New Delhi: Serum Institute of India (SII) said Thursday it is putting on hold clinical trials of an experimental COVID-19 vaccine. The Serum Institute has been enlisted to manufacture a billion doses of the COVID-19 vaccine on trial.
“We are reviewing the situation and pausing India trials,” SII said in a statement. It should be stated here that SII is largest manufacturer of vaccines by volume in the world.
The move came a day after SII stated that it would push ahead with the trials in India. SII had said so despite British drugmaker AstraZeneca hitting a pause button following an unexplained illness in a study participant.
The pause by SII came after the Drugs Controller General of India (DCGI) issued it a show-cause notice. It asked SII why trials should not be suspended in India until patient safety is established.
“We (Serum Institute of India), were going by DCGI’s direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols,” SII had said in a tweet.
The company said Thursday it was following DCGI’s instructions and cannot comment further.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front,” SII said.
AstraZeneca has paused its clinical trials worldwide. It wants to investigate if the illness seen in the participant happened by chance or as a result of the treatment.
Serum Institute had in June signed a deal to produce AstraZeneca’s experimental vaccine for low and middle-income countries. Human trials of the vaccine candidate were being conducted in India in parallel to AstraZeneca’s effort. Few details of the human trials in India have been released so far.
The vaccine is being developed by AstraZeneca and Oxford University. It is being considered one of the most likely contenders to reach the market first.