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Serum Institute of India has clarified that trials in India on the AstraZeneca-Oxford University’s Covid-19 vaccine candidate were running “smoothly” and in “strict adherence” to protocols.
“So far, there are no concerns. However, we are going through the data that is available and will make further statement, if needed," a note from Serum Institute said, in response to concerns being raised of AZ and the Oxford University global trials, after they divulged that an “error” had resulted in a shortened dose of the vaccine being used in the trial. Serum has a production and distribution alliance on the AZ-Oxford vaccine candidate.
Also read : Serendipity and science aside, AZ-Oxford Covid-19 vaccine analysis raises many questions
Though the outcome of the shortened dosing pattern (a half dose, followed by a second, full dose) showed greater efficacy in an interim analysis that was shared globally earlier this week, several scientific voices have called for greater transparency and answers on whether this would result in revised protocols. The analysis through was restricted to the United Kingdom and Brazil arms of the trial.
“The AstraZeneca-Oxford 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,” Serum Institute said.
According to a representative with the Indian drug regulatory authority, Serum was continuing with the two-dose vaccine and hence nothing changes here yet. If there is a change in trial protocol in the UK and that translates to India, then it would come up for review, the source said.
Meanwhile, AstraZeneca has reportedly indicated that an additional global trail could be undertaken, following the improved outcome seen on the shortened dosing pattern. “The company wants the new test to confirm the 90% efficacy rate that the shot showed in a portion of an existing trial, Chief Executive Officer Pascal Soriot said, in a report.
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