Inovio Pharmaceuticals Inc (INO)

[Lakers_w]

The National Directorate of Sanitary Surveillance (DINAVISA), of the Republic of Paraguay, granted this February 14 the emergency use authorization (EUA) to the Taiwanese vaccine against COVID-19 MVC-COV1901, produced by the biotechnological laboratory Medigen Vaccine Biologics Corporation (MVC), for application in adults from 18 years of age.

The certification ceremony was held at the Ministry of Public Health and Social Welfare, with the presence of the Minister, Dr. Julio Borba; the director of the DNVS, QF María Antonieta Gamarra; the director of the PAI, Dr. Héctor Castro; as well as the ambassador of the Republic of China (Taiwan), Mr. José Han; Project Manager, Medigen Vaccine Biologics Corporation (MVC), Mr. Evan Tu; the legal representative of MVC, Dr. Gabiela Horvath; and other authorities.

It is important to note that, in order to grant this approval, a team of professionals from the National Sanitary Surveillance Directorate carried out an exhaustive evaluation and inspection of the Medigen laboratories in Taiwan, whose establishment was certified for compliance with the requirements of good manufacturing and control practices (GMP).

It is worth mentioning that the results of the clinical studies of the MVC-COV1901 phase 3 vaccine in Paraguay showed that it meets the required requirements in terms of safety, tolerability and high immunogenicity, giving the conclusion to authorize its emergency use. The criteria for granting emergency use followed the international guidelines of the World Health Organization (WHO).

The MVC-COV1901 vaccine was developed from a traditional protein subunit platform, in collaboration with the US National Institutes of Health (NIH). Its profile is with a two-dose intramuscular application format, with an interval of 4 weeks between both doses, and its storage temperature is from 2 to 8 °C.

The MVC laboratory is certified by the health authority of the Taiwan Food and Drug Administration (TFDA), which is based on the PIC's Guides for Good Manufacturing Practices and Good Storage and Distribution Practices. The MVC-COV1901 Vaccine has the emergency use certificate granted by the TFDA on July 19, 2021 and, currently, in Taiwan it is used as a reinforcement or booster dose.

It is emphasized that the DNVS will continue to monitor the safety of the vaccines used in the country, to ensure that these products always meet local and international standards of safety and efficacy.

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults

The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.

Locations: Paraguay
Hospital Fundación Tesai
Ciudad del Este, Paraguay
Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo, Paraguay
https://clinicaltrials.gov/ct2/history/NCT05011526?A=2&B=3&C=merged#StudyPageTop