BRITISH pharmaceutical company AstraZeneca has filed an application to conduct clinical trials in the Philippines for its candidate vaccine against coronavirus disease 2019 (Covid-19).
In a virtual press briefing Friday, November 20, 2020, Food and Drug Administration (FDA) Director General Eric Domingo said the Vaccine Expert Panel of the Inter-Agency Task Force for the Management of Emerging Infectious Diseases was evaluating AstraZeneca’s application.
As of Friday, Domingo said only the application of Sinovac Biotech Ltd. of China was endorsed by the panel to FDA.
Other applications being evaluated by the panel came from Janssen Pharmaceutica of Belgium, Gamaleya Research Institute of Russia, and Clover Biopharmaceuticals of China.
Department of Health (DOH) Undersecretary Maria Rosario Vergeire said AstraZeneca expressed its intent to conduct clinical trials in a recent meeting with vaccine czar Carlito Galvez Jr.
"This is a good indication because the Philippine government would want to try out this product to Filipinos before they are used for mass vaccination," said Vergeire.
Meanwhile, Domingo said the FDA will come up with the guidelines, process and requirements for the issuance of an Emergency Use Authorization (EUA) once they are given the authority.
He said this might help the country secure Covid-19 vaccines in the first quarter of 2021.
"We will be able to take a look at the evalautions that were done by these reliable regulatory agencies and that will hasten the process of having them available here," he said.
Domingo stressed that an EUA will be issued for vaccines that are already in advanced stages of development.
"This is a risk-based procedure for assessing a vaccine that is still in development. Clinical trials are still going on, but you can assess it quickly if the risk is low and the possible benefit is very high," he said.
Earlier, Galvez estimated that Covid-19 vaccines might become available in the country in the second quarter of next year. (HDT/SunStar Philippines)