Export and priority regions. Regulatory and industry tools TECHNOLOGY TRANSFER RUSSIA AND NICARAGUA “INSTITUTO MECHNICOV” CECMED as PAHO Reference Agency Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba

Opening meeting of the Transfer Project (Managua (February, 15th-18th) XII Meeting Technical Advisory Committee (Managua, April, 11th-13th) 2015 2016 2017 2018 2019 Cooperation meeting TC and 1st TAC (Havana, March 23th -26th )

Modification Registration GMP and Registration 16-01-28 GMP and Modification Registration 19-03-27 2015 2016 2017 2018 2019

Workshop: Introduction of the Russian Anti-Influenza Vaccine March 30th and 31st , 2016 Registration Vaccination Vigilance Change of contraindications for its application in pregnant women To analize the correspondence between the dosis available and risk population Recommendations of aspects to include ESAVIs in the design of active surveillance

41 lotes 2 943 579 dosis 2019 * 2016 2017 2018 7 lots 687 600 doses Low reactogenicity, no warning signs found in relation to other types of influenza vaccines. Data derived from ESAVI surveillance did not record any unusual events and no security issues related to the application are reported. The vaccine can be administered safely and effectively during any trimester of pregnancy. According to the benefit/risk evaluation the vaccine obtained was classified as Level III , being the risk / benefit ratio very FAVORABLE * Vaccine manufactured at the Latin American Biotechnology Institute MECHNIKOV

Export and priority regions. Regulatory and industry tools TECHNOLOGY TRANSFER RUSSIA AND NICARAGUA “INSTITUTO MECHNICOV” CECMED as PAHO Reference Agency Dr. Rafael Pérez Cristiá MD, PhD Head of CECMED - Cuba