The Serum Institute of India (SII) said on Wednesday that the drugmaker will follow instructions from the central drug regulator on suspending the Oxford-AstraZeneca COVID-19 vaccine trial in India. The Controller General of Drugs of India (DCGI) issued a notice of demonstrative cause to the Serum Institute of India on Wednesday for failing to inform it about the pharmaceutical giant AstraZeneca that has paused clinical trials of the Oxford vaccine candidate for COVID-19 in other countries.
On September 8, clinical trials of one of Oxford-AstraZeneca’s COVID-19 vaccines were suspended in the UK after a participant developed an unexplained illness.
In his show of cause notice, the Comptroller General of Drugs of India, Dr. VG Somani, asked the SII why the permission granted to conduct the phase 2 and 3 clinical trials of the candidate vaccine in the country is not suspended until patient safety is established.
“Whereas Serum Institute of India Pvt Ltd, Pune, has so far not informed the central licensing authority about the pause of the clinical trial carried out by AstraZeneca in other countries and has not provided an analysis of victims of the serious adverse event informed with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the vaccine in question in the country in light of safety concerns, “said the notice of proof of cause.
Commenting on the program’s cause notice, the Pune-based vaccine maker said: “We followed DCGI’s instructions and have not been told to stop trials so far. If DCGI has any safety concerns, we will follow their instructions and We will comply with standard protocols. “
In the notice of show of cause, the drug regulator also mentioned that clinical trials have been suspended in the countries where it is being carried out, that is, the US, the UK, Brazil and South Africa. The company was also asked why it had not submitted a loss analysis of the serious incident reported.
Last month, the DCGI had granted Pune-based IBS permission to conduct phase 2 and 3 human clinical trials of the coronavirus vaccine candidate.
Serum Institute of India partnered with AstraZeneca to manufacture the COVID-19 candidate vaccine developed by the University of Oxford, for India and low- and middle-income countries. The Pune-based vaccine manufacturer previously shortlisted 17 sites in India for the phase II clinical trial of the COVID-19 vaccine. At least 1,600 candidates between the ages of 18 and 55 will participate in the trial.
In stopping the Oxford COVID-19 vaccine trial in the UK, vaccine manufacturer AstraZeneca said in a statement that “we voluntarily stopped vaccination to allow review of safety data by an independent committee.” “This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials,” the company added.
Earlier Wednesday SII said: “We cannot comment much on the UK trials but they have been paused for further review and hope to restart soon. As far as the Indian trials are concerned, it continues and we have faced no problems in absolute “.
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