Introduction: Varicella is a highly contagious infection that can lead to serious complications, particularly in high-risk groups; however, it is vaccine preventable. Disease awareness and understanding of the disease burden can strongly influence vaccine coverage. This review provides insight into the current epidemiology and the importance of varicella from both public health and economic perspectives across the Asia-Pacific (APAC) region. Areas covered: A systematic literature review was conducted to identify studies on the incidence, seroprevalence, fatality rate and complication rate of varicella. Economic burden studies were also captured. Altogether, 125 studies were identified across the region; these were supplemented by government reports (gray data). Reported vaccine coverage varied from 2.8% to 97%; a key influencing factor was inclusion of the varicella vaccine in national immunization programs. In general, varicella incidence in the unvaccinated population was highest in children ≤5 years old and seroprevalence increased with age. Economic analyses highlighted the cost-saving potential of vaccination programs, especially from a societal perspective. Expert opinion: Varicella-related data varied greatly across the APAC region, highlighting the need to better understand the burden of varicella in this area, and particularly identified the need for better surveillance and reporting.
Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on
Rotarix
™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of
Rotarix
™ were administered according to the local prescribing information (PI). The occurrence of at least Grade “2”/”3” solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade “2”/”3” solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of
Rotarix
™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.
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