Duque denies receiving letter from Sinopharm regarding request for clinical trials By LLANESCA T. PANTI, GMA News Published January 1, 2021 1:54pm Health Secretary Francisco Duque III on Friday denied that he did not act on a request of Chinese firm Sinopharm to conduct clinical trials for its COVID-19 vaccine in the Philippines. Interviewed on Super Radyo dzBB, Duque said he is not aware of any letter supposedly sent by Sinopharm in May 2020 requesting authorization to conduct clinical trials. “Wala akong alam [na sulat na nakarating sa akin]. Ang alam ko lang na nag-apply for Phase 3 clinical trials iyong Janssen, sa Johnson and Johnson ‘yun,” Duque said.
SunStar Janssen Pharmaceuticals will conduct clinical trials in the Philippines for its Covid-19 vaccine candidate. (jnj.com) + December 29, 2020 THE Food and Drug Administration (FDA) has approved the application of Janssen Pharmaceuticals Inc., making it the first company to conduct clinical trials for a coronavirus disease 2019 (Covid-19) vaccine candidate in the Philippines. In a virtual press briefing on Tuesday, December 29, 2020, FDA Director General Enrique Domingo announced that Janssen’s application was approved Monday, December 28. He said he expected Janssen to begin the clinical trials right after the New Year holiday. Domingo said the Vaccine Experts Panel (VEP) will identify the venue of the clinical trials as part of the protocol.
SunStar Editorial Cartoon by Enrico Santisas + December 29, 2020 EARLIER this month, President Rodrigo Duterte issued Executive Order 121, granting the Food and Drug Administration (FDA) the power to grant Emergency Use Authorization (EUA) for Covid-19 drugs and vaccines. The EUA cuts the validation process from six months to four weeks. In its application, a vaccine company needs to present data analysis on a minimum of half of the vaccine test recipients in its third phase of clinical trials, with at least two months of safety evaluation. In a virtual press briefing on Dec. 29, 2020, FDA Director General Enrique Domingo revealed that as of this time, the agency is yet assessing the applications of Sinovac Biotech Ltd. and Clover Pharmaceuticals, Chinese drug manufacturers both.
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Duque on COVID-19 vaccines: 'There are no favorites here' inquirer.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from inquirer.net Daily Mail and Mail on Sunday newspapers.
By LLANESCA T. PANTI, GMA News Published December 14, 2020 11:18am Updated December 14, 2020 11:35am A Sinovac Biotech LTD vaccine candidate for COVID-19 coronavirus was placed on display at the China International Fair for Trade in Services (CIFTIS) in Beijing on September 6, 2020. The Department of Health said on Monday, Dec. 14, 2020 that the Sinovac COVID-19 vaccine is being evaluated by the Food and Drug Administration. Noel Celis/AFP Chinese firm Sinovac’s COVID-19 vaccine is being evaluated by the Food and Drug Administration even if it has yet to be approved by the Ethics Review Board, the Department of Health (DOH) said Monday. Health Undersecretary Maria Rosario Vergeire noted that this evaluation was above board and preliminary, considering that Sinovac has already secured the approval of the Vaccine Experts Panel (VEP) under the Department of Science and Technology (DOST).
Janssen gets nod of experts' panel, moves closer to COVID vaccine clinical trials inquirer.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from inquirer.net Daily Mail and Mail on Sunday newspapers.
By LLANESCA T. PANTI, GMA News Published December 11, 2020 5:07pm At least two COVID-19 vaccines are being evaluated by the Food and Drug (FDA) administration for emergency use authorization, the Department of Health said Friday. Health Undersecretary Rosario Vergeire announced that Janssen the COVID-19 vaccine developed by Johnson and Johnson has already secured approval from the Vaccine Experts panel and the Ethics Review Board alongside that of Clover, a Chinese firm. “Janssen has recently secured positive recommendation from the Vaccine Experts Panel (VEP) after getting one from Ethics Board. Ibig sabihin nito papasok na sila sa proseso ng FDA,” Vergeire said in an online forum.
FDA Director-General Rolando Enrique Domingo said that Astrazeneca has already withdrawn its application.. “Yes. They said they have enough data already,” Domingo said in a text message. To note, Astrazeneca has applied to hold Phase III clinical trials in the country. It already passed the evaluation of the Philippines’ Single Joint Review Ethics Board one of three stages of evaluation before a clinical trial can commence. Last month, the country signed a supply deal with Astrazeneca for at least 2.6 million doses of its candidate vaccine. Among the vaccine developers applying for a clinical trial in the Philippines, Clover Biopharmaceuticals and Sinovac Biotech from China, have already secured approval from the country’s Vaccine Experts Panel and the Single Joint Review Ethics Board.
Don't be complacent, DOH warns public as COVID risk 'still high' – Manila Bulletin mb.com.ph - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from mb.com.ph Daily Mail and Mail on Sunday newspapers.