INDIA. Mumbai. The Drug Controller General of India (DGCI) issued a show-cause notice to the Pune based Serum Institute of India (SII) for progressing with the COVID-19 vaccine trials and not sending a report about the patient, who recently took ill after the vaccine was administered to him in the UK.
In the notice dated 09 September DCGI Dr. V G Somani has stated that the permission was given to the SII, on 02 August 2020 to conduct Phase II and III clinical trials of “ChAdOx1 nCov-19” coronavirus vaccine (recombinant), at various sites in the country to determine its safety and immunogenicity.
However, it has been widely reported in national and international media that “AstraZeneca PLC”, the British-Swedish pharma giant, has paused the ongoing trial of the nCov-19 coronavirus vaccine since a volunteer developed an unexplained illness. Besides, clinical trials have been put on hold across the countries where it is conducted – the USA, Brazil, and South Africa.
As per condition Number 2 of the permission granted to the SII, the clinical data generated in these trials shall be considered along with the data from the “Astrazeneca/Oxford” clinical trial. However, the SII has not informed the Central licensing authority (DCGI) about the pausing the clinical trial carried out by M/s Astrazeneca in other countries and has also not submitted a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase II and III trial of the subject vaccine in the country in light of the safety concerns.
Show cause notice
A show-cause notice was issued under Rule 30 of the New Drugs and Clinical Trial Rules 2019, why the permission granted in Form CT-06 (No CT-18/2020 dated 02 August 2020) should not be revoked till patient safety is established. “Your reply shall reach undersigned immediately, else it shall be construed that you have no explanation to offer and the action deemed fit will be taken against you”, the notice added.
The SII which began with clinical trials in August, was in the process of enrolling volunteers for the phase III trial of the “Covishield”, being developed jointly by the Oxford University and “AstraZeneca”. As per the plan the SII was expected to conduct the clinical trials under phase III on 1,600 participants are across 17 sites in India.
Reacting to the DCGI notice, in a statement, SII on Thursday said that it was halting the trial of the Oxford University-Astrazeneca COVID-19 vaccine in India until British-Swedish drug maker restarts the trial. The move came a day after it received a show cause notice from the DCGI. “We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions,” SII said.
In an earlier statement, SII had said that the Indian trials are continuing and they have faced no issues at all.
“AstraZeneca”, developing the vaccine jointly with “Oxford University”, in media reports had said that a volunteer had suffered “an unexplained illness” and such pauses in drug trials are “routine” and it is too early to determine the sick participant’s specific diagnosis.
Oxford vaccine failed earlier too
It may be recalled that the trials by “AstraZeneca”, were halted once earlier, in July, after a participant had developed neurological problems. The patient was later diagnosed with multiple sclerosis, something that was assessed to be unrelated to the vaccine.
The trials in India, which began in August, are different stages. So far nearly 100 participants have been injected with the vaccine. The data generated from these participants have to be submitted to an independent expert body, that will assess it for safety and then decide whether further enrolment of more volunteers could be permitted.
Vaccine by Indian Pharma Company
Besides “Covashield” being manufactured by AstraZeneca/Oxford, another vaccine “Covaxin” is being manufactured by Indian pharmaceutical company “Bharat Biotech”. It is an “inactivated” vaccine” which works by injecting doses of the virus that have been killed aiming to prompt the body to build antibodies against it without the virus posing a threat. The company has completed phase I of the trials and is in the process of conducting phase II trials at Post Graduate Institute (PGI) Rohtak(Haryana), on 300 volunteers, aged between 12 years and 65.