No COVID-19 vaccine yet — FDA

CEBU, Philippines — No COVID-19 vaccine has been approved yet in the country or abroad amid reports that a coronavirus vaccine is being sold online.

Food and Drugs Administration (FDA) Director General Dr. Rolando Enrique Domingo made the clarification following reports of a Chinese online ad, claiming that a vaccine was being sold for P50,000 per shot at a Makati clinic.

“We would just like to remind everybody that there are still no registered COVID-19 vaccines in the Philippines. Kung meron kayong nakikitang nag-a-advertise, nagbebenta, at sinasabi na meron na, please report them directly to us at FDA,” he said in a virtual presser with the Department of Health.

Selling vaccines not approved by the FDA is illegal.

Domingo said FDA conducted an investigation into the report and inspected the facility, but found no vaccines.

He said the first vaccine developer who applied for clinical trials in the Philippines is still undergoing ethical review and is pending approval.

“Wala pang approved na clinical trials. The most advances are still going under evaluation and we hope to have a decision on that in one to two weeks para malaman kung pasado siya o hindi,” he said.

As of now, there are three sponsoring companies—China’s Sinovac sponsored by IP Biotech, Clover of Clover Biopharmaceutricals – Australia, and Janssen Vaccines of Johnson and Johnson, USA—that have submitted to FDA their clinical trial applications.

Based on FDA update, Sinovac is already done with its vaccine expert panel evaluation and is now with the ethics review and FDA evaluation, while the others are still being evaluated by the experts’ panel.

“Sinovac is already endorsed positively by the vaccine expert’s panel and is now undergoing ethics review and regulatory review by the FDA,” said Domingo.

Russia’s Sputnik V from Gamaleya Center, on the other hand, still has to give its reply to some of the expert panel’s queries.

Domingo clarified that donated vaccines still need approval from the FDA.

“Donation is not a way to get a marketing authorization of any product in the Philippines,” he said. — KQD (FREEMAN)