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Serum Institute To Resume COVID-19 Vaccine Trials In India After Nod From Drugs Controller General Of India

According to Adar Poonawalla, CEO and Owner, Serum Institute of India, conclusions should not be drawn until the trials of the Oxford University’s COVID-19 vaccine are fully concluded so that the process of vaccine development remains unbiased

Serum Institute To Resume COVID-19 Vaccine Trials In India After Nod From Drugs Controller General Of India
Highlights
  • Oxford University and AstraZeneca are developing COVID-19 vaccine AZD1222
  • Phase 3 trials of AZD1222 were halted as a volunteer got ill
  • AZD1222 will be manufactured in India as Covishield

New Delhi: Hours after clinical trials for AstraZeneca and Oxford University coronavirus vaccine resumed on Saturday in the UK, pharma major Serum Institute of India (SII) said it will resume the trials in India once Drugs Controller General of India (DCGI) gives it requisite permission. AstraZeneca PLC had on September 6 paused the trial of coronavirus vaccine (recombinant) as a volunteer developed an unexplained illness. It was also reported that the clinical trials had been put on hold in other countries including USA, UK, Brazil and South Africa.

Also Read: AstraZeneca Vaccine Trial Pause A ‘Wake-Up Call’, Says WHO

Following the developments, India’s top drugs regulator had asked SII to suspend any new recruitment in phase two and three clinical trials for COVID-9 vaccine till further orders.

The DCGI directed the pharma company to increase safety monitoring of the subjects already vaccinated with the candidate vaccine and submit its plan and report.

SII now has to submit clearance from Data and Safety Monitoring Board (DSMB), UK and DSMB India to obtain clearance from DCGI’s office before it can resume trials, officials said.

Once DCGI will give us the permission to restart the trials in India, we will resume the trials, Serum Institute of India said in its statement.

According to the reports on Saturday, clinical trials for AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

Also Read: Serum Institute To Produce COVID-19 Vaccine Candidate Developed By Oxford University, Will Be Called Covishield In India

The company said that that the “standard review process triggered a voluntary pause” to all global trials on September 6 so that independent committees and internal regulators could review the safety data.

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic, Astra Zeneca said in a statement.

Adar Poonawalla, CEO and Owner, Serum Institute of India, said no conclusions should be drawn till the trials are completed.

As I’d mentioned earlier, we should not jump to conclusions until the trials are fully concluded. The recent chains of events are a clear example why we should not bias the process and should respect the process till the end. Good news, UniofOxford, he said in a tweet.

India’s top drugs regulator granted permission to SII on August 2 to conduct phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity.

The vaccine will be manufactured by Serum Institute in India under technical collaboration with Oxford University and AstraZeneca which have developed the candidate vaccine.

Also Read: DCGI Gives Nod To Serum Institute To Hold Phase II, III COVID Vaccine Trials

(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)

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