Serum Institute next phase of Covishield trial only after safety review complete
AstraZeneca had signed a pact with Serum Institute of India in June for manufacturing a billion doses of the vaccine at its Pune facility. Serum Institute of India is also conducting phase 2 and 3 trials of 1,600 patients across 17 sites in India
PremiumNEW DELHI: Serum Institute of India will begin the next phase of trial for Covishield vaccine after the Data Safety Monitoring Board completes review of the covid-19 vaccine, while AstraZeneca plc also temporarily halted the phase 3 clinical trial of its vaccine after observing an ‘unexplained illness’ in a patient who was given the dose.
The data submitted to Data Safety Monitoring Board was for the phase 2 trial and the next phase will begin as soon as the clearance from the board comes, a principal investigator of one of the sites said.
AstraZeneca had signed a pact with Serum Institute of India in June for manufacturing a billion doses of the vaccine at its Pune facility. Serum Institute of India was also conducting phase 2 and 3 trials of 1,600 patients across 17 sites in India.
“Our trial was already on hold across the 17 sites since last Wednesday because a DSMB review is ongoing after 100 patients were given the vaccine. Now that this one case has also come into light, that will also be reviewed, we will seek further directions on the trial," another principal investigator said on condition of anonymity.
Serum Institute said the pausing of trials in the UK will not have any impact and that the trial continues as it did. “We can't comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all," the company said.
While the UK-based company did not give details on the nature of the adverse effect, it said it plans to resume the study after conducting an expedited review of the safety data by an independent committee.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully," AstraZeneca said in a statement.
“We are working to expedite the review of the single event to minimise any potential impact on the trial timeline."
Astrazeneca is conducting trials of the vaccine, code-named AZD1222, in the UK, Brazil, South Africa and the US, and also plans to start trials in Japan and Russia. These trials will enrol up to 50,000 participants globally, the company had said in a statement on 31 August.
Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.
In July, interim results from the Phase I/II trial were published in The Lancet, which showed that the vaccine was tolerated and generated robust dual immune responses against the SARS-CoV2 virus in all evaluated participants.
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