Serum to submit data on two full doses of Covid-19 vaccine within deadline

Serum Institute of India (SII) will submit data from the two full doses’ clinical trials in the country to the Indian regulator within the planned timeline.
 

Sources said the UK partner, AstraZeneca, would also submit the current data set to the regulator as planned, and provide additional test results, if sought. If the Indian regulator seeks additional data on a wider population for the primer-booster dose regimen, then it can delay timelines.
 

SII is on track with the 1,600 subject clinical trials in India with two full doses and there have been no manufacturing errors or other issues with the trial process. People in the know have indicated that the interim data shows the lowest efficacy of 60-70 per cent, which meets the minimum efficacy criterion set by India at 50 per cent.
 

Meanwhile, data from the UK trials is on around 8,895 people for the two full doses' regimen and around 2,741 for the primer-booster dose regimen. The primer-booster dose regimen had shown an efficacy of 90 per cent while the other one has shown an efficacy of 62 per cent.
 

A person in the know said, “The data meets the efficacy criterion of the Indian regulator and will be submitted. If the regulator seeks further data on the primer-booster regimen, then it would be submitted after the tests.” AstraZeneca chief executive officer (CEO) Pascal Soriot had said that the firm will conduct an additional global clinical trial to assess the efficacy of its Covid-19 vaccine instead of adding an arm to an ongoing US trial. This controversy was sparked after AstraZeneca admitted to a manufacturing error that led to the different dosing. US researchers had pointed out that the higher efficacy was reported in a younger population, thus casting a doubt on whether the primer-booster regimen will have the same impact on a larger demography.
 

AstraZeneca has said that it does not expect the additional trial to hold up regulatory approvals in the UK and EU. On Thursday, an SII spokesperson had said, “The vaccine is safe and effective. Even the lowest efficacy results are at 60-70  per cent, making it a viable vaccine against the virus. That said, varied age groups with different dosage forms will result in slight variations and efficacy. We must be patient and not panic.”