the European Commission in September 2009 upon recommendations of the European Medicines Agency for use when H1N1 influenza pandemic declared by the World Health Organization or European Union.
– 2-component vaccine consisting of an H1N1 immunizing antigen (as a suspension), and an
AS03 adjuvant (as an oil-in-water emulsion).
– Antigen per 0.5mL dose: Split influenza virus, inactivated, containing antigen isolated from virus propagated in eggs equivalent to A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75μg haemagglutinin.
– Preservative per 0.5mL dose: 5μg Thimerosal USP or 2.5 micrograms organic mercury (Hg).
AS03 adjuvant per 0.5mL dose: 10.69 mg squalene, 11.86 mg DL-α-tocopherol, 4.86 mg polysorbate 80.
– Antigen suspension vial: Thimerosal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections. The drug substance contains trace residual amounts of egg proteins, formaldehyde, sodium deoxycholate and sucrose.
– Adjuvant emulsion vial: Sodium chloride, disodium hydrogen phosphate, potassium
dihydrogen phosphate, potassium chloride, water for injections.
– Limited clinical experience in healthy adults aged 18-60 years and no clinical experience in the elderly, in children or in adolescents.
– Pregnancy and Lactation: No data.
– No studies on the effects on the ability to drive and use machines.
– Evaluation of pharmacokinetic properties not required for vaccines.
– Side Effects: Headache; Fatigue; Redness or swelling at the injection site; Shivering; Sweating; Aching muscles, joint pain; Reactions at the injection site such as bruising, itching and warmth; Fever; Swollen lympth nodes; Feeling sick, diarrhea; Dizziness; Generally feeling unwell; Unusual weakness; Vomiting, stomach pain, uncomfortable feeling in the stomach or belching after eating; Inability to sleep; Tingling or numbness of the hands or feet; Shortness of breath; Pain in the chest; Itching, rash; Pain in the back or neck, stiffness in the muscles, muscle spasms, pain in extremity such as leg or hand; Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to shock; Fits; Severe stabbing or throbbing pain along one or more nerves; Low blood platelet count which can result in bleeding or bruising; Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney problems); Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome.

Governments & H1N1 Influenza Vaccine
UK Government: 60 million doses.
French Government: 50 million doses.
Government of Belgium: 12.6 million doses (total population).
Government of Finland: 5.3 million doses, expected to be used in conjunction with government’s existing stockpile of GSK’s adjuvant system.
US Government: A(H1N1) influenza antigen and proprietary adjuvant system AS03, 7.6 million doses of unadjuvanted H1N1 pandemic vaccine, produced in multi-dose vials from bulk vaccine manufactured at facility in Quebec, 250 million doses of pandemic (H1N1) adjuvanted vaccine, and pandemic products worth $250 million.
– 9 government contracts for a further 96 million doses.
– 22 government orders agreed to supply a further 149 million doses.
– Total number of doses ordered for pandemic vaccines: 440 million.
– Discussions with governments for further supplies.

2009
– The UK Government purchases 18 million treatment courses of antivirals and 10.6 million treatment courses of Relenza (zanamivir) for use in an influenza pandemic. The UK becomes the 2nd European country, alongside France, to hold a treatment stockpile sufficient to treat 50% of their population. Zanamivir constitutes approximately a 3rd of the UK’s current antiviral stockpile. Since 2003, Relenza has been supplied to 26 governments for the purposes of pandemic stockpiling and on average the product constituted 13% of these stockpiles. Production levels for Relenza increased to produce between 50-60 million treatment packs of Relenza per year.
– New alliance with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. to develop and manufacture influenza vaccines in China.
– Worldwide agreements with Enigma Diagnostics Limited to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction technology platform, the Enigma ML (Mini Laboratory).
– Relenza Rotacaps, alternative Relenza treatment, granted temporary approval by Swedish regulators, as part of an application submitted under the European mutual recognition procedure for distribution during a pandemic. In discussions with regulatory authorities around the world to secure further approvals.
– Contracts in place to supply Relenza to over 60 governments.
– Allocated 10% of new Relenza production capacity for developing countries and intended donation of 2 million doses of Relenza to the WHO.
– Tiered-pricing policy for Relenza, again based on World Bank classification of countries.
– Donation to the WHO of 50 million doses of H5N1 pre-pandemic vaccine to the new candidate A (H1N1) adjuvanted influenza vaccine and supply to developing countries under a tiered-pricing policy based on World Bank classifications and GAVI eligibility.
– Worldwide collaboration and license agreement with Vivalis devoted to developing a new way of producing both seasonal and pandemic human influenza vaccines. Milestones included the designing of a manufacturing process capable of obtaining a high level of virus productivity compatible with industrial development and an important step in the characterization of the sanitary status of the EB66 cell line.
– Agreement with Kaketsuken to co-develop influenza vaccines, including pandemic influenza vaccines, produced using EB66 cell-culture technology in Japan.
– GSK expects to increase annual production capacity of Relenza to 190 million treatment courses by the end of 2009.
European Commission grants marketing authorisation of pandemic (H1N1) adjuvanted vaccine Pandemrix for pandemic H1N1 2009 influenza.
– Agreement with the World Health Organization to donate 50 million doses of adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need.
FDA approves supplemental biologics license application for unadjuvanted influenza A (H1N1) pandemic vaccine.
Health Canada approves adjuvant-free H1N1 vaccine for pregnant women and healthy individuals aged 10 to 64.
– 172,000 doses of Arepanrix, distributed to almost half of the country, recalled after 6 Canadians experienced severe allergic reaction called anaphylaxis, which causes breathing problems, low blood pressure and swelling of the tongue, lips and eyes. Confirmed 24 cases including one person who died after getting vaccinated.
World Health Organization awards prequalification for global use of Arepanrix, adjuvanted H1N1 pandemic vaccine manufactured in Canada.

2008
– European licence for Pandemrix, a “mock-up” pandemic vaccine, and first company to obtain a European licence for a pre-pandemic vaccine, Prepandrix, designed to raise immune protection against several strains of the H5N1 virus.
– Exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. as a preliminary step in forming a Joint Venture company to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.

2007
– Contract from the U.S. Department of Health and Human Services for the development of pre-pandemic and pandemic flu vaccines.
– Donation of 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine to the World Health Organization in support of stockpile initiative.
– Second task order for 22.5 million doses of 15µg H5N1 bulk vaccine antigen from the U.S. Department of Health and Human Services.
– Agreement with the U.K. Government to provide pandemic influenza vaccine in the event of a flu pandemic.
– Agreement with Vivalis to develop and commercialise new human influenza vaccines based on Vivalis‘ proprietary EBx cell line technology. Under this worldwide collaboration and license agreement, Vivalis participates in the vaccine process development, and GlaxoSmithKline Biologicals is entitled to use Vivalis‘ avian embryonic stem cell derived EBx cell lines and related technologies to produce seasonal and pandemic human flu vaccines.
– New generation H5N1 split antigen pre-pandemic influenza vaccine accepted for review by the Committee for Medicinal Products for Human Use in Europe.

2006
– GSK produces over 10 million packs of anti-flu treatment Relenza in one year.
– International clinical human trial programme to test two pandemic vaccines against the H5N1 strain of the avian influenza virus in humans.
– $274 million contract from the U.S. Department of Health and Human Services to speed the development of new cell culture-based seasonal and pandemic influenza vaccines and to scale-up cell culture manufacturing capability at its Marietta, PA facility.
– Daronrix, first generation alum-adjuvanted inactivated whole virus candidate flu vaccine for use once a pandemic has officially been declared by the WHO/E.U., receives positive opinion from Europe’s Committee for Medicinal Products for Human Use. This is a first step in the preparation against a possible H5N1 pandemic.
– Task order for 5 million doses of H5N1 clade 2 bulk antigen at 15µg HA/dose from the U.S. Department of Health and Human Services.
– Shipping of 25 million doses of Fluarix and FluLaval to U.S.
– Supply contract with the Swiss Federal Office of Public Health for 8 million doses of H5N1 antigen influenza vaccine and its proprietary adjuvant for pre-pandemic use.
– Licensing agreement with Simcere Pharmaceutical Group of Nanjing, China, granting Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam and all Least Developed Countries.
– Approval in the E.U. of anti-viral Relenza (zanamivir for inhalation) in the prevention (prophylaxis) of influenza A and B in adults and children 5 years of age and above.
– Agreement with the U.S. Government to provide the anti-viral Relenza (zanamivir for inhalation) as they prepare for a potential influenza pandemic.

2005
– GSK’s acquisitions: a major influenza vaccine manufacturer, ID Biomedical Corporation; a vaccine manufacturing site in Marietta, Pennsylvania, for cell-culture-based flu vaccines and secondary operations; Corixa Corporation, for its work in developing innovative adjuvants designed to stimulate immunity.
FDA approves Fluarix, an influenza virus vaccine.
– GSK CEO JP Garnier meets U.S. President Bush to discuss pandemic flu planning.

Rotavirus

Rotarix
– Approved by the FDA in 2008.
– Liquid suspension of the live attenuated human rotavirus RIX4414 strain.
– Doses: 1-mL administered orally, 1st dose at 6 weeks of age, 2nd dose after an interval of at least 4 weeks and prior to 24 weeks of age.
– Each 1-mL dose contains a suspension of at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution.
– Live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P[8] type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus.
– The lyophilized vaccine contains amino acids, dextran, Dulbecco’s Modified Eagle
Medium, sorbitol, and sucrose.
– Dulbecco’s Modified Eagle Medium contains sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red.
– The liquid diluent contains calcium carbonate, sterile water, xanthan, and an antacid component (calcium carbonate).
– Contaminated with DNA from porcine circovirus 1, a virus from pigs, in both the cell bank and the seed from which the vaccine is derived, suggesting presence from the early stages of vaccine development.
– Vaccinations: More than 1 million children in the United States and 30 million worldwide.
– 8 clinical studies: 68 deaths following administration of ROTARIX (1/540) and 50 deaths following placebo administration (1/689). The most commonly reported cause of death following vaccination was pneumonia, observed in 19 recipients of ROTARIX and 10 placebo recipients.
– Postmarketing Experience: Intussusception (including death), hematochezia,
gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency
Disease; Idiopathic thrombocytopenic purpura; Kawasaki disease; Maladministration.
– Animal reproduction studies not conducted.
– Not known whether can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity.
– Safety and effectiveness in infants younger than 6 weeks or older than 24 weeks of age not evaluated.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Varicella

Varilrix
– Lyophilised preparation of the live attenuated Oka strain of varicella-zoster virus, obtained by propagation of the virus in MRC5 human diploid cell culture.
– Each 0.5ml dose of the reconstituted vaccine contains not less than 10 plaque-forming units
(PFU) of the varicella-zoster virus, amino acids, human albumin, lactose, neomycin sulphate, polyalcohols, mannitol, sorbitol.
– Manufacture includes exposure to bovine derived materials.
– As for any vaccine, may not result in protection from subsequent infection with varicella virus in 100% of subjects.
– Duration of protection: Unknown.
– Safety and efficacy not established in persons who are known to be infected with HIV, with or without evidence of immunosuppression.
– Contraindicated in pregnant women as the possible effects on foetal development are unknown.
– Pregnancy should be avoided for 3 months after vaccination.
– Effect on breast fed infants of the administration to their mothers not evaluated in clinical studies.
– May be administered at the same time as a measles-containing vaccine.
– Salicylates should be avoided for 6 weeks after varicella vaccination as Reye’s syndrome has
been reported following the use of salicylates during natural varicella infection.
– Post-marketing Data: Encephalitis viral, herpes zoster and varicella; Hypersensitivity, anaphylactic reactions; Convulsions, cerebellar ataxia.
– Events reported in children: Pain at the injection site, redness, swelling, swelling
(>2cm), redness (>2cm), injection site reaction, contact dermatitis; Fever, rash, injury, viral infection; Varicella-like rash, fever >39°C, fatigue, pain, infection, bacterial infection, fungal infection; Malaise; Pruritis, eczema, purpura, sweat gland disorder,
dry skin, urticaria; Diarrhoea, abdominal pain, vomiting, toothache, nausea, dyspepsia; Arthralgia, myalgia; Headache, nervousness, somnolence, irritability; URTI, coughing, pharyngitis, rhinitis, asthma, sinusitis, respiratory disorder; Conjunctivitis, otitis media, earache.
– Events reported in adults: Pain at the injection site, injection site reaction, redness,
injection site inflammation, injection site mass; Fever, fatigue, chest pain, injury, malaise, infection viral, Varicella-like rash; Dermatitis, pruritis, rash, urticaria; Diarrhoea, abdominal pain, vomiting, nausea, gastroenteritis; Headache, dizziness, migraine,
somnolence, irritability; URTI, pharyngitis, asthma, bronchitis, coughing, sinusitis, rhinitis, sputum increased; Lymphadenopathy, lymphadenopathy cervical; Arthralgia, back pain, myalgia; Conjunctivitis.

Diphtheria and Tetanus

Pediarix
– Diphtheria and tetanus toxoids, inactivated pertussis toxin, formaldehyde-treated filamentous hemagglutinin and pertactin (69 kiloDalton outer membrane protein), hepatitis B surface antigen, plus poliovirus Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett).
– Diphtheria toxoid, tetanus toxoid, and pertussis antigens are the same as those in Infanrix.
– Hepatitis B surface antigen is the same as that in Engerix-B.
– Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use)
is manufactured by Novartis Vaccines and Diagnostics GmbH & Co., Marburg, Germany.
– Culture media: Bovine protein, Lathan medium derived from bovine casein, Linggoud-Fenton medium derived from bovine extract, Monkey kidney tissue culture (Vero), synthetic or semisynthetic.
– Excipients: Aluminum Hydroxide, Aluminum Phosphate, Bovine Protein, Lactalbumin, Hydrolysate, Formaldehyde or Formalin, Glutaraldhyde, Monkey Kidney Tissue, Neomycin, 2-Phenoxyethanol, Polymyxin B, Polysorbate 80, Yeast Protein.
– Indicated for active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 as a 3-dose primary series in infants born of HBsAg-negative mothers, beginning as early as 6 weeks of age.
– Should not be administered to any infant before the age of 6 weeks, or to individuals 7 years of age or older.
– Infants born of HBsAg-positive mothers should receive Hepatitis B Immune Globulin (Human) and monovalent Hepatitis B Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination series according to a particular schedule.
– Infants born of mothers of unknown HBsAg status should receive monovalent Hepatitis B
Vaccine (Recombinant) within 12 hours of birth and should complete the hepatitis B vaccination
series according to a particular schedule.
– The primary immunization series is 3 doses of 0.5 mL, given intramuscularly, at 6 to 8 week intervals (preferably 8 weeks). The customary age for the first dose is 2 months of age, but it may be given starting at 6 weeks of age.
– Should not be administered to any infant before the age of 6 weeks.
– As with any vaccine, may not protect 100% of individuals receiving the vaccine.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
– Not indicated for women of child-bearing age.
– Animal reproduction studies not conducted.
– Not known whether can cause fetal harm when administered to a pregnant woman or if can affect reproductive capacity.
– Not indicated for use in adult populations.
– Safety and effectiveness in infants younger than 6 weeks of age not evaluated.
– Not recommended for persons 7 years of age or older.
– In 14 clinical trials, 5 deaths were reported among 8,088 (1/1617) recipients. Included 2 cases of Sudden Infant Death Syndrome, 1 case of convulsive disorder, 1 case of congenital
immunodeficiency with sepsis, and 1 case of neuroblastoma.
– Postmarketing Reports: Cyanosis; Diarrhea, vomiting; Fatigue, injection site cellulitis,
injection site induration, injection site itching, injection site nodule/lump, injection site pain, injection site reaction, injection site redness, injection site swelling, injection site vesicles, injection site warmth, irritability, limb pain, limb swelling, pyrexia, Sudden Infant Death Syndrome; Anaphylactic reaction, anaphylactoid reaction, hypersensitivity; Upper respiratory tract infection; Abnormal liver function tests; Anorexia; Bulging fontanelle, convulsions, depressed level of consciousness, encephalitis, febrile convulsion, hypotonia, hypotonic-hyporesponsive episode, lethargy, somnolence; Crying, insomnia, nervousness, restlessness, screaming, unusual crying; Apnea, cough, dyspnea; Angioedema, erythema, rash, urticaria; Pallor, petechiae.

Kinrix
– Initial U.S. Approval: 2008.
– Each 0.5-mL dose is formulated to contain 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin , 25 mcg of filamentous hemagglutinin, 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett).
– Each 0.5-mL dose contains 4.5 mg of NaCl and aluminum adjuvant (not more than 0.6 mg aluminum by assay). Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80). Neomycin sulfate and polymyxin B are used in the poliovirus vaccine manufacturing process and may be present in the final vaccine at ≤0.05 ng neomycin and ≤0.01 ng polymyxin B per dose.
– Diphtheria toxin: Produced by growing Corynebacterium diphtheriae in Fenton medium containing a bovine extract.
– Tetanus toxin: Produced by growing Clostridium tetani in a modified Latham medium derived from bovine casein.
– The acellular pertussis antigens (PT, FHA, and pertactin) are isolated from Bordetella
pertussis culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated
from the fermentation broth; pertactin is extracted from the cells by heat treatment and
flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and pertactin are treated with formaldehyde. Diphtheria and tetanus toxoids and pertussis antigens (inactivated PT, FHA, and pertactin) are individually adsorbed onto aluminum hydroxide.
– Each of the 3 strains of poliovirus is individually grown in VERO cells, a continuous line of monkey kidney cells, cultivated on microcarriers. Calf serum and lactalbumin hydrolysate are used during VERO cell culture and/or virus culture.
– Indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the 5th dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix for the 1st 3 doses and Infanrix for the fourth dose.
– Animal reproduction studies not conducted.
– Not known whether can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity.
– Not evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
– Safety and effectiveness in children younger than 4 years of age and children 7 to 16 years of age not evaluated. Not approved for use in persons in these age groups.

Infanrix
– Culture media: Cohen-Wheeler or Stainer-Scholte media, Lathan medium derived from bovine casein, Linggoud-Fenton medium derived from bovine extract, synthetic or semisynthetic.
– Excipients: Aluminum Hydroxide, Bovine Extract, Formaldehyde or Formalin, Glutaraldhyde, 2-Phenoxyethanol, Polysorbate 80.

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