Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials.
NEW DELHI: The Serum Institute of India (SII) got the approval on Friday to start human trials in India for the Covid-19 vaccine candidate developed by University of Oxford, after the company submitted a revised protocol to the drug regulatory authority, people in the know told ET.
On Wednesday, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials.
According to the minutes of Wednesday's meeting, the SEC had asked Serum to distribute clinical trial sites across India and demarcate the phase-II and Phase-III part of the protocol. ET has seen the minutes of the meeting.
As per the new proposal, 1,600 people will participate in the trials in over 20 cities spread across India.
A meeting of the SEC was called on Friday where it gave the approval to Serum's amended protocol, a government official said.
Serum has tied up with Swedish-British drug maker AstraZeneca to produce around a billion doses for low- and middle-income countries by early next year.
The group of experts had earlier asked the Pune-based company to also revise the dropout rate of 41% proposed in the study "to keep the rate at par with other vaccine studies".
"Immunogenicity shall be either primary or secondary objective," stated the minutes of the meeting. It added that cellular immunity - the ability of the body to develop cells that specifically target and protect against the virus -should be a part of the immunogenicity assessment, among other recommendations.
The committee had also said an interim analysis of the participants being studied for an immune response might be carried out "only after day 58, both for safety and immunogenicity".
Source - The Economic Times
Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out
Adar Poonawalla awarded 'Business Leader of the Year' 2023 by the International Advertising Association (IAA) India Chapter
Cyrus Poonawalla Group appoints Keki Mistry as Strategic Advisor to all the Financial Services Ventures led by Adar Poonawalla
R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana
Department of Biotechnology announces the scientific completion of India's first qHPV vaccine ‘CERVAVAC’
Adar Poonawalla, CEO, Serum Institute of India, receives the award for the Outstanding Business Leader of the Year
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
Serum Institute Of India sends out Covishield vaccine - Consignment of Covishield Vaccine arrived in Delhi, Chennai, Kolkata, Guwahati, Shillong, Ahmedabad, Hydrabad, Vijayawada, Bhubaneswar, Patna, Bengaluru, Lucknow, Chandigarh
Serum Institute of India launches India’s first fully indigenously developed pneumococcal vaccine, 'PNEUMOSIL'
Oxford COVID-19 vaccine: Serum Institute likely to submit final Covishield trial data within 10 days
SII’s Adar Poonawalla on Covid vaccine, pricing and rollout at Hindustan Times Leadership Summit 2020
COVISHIELD Completes Enrolment of Phase III clinical trials under partnership of ICMR and Serum Institute of India
Government Secures Vaccine Supplies For Half Of The Indian Population From Serum Institute And Novavax
IAVI, Merck, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
Serum Institute Of India Takes A Multipronged Approach In Quest To Produce World’s First Covid-19 Vaccines
Serum Institute of India to produce up to an additional 100 million covid 19 vaccine doses for india and low and midle income countries in 2021
Adar Poonawalla CEO of Serum Institute of India, the world’s largest vaccine manufacturer, explains the timing, challenges & cost of vaccinating the world against COVID-19
Serum Institute looking for a $1 billion shot to fight covid, talks on with Blackstone, KKR and others
Serum Institute of India Says Covid Vaccine Likely to Be Ready by End of 2020, Final Pricing in 2 Months
Serum institute of india to produce up to 100 million covid-19 vaccine doses for india and low-and middle-income countries as early as 2021
50% of our Covid vaccines will be for India, people won't have to buy them, govts will pay: Adar Poonawalla
AstraZeneca vaccine's success in early human trials, Will Begin AstraZeneca Vaccine Trial in India After Applying for Licence Next Week, Says Serum Institute
Serum Institute of India CEO: ‘We plan to make millions of doses of Covid vaccine over three months’:’
New supply agreement between UNICEF and Serum Institute of India makes pneumococcal conjugate vaccine available at US$2.00 per dose, a 43 % reduction from the Gavi price at the start of the Advance Market Commitment
Serum Institute confident of manufacturing Covid vaccine’s 100 million doses if trials establish efficacy
Serum Institute’s Journey To Success | ET NOW Covid-19 vaccine possible by Q2 of 2022: Adar Poonawalla
Adar Poonawalla discusses Serum Institute's progress in the global battle against COVID-19 with Shereen Bhan, CNBC-TV18
Adar Poonawalla talks with Aabha Bakaya about the success story of Serum Institute of India. Tune in to know all about the journey of the company.
Bill Gates confers Indian Council of Medical Research "Lifetime Achievement Medal" on Dr. Cyrus Poonawalla
Dr. Cyrus Poonawalla conferred with 'Lifetime Achievement Award’ by the Asian Business Leadership Forum
Dr. Cyrus Poonawalla conferred with the prestigious honorary degree by the University of Oxford, U.K.