Pune-based Serum Institute (SII), which is conducting Oxford University and AstraZeneca's coronavirus vaccine trials in India, will submit data from the two full doses of clinical trials in the country to the Drugs Controller General of India (DCGI) within the planned deadline. The British-Swedish drug maker AstraZeneca would also submit the current data set to the Indian regulator within the stipulated time, and also provide additional study results, if sought, reported Business Standard.
On November 23, the world heard how AstraZeneca and Oxford University's COVID-19 vaccine was highly effective in advanced trials. However, questions were raised about the clinical trials, when AstraZeneca revealed three different data on the vaccine's efficacy--an overall efficacy of 70 per cent, a lower one of 62 per cent and a high of 90 per cent.
A press note released by Oxford University on Monday, November 23, revealed that the COVID-19 vaccine has shown 70 per cent efficacy. It further added that the inoculation could be around 90 per cent effective under "one dosing regimen" when administered as a half dose followed by a full dose a month later.
However, in India, the Serum Institute administered its Covidshield vaccine to around 1,600 participants as two full doses 28 days apart. The SII data has met the efficacy criteria of the Indian drug regulator and will be submitted soon, the daily added.
The SII sought permission to test only the full-dose regimen in India therefore it can only ask for emergency use of authorisation for the full dose regimen only. SII might have to conduct additional tests if they ask for marketing permission for half dose, which has 90 per cent efficacy.
Meanwhile, reports have surfaced that AstraZeneca Plc could run an extra global trial as the drugmaker tries to straighten out dubiety and confusion around favourable results in its current study. The company is hoping for the new test to substantiate the 90 per cent efficacy rate the inoculation demonstrated in a portion of an ongoing trial.