The vaccine manufactured in Nicaragua meets international quality standards

The World Health Organization (WHO) has confirmed compliance with international quality standards for the fractionated inactivated influenza vaccine produced by the Saint Petersburg Institute for Vaccine and Serum Scientific Research (IICVSSP), which is the parent company of the Institute. Latinoamericano de Biotecnología MECHNIKOV in Nicaragua and supplies the bulk product of the vaccine for formulation, filling and packaging in our Plant. After receiving prequalification from the WHO, IICVSSP will be able to export its vaccine as part of the supply of international organizations and funds, the representative of the IICVSSP told TASS on Friday.

In February, the official representative of the WHO, Dr. Ute Rosskopf, responsible for interaction with laboratories, regulatory activities and safety, confirmed the full compliance of the influenza vaccine produced by the IICVSSP with world quality standards . "The WHO testing result supports the acceptability of the fractionated inactivated influenza vaccine produced by IICVSSP, Russian Federation, for prequalification," the statement said.

Prequalification is a service provided by WHO to assess the quality, safety and efficacy of medicines. Together with IICVSSP, the MECHNIKOV Institute plans to receive prequalification of its vaccine in 2021. Prequalification by the WHO is a crucial condition for the access of the drug to markets worldwide.

WHO Test report - Download

WHO Letter - Download