Pentavalent vaccine

Pentavalent vaccine
Vaccine description
Target disease DTP-HepB-Hib (diphtheria, tetanus, whooping cough, hepatitis B, haemophilus influenza type B)
Type Conjugate vaccine
Clinical data
Trade names Quinvaxem, Pentavac PFS, Easyfive TT
Routes of
administration		 Intramuscular
Identifiers
ATC code J07CA11 (WHO)
ChemSpider none

A pentavalent vaccine is five individual vaccines conjugated in one intended to actively protect infant children from 5 potentially deadly diseases: Haemophilus Influenza type B (a bacteria that causes meningitis, pneumonia and otitis), whooping cough, tetanus, hepatitis B and diphtheria.[1]

During studies and tests, the conjugated liquid DTPw-HepB-Hib vaccine was found to have positive safety when administered as a booster to young children who have been given a vaccination course with another pentavalent booster that requires a change in constitution and was also found to be adequately immunogenic.[2]

The wholesale cost of the pentavalent vaccine is about 15.40 USD.[3]

Types

Common versions of pentavalent vaccines include ComBE Five, Pentavac PFS, Easyfive, Pentaxim (DTaP), shan-5, and Quinvaxem (DTwP).[4][5]

Pentavac PFS

Pentavac PFS is a pentavalent vaccine manufactured in India by Pune-based pharmaceutical company Serum Institute of India and was the lowest cost pentavalent vaccine in India.[6]

Easyfive TT

Produced by Panacea Biotec, Easyfive was removed from the WHO's list of pre-approved and prequalified vaccines in mid-2011.[7] Thereafter, in September 2013, WHO re-approved Easyfive after a positive result in the re-evaluation of the vaccine.[8]

Shan-5

Shan-5 is an efficient vaccine against Diphtheria, Tetanus, Pertusis, Hepatitis-b and HIB; produced by Shantha Biotech (A Sanofi Company). Shan-5 is WHO Prequalified vaccine and got WHO approval in the year 2014.[9]

ComBE Five

CombeFive is the pentavalent vaccine manufactured in India by Hyderabad-based Pharmaceutical & Biologics company Biological E and was one of the lowest cost pentavalent vaccine in India with WHO approval.

Quinvaxem

In March 2006, the Korea Food and Drug Administration (KFDA) awarded Quinvaxem the rights to distribution and sale.[10] The vaccine was being developed and manufactured by Crucell in Korea and was co-produced by Chiron Corporation (that was eventually purchased by Novartis International AG on April 20, 2006), which provides four out of the five vaccine elements in bulk.[11][12]

Side effects

Controversy

India

Late 2013, it was found that the Pentavalent vaccine manufacturer - The Serum Institute in India was distributing 2 sets of Pentavac PFS vaccines for administration. One set with manufacturing and expiry dates was being provided to private hospitals, while the other set without manufacturing and expiry dates was being distributed to government hospitals.[15] It was later clarified that the dates not appearing on one set of vaccines did not contravene any regulations as they were supplied by UNICEF and was legal under Rule 94 applicable to exports under Indian Law.

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.[16]

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.[17]

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.[18] Thereafter, the WHO also released an online FAQ for Quinvaxem and its use [19]

The reported events in Vietnam, Sri Lanka, Bhutan, and India caused widespread panic to spread to other developing nations regarding the use of the vaccine.[20] 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.[21]

Quinvaxem

The most widely administered pentavalent vaccine globally - Quinvaxem has been administered to 400 million children[22] as of 2013. This was after Crucell had procured an order worth US$110 million (in 2010) from UNICEF for the distribution of the vaccine for free to many of the developing nations.[23]

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.[24] This order brought the total revenue from Quinvaxem alone to US$910 million for Crucell since its initial launch in 2006.[25]

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.[26] In 2014 South Sudan became the last of the 73 GAVI-supported countries [27] 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 and by Sanofi Pasteur MSD.[28][29] Another competing vaccine - Easyfive, produced by Panacea Biotec was removed from the WHO's list of pre-approved and prequalified vaccines in mid-2011[30]

References

  1. ↑ "Immunisation and Pentavalent Vaccine". UNICEF.
  2. ↑ Suárez, Eduardo; Asturias, Edwin J.; Hilbert, Anne Katrin; Herzog, Christian; Aeberhard, Ursula; Spyr, Christian (2010). "A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador". Revista Panamericana de Salud Pública 27 (2): 117–24. doi:10.1590/S1020-49892010000200005. PMID 20339615.
  3. ↑ "Vaccine, Pentavalent". International Drug Price Indicator Guide. Retrieved 6 December 2015.
  4. ↑ "Products". Vaccine World.
  5. ↑ "'Shan5' vaccine gets WHO nod". Business Standard.
  6. ↑ "Pentavalent vaccines: A new era in immunization". BioSpectrum.
  7. ↑ "Pentavalent vaccine, Easyfive, removed from WHO list of prequalified vaccines". WHO.
  8. ↑ "WHO gives nod to Panacea Biotec's Easyfive TT". BioSpectrum.
  9. ↑ "Sanofi launches Shan5 paediatric pentavalent vaccine". The Economic Times. PTI.
  10. ↑ "Crucell Announces Second Quarter 2006 Results". Marketwired.
  11. ↑ "Crucell's Quinvaxem gets WHO prequalification". The Pharma Letter.
  12. ↑ "Crucell Announces Product Approval in Korea for Quinvaxem Vaccine". Marketwired.
  13. ↑ Quinvaxem inj. (DTP-HepB-Hib fully liquid combined vaccine)
  14. ↑ 70 cases of reactions after Quinvaxem vaccination
  15. ↑ "Pentavalent vaccine maker claims Unicef exemption on manufacturing dates". Times Of India.
  16. ↑ "4th baby dies as Vietnam brings back controversial Quinvaxem". Thanh Niên.
  17. ↑ Another baby dies after Quinvaxem vaccination
  18. ↑ Safety of Quinvaxem (DTwP-HepB-Hib) pentavalent vaccine.
  19. ↑ WHO - Frequently Asked Questions (FAQs) Quinvaxem vaccine
  20. ↑ "Infant deaths cast shadow on scale-up of pentavalent vaccine use". The Hindu Business Line.
  21. ↑ "Pentavalent vaccine is safe,assures IAP". The Indian Express.
  22. ↑ "4th baby dies as Vietnam brings back controversial Quinvaxem". Thanh Niên.
  23. ↑ "Crucell Announces New Award of $110 Million...". PRNewswire.
  24. ↑ "Crucell Announces New Award of $110 Million...". PRNewswire.
  25. ↑ "Crucell Receives $110M UNICEF Contract for Quinvaxem Pediatric Vaccine". GEN Eng News.
  26. ↑ "Pentavalent Vaccine" (PDF). World Health Organization.
  27. ↑ "With GAVI support, pentavalent vaccine is available in the 73 poorest countries". GAVI Alliance.
  28. ↑ "List of vaccines". Sanofi Pasteur MSD.
  29. ↑ "Serum Institute of India vaccines". Serum Institute of India.
  30. ↑ "Pentavalent vaccine, Easyfive, removed from WHO list of prequalified vaccines". WHO.

External links

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