FDA: PHL clinical trials for 3 COVID-19 vaccines – Janssen, Clover, Sinovac – ready to begin

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Food and Drug Administration director Eric Domingo explaining the approved clinical trials for COVID-19 vaccines which are about to begin in the country. (Screenshot of Laging Handa press briefing on Jan. 28, 2021/ Courtesy PCOO/RTVM)

(Eagle News) — The Food and Drug Administration (FDA) said that three clinical trials for COVID-19 vaccines which it had earlier approved are about to begin in the country.

These are the Phase 3 clinical trials for the vaccines developed by Janssen Pharmaceuticals of Johnson and Johnson, Clover Biopharmaceuticals, and Sinovac.

So wala na po tayong pending ngayon na mga applications for clinical trials with FDA, and all these three clinical trials have been given the go signal by FDA. Karamihan sa kanila ay nasa preparatory stage na po ngayon at mag-uumpisa na,” FDA director general Eric Domingo said in a Laging Handa press briefing on Jan. 28.

Domingo said that the first to be given approval for clinical trials in the country was Janssen Pharmaceuticals, followed by Clover, and finally Sinovac.

The FDA approved the application for clinical trial of Janssen vaccines on Dec. 28 last year.  Janssen applied for clinical trial in the Philippines for its vaccine on Dec. 13.

(FILES) In this file photo the Johnson & Johnson logo is seen above an entrance to a building at their campus in Irvine, California on August 28, 2019. – The US government on August 5, 2020 announced a new $ 1 billion investment in a COVID-19 vaccine being developed by Johnson & Johnson, guaranteeing 100 million doses. J&J, via its subsidiary Janssen, had already received $ 456 million in March. The new money will allow the company to ramp up production so that doses are ready for shipping if and when the drug receives regulatory approval. (Photo by Mark RALSTON / AFP)

On Jan. 8 this year, the FDA approved the clinical trial application of Clover Biopharmaceuticals which had earlier partnered with the Coalition for Epidemic Preparedness Innovations (CEPI), GSK, and Dynavax for the advancement of its COVID-19 vaccine program.  Domingo said that Clover Biopharmaceuticals had applied for a clinical trial on Nov. 25, 2020.  The Clover vaccine clinical trial is a joint Chinese-Australian initiative, he said.

The third vaccine developer to be given approval is the Chinese biopharmaceutical firm, Sinovac. The FDA approved its application on Jan. 15, 2021.  The firm applied on Oct. 10 last year.

A medical worker opens a box of doses of the Chinese Sinovac vaccine at Kartal Lutfi Kirdar Sehir Hospital in Istanbul, on January 14, 2021. – Turkey on January 13 approved the emergency use of a coronavirus jab developed by China’s Sinovac, paving the way for a national vaccination drive that will start with healthcare workers. (Photo by Ozan KOSE / AFP)

Domingo said that these three clinical trials “can start anytime” after getting the FDA approval.

Kaya lang it usually takes a few weeks for preparation ng site and of course before they start recruiting volunteers for the clinical trials,” he said.

“But I believe they will be starting very soon kasi alam ko nagre-ready na rin talaga sila sa mga hospitals,” he added.

The FDA chief said that applications for clinical trial for vaccines pass through a rigorous process before they are given the green light by the FDA.  These would first have to pass through the Philippine Vaccine Expert Panel, and the Ethics Board, before finally going to the FDA.

Presently, Domingo said that the FDA is just waiting for the application of the Department of Science and Technology (DOST) and the Department of Health (DOH) for the World Health Organization (WHO) Solidarity Vaccine Trial.

The FDA said that there are 64 vaccines against COVID-19 which are currently undergoing clinical trials worldwide.

(Eagle News Service)

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