Medigen Vaccine Biologics Corp (高端疫苗) has applied to Paraguay’s National Health Monitoring Directorate to conduct phase 3 clinical trials for its COVID-19 experimental vaccine in the country, the company said in a filing with the Taipei Exchange (TPEX) on Tuesday.
The company would collaborate with the National University of Asuncion in Paraguay to conduct phase 3 clinical trials in a university-affiliated hospital, the filing said.
After discussions with the Paraguayan regulator, the vaccine maker said that it would adopt immunobridging to compare the overall level of protection provided by its vaccine candidate with that of the AstraZeneca COVID-19 vaccine.
Photo courtesy of the Presidential Office via AP
Immunobridging is a means of inferring a vaccine’s efficacy by comparing the immune response of participants given an approved vaccine with the response of others given the experimental vaccine.
Conducting the phase 3 clinical trials in Paraguay and registering its COVID-19 vaccine in the country would help Medigen gain a foothold in the markets of Central and South America, it said.
The company said that it is also in talks with EU regulators, as it plans to conduct phase 3 clinical trials in other markets.
Medigen on Tuesday did not disclose how many participants would be enrolled in the trials in Paraguay, the time frame for completing the trials or their cost.
Medigen chief executive officer Charles Chen (陳燦堅) told a news conference last month that the company had considered recruiting about 30,000 participants for the phase 3 clinical trials.
Phase 2 clinical trials for the vaccine, which were completed on June 9, raised no major safety concerns, the company said, adding that the data on the generation of neutralizing antibodies were generally well-received.
On June 15, Medigen said that it applied to the Food and Drug Administration (FDA) for emergency use authorization for the vaccine.
In related news, UBI Pharma Inc (聯亞藥) last month said that its US-based affiliate, Vaxxinity, had signed a contract with the Paraguayan government to supply 1 million doses of its COVID-19 vaccine.
“So far neither we nor our parent company, United Biomedical Inc (聯亞生技), have been assigned to produce the 1 million doses,” UBI Pharma said in a TPEX filing.
United Biomedical is another local company working on the development of a COVID-19 vaccine and has also applied to the FDA for emergency use authorization of its vaccine candidate, UB-612, after releasing interim results from its phase 2 clinical trials.
The company aims to begin phase 3 clinical trials in India with 11,000 participants.
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