Medigen to apply for vaccine EUA
Courtesy of ICRT
Local drug maker, Medigen, says it is seeking an Emergency Use Authorization (EUA) for its coronavirus vaccine candidate after its Phase II clinical trials showed promising results.
According to the company, trial results for its two-dose recombinant protein vaccine showed no major safety concerns, as no participants in the study experienced severe adverse reactions. Medigen says it met governmental safety and efficacy thresholds as well as the review standards for EUA of domestic vaccines.
The drug maker says it will submit an application to Taiwan’s Food and Drug Administration (FDA), increasing the chances that its jab will become Taiwan's first coronavirus vaccine to reach the market.
Medigen says it also plans to apply with the European Medicines Agency and other international health authorities to begin Phase III clinical trials as soon as possible.
Medigen has said its recombinant protein vaccine has been developed in collaboration with the US National Institutes of Health.
Medigen is one of two local companies in Phase II trials for a coronavirus vaccine candidate.
In related news, Taiwan’s FDA has released its standards for granting EUAs to locally developed coronavirus vaccines.
FDA officials say they want to make sure that domestically produced vaccines are safe and can offer adequate protection. Pharmaceutical companies must have the data of at least 3,000 people in their clinical trials, and the neutralizing antibody levels in the body should be equal to or higher than those in the people who received AstraZeneca vaccine shots.
Neutralizing antibody levels are highly predictive of immune protection from symptomatic Covid-19 infection.
The FDA stresses that these standards are the consensus reached by experts in the fields of clinical trial, statistics, pharmacology and public health after months of discussions.
However, the standards do not mention that Taiwanese-made vaccines will have to conduct a third phase of clinical trials, something that World Health Organization-approved vaccines have to do before being granted EUAs.
According to the FDA's Medical Products Division, the criteria mainly focus on evaluating a vaccine candidate' safety and efficacy before considerations of issuing an EUA.
The FDA says it collected data concerning the level of neutralizing antibodies 200 Taiwanese people developed after taking the AstraZeneca vaccine to determine the level of efficacy of a locally-developed vaccine candidate.
The Centers for Disease Control on 30 May signed a contract with Medigen and another local pharmaceutical company to buy five million doses of coronavirus vaccines from each, a move that has caused controversy with critics saying that the CDC should have waited for the Phase II results.