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FDA team off to Russia to inspect vaccine plant

FDA team off to Russia to inspect vaccine plant Mayen Jaymalin © DOH Facebook Photo FDA team off to Russia to inspect vaccine plant MANILA, Philippines A team from the Food and Drug Administration (FDA) is flying to Russia to look into the vaccine manufacturing plant of Gamaleya Research Institute’s Sputnik V vaccine against COVID-19. “Two or three inspectors are scheduled to go to Russia next week to inspect the manufacturing site for conformance to good manufacturing practice (GMP) standards,” FDA director general Eric Domingo said yesterday. Domingo said checking the manufacturing plant is necessary in determining whether or not the FDA will approve Gamelaya’s application for emergency use authority (EUA) for its vaccine, which the Philippine government considers purchasing.

Please, participate in vaccine clinical trials , Task Group on Vaccine Evaluation and Selection appeals to public

(PIXABAY / MANILA BULLETIN) Department of Science and Technology Undersecretary Rowena Cristina Guevara, who chairs the task group, made the appeal during the televised “Laging Handa” briefing on Saturday. “Amin pong ine-encourage ang ating mga kababayan, pag ang barangay nyo po napili sa isang mga site ng mga clinical trial, sana po ay sumali po tayo dito sa ating clinical trials kasi kailangan nating makahanap ng mga bakuna at epektibo, safe at efficacious po (We are encouraging our countrymen, that when your barangay is selected as one of the sites of the clinical trial, we hope you participate in our clinical trials because we need to find effective, safe, and efficacious vaccines),” she said.

DOST cites importance of vaccine clinical trials

Published February 17, 2021, 9:32 AM People may be wondering what is the difference between the vaccine clinical trials, which involved the Task Group on Vaccine Evaluation and Selection (TG-VES) of the Department of Science  and Technology (DOST) and the actual vaccination program that is set to be implemented by the  Duterte government within this month.  (Photo by Robyn Beck / AFP / FILE PHOTO / MANILA BULLETIN) Department of Science and Technology Secretary Fortunato T. de la Peña is gracious enough  to walk us through how clinical trials are being conducted.  “‘Yung clinical trials na involved ang DOST through the Task Group on Vaccine Evaluation and Selection ay part pa ng process bago makabuild ng sufficient basis to determine its safety and efficacy (The clinical trials involving the DOST through the Task Group on Vaccine Evaluation and Selection are still part of the process before building a sufficient basis to determine its safety and efficacy),” he told th

COVID-19 stricken areas to be prioritized in month-long clinical trials-DOST

Published February 4, 2021, 2:12 PM The areas with high incidence of coronavirus disease-2019 (COVID-19) are to be prioritized in the clinical trials of vaccines developers that have been been approved to conduct their Phase 3 clinical trials in the Philippines, according to Department of Science and Technology (DOST) Secretary Fortunato dela Peña. Department of Science and Technology Secretary Fortunato dela Peña (TOTO LOZANO/ Presidential Photo / MANILA BULLETIN FILE PHOTO) During the televised “Laging Handa” briefing, he said the clinical trials in COVID-19 risk areas will be conducted for “one month or less”. “Required na ang pagdadausan ng clinical trials at ito naman ay hindi magtatagal siguro ng isang buwan or even less, ay gagawin sa mga lugar na mataas ang incidence ng COVID-19 at kailangan ay mataas na incidence na yun ay consisitent over the last the last two weeks bago magumpisa ang clinical trials (It is required that the clinical trials, which may last f

DOST to meet with WHO to tackle Solidarity Vaccine Trials protocols

Published February 4, 2021, 1:10 PM The Department of Science and Technology (DOST) as Chair of the Task Group on Vaccine Evaluation and Selection (TG-VES) is set to meet on Friday with the World Health Organization (WHO) to discuss the upcoming conduct of the WHO Solidarity Vaccine Trials (SVT) in the country. (Photo by Owen Humphreys / POOL / AFP) DOST Secretary Fortunato dela Peña bared this during the televised “Laging Handa” briefing held on Thursday, Feb. 4. He said they are hopeful that the WHO will finally issue the final Standard Operating Procedures (SOPs) and specific protocols on the conduct of the SVT in the country

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