[ad_1]
UK pharmaceutical firm AstraZeneca has abandoned its offer to conduct clinical trials in the Philippines for its 2019 coronavirus disease (Covid-19) candidate vaccine because they have collected enough data, the Food and Drug Administration (FDA) announced on Friday, 11 April. December 2020.
AstraZeneca had received clearance from the Single Joint Research Ethics Board (SJREB) and was awaiting technical clearance from the Vaccine Expert Panel (VEP) before undergoing FDA evaluation.
“Yes (they will not continue with clinical trials). They said they already have enough data,” FDA Director General Eric Domingo said in an interview on Friday, December 11, 2020.
However, AstraZeneca will continue to supply vaccines to the Philippines. The company previously signed a tripartite agreement with the Philippine government and the private sector for the supply of 2.6 million doses of its vaccine in 2021.
“They (AstraZeneca) can still apply for the emergency use authorization (USA),” Domingo said. The FDA is authorized to issue an EUA to allow the use of a Covid-19 vaccine even while studies on its efficacy are still being conducted.
This leaves only four companies wanting to conduct independent clinical trials in the Philippines for their candidate Covid-19 vaccines.
Of the four, Clover Biopharmaceuticals of China and Janssen Pharmaceutica of Belgium are leading the race, both approved by VEP and SJREB.
Both will now be evaluated by the FDA, Department of Health (DOH) Secretary Francisco Duque III said at a news conference on Friday.
Sinovac Biotech Ltd. of China was approved only by the VEP and was still awaiting approval from the ethics board. Russia’s Gamaleya Research Institute, which has also submitted an application, has yet to obtain approval from either the VEP or the ethics board.
Applicants for clinical trials must obtain approval from both the VEP and the ethics board with the FDA.
These clinical trials are independent of the solidarity trials of the World Health Organization (WHO), which will begin in January 2021.
“Hopefully the solidarity trials will start in the second week of January. So that’s three to four weeks from now,” Duque said.
“We hope that in the solidarity trial there will be as many vaccines as we can have. The more, the better we will have options to choose from,” Duque said.
DOH officials are scheduled to meet their WHO counterparts on Saturday via Zoom. (HDT / SunStar Philippines)
[ad_2]
