MANILA, Philippines — The Food and Drug Administration (FDA) yesterday approved the application of Chinese firm Clover Biopharmaceuticals to conduct clinical trials in the Philippines for its COVID-19 vaccine.
This made Clover the second vaccine manufacturer allowed to do the trial in the Philippines, following Belgium’s Janssen, which is owned by US multinational Johnson & Johnson.
It also leaves Sinovac, another Chinese company, as the only manufacturer with pending application with the FDA.
In a statement, FDA director general Eric Domingo said they are currently awaiting response for clarification for the proposed study on the Sinovac Life science vaccine before issuing a decision on the application.
Domingo said the FDA continues to accept applications for COVID-19 vaccine trials in the Philippines.
This came as Russia’s Gamaleya Institute withdrew its application to do clinical trial for its COVID-19 vaccine Sputnik V
in the Philippines, expressing instead its interest to apply for emergency use authorization (EUA) to be able to supply the country with its vaccine.
“Gamaleya has withdrawn its application on Jan. 6… They expressed their intention to apply for EUA through a letter of intent to the FDA dated Jan. 6,” said FDA Undersecretary Rowena Guevarra during a press briefing of the Department of Health.
Domingo said Gamaleya’s submission for EUA “was pre-assessed and the applicant was instructed to comply with the lacking documents.”
In Dec. 10 last year, Belgium’s AstraZeneca had also pulled out its application for clinical trial and submitted, instead, an application for EUA on Jan. 6.
Aside from AstraZeneca, the United States’ Pfizer is also seeking an application for emergency use of COVID-19 in the Philippines.
According to Guevarra, the Task Force on Vaccine Selection and Evaluation is working with 25 “bilateral partners” that are willing to conduct clinical trials in the country. These partners are comprised of foreign “biotechnology pharmaceutical companies” in 10 countries that are also interested to do local manufacturing and distribution of vaccines in the Philippines. – Rainier Allan Ronda