The Advisory committee for vaccines and immunization practices (ACVIP)
recommendations of 2018-19 are a mix of best practices for individual
children, and for community use, based on published studies, World
Health Organization (WHO) recommendations, and National immunization
program.
Author cites the Centre for Disease Control (CDC),
USA recommendation that the fourth dose of Hepatitis B vaccine should
not be administered before 24 weeks whereas WHO recommends birth dose
(using monovalent vaccine) to all infants followed by 2 or 3 additional
doses (monovalent or combined vaccines) to complete the primary series
with minimum 4 weeks’ interval between doses [1]. CDC recommends primary
vaccination at 2,4,6 months whereas WHO recommends primary vaccination
at 6,10,14 weeks and the ACVIP recommends the latter. Indian studies
using different schedules as 0,6,14 weeks and 0,1,2 months [2] and
6,10,14 weeks [3,4] have also reported adequate immunogenicity. All the
3-dose hepatitis schedules protect from the disease for as long as 15-20
years. Even if protective antibody titers decline with time, long-term
protection relies on immunological memory that allows a protective
anamnestic response after exposure to Hepatitis-B virus.
The effectiveness of licensed acellular pertussis (aP)
and whole cell pertussis (wP) vaccines in preventing disease is similar
in the first year of life [5], and hence the committee accorded near
equal status to both types of the vaccines [6]. Clinical phase III
studies in India demonstrated that the aP containing vaccines elicit a
robust immune response in Indian children following a primary
immunization schedule at 6, 10 and 14 weeks of age [7,8].
In view of limited manufacturing capacity for IPV,
WHO has supported fractional IPV (fIPV) use and hence government has
adopted the same. ACVIP recommends administration of full dose of IPV at
6,10,14 weeks as preferred option, and when this is not feasible the
fIPV at 6 and 14 weeks along with bOPV at 6,10,14 weeks.
Reasons for introduction of influenza vaccine have
been clearly detailed in the ACVIP recommendations [9].
As Measles-Rubella (MR) vaccine has been introduced
in the national immunization schedule and in MR campaign, the same was
mentioned. ACVIP supports the national MR campaign. We have not changed
the earlier recommendations at all on Measles Mumps Rubella (MMR)
vaccine.
Regarding TCV, the committee has brought down the age
for the vaccination based on adequate immunogenicity data from earlier
studies. The recommendation from 6 months onwards is to suit the
convenience and avoid overcrowding of vaccinations around 9 months. The
need for second dose of TCV has not been convincingly established though
most studies indicate that a single dose might provide adequate antibody
titres for up to 5 years. Until hard data is generated or available, we
have endorsed the WHO recommendation of a single dose as of now.
Antibody titres have been reported to be sufficient for 30 months after
one dose and enough data is not there as of now to justify a booster at
2 years. It should be noted that no international scientific body has
endorsed booster doses.
Infants in developing countries are at risk of
developing rotavirus gastroenteritis at an earlier age than those in
developed countries. Hence, it is ideal if immunization schedule is
completed early. A recent meta-analysis [10] showed that 6,10 weeks’
schedule for rotavirus 1 (RV1) is immunologically inferior to 10,14
weeks’ schedule. However, the authors mentioned that the correlates of
protection of anti-rotavirus IgA levels are not known and "the
association between vaccine schedule and immunogenicity does not provide
evidence of a difference in disease protection" [9]. The upper age limit
of 12 months follows the same in National immunization schedule which
recommends beginning of RV immunization up to 1 year of age. This age
limit is for catch-up immunization.
References
1. World Health Organization. WHO Recommendations for
Routine Immunization - Summary Tables, Table I. Available from:
https://www.who.int/immunization/policy/Immuni-zation_routine_table1.pdf?ua=1.
Accessed March 15, 2019.
2. Mittal SK, Rao S, Kumar S, Aggarwal V, Prakash C,
Thiruparam S. Simultaneous administration of hepatitis B vaccine with
other EPI vaccines. Indian J Pediatr. 1994;61:183-8.
3. Kumar TS, Abraham P, Raghuraman S, Cherian T.
Immunogenicity of indigenous recombinant hepatitis B vaccine in infants
following 0, 1, 2 month vaccination schedule. Indian Pediatr.
2000;37:75-80.
4. Gomber S, Sharma R, Ramchandran VG, Talwar V,
Sinha B. Immunogenicity of Hepatitis B vaccine incorporated into
Expanded Program of Immunization Schedule. Indian Pediatr. 2000;37:411.
5. Pertussis vaccines: WHO position paper – August
2015. Weekly Epidemiological Record. No. 35. 2015;90:433-60.
6. Witt MA, Arias L, Katz PH, Truong ET, Witt DJ.
Reduced risk of pertussis among persons ever vaccinated with whole cell
pertussis vaccine compared to recipients of acellular pertussis vaccines
in a large US cohort. Clin Infect Dis. 2013;56:1248-54.
7. Chhatwal J, Lalwani S, Vidor E. Immunogenicity and
safety of a liquid hexavalent vaccine in Indian infants. Indian Pediatr.
2017;54:15-20.
8. Lalwani SK, Agarkhedkar S, Sundaram B,
Mahantashetti NS, Malshe N, Agarkhedkar S, et al. Immunogenicity
and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib
in Indian infants. Hum Vaccin Immunother. 2017;13:120-7.
9. Balasubramanian S, Shah A, Pemde HK, Chatterjee P,
Shivananda S, Guduru VK, et al. Indian Academy of Pediatrics
(IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP)
Recommended Immunization Schedule (2018-19) and Update on Immunization
for Children Aged 0 Through 18 Years. Indian Pediatr. 2018;55:1066-74.
10. Gruber JF, Gruber LM, Weber RP, Becker-Dreps S,
Jonsson Funk M. Rotavirus vaccine schedules and vaccine response among
infants in low- and middle-income countries: A systematic review. Open
Forum Infect Dis. 2017;4:2.