FDA, Janssen’s COVID-19 clinical trial approved; starting in January

MANILA – It is possible that in the coming weeks, the clinical trial or study of Johnson & Johnson Janssen Pharmaceutical Company will begin with their COVID-19 vaccine here in the Philippines.

The Food and Drug Administration (FDA) has approved the company’s application to study the population of the country to see if their vaccine is effective and safe.

“Yesterday, we’ve already approved on. This is the clinical trial of Janssen, this has been given the go signal by FDA, ”said Usec. Eric Domingo, director general of the agency.

“Maybe they will start their clinical trial after new year.”

The vaccine expert panel of the Department of Science and Technology (DOST-VEP) said that the ball is now in place to coordinate the selection of trial sites. The recruitment of participants is also a twin of preparation.

Aside from Janssen, Chinese companies Sinovac Biotech and Clover Biopharmaceutical also hope to have their vaccine trial in the country.

But for now, their application to the FDA is still pending.

“Yung Clover may hinihintay na lang tayo mga konting documentation from the proponent para makumpleto yung requirements. Yung Sinovac nag-request sila ng kaunting change sa kanilang research design, so we have to give it back sa reviewers natin para sa final clearance.”

“Once na matapos yon at ma-complete yung requirements, then they will also be given the approval.”

Domingo clarified that there is no replacement vaccine supply for them to grant approval to companies that submit applications for clinical trials.

He said the only most important requirement that they ask the manufacturers is the promise that the participants will be safe.

“The good thing about is we will be contributing to the world knowledge on the development of a potential useful vaccine, and also if this turns out to be a good vaccine, then at least we know that in a few thousand Filipinos it has been tested and we’ve seen the effect and adverse effects. ”

“That will make it easier for us to make decisions when it comes to authorization and maybe the actual use.”