The Drug Controller General of India (DCGI) V G Somani will take a call after he receives data from the Data and Safety Monitoring Board (DSMB) in the UK as well as India
"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 told a virtual briefing from Geneva
Serum Institute of India (SII) on Thursday said it is pausing clinical trials of AstraZeneca Oxford COVID-19 vaccine candidate in the country. Earlier this week, AstraZeneca said it had paused the trials because of 'an unexplained illness' in a participant in the study. However, SII on Wednesday said it was continuing with the trials and had not faced any issues. SII's latest announcement also comes against the backdrop of the central drug regulator DCGI issuing a show-cause notice to SII for not informing it about AstraZeneca pausing the clinical trials of the Oxford vaccine candidate in other countries. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials," SII said in a statement. The Pune-based vaccine maker also said it is following instructions of the Drugs Controller General of India (DCGI), it added. In the show-cause notice, DCGI V G Somani had asked SII as to why the permission granted for conducting phase 2 and 3 clinical trial
Serum Institute of India has put trials of AstraZeneca's Covid-19 vaccine candidate on hold until the British drugmaker restarts the trials, Serum said
On Wednesday, Maharashtra and Delhi recorded their highest single-day spike of 23,816 and 4,039 cases, respectively
On Tuesday, AstraZeneca had decided to stop trials after a participant fell sick with an unexplained illness.
The DGCI sought an immediate reply saying else "it shall be construed that you have no explanation to offer and action deemed fit will be taken against you"
Anthony Fauci said that AstraZeneca's decision to pause global trials of its coronavirus vaccine was unfortunate but not an uncommon safety precaution in a vaccine development process
Shares of AstraZeneca Pharma, closed over 3 per cent lower on Wednesday after its Covid-19 vaccine study was paused following a participant's unexplained illness
All that happened in the markets today.
According to the health ministry, Maharashtra, Andhra Pradesh, Karnataka, Uttar Pradesh and Tamil Nadu account for 62% of total active coronavirus cases in the country
The promise to play by established rules underlines a highly politicised debate over what action is needed to rein in Covid-19 quickly and to jumpstart global business and trade
The company, which is formulating and testing the vaccine in collaboration with Oxford University, is among the front-runners for last-stage trials of potential virus vaccine
Late-stage studies of AstraZeneca's Covid-19 vaccine candidate are on temporary hold while the company investigates whether a recipient's "potentially unexplained" illness is a side effect of the shot
Higher share of patented products, scope for margin improvement and chronic portfolio are key positives
The stock of the company was trading higher for the fifth straight day, surging 26 per cent during the period.
Astrazeneca said on Friday it is beginning Phase 1/2 clinical trials in Japan of its coronavirus vaccine candidate
AstraZeneca Plc, the company's parent firm, is expected to release initial data on whether a vaccine can stop people from getting the virus on September 15
The phase 3 trial is being implemented as part of Operation Warp Speed, a multi-agency collaboration led by the US Health and Human Services
The trial is being conducted under U.S. government's Operation Warp Speed program, which aims to accelerate development, manufacturing and distribution of vaccines and treatments for Covid-19