1. 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

2. 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 )

3. Modification Registration
GMP
and
Registration
GMP
and
Modification Registration
2015
2016
2017
2018
2019

4. 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

5. 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

6. 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