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?
Actively personalized vaccination trial for newly diagnosed glioblastoma
Experts have proposed a plan to accelerate the rollout of a potential COVID-19 vaccine in India by combining multiple phases of the vaccine development process. The proposal has been published as a commentary in the latest issue of the Indian Journal of Medical Research, the peer-reviewed in-house journal of the Indian Council of Medical Research. … [Read more...] about Coronavirus | Experts moot combining vaccine trial phases to speed up rollout in India
Adequate review“On Sunday [06/09/2020] our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee,and the national regulators. All routine follow-up appointments continued as normal during this period. The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA (Medical and Healthcare Products Regulator Agency), the trials will recommence in the UK,” the Oxford vaccine group said in a statement. … [Read more...] about Coronavirus | Oxford vaccine trials to resume in U.K.
Oxford University — one of the leading Covid-19 vaccine developers in the global race — resumed its trial for testing the drug it is developing with pharmaceutical company AstraZeneca on Saturday. The resumption in proving the drug’s efficacy comes two days after it had to stop the trial after a UK volunteer reportedly fell ill. … [Read more...] about Oxford, AstraZeneca to resume coronavirus vaccine trial: Why it matters
The companies, including AstraZeneca, Pfizer Inc and GlaxoSmithKline, issued what they called a “historic pledge” after a rise in concern that safety standards might slip in the face of political pressure to rush out a vaccine. … [Read more...] about Coronavirus | Oxford vaccine trial put on hold over safety concern