INTRODUCTION:

Globally diarrheal diseases are the leading cause of childhood mortality and morbidity. Rotavirus is one of the main causative agents responsible for diarrheal diseases in children under-five year of age. In India, Rotavirus alone is responsible for nearly 80,000 to one lakh deaths, about 9 lakh hospitalizations and 32.7 lakh OPD cases of severe diarrhea every year. Further, it contributes to malnutrition, delayed physical and mental development among children.¹

Thus WHO recommends the introduction of Rotavirus vaccine in every country’s routine immunization schedule.

Rotavirus- Structure:

Rotavirus a triple-layered viral particle that belongs to the viral family Reoviridae. The virus looks like a wheel in shape under an electronic microscope, thus it is named as “rota”. The viral genome consists of 11 segments of double-stranded RNA that encode six structural and six nonstructural viral proteins. The G protein and P protein are the structural viral proteins that are present in outermost viral layer. They are responsible for the production of neutralizing antibodies and provide protective immunity to the host. In humans, at least 19 G genotypes (14 serotypes) and 27 P genotypes (14 serotypes) have been identified. There are the variations in the G- and P-types combination between different strains. These strains are identified by a binomial typing system. There may be the region –wise, country-wise and season –wise variations in Rotavirus strains. There are five G-P combinations (G1P[8], G2P[4], G3P[8], G4P[8]) and G9P[8]) that contributes about 90% of all Rotavirus infections in human beings. The G1P[8] type is the most prevalent. In India the most common serotypes are G1P[8], G2P[4], G9P[8], and G9P[4] and many other serotypes are also being detected.²

Incubation Period, Sign and Symptoms, High Risk Group:

The Rotavirus infection has an incubation period of 2 days approximately.³ Symptoms may include fever, nausea, vomiting, abdominal cramps, and frequent watery diarrhea that may last up to eight days. Severe diarrhea may lead to dehydration, electrolyte imbalance, shock and death if not treated adequately.⁴The Rotavirus infection primarily affects the infants and young children.³

Mode of Transmission, Diagnosis and Treatment:

The disease is spread mostly by fecal-oral route, person-to-person close contact and by fomites. Rotaviruses are probably also transmitted by other modes such as respiratory droplets. Because it spreads from person-to-person so it is difficult to control Rotavirus infections through improvements in hygiene and sanitation.⁵The virus is detected in stool specimen by various tests are available including ELISA, latex agglutination assays, strip-based tests, and Reverse Transcription Polymerase Chain Reaction (RT-PCR). There is no specific treatment available to treat Rotavirus diarrhea. Symptomatic treatment includes prevention of dehydration with oral rehydration therapy (ORS). Severe dehydration requires hospitalization for intravenous (IV) fluids. Vaccination is only the key intervention for the prevention of Rotavirus diarrhea.^{2, 3}

Types of Rotavirus Vaccine:

Three live oral Rotavirus vaccines available in India are :

1. Rotarix (RV1):

It is a human monovalent live Rotavirus vaccine contains single live attenuated human strain of 89-12 [type G1P1A(8)] Rotavirus. The vaccine is available in the form of lyophilized powder that is reconstituted before administration. Each dose is of 1-ml. The vaccine is given in 2 doses at 10 and 14 weeks. The vaccine and the diluents should be stored at 2 to 8°C and must not be frozen.

2. RotaTeq (RV5):

It is a human bovine pentavalent live vaccine consists of five reassortants between the bovine WC23 strain and human G1, G2, G3, G4 and P1A[8] Rotavirus strains. Each vial is of 2-ml. The vaccine is available as a liquid form and no reconstitution is needed. The vaccine is given in 3 doses at 6, 10 and 14 weeks. It should be stored at 2 to 8°C.

3. Rotavac (ORV116E):

It is a monovalent vaccine containing bovine human reassortant strain characterized as G9 P [11], with the VP4 of bovine Rotavirus origin, and all other segments of human Rotavirus origin. The vaccine strain was isolated from asymptomatic infants, with mild diarrhea by Indian researchers in 1985 at AIIMS, New Delhi.⁵ Later a low cost indigenous vaccine was developed under a public-private partnership between the Ministry of Science, Ministry of Health and Family Welfare and Bharat Biotech under ‘Make in India’ initiative.¹ The vaccine is given in 3 doses at 6 weeks, 10 weeks and 14 weeks.^{5, 6}

Rotavirus Vaccine under Universal Immunization Programme (UIP):

Till December 2015, the Rotavirus vaccines was available in India only through the private sector.⁷ On 26 March, 2016 an indigenously developed Rotavirus vaccine (ORV116E) was introduced in immunization schedule in four states namely Andhra Pradesh, Haryana, Himachal Pradesh and Odisha. The vaccine is available free of cost under UIP. Depending upon the success of Rotavirus vaccine in future, it will be expanded to the entire country in a phased manner. In addition to reducing childhood deaths, Rotavirus vaccine will be able to reduce out of pocket expenditure and cost of health care delivery.¹

Government of India operational guidelines for introduction of the Rotavirus vaccine in Universal Immunization Programme

Rotavirus vaccine (ORV116E):

Rotavirus vaccine is a live attenuated, oral liquid vaccine and is available in 10 dose vial and does not require reconstitution. Each dose is of 5 drops (0.5ml). The vaccine is available in a liquid frozen form. In liquid form, the vaccine is generally pink in colour and may sometimes change colour to orange or light yellow. This change in colour does not impact the quality of the vaccine. The vaccine is supplied with a pink coloured dropper that is longer and wider than the dropper used for OPV.

Storage:

The Rotavirus vaccine should be stored at -20°C at Government Medical Stores Depot, State, Regional and district stores, in the walk-in freezers (WIFs) or deep freezers (DFs). Cold chain points below district level should store vaccine at +2°C to +8°C, in ice-lined refrigerators (ILRs). In the ILR, Rotavirus vaccine should be stored at or above BCG level. It should be transported in cold boxes with conditioned ice-packs along with other UIP vaccines.

VVM2:

Rotavirus Vaccine vial has Vaccine Vial Monitor-2 (VVM2) with a central square that changes its colour progressively. As long as the colour of this square is lighter than the colour of the outer circle, the vaccine can be used. As soon as the colour of the central square is the same colour or darker than the outer circle, the vial should be discarded.

Vaccination schedule:

The Rotavirus vaccine is administered in 3 doses at 6, 10 and 14 weeks along with the other UIP vaccines. No booster dose of Rotavirus vaccine is recommended. (Table-1)

Method of Administration:

Before administering the vaccine, always check the expiration date. Pull out the aluminum seal along the indicated mark. Then tear it off to remove it. After that pull out the rubber stopper and connect the dropper firmly to the vial. Write the date and time of opening the vial. Then open the dropper cap. Position dropper at 45^o angle. Administer 5 drops into the mouth of the baby. Ensure that the dropper does not touch the mouth of the baby. Observe the child for 30 minutes after vaccination. Once opened, the vial is to be used within 4 hours.

Table -1 Updated Immunization Schedule including Rotavirus vaccine²

AGE	SCHEDULE
At birth	BCG, OPV-0, Hep-B birth dose
6 weeks	OPV-1, Rota-1, Pentavalent-1
10 weeks	OPV-2, Rota-2, Pentavalent-2
14 weeks	OPV-3,Rota-3,IPV,Pentavalent-3
9 months	MCV-1, Vit A*, JE-1#
16-24 months	DPT-Booster 1, OPV-Booster, MCV -2, JE-2^#
5-6 Years	DPT-Booster -2
10 years	TT
16 years	TT

*Vitamin A to be given every 6 months till five years of age.

^#JE vaccine given in selected districts.

BCG: Bacillus Calmette-Guerin; Pentavalent [DPT: Diphtheria-Pertussis-Tetanus; Hep B: Hepatitis B; Hib: Haemophilus influenzae type b]; JE: Japanese Encephalitis; MCV: Measles containing vaccine- measles alone or MR/MMR; OPV: Oral Polio Vaccine; TT: Tetanus Toxoid; IPV: Inactivated Poliovirus Vaccine; Rota- Rotavirus vaccine

Phasing in:

Only the infants coming for the first dose of OPV and pentavalent are administered Rotavirus vaccine. These children are given 2nd and 3rd doses in subsequent visits as per the schedule. The maximum upper age limit for giving first dose of Rotavirus vaccine is one year. If the child has received first dose of Rotavirus vaccine by 12 months of age, two more doses of the vaccine should be given with an interval of 4 weeks between two doses to complete the course. Infants, who are coming for their second or third dose of OPV and pentavalent, will complete the schedule with OPV and pentavalent vaccine only. Rotavirus vaccine is not to be started with second or third dose of OPV and pentavalent vaccine.

Contraindications:

History of allergic reaction to the vaccine, intussusceptions, abdominal surgery, intestinal malformation and immunodeficiency are the conditions when Rotavirus vaccine must not be administered. Mild illness such as upper respiratory tract infection or mild diarrhea is not a contraindication. Breast feeding before or after vaccination does not impair the response to Rotavirus vaccine. Rotavirus vaccine provides protection for at least first 2 years, when the risk of Rotavirus diarrhea is maximum.

Adverse Events Following Rotavirus Immunization:

Rotavirus vaccine may be associated with mild and transient symptoms included vomiting, diarrhea, cough, running nose, fever, irritability and rash. Symptomatic treatment should be given for the management. The diarrheal episodes should be managed with ORS and Zinc supplements. Rarely allergic reaction and anaphylaxis may occur with the Rotavirus vaccine. If it occurs, child should be rushed to the nearest health facility and further doses should not be given. In rare cases, intussusceptions has been found associated with some Rotavirus vaccines. In such case immediate referral should be done to the designated healthcare facility for management. Surveillance measures are recommended for documenting this rare serious event.² The nurses working in pediatric departments, MCH centers, community areas and other health workers such ANMs, ASHAs, Anganwadi workers and must keep themselves update regarding the latest advances in the immunization schedule under UIP. They have to work hard for the 100% coverage of Rotavirus vaccine with other vaccines under UIP. This emphasis the need for interactive training and orientation programmes through Power Point presentations, role plays, exercises and discussions as per government guidelines. The mothers should be educated and encouraged to report to nearby health centers on the due dates of immunization, safety of immunization card and early reporting of the adverse events following Rotavirus immunization. Nurse educators can also incorporate the procedure of Rotavirus vaccine administration in the curriculum of nursing students for their future preparation.

REFERENCES:

1. Press Information Bureau. GOI. Shri JP Nadda launches Rotavirus vaccine as part of Universal Immunization Programme; terms it a 'historic moment' [Internet].2016 Mar [cited 2016 May 3] Available from URL:http://pib.nic.in/newsite/PrintRelease.aspx?relid=138342

2. GOI. Operational guidelines on Introduction of the Rotavirus Vaccine in the UIP in India. [Internet]. 2016 Mar [cited 2016 May 3].Available from URL: https://www.itsu.org.in/repositoryresources/rotavirus-operational-guidelines.pdf

3. CDC. Clinical Information-Rotavirus. [Internet] [cited 2016 May 3] Available from: URL:https://www. cdc.gov/rotavirus/clinical.html

4. Ahmed J. Rotavirus Vaccine [Internet] [cited 2016 May 3] Available from: URL:http://www. pediatriconcall.com/forpatients/vaccination/Article.aspx?artid=402andtab=1

5. IAP. Guidebook on Immunization 2013–14. [Internet] [cited 2016 May 3] Available from: URL:http://iapindia.org/files/IAP%20Guidelines/IAP%20Guidebook%20on%20Immunization%202013-14.pdf

6. IAP. Recommended Immunization Schedule for Children Aged 0 through 18 years – India, 2014 and Updates on Immunization [Internet] [cited 2016 May 3] Available from: URL:http://www.indianpediatrics. net/oct2014/785.pdf

7. Rotavirus shots in govt. plan from Jan. The Pioneer [newspaper on the Internet]. 2015 Nov. [cited 2016 May 3]; para. 6. Available from: URL:http://www.dailypioneer.com/nation/rotavirus-shots-in-govt-plan-from-jan.html

Received on 27.07.2016 Modified on 24.08.2016

Int. J. Adv. Nur. Management. 2016; 4(4): 425-428.

DOI: 10.5958/2454-2652.2016.00094.9