Phase-III trial of Oxford vaccine to begin in Pune next week

"The phase-III trial of ''Covishield'' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. Around 150 to 200 volunteers will be administered the vaccine candidate dose," he said.

 

Pune:

he phase-III human clinical trial of the COVID-19 vaccine developed by Oxford University and being manufactured by the Serum Institute of India (SII) will begin at the Sassoon General Hospital in Pune next week.
Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe told this to PTI on Saturday.

"The phase-III trial of ''Covishield'' vaccine will begin at Sassoon hospital from next week. It is likely to start on Monday. Some volunteers have already come forward for the trial. Around 150 to 200 volunteers will be administered the vaccine candidate dose," he said.

"From Saturday, the hospital started enrolling volunteers for the trial. Those who are willing to volunteer for the vaccination should contact the hospital," he said.

Under phase-II, trials were conducted at Bharti Vidyapeeth Medical College and also KEM Hospital in the city.

The SII has partnered with British-Swedish pharma company AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.

Earlier this month, the SII had paused the clinical trials of the vaccine candidate in the country.

The Drugs Controller General of India (DCGI) had on September 11 directed the SII to suspend any new recruitment in the phase-II and III clinical trial of the vaccine till further orders after AstraZeneca paused the trials in other countries because of "an unexplained illness" in a participant in the study.

However, on September 15, the DCGI gave permission to the SII to resume clinical trial of the vaccine. 

Meanwhile, Union Health Minister Harsh Vardhan said nearly 30 coronavirus vaccine candidates are under development in India, .

Three of the nearly 30 coronavirus vaccine candidates in the country are in advanced stages of clinical trials, while four are in the pre-clinical development stage, Vardhan said.

A high-level expert group is looking into matters related to vaccine distribution and immunisation, he said.

"Nationally, nearly 30 vaccine candidates are under development, by both industry and academia. These vaccines are in different stages of pre-clinical and clinical development of which three candidates are in the advanced stage of Phase I/II/III trials and four are in the advanced pre-clinical development stage," Harsh Vardhan said in a written response to a question in the Lok Sabha.

"Once available, the coronavirus vaccine distribution follows the same route as for the current practice of vaccines distribution under Universal Immunisation Program (UIP)," he added.

So far, 44,452 clinical samples and 17 virus isolates have been collected which are accessible to researchers and industry for developing diagnostics, therapeutics and vaccines, the minister said.

In a separate reply, the Health Minister said that if the advanced clinical trials of COVID-19 vaccine succeed, then the vaccine is likely to be available by the end of the first quarter of 2021.

The Ministry of AYUSH received 154 misleading advertisements on AYUSH-related claims for COVID-19 treatment from different parts of the country till August 2020, he said in response to a question.

The ministry has issued directives to state/UTs to initiate necessary action against the defaulters and alleged manufacturers/ advertisers acting in contravention of the provisions of Drugs and Cosmetics Act, 1940 and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, he informed the Lok Sabha.The states/UTs have also been directed to send details of the clinical trials of AYUSH medicines claimed for the prevention or treatment of coronavirus for verification, he said.
"But, incidences of COVID-19 related exaggerated claims and misleading advertisements of ASU drugs have been reported by pharmacovigilance centres and forwarded to State Licensing Authorities/Drug Controllers and individual advertisers/manufacturers for corrective action," he said.

"The Ministry of AYUSH received 154 misleading advertisements on AYUSH-related claims for COVID-19 treatment from different parts of the country till August 2020," he said.


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