What happened in the case of AstraZeneca?For the vaccine candidate, called AZD1222 for now, the company had begun recruiting 30,000 volunteers for Phase-3 trials in the United States. The Pune-based Serum Institute of India, which had been contracted to manufacture a hundred million doses for 92 countries including India, had also started to test the vaccine on a proposed group of 1,600 volunteers in India. However, it emerged that a recipient of the vaccine in the United Kingdom contracted transverse myelitis, an inflammation of the spinal cord, and this led AstraZeneca to pause its trials. Suspension of vaccine trials is not out of the ordinary but Serum Institute initially said it would not halt the India trial because no adverse reactions had been reported here. However, after a show-cause notice from the regulator, the Drugs Controller- General of India, the company said it would halt recruitment of volunteers until AstraZeneca finishes evaluation of the safety data. … [Read more...] about The Hindu Explains | Why is Phase-3 of COVID-19 vaccine trial complicated?
Ebola vaccine trial underway
In such trials, a group of volunteers get the vaccine and another a placebo and neither researcher nor doctor, in the ideal trial, know who got what. Vaccines that prove their mettle are licensed and allowed to be manufactured and distributed and once widely available, are surveilled by marketing companies for evidence of adverse events or whether it protected against the infection. … [Read more...] about Coronavirus | Experts moot combining vaccine trial phases to speed up rollout in India
Meanwhile, Prime Minister Narendra Modi on Saturday cautioned people against lowering their guard till an effective anti-coronavirus medicine is developed. With a slogan to to drive home his point, Mr Modi said, “Jab tak dawai nahi, tab tak dhilai nahi’ (No carelessness till a medicine is found).” … [Read more...] about Coronavirus | Oxford vaccine trials to resume in U.K.
The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world. It is also one of the nine candidates around the world currently in late-stage Phase 3 human trials. … [Read more...] about Oxford, AstraZeneca to resume coronavirus vaccine trial: Why it matters
DGCI has earlier sent a show-cause notice to the Pune-based firm, questioning why it has not stopped trials while trials have been stopped in four other countries after a UK volunteer reportedly showed symptoms of neurological disorder which affects the spinal cord. Following this, Serum Institute of India paused the phase 3 trial in India, which was scheduled to begin next week. … [Read more...] about Serum Institute to resume Covid-19 vaccine trial after DGCI gives nod