What happens in Phase-4?A drug or vaccine candidate that clears Phase-3 is usually approved and licensed and the entire infrastructure of the company is devoted to ramping up production and working out the logistics of storing the drug or vaccine safely without it degrading or losing potency. Once the product goes out into the field, there is post-marketing surveillance, or a Phase-4, where all instances of the product’s failure and adverse events are recorded. Companies are expected to furnish periodic data to the drug regulator. … [Read more...] about The Hindu Explains | Why is Phase-3 of COVID-19 vaccine trial complicated?
Hiv vaccine trials network
“This phase will telescope the conventional Phases 3 and 4, with clustered randomisation of control populations built into the rollout design, instead of having a separate control arm. From those receiving the emergency use authorized vaccine, defined end point measures of neutralizing antibody titres will be monitored among selected individuals, as also among those in the cluster control groups to continuously provide efficacy data,” say the authors Amit Dinda, of the All India Institute of Medical Sciences (AIIMS), Delhi; Santanu Tripathi, of the Calcutta School of Tropical Medicine, West Bengal and Bobby John, of Aequitas Consulting Pvt Ltd. … [Read more...] about Coronavirus | Experts moot combining vaccine trial phases to speed up rollout in India
The vaccine candidate developed by researchers at the University and in partnership with the UK biopharma company, AstraZeneca was paused earlier this week after reports emerged of a “serious adverse event” in a volunteer in the United Kingdom who was part of the trial. The trial is being conducted in the United States, Brazil, South Africa. The Serum Institute of India, which has partnered with AstraZeneca, had begun a trial in India that was also paused. … [Read more...] about Coronavirus | Oxford vaccine trials to resume in U.K.
“To tackle the global Covid-19 pandemic, we need to develop vaccines and therapies that people feel comfortable using, therefore it is vital to maintain public trust that we stick to the evidence and do not draw conclusions before information is available,” Summers was quoted as saying by news agency Associated Press. … [Read more...] about Oxford, AstraZeneca to resume coronavirus vaccine trial: Why it matters
The World Health Organization’s (WHO) chief scientist on Thursday said AstraZeneca’s pause of an experimental vaccine for the coronavirus after the illness of a participant is a “wake-up call”. “This is a wake-up call to recognise that there are ups and downs in clinical development and that we have to be prepared,” Soumya Swaminathan said. … [Read more...] about Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod