Elaboración, tramitación, aprobación, modificación, derogación o rechazo de acuerdo, declaraciones o decisiones del Congreso Nacional o sus miembros incluídas comisiones.

Dear Sir/Madam<br /> The below mentioned is for your kind consideration:<br /> <br /> Product & Trial Overview <br /> Rotavac 5D® is an oral RV vaccine, which has been tested in multiple geographies around the world (North America, Africa, the Middle East & Southeast Asia). Based on various Efficacy and Immunogenicity studies, the vaccine is WHO-prequalified and has been used in multiple NIPs since 2012.<br /> A total of 16 Hospital/community-based Clinical trial sites were onboarded for this study. In the Rotavac 5D® Chile study, the first subject first visit (FSFV) was on 07 Jul 2023. A total of 5,800 infants were to be recruited for this study in a 1:1 ratio, blinded to receive either vaccine or placebo, along with the PNI vaccines. As per protocol for the estimation of vaccine Efficacy (VE), we considered all infants who developed severe GE caused by non-vaccine RV strain with onset at least 14 days after the third dose of Vaccine or Placebo, respectively, through 8 months+14 days post-dose 3. We defined severe rotavirus gastroenteritis cases (SRVGE) as cases meeting the definition of acute diarrhea, positive to rotavirus with a Vesikari score of >11.<br /> Study Conduct & RV seasonality in Chile<br /> The RV seasonality and year-on-year RV force of infection have varied greatly, which, like other infectious diseases, may be in part a post-COVID-19 effect. The timing of July 2023, when we started the study, it may not have coincided with the RV rebound infection, which was observed and spiked in 2023 compared with 2022. This likely played a role in that only 02 cases of SRVGE as per the per-protocol case definition, occurred in December 2023 out of a total recruitment of 1,125 subjects. As shown below (Figure 1), by June 2024, our total recruitment increased to 2,565 in the following six months, with only 7 SRVGE cases noted. Between July 2024 and early January 2025, we completed total recruitment of 4,270 subjects and accumulated a total of 37 cases of SRVGE, meeting our initial target for efficacy.<br /> <br /> <br /> DESARROLLO DE LA REUNIÓN:<br /> <br /> Interesado realiza presentación del producto Rotavac 5D, respecto la información de eficacia y seguridad, que se realiza en idioma inglés. <br /> Esta solicitud ya está en curso en el ISP y se indica acerca del estado de tramitación y posibles fechas de fechas de emisión de resolución. <br /> <br /> Gracias