On Wednesday, the central drug regulator shut down the company because it did not inform it that pharmaceutical giant AstraZeneca had suspended clinical trials of Oxford COVID-19 vaccine applicants in countries.
On 8 September, trials of one of Oxford-AstraZeneca’s COVID-19 vaccines were suspended in the UK after a player developed an unexplained disease.
In his justification, Dr. VG Somani, Comptroller-General for Medicines of India, asked the SII why the authorization granted for phase 2 and 3 clinical trials of the candidate vaccine in the country would not be suspended. until patient protection is established.
“While the Serum Institute of India Pvt Ltd, Pune, has so far not informed the Central Licensing Authority of the suspension of the AstraZeneca clinical trial in other countries, nor has it submitted an investigation of those affected by the severe adverse occasion reported with the experimental vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in consultation in the country amid the protection problems “Array noted realization of justification.
In conducting the justification, the drug regulator also discussed that clinical trials have been suspended in the countries where they are being conducted, namely the United States, United Kingdom, Brazil and South Africa.
The director of the U. S. National Institutes of Health is a member of the U. S. National Institutes of Health. Francis Collins told a Senate committee Wednesday that the COIVD-19 vaccine trial largely monitored through AstraZeneca Plc had stopped due to a “spinal problem. “
“This is based on a serious single adverse occasion that may have nothing to do with the vaccine, however, it is the most productive prudent technique to temporarily provoke and look and see if there is any other evidence to fear,” Collins told the Senate committee on Wednesday.
The Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed through Oxford University for India and low- and middle-income countries. Phase II clinical trial of the COVID-19 vaccine involving at least 1,600 applicants between the age of 18 and 55.
AstraZeneca Plc executive leader Pascal Soriot said the coronavirus vaccine the company is developing with Oxford University could still be in a position before the end of the year. Deaths worldwide due to the COVID-19 pandemic exceeded 900,000.
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