PMID- 37593522
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230823
IS  - 2590-1362 (Electronic)
IS  - 2590-1362 (Linking)
VI  - 15
DP  - 2023 Dec
TI  - Post-marketing safety surveillance of the rotavirus vaccine in India.
PG  - 100362
LID - 10.1016/j.jvacx.2023.100362 [doi]
LID - 100362
AB  - BACKGROUND: ROTASIIL, an oral live attenuated bovine-human reassortant 
      pentavalent rotavirus vaccine, was approved in 2017. This post-marketing 
      surveillance (PMS) was conducted to collect real-world data on the safety of 
      ROTASIIL in India. METHODS: Observational, active PMS was conducted in 
      approximately 10,000 infants aged >/= 6 weeks. ROTASIIL was administered as a 
      3-dose regimen, at least 4 weeks apart, beginning at >/= 6 weeks of age 
      concomitantly with other Expanded Programme on Immunization (EPI) vaccines. 
      Participants were followed for one month after the last dose. The adverse events 
      (AEs) and serious adverse events (SAEs), including intussusception (IS) reported 
      during the follow up period were collected. FINDINGS: A total of 9940 infants 
      were enrolled and were considered for safety analysis. Around 9913 (99.7 %) 
      infants received 2 doses, while 9893 (99.5 %) infants completed all three doses. 
      Total 3693 AEs were reported in 2516 (25.3 %) participants. Most of these AEs 
      were pyrexia (78.01 % of events) and injection-site reactions (19.14 % of 
      events). Nearly all AEs were causally unrelated to orally administered ROTASIIL 
      and could be caused by the concomitant injectable vaccines. Only 4 AEs (2 events 
      of vomiting and 1 event each of discomfort and pyrexia) in 4 (<0.1 %) 
      participants could be related to ROTASIIL. AEs were of mild or moderate severity 
      and all resolved without any sequelae. A total of 2 SAEs (acute otitis media and 
      skull fracture) were reported in 2 (<0.1 %) participants and were not related to 
      ROTASIIL and recovered without sequelae. No case of IS was reported. 
      INTERPRETATION: ROTASIIL was safe and well tolerated in this study. No safety 
      concerns were reported. FUNDING: The study was funded by SIIPL which is the 
      manufacturer of the study product.
CI  - (c) 2023 The Authors. Published by Elsevier Ltd.
FAU - Kang, Gagandeep
AU  - Kang G
AD  - Translational Health Science and Technology Institute, Faridabad, India.
FAU - Lakhkar, Anand
AU  - Lakhkar A
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Bhamare, Chetanraj
AU  - Bhamare C
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Dharmadhikari, Abhijeet
AU  - Dharmadhikari A
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Narwadkar, Jyoti
AU  - Narwadkar J
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Kanujia, Arti
AU  - Kanujia A
AD  - LabCorp Scientific Services & Solutions Pvt Ltd, Mumbai, India.
FAU - Desai, Sajjad
AU  - Desai S
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Gunale, Bhagwat
AU  - Gunale B
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Poonawalla, Cyrus S
AU  - Poonawalla CS
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
FAU - Kulkarni, Prasad S
AU  - Kulkarni PS
AD  - Serum Institute of India Pvt. Ltd., Pune, India.
LA  - eng
PT  - Journal Article
DEP - 20230801
PL  - England
TA  - Vaccine X
JT  - Vaccine: X
JID - 101748769
PMC - PMC10430202
OTO - NOTNLM
OT  - Post-marketing surveillance
OT  - Rotavirus vaccine
OT  - Safety
COIS- Anand Lakhkar, Chetanraj Bhamare, Abhijeet Dharmadhikari, Jyoti Narwadkar, Sajjad 
      Desai, Bhagwat Gunale and Prasad S. Kulkarni are employees of SIIPL. Cyrus S. 
      Poonawalla is the chairman and managing director of SIIPL. The principal 
      investigator, Gagandeep Kang served in an honorary capacity and received no 
      payments for the study. All other authors declare no competing interests.
EDAT- 2023/08/18 06:43
MHDA- 2023/08/18 06:44
PMCR- 2023/08/01
CRDT- 2023/08/18 03:55
PHST- 2023/04/27 00:00 [received]
PHST- 2023/07/29 00:00 [revised]
PHST- 2023/07/31 00:00 [accepted]
PHST- 2023/08/18 06:44 [medline]
PHST- 2023/08/18 06:43 [pubmed]
PHST- 2023/08/18 03:55 [entrez]
PHST- 2023/08/01 00:00 [pmc-release]
AID - S2590-1362(23)00103-1 [pii]
AID - 100362 [pii]
AID - 10.1016/j.jvacx.2023.100362 [doi]
PST - epublish
SO  - Vaccine X. 2023 Aug 1;15:100362. doi: 10.1016/j.jvacx.2023.100362. eCollection 
      2023 Dec.