Mumbai: Indian drug-making company Serum Institute of India (SII) on Thursday announced that they are holding the trials in India upon the COVID-19 vaccine candidate from its partner company- AstraZeneca.
SII, in a statement, said, “We are reviewing the situation and pausing India trials,” was quoted as saying by the Times of India.
AstraZeneca on Tuesday said that it had paused it’s trials for the COVID-19 vaccine because it was recorded that a participant suffered an unexplained illness. However, it’s partner, SII during that time said that its trials in India were still going on.
The British company, AstraZeneca that is developing the vaccine along with the researchers of Oxford University also said that it has stopped the further process for last-stage trials of the coronavirus vaccines to allow an independent committee to review the safety data. It was also working to lessen any kind of potential impact on its timeline.
“It is obviously a challenge to this particular vaccine trial,” Britain’s health secretary Matt Hancock told Sky News.
According to reports, the patient was suffering from neurological symptoms which is linked to a rare spinal inflammatory disorder, known as transverse myelitis. AstraZeneca said that the final diagnosis was still left as more tests were being carried out.
AstraZeneca is Britain’s largest drugmaker according to market value. It has also agreed to supply three million doses to the governments worldwide.
The company on Wednesday, also confirmed that it has suspended the vaccine trials in July in other countries after it was found that a candidate was having multiple sclerosis. However, SII said that it was still continuing its trials because they didn’t found any kind of issue in India.
The Drug Control General of India (DCGI) sent a show-cause notice to the SII which said that the central licensing authority was not informed about the clinical trials that were paused by AstraZeneca in other countries. Also, the company had “not submitted casualty analysis of the reported serious adverse event with the investigational vaccine”. Serum was asked to respond “immediately,” as quoted by Business Line.
Last month, SII announced its partnership with Gavi, the Vaccine Alliance, along with Bill & Melinda Gates Foundation to increase the manufacture and delivery of over 100 million doses of the vaccine to India as well as other low and medium-income countries around the world.