A total of 10 medical institutes have been selected for the pan-India vaccine trial.
In fact, the vaccine-maker received a show-cause notice from the DCGI for not informing it immediately and halting the trial on the same day.
In its statement, AZ said it would update all trial investigators and participants with relevant information, which would be disclosed on global clinical registries, according to the clinical trial and regulatory standards.
According to instructions issued by DCGI following SII's response on September 10, the Pune firm will only be able to resume vaccination in the Indian trials of this vaccine candidate once it submits safety clearances from DSMB in India as well as the United Kingdom board that reviewed the global safety issue.
Out of these, nine vaccines are now in large-scale efficacy trials and one of these is likely to be the first vaccine.
Russian Federation was criticized in the West for allegedly rushing the development of Sputnik V, and for rolling out the vaccine before concluding a third stage of clinical trials.
"There are majorly three phases of a vaccine or drug trial". The vaccine, co-developed with National Institute of Allergy and Infectious Diseases, underwent trials at 89 sites across the US.
Twenty-nine vaccines in small-scale safety trials (Phase 1).
"This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials".
In this instance, a rapid review by the MHRA led to a recommendation the trials be restarted.
Another closely watched vaccine candidate is from the joint stable of German drug developer BioNTech, US-based pharma major Pfizer and Chinese Fosun Pharma. Their mRNA-based vaccine candidate "BNT162" is in late-stage trials in US, Brazil, Argentina and Germany. The regulator also asked the company to suspend new recruitment of subjects in phase 2 and 3 clinical trials till further orders.
CEO Kirill Dmitriev on Saturday said that temporary suspension of AstraZeneca COVID-19 vaccine candidate trials clearly showed the "fallacy of the approach" when countries "exclusively rely on novel and untested platforms" while choosing a vaccine for widespread use.
The Russian group of companies R-Pharm has agreed with AstraZeneca on the production of a vaccine against COVID-19, Alexey Repik, chairman of the board of directors of R-Pharm, said on the air of the state channel Russia-24 in July. "They have to be followed up for a certain length of time, a minimum of six months to be able to assess both on the protective efficacy and safety", she said, indicating that more details on the other Covid-19 vaccines in advanced trials would possibly be available by later this year or early next. However, these trials are unlikely to tell us anything about the localised response in the nose, throat and airways - where the virus primarily attacks and invades cells.