Pune-based vaccine manufacturer Serum Institute of India on Thursday stopped on Thursday’s ongoing clinical trials of the Covid-19 vaccine in the country. “We are reviewing the scenario and postponing trials in India until AstraZeneca restarted rehearsals,” said a post through the Added Company that the company was following the orders of the Indian Drug Attorney General (DCGI) and would not be able to comment further on the trials.
The company did not comment on the effect of this resolution on its vaccine production projects in India. Serum has partnered with AstraZeneca to conduct trials and manufacture Covid-19 vaccine doses from The University of Oxford in India at its Pune plant.
The resolution to suspend trials conducted after the company closes through Dr VG Somani, Comptroller-General for Medicines of India, for not informing AstraZeneca of postponing clinical trials of the Oxford Covid-19 vaccine in other countries and not presenting victim data. investigation of the reported serious adverse event.
DcGI asked Serum why the August 2 authorization for phase 2 and 3 clinical trials of the candidate vaccine does not deserve to be suspended. A serum team was in Delhi to meet with officials and then announced that they were finishing rehearsals.
Serum in the recruitment procedure of 1,600 participants for the trial in India and had begun administering the injections at 17 control sites across the country. He had started producing Covid-19 vaccines at his plant in Pune and planned to manufacture 60 to 70 million doses consistent with the month.
AstraZeneca has voluntarily suspended vaccination to review protection knowledge through an independent committee. They called it regime action and hope to resume it after the review.
AstraZeneca and Oxford introduced phase 3 trials for the Covid-19 vaccine in August with trials in the United States, the United Kingdom, Brazil, South Africa and India and covered 30,000 participants at one hundred sites to assess the safety, efficacy and immunogenicity of the vaccine. Vaccine.
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