Janssen candidate vaccine first to be approved for PH trials

APPROVED FOR TESTING Janssen’s candidate vaccine leverages its AdVac platform, which was also used to develop and manufacture an Ebola vaccine regimen, and construct its Zika, RSV and HIV investigational candidate vaccines. —REUTERS

The Food and Drug Administration (FDA) has approved the application of Belgium-based Janssen Pharmaceutica to conduct a clinical trial of its vaccine candidate against the coronavirus disease (COVID-19) in the Philippines.

“We received three clinical trial applications, and we have already approved one: the clinical trial of Janssen,” FDA Director General Eric Domingo said in Filipino in an online media briefing on Tuesday.

Janssen, a subsidiary of Johnson & Johnson, will be the first to hold clinical trials in the Philippines.

Domingo said the FDA was still reviewing the applications of Clover Biopharmaceuticals and Sinovac.

According to Janssen’s website, the candidate vaccine leverages the company’s AdVac platform, which was also used to develop and manufacture an Ebola vaccine regimen, and construct its Zika, RSV and HIV investigational candidate vaccines.

Clover has yet to submit some additional documents, while Sinovac requested to change its trial protocol and research design, Domingo said. “I think in the next few weeks, they will be ready to begin the clinical trials,” he said.

DOST decides where

The FDA chief explained that after Janssen’s completion of all regulatory paperwork and clearances, the next step would be for the vaccine expert panel of the Department of Science and Technology (DOST) to assign an area where it would conduct the clinical trial.

Pending preliminary preparations, the subjects for the trial can then be recruited, after which the trial proper can begin.

Asked if there will be any form of quid pro quo that will allow Filipinos free or early access to Janssen’s potential vaccine should it prove effective, Domingo said no.

“We don’t ask for those requirements. The good thing about this is we are contributing to the world knowledge for a potential useful vaccine,” he said.

Should the Janssen candidate vaccine prove effective, Domingo said a sufficient bonus would be that “a few thousand” Filipinos would have gotten it early.

“It will also be easier to decide on the regulatory aspect [since we are able to observe their trial,]” he added.

Domingo said only Pfizer had so far applied for emergency use authorization (EUA) for its vaccine in the country. He said the FDA was expecting more vaccine developers to submit EUA applications by January 2021.