Human trials of the Oxford-AstraZeneca vaccine candidate resumed in the UK on Saturday, but the process is likely to take longer in India after the country’s drug regulator asked the Serum Institute of India, the pharmaceutical company which partnered with the UK. company – suspend hiring and apply for permits again.
The experimental AZD1222 is considered the darling for a Covid-19 vaccine and is the only candidate in phase 2/3 trials among Indians. Earlier this week, trials of the vaccine were suspended after a volunteer in the UK developed severe symptoms.
“Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have been resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so,” AstraZeneca said in a communicated on Saturday.
Hours earlier, India’s Comptroller General of Drugs of India (DCGI) said in a letter that the SII will need to submit separate clearances from the UK and India data security monitoring board (DSMB) before it can request permission to resume recruiting volunteers for the test.
DCGI has also directed the Pune-based vaccine producer to closely follow up on all the people who have been dosed with vaccines as part of the trial so far and to report immediately.
On Wednesday, a day after AstraZeneca announced the global suspension, the SII said it was continuing with the trials. DCGI issued a demonstrative cause notice shortly thereafter, after which the Pune-based company, which is the world’s largest vaccine manufacturer, said it would also halt trials in India.
“… After careful consideration of your response and the recommendations of the DSMB in India, in exercise of the powers conferred by Rule 30 of the 2019 New Medicines and Clinical Trials Rules, I direct you to… suspend any new recruitment in phase II / III clinical trials… until new orders. Increase the follow-up of the safety of the subjects already vaccinated with the test vaccine and present the plan and the report ”, said the letter sent by Dr. VG Somani, DCGI.
“Submit authorization from DSMB UK and DSMB India to obtain clearance from this office prior to resuming future recruitment in the trial…” added the letter from the drug controller.
While no safety concerns were noted from the India study (part 1 of the phase 2 study) by the DSMB, India with the first dose and from the 7-day post-vaccination safety data, recommended stopping enrollment until ongoing investigations of serious adverse reactions are reported. in the UK the study has been completed and the sponsor and UK DSMB are satisfied that it does not pose any safety concerns.
According to an official from the drug controller’s office who asked not to be named, the department studied the documented side effects in the patient and the DSMB India’s recommendations, before concluding that further investigation was required.
“Transverse myelitis (inflammation of both sides of a section of the spinal cord) is a serious neurological disorder. Research is being done to find out the cause behind the participant who developed it and whether it was reversible or not. The department is closely monitoring your investigation into the matter, and until you are fully satisfied regarding the safety concerns, there is no chance to restart the trials. It is a matter of the indigenous security and cannot be taken lightly, ”said this person.
“The company has been asked to closely monitor all those who have received the vaccine dose for any adverse reactions. All participants will need to be contacted personally and a plan on how to [SII] we are going to do it and the report should be sent immediately to the DCGI. ”
The official also said it is important to have the proper safeguards and monitoring because this will set a precedent for other human trials related to the Covid-19 candidate vaccines in the country. “These are all new vaccine candidates that are being experimented on and so safety and protection must be much more robust. Everybody is waiting for this vaccine and we cannot afford to be lax. “
SII representatives declined to comment.
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