Quinvaxem

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Quinvaxem is a Pentavalent vaccine, which is a conjugation of five individual vaccines in one that protect children in infancy from: Diphtheria, Tetanus, Whooping Cough (or Pertussis), Hepatitis B and Haemophilus Influenza type b (the bacteria that causes meningitis, pneumonia and otitis)[1]

In March 2006, the Korea Food and Drug Administration (KFDA) awarded licensure to Quinvaxem.[2] The vaccine was being produced by Crucell in Korea and was co-developed along with Chiron Corporation (that was eventually acquired by Novartis International AG on April 20, 2006), which supplies (in bulk) four out of the five vaccine components.[3] [4]

Mid-2010, Crucell had procured an order worth US$110 million from UNICEF for the distribution of the Quinvaxem Vaccine for free to many of the developing nations.[5] This order brought the total revenue from Quinvaxem alone to US$910 million for Crucell since its initial launch in 2006.[6]

In 2012, UNICEF and the World Health Organization had issued and recommended a joint statement to the Immunization Division, Ministry of Health and Family Welfare, Government of India and other developing nations in separate documents about the use of Pentavalent vaccines for the prevention of the 5 leading diseases responsible for death in children.[7] In 2014 South Sudan became the last of the 73 GAVI-supported countries [8] to introduce the five-in-one vaccine, which was first launched in Guyana in 2001.

Its main competitor is the vaccine Pentavac manufactured by the Serum Institute of India (or Bharat Serum) and by Sanofi Pasteur MSD.[9][10] Another competing vaccine - Easyfive, produced by Panacea Biotec was removed from the WHO's list of pre-approved and prequalified vaccines in mid-2011[11]

Vaccine composition and side effects

Composition and administration

The Quinvaxem vaccine is a homogeneous liquid which contains inactivated whooping cough or pertussis organisms, puréed diphtheria and tetanus toxoids, with Hib components as a bacterial vaccine containing highly puréed mixed, non-infectious Haemophilus influenzae type b (Hib) capsular polysaccharide and combined with highly puréed, non-infectious particles of hepatitis B surface antigen (HBsAg) chemically conjugated to a protein CRM197 (by cross-reacting material derived from Corynebacterium diphteriae strain C7(ß197) M8) adsorbed on aluminium phosphate gel and suspended in isotonic sodium chloride solution.[12]

Before use, the vial with the vaccine should be shaken in order to homogenise or effectively mix the liquid suspension. The vaccine should be injected intramuscularly. The anterolateral part of the upper thigh is the preferred site of injection. A sterile syringe and sterile needle must be used for each injection.

Side Effects

  • Gastrointestinal disorders: Common: diarrhoea, vomiting.[13]
  • General disorders and administration site conditions: Very common: Injection site pain and swelling accompanied by fever.[14]
  • Common: Injection site redness.
  • Metabolism and nutrition disorders: Very common: feeding disorders.
  • Nervous system disorders: Very common: sleepiness.
  • Psychiatric disorders: Very common: irritability. Common: crying.

Cost

Quinvaxem which is distributed as a 0.5mL vial is priced differently amongst countries but average around $26.10 per vial.[15][16]

Quinvaxem History & Controversy

Vietnam

Vietnam has been administering around 4.5 million Quinvaxem shots to 1.5 million children every year and the vaccination count has crossed 400 million globally in 2013.[17]

Since November 2013, about 1,500 children in Da Lat (Vietnam) have been vaccinated with Quinvaxem, the department reported. Since the vaccine was first used in 2007, at least 63 children have died after being vaccinated. The vaccine was suspended by the Health Ministry in May 2013 after nine children died post-vaccination. However, after investigations showed that the vaccine was safe to use, it has been re-used for the National Extended Vaccination program since October 2013, five months after its suspension.[18]

After the incidents in Vietnam, a joint statement was released by WHO and UNICEF confirming the safety of Quinvaxem and approval for its continued use as a pentavalent vaccine, after careful investigation, it was found that the fatalities reported in Vietnam were either coincidental health problems related in time but not related to the use of Quinvaxem, or cases for which the information available does not allow for a definite conclusion.[19] Thereafter, the WHO also released an online FAQ for Quinvaxem and its use [20]

The reported events in Vietnam, Sri Lanka, Bhutan & India caused widespread panic to spread to other developing nations regarding the use of the vaccine.[21] In response to this, the IAP or Indian Academy of Pediatrics had released a statement in support of Quinvaxem and other Pentavalents in an attempt to curb the alleged malicious information disseminated by the vaccine's critics in India.[22]

References

  1. "Immunisation and Pentavalent Vaccine". UNICEF.
  2. "Crucell Announces Second Quarter 2006 Results". Marketwired.
  3. "Crucell's Quinvaxem gets WHO prequalification". The Pharma Letter.
  4. "Crucell Announces Product Approval in Korea for Quinvaxem Vaccine". Marketwired.
  5. "Crucell Announces New Award of $110 Million..." PRNewswire.
  6. "Crucell Receives $110M UNICEF Contract for Quinvaxem Pediatric Vaccine". GEN Eng News.
  7. "Pentavalent Vaccine" (PDF). World Health Organization.
  8. "With GAVI support, pentavalent vaccine is available in the 73 poorest countries". GAVI Alliance.
  9. "List of vaccines". Sanofi Pasteur MSD.
  10. "Serum Institute of India vaccines". Serum Institute of India.
  11. "Pentavalent vaccine, Easyfive, removed from WHO list of prequalified vaccines". WHO.
  12. "A Summary Of Product Characteristics (Quinvaxem)" (PDF). US FDA.
  13. Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine)
  14. 70 cases of reactions after Quinvaxem vaccination
  15. "Quinvaxem uses and description". igenericdrugs.com.
  16. "Quinvaxem Inj. uses and description". igenericdrugs.com.
  17. "4th baby dies as Vietnam brings back controversial Quinvaxem". Thanh Niên.
  18. Another baby dies after Quinvaxem vaccination
  19. Safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine.
  20. WHO - Frequently Asked Questions (FAQs) Quinvaxem vaccine
  21. "Infant deaths cast shadow on scale-up of pentavalent vaccine use". The Hindu Business Line.
  22. "Pentavalent vaccine is safe,assures IAP". The Indian Express.
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Portions of content adapted from Wikipedias article on Quinvaxem licensed under GNU FDL.

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