Updated: Aug 1, 2020 6:39:35 AM
On Friday, an expert committee recommended that the Serum Institute of India be allowed to conduct advanced human trials of the Oxford Covid-19 vaccine candidate in India after the Pune-based company revised its proposal, said learned the Indian Express.
If the head of India’s supreme drug regulatory body approves this, Serum will be able to launch the trials here, which will put it ahead of the Indian race for a Covid-19 vaccine.
The development comes three days after the Subject Matter Expert Committee (SEC) for Covid-related Therapies on Tuesday recommended changes to Serum’s earlier protocol to conduct the trials here. Serum has a connection with the Swedish-British company AstraZeneca, which developed the vaccine with the University of Oxford, to manufacture this vaccine for low- and middle-income countries. Following these recommendations, the firm quickly changed its proposal and resubmitted it, The Indian Express learned.
The SEC, which met again on Friday evening to assess the revised proposal, recommended that the Central Pharmaceutical Standards Supervisory Organization allow Serum to conduct Phase II / III trials here, two sources familiar with the development said. . The next step will be for the Comptroller General of Drugs of India to study the recommendations and to appeal on the proposal.
The panel also suggested that permission to market the vaccine, which Serum calls “Covishield”, be granted after reviewing data generated from both India and international trials, one of the sources said.
The company plans to conduct its Phase II / III trials on approximately 1,600 participants, a government official told The Indian Express.
Serum declined to comment on the development.
Among the changes Serum has made to its protocol has included expanding the number of test sites to around 20 facilities across India, a senior government official said.
This is because, among its previous observations, the SEC had felt that Serum should take a “pan-Indian” approach to the test sites it was considering. While it is unclear how many test sites Serum offered in its earlier protocol, the company’s CEO Adar Poonawalla previously told The Indian Express that he intends to conduct the trials in two cities – Pune and Mumbai.
The committee on Tuesday recommended a total of eight amendments to Serum’s advanced stage testing protocol. These included recommendations related to how the trials would test the vaccine’s ability to elicit an immune response – the committee felt the trials needed to be reviewed to examine the vaccine’s ability to induce a cellular immune response.
Cellular immunity includes developing the ability of specific white blood T cells that can attack and kill the virus because T cells typically stay in the body longer than antibodies and act as a memory response, two said. people involved in vaccine development and testing. , seeking anonymity.
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