EuBiologics is struggling to get a comparative vaccine to conduct a phase 3 trial of a Covid-19 vaccine, industry officials said.

A comparative vaccine is essential for a comparative immunogenicity study because a vaccine candidate should prove its non-inferiority to the authorized vaccine.

EuBiologics struggles to get a comparative vaccine to conduct a phase 3 trial of EuCorVac-19, a Covid-19 vaccine candidate.
EuBiologics struggles to get a comparative vaccine to conduct a phase 3 trial of EuCorVac-19, a Covid-19 vaccine candidate.

Compared to a placebo-controlled trial, a comparative study can save cost and time.

As it has become easy to recruit trial participants with the rising vaccination rate, the Ministry of Food and Drug Safety allowed a comparative trial of a Covid-19 vaccine.

Earlier, EuBiologics said it would use AstraZeneca’s Covid-19 vaccine as a comparative vaccine in a phase 3 study, but AstraZeneca recently denied it.

It became uncertain whether EuBiologics could use the AZ’s vaccine to proceed with a phase 3 study.

In a phone interview with Korea Biomedical Review on Thursday, an AstraZeneca official denied the rumor about the supply of the AZ vaccine for EuBiologics’ phase 3 trial and said: “it was something he never heard of.”

AstraZeneca’s supply of Covid-19 vaccine for SK Bioscience’s phase 3 trial was part of a three-party agreement for the global supply of Covid-19 vaccine among the Ministry of Health and Welfare, SK Bioscience, and AstraZeneca in July, the official said.

AstraZeneca provides its Covid-19 vaccine as a comparative vaccine for SK Bioscience’s global phase 3 trial of GBP510, a Covid-19 vaccine candidate.

The Ministry of Food and Drug Safety, which approved SK Bioscience’s phase 3 study of GBP510, said on Aug. 10 that securing a comparative vaccine was an issue that should be resolved between companies.

At the time, Food and Drug Safety Minister Kim Gang-lip said the government made various requests for cooperation to the AZ headquarters or international organizations such as CEPI and the WHO to help SK Bioscience secure a comparative vaccine.

However, in the final stage, SK Bioscience’s direct consultation with AZ led to the purchase of the AZ vaccine for comparison, Kim noted.

The AstraZeneca official’s remarks have dimmed the possibility for EuBiologics to conduct a phase 3 trial of its vaccine candidate EuCorVac-19.

EuBiologics, which applied for a local phase 3 study of EuCorVac-19 to the MFDS on Tuesday, has repeatedly said it would use the AZ’s product as a comparative vaccine.

“The application for a phase 3 study of EuCorVac-19 includes a plan to use the AZ vaccine as a comparative vaccine. However, we did not include it in the public filing because it was not mandatory,” an official at EuBiologics said.

The official said there might be “changes” in a comparative vaccine. Still, the company would make every effort to secure a comparative vaccine before getting the nod for the domestic phase 3 study.

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