Post-marketing safety surveillance of the rotavirus vaccine in India.

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.

Active safety surveillance of rabies monoclonal antibody and rabies vaccine in patients with category III potential rabies exposure.

Background: A vero cell-based inactivated Rabies Vaccine (Rabivax-S) and Rabies Human Monoclonal Antibody (Rabishield) have been approved since 2016. A post-marketing surveillance was conducted in India from 2020 to 2021 to gather real world safety data on Rabivax-S and Rabishield.

Methods: This was non-interventional active surveillance in patients with category III potential rabies exposure who were administered a post-exposure prophylaxis (PEP) regimen (Rabishield and Rabivax-S) by their healthcare providers (HCPs) as per the dosages and regimens mentioned in the package insert approved by the Indian regulators.

Management of febrile neutropenia in malignancy using the MASCC score and other factors: Feasibility and safety in routine clinical practice.

Background: The current standards for empirical broad-spectrum intravenous antibiotic (AB) treatment, combined with hospitalization, are cautious and safe, but lead to over-treatment of a substantial group of patients. We need to validate parameters to identify these low-risk febrile-neutropenia (FN) patients, who could then be safely treated in an outpatient setting with minimal/no AB treatment.

Materials And Methods: A retrospective analysis for validation of a risk-assessment model in FN patients was done on a patient population from January 2007 to December 2008.