Pioneer clinical research

Europe’s medicines regulator said on Thursday it had started a rolling review of Russia’s Sputnik V COVID-19 vaccine, an important display of confidence in the shot that paves the way for its potential approval across the 27-nation bloc. Hungary became the first EU country to grant the Russian vaccine emergency national approval in January, Slovakia has ordered shipments, and Czech Prime Minister Andrej Babis has said his country could move to use Sputnik V. The European Medicines Agency (EMA) said in a statement it would review data from ongoing trials of the vaccine until there was enough evidence for a formal marketing authorisation application. EMA’s ‘rolling reviews’ are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is ready. “While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said. Kirill Dmitriev, CEO of the RDIF sovereign wealth fund that is promoting Sputnik V internationally, hailed the start of EMA’s rolling review as an important moment for Russia which he said showed its application had been a strong one. “Sputnik V can act as a bridge between Russia and Europe, but its roll out should not get bogged down in politics,” Dmitriev told Reuters, praising Germany, France, Italy and Austria for what he called their pragmatic approach to Sputnik V. The shot’s efficacy was initially greeted with scepticism by some Western scientists after Russia approved it in August last year without waiting for the results of full clinical trials. However, scientists said it was almost 92% effective in fighting COVID-19, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month. The two-shot vaccine uses two different weakened common cold viruses to deliver immune-building protein to the human body. Dmitriev said …

[Read more...] about Europe starts formal review of Russia’s Sputnik V COVID-19 vaccine

The pair were presented with the Shining Star Achievement in the Research category during an online awards ceremony held at 7 a.m. on December 9. The Shining Star Achievement in Research award is given in recognition of influential scholarly contributions in any discipline, typically in the form of scholarly journal articles that are published, or alternatively books, book chapters, or other expressions of scholarly collaboration. Prof. Tran Xuan Bach was born in 1984 and is currently vice head of the Health Economics Department at Hanoi Medical University. He possesses extensive experience in relation to research, surveillance, and evaluation of global health threats in the Asia-Pacific region. His work has won him numerous international and domestic awards in the past, including the Hopkins Center for AIDS Research's International Research Award. He has also published over 300 papers in a number of highly regarded international journals, including The Lancet, Bulletin of the World Health Organization, and AIDS and Behavior. Most notably, Prof. Bach is the youngest professor in recent decades to work at Johns Hopkins University in the United States, the world leader in terms of public health. According to details released by the university, he has extensive experience in advising various U.N. agencies, international organisations, and governments on issues such as global health and development in Southeast Asia. Meanwhile, born in 1975 Prof. Tran Thi Ly was previously employed as a lecturer at Hue University, although she is currently working at the Faculty of Arts and Education at Deakin University in Australia. First arriving in Australia in 2001, Prof. Ly has gone on to produce extensive research on the international education sector, including writing the first English-language book on Vietnamese higher education. She has won more than 30 awards, prizes, scholarships, and grants for research, including the prestigious Australian Research Council …

[Read more...] about Two local scientists win Noam Chomsky Global Connections Awards

The Institute of Vaccines and Medical Biologicals (IVAC) on Friday started recruiting volunteers for the initial phase of clinical trials for the second Made-in-Vietnam Covid-19 vaccine known as Covivac. Illustrative photo by VNA According to IVAC, they will select 150 volunteers aged between 18 and 59 for the first phase of human trials, in which they will be injected with two 0.5 ml doses of the vaccine 28 days apart. Volunteers will remain at the clinical trial area for a period of 24 hours after receiving their shots in order to allow them to be under strict health observations by the research team. The aim of the first phase is to evaluate the safety of the doses, along with the patient’s immune response to the vaccine, thereby identifying the optimal level of the doses so trials can move on to the second phase. Through pre-clinical assessments carried out in India, the United States, and Vietnam, the locally-produced Covivac vaccine has recorded a strong immunological effect on laboratory animals and has so far proved to be safe. IVAC's director, Duong Huu Thai said the research project on the vaccine has been running since May, 2020, with the co-operation of scientists from universities, research institutes, and international organisations, adding that it has been produced from embryonic egg production technology, which is safe for animals. Thai emphasised that the Covivac vaccine was also proved to be effective against the new SARS-CoV strain detected in both the UK and South Africa. The vaccine is expected to be launched later this year after passing through three phases of human trials. Moving forward, the IVAC plans to offer the Covivac vaccine at a price of VND60,000 per dose. Furthermore, as the first domestically-produced Covid-19 vaccine, Nanocovax, which has been developed by Nanogen Pharmaceutical Biotechnology JSC, has now moved onto its second phase of human trials. …

[Read more...] about Vietnam recruits volunteers for human trials of second Covid-19 vaccine