Vaccines clinical trials

US symposium features life, career of President Hồ Chí Minh Party, State leaders pay tribute to President Hồ Chí Minh Special stamp released to commemorate President Hồ Choosing the perfect place for Uncle Hồ’s statue Tree-planting campaigns launched to mark President Hồ Chí Minh’s birthday Volunteers for Việt Nam's second COVID-19 vaccine, COVIVAC, apply for human trial participation at Hà Nội Medical University on Friday. — VNA/VNS Photo Minh Quyết HÀ NỘI — Volunteers aged from 18-59 and living in Hà Nội, can register for human trials of Việt Nam’s second COVID-19 vaccine candidate COVIVAC from Friday morning. In the first phase,150 healthy volunteers will be injected with two 5ml doses over 28 days. They will be divided into five groups, including one group provided with placebo shots, and their health will be closely monitored within 24 hours after injections. Each volunteer will have their health checked up to eight times in 12 months. After 43 days since the first phase starts and shows good results, the second phase will be carried out at the medical centre of Thái Bình Province’s Vũ Thư District, with 300 volunteers. The homegrown vaccine has been developed by the Nha Trang-based Institute of Vaccines and Medical Biologicals (IVAC) and the Hà Nội Medical University since last May, using primary chicken embryo cell culture, a technique the institute used previously to successfully produce seasonal flu vaccines. COVIVAC has undergone pre-clinical trials in India, the US, and Việt Nam, said IVAC Director Dr. Dương Hữu Thái, adding that results showed that it satisfies all conditions to be tested on humans. The vaccine candidate demonstrated high immunogenicity during pre-clinical trials. It was created based on studies of new SARS-CoV-2 strains. This vaccine is expected to cost around VNĐ60,000 (US$2.59) per dose. Volunteers can register to participate in the trial at the Hà Nội Medical …

[Read more...] about Volunteers sought for second locally made COVID-19 vaccine trials

The second stage has been carried out by the university and the Ho Chi Minh City-based Pasteur Institute since February 26. The trials have been taking place at the university in Hanoi along with the medical centre of Ben Luc district in the southern province of Long An, featuring the participation of 560 volunteers aged between 12 and 75, including 80 individuals over the age of 60. Lieutenant General Do Quyet, director of the Military Medical University, said since the trial involves the participation of numerous volunteers suffering from underlying health conditions, competent authorities have prepared for a range of scenarios to ensure the safety of all volunteers. …

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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