The Philippines has approved the application of Janssen Pharmaceutica to conduct Phase 3 clinical trials for its COVID-19 vaccine in the country, the Food and Drug Administration (FDA) announced on Tuesday, December 29.
“Yesterday we already approved one, this is the clinical trial application of Janssen. This has been given the go-signal by FDA,” FDA Director General Enrique Domingo said in a press briefing.
With the regulatory aspect of its application done, the FDA chief said Janssen’s trials could begin in the “next few weeks” after the Department of Science and Technology assigns areas to be included and recruits volunteers.
The Janssen Pharmaceutica trials mark the first late stage trials for a COVID-19 vaccine in the Philippines. The company is one of 3 firms that applied for trials in the country, with China’s Sinovac and Clover Biopharmaceuticals still undergoing regulatory review.
Domingo welcomed the start of Janssen’s trials, saying these would allow the Philippines to contribute to worldwide knowledge on the development of a COVID-19 vaccine. The trials will also help scientists and medical experts confirm the effects of the vaccine on Filipinos.
Janssen, the pharmaceutical firm of Johnson & Johnson, is developing a vaccine using a “non-replicating viral vector” called Adenovirus 26, which has been genetically engineered so it can still invade cells but can’t replicate and cause disease. The company used the same method to develop vaccines for Ebola and other diseases.
Unlike most other candidates, Janssen’s vaccine utilizes a single dose. Despite this, the company said it would use some Phase 3 trials to study the effects of two doses given 56 days apart.
Its vaccine can also be stored in standard refrigerated facilities, making the prospect of distributing and administering vaccines easier for lower income countries like the Philippines. – Rappler.com