Improving rotavirus vaccine coverage: Can newer-generation and locally produced vaccines help?

Figures & data

Table 1. A comparison of rotavirus vaccines.

	Internationally-available		Licensed for national markets
Name	Rotarix	RotaTeq	Rotavac	Rotasiil	LLR	Rotavin-M1
Manufacturer, country	GlaxoSmithKline Biologicals, Belgium	Merck, USA	Bharat Biotech International Limited, India	Serum Institute of India Limited, India	Lanzhou Institute of Biological Products, China	Center for Research and Production of Vaccines, Vietnam
Strain(s) present in vaccine	Attenuated human G1P[8] strain	Human-bovine reassortant strain with G1, G2, G3, G4, and P[8] proteins	Human G9, P[11] strain	Human-bovine reassortant pentavalent (G1-G4, G9) strain	Lamb G10P[12] strain	Human G1P[8] strain
Presentation	1. Liquid vaccine in oral, single-dose applicator	Liquid vaccine in oral, squeezable tube	Liquid vaccine in single- and multi-dose vial. Liquid antacid buffer given before the vaccine	Lyophilized vaccine, reconstituted with calcium carbonate buffer	Liquid vaccine with buffer	Liquid vaccine in single-dose vial.
	2. Liquid vaccine in squeezable, polyethylene single-dose tube
	3. Lyophilized vaccine, reconstituted with calcium carbonate buffer and oral applicator
Vaccine vial monitor (VVM) on label^15	Yes, VVM 14	None	Yes, VVM 2	Yes, VVM 30	None	None
Storage requirements	2 to 8º C, not frozen and protected from light	2 to 8º C, not frozen and protected from light	Frozen at −20ºC ± 5ºC	Stable at 37°C for two years and 40°C for six months	2 to 8°C	Frozen at −20ºC ± 5ºC
Route of administration	Oral	Oral	Oral	Oral	Oral	Oral
Number of doses and schedule of administration	Two doses, given on same schedule as DPT vaccine	Three doses, given on same schedule as DPT vaccine	Three doses, four weeks apart, beginning at 6 weeks of age	Three doses, four weeks apart, beginning at 6–8 weeks of age	One dose every year for three years between 2 and 35 months of age	The first dose from 6 weeks of age. The second dose after 1–2 months. Should be given before 6 months of age.
Vaccine efficacy (95% CI) against severe rotavirus gastroenteritis during the first year, developing country study location	61% (44 to 73%), South Africa and Malawi^33	59% (40 to 72%), Ghana, Kenya, Mali, Bangladesh and Vietnam^34	56% (37 to 70%) Delhi, Pune and Vellore^16	67% (50–78%), Niger^18	Not available	Not available
Licensure and WHO prequalification^15	Internationally licensed, Prequalified in 2007	Internationally licensed, Prequalified in 2008	Licensed in India	Licensed in India	Licensed in China	Licensed in Vietnam
Price per vaccination course	From approximately US$0.50 in GAVI-eligible countries up to US$185–$226 in the USA^1		US$ 2.50^2	US$ 6.00 maximim^3	US$ 24.00^4	US$ 17.60^5

¹ Price varies depending on the country¹²

² Each dose of Rotavac will be available at about 54 Indian Rupees equivalent to US$0.84³⁵

³ Each dose of Rotasiil will be available at under US 2.0. A Gavi subsidized price will also be available.

⁴ The cost for a single dose of LLR is US$24.00 as it is listed as a second-category vaccine and fully charged to users³⁶

⁵ Each dose of Rotavin-M1costs around VND200,000 equivalent to US$8.80³⁷

Bill and Melinda Gates Foundation. Currently available vaccines and introduction status. http://rotacouncil.org/wp-content/uploads/2017/05/Singapore-Slides-Carey-Final.pdf Accessed 5 October 2017.

 Google Scholar

Madhi SA, Cunliffe NA, Steele D, Witte D, Kirsten M, Louw C, et al. Effect of human rotavirus vaccine on severe diarrhea in African infants. N Engl J Med. 2010;362(4):289–98. doi:10.1056/NEJMoa0904797. PMID:20107214.

 PubMed Web of Science ®Google Scholar

Breiman RF, Zaman K, Armah G, Sow SO, Anh DD, Victor JC, et al. Analyses of health outcomes from the 5 sites participating in the Africa and Asia clinical efficacy trials of the oral pentavalent rotavirus vaccine. Vaccine. 2012;30 Suppl 1:A24–9. doi:10.1016/j.vaccine.2011.08.124. PMID:22520132.

 PubMed Web of Science ®Google Scholar

Bhandari N, Rongsen-Chandola T, Bavdekar A, John J, Antony K, Taneja S, et al. Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial. Lancet. 2014;383(9935):2136–43. doi:10.1016/S0140-6736(13)62630-6. PMID:24629994.

 PubMed Web of Science ®Google Scholar

Isanaka S, Guindo O, Langendorf C, Seck AM, Plikaytis BD, Sayinzoga-Makombe N, et al. Efficacy of a lowcost, heat-stable oral rotavirus vaccine in Niger. N Engl J Med. 2017;376:1121–30. doi:10.1056/NEJMoa1609462. PMID:28328346.

 PubMed Web of Science ®Google Scholar

Rota council. Rotavirus: common, severe, devastating, preventable. http://rotacouncil.org/wp-content/uploads/2016/11/Rotavirus-Severe-Preventable-White-Paper-Full.pdf Accessed 5 October 2017.

 Google Scholar

Bharat Biotech rolls out a low-cost vaccine against Rotavirus Diarrhoea. https://indiabioscience.org/news/2013/bharat-biotech-rolls-out-a-low-cost-vaccine-against-rotavirus-diarrhoea Accessed 23 January 2017

 Google Scholar

Cui S, Tobe RG, Mo X, Liu X, Xu L, Li S. Cost-effectiveness analysis of rotavirus vaccination in China: Projected possibility of scale-up from the current domestic option. BMC Infect Dis. 2016;16(1):677. doi:10.1186/s12879-016-2013-1. PMID:27846803.

 PubMedGoogle Scholar

Vietnam produces diarrhoea vaccine. http://baodongnai.com.vn/english/health/201402/vietnam-produces-diarrhoea-vaccine-2294722/. Accessed 30 April 2017

 Google Scholar