The Comptroller General of Medicines of India (DCGIon) issued a statement of justification to the Serum Institute of India on Wednesday for failing to inform it that pharmaceutical giant AstraZeneca had suspended clinical trials of the Oxford candidate vaccine for COVID-19 in other 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 asked the SII why the authorization granted to conduct phase 2 and 3 clinical trials of the candidate vaccine in the country would be suspended until patient protection was established.
“Whereas the Serum Institute of India Pvt Ltd, Pune has so far not informed the central licensing authority regarding the suspension of the clinical trial conducted through AstraZeneca in other countries and has not submitted an investigation of those who suffered the serious adverse occasion reported with the investigational vaccine for the continuation of the clinical trials of phase 2 and 3 of the vaccine in consultation in the country in the light of protection considerations “, indicates the note consulted cause, according to the press agency PTI.
Commenting on the cause-of-exposure notice, the Pune vaccine manufacturer said: “We are complying with DCGI commands and have therefore not been asked to suspend testing. If DCGI has any security issues, we will stick to your commands and comply with popular protocols. “
In the justification notice, the drug regulator also commented that clinical trials have been suspended in the countries where they are being conducted, the United States, the United Kingdom, Brazil and South Africa.
Last month, DCGI authorized the Pune-based IBS to conduct 2 and 3 human clinical trials on the coronavirus vaccine candidate.
The Serum Institute of India has partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed through the University of Oxford, for India and low- and middle-income countries. In the past, the Pune-based vaccine manufacturer decided on 17 sites in India for the Phase II clinical trial of the COVID-19 vaccine. At least 1,600 applicants between the age of 18 and 55 will participate in the trial.
With regard to the discontinuation of the Oxford COVID-19 trial in the UK, vaccine manufacturer AstraZeneca said in a statement that “we have voluntarily suspended vaccination to allow review of protection knowledge through an independent committee. “”This is a regime action that will have to happen whenever there is a potentially unexplained disease in one of the trials, while being investigated, making sure to maintain the integrity of the trials,” the corporation added.
Earlier on Wednesday, the SII said: “We comment on UK testing, but they have been suspended for additional attention and hope to restart soon. As for the Indian tests, this continues and we had no problems. “
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