Serum Institute of India seeks DCGI permission for phase 2/3 clinical trials of Oxford’s COVID ‘vaccine’

New Delhi, July 25

Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of the potential vaccine, highly-placed sources said on Saturday.

The sources told PTI that the Pune-based drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of ‘Covidshield’.

“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ (COVID-19) in healthy Indian adults. The firm said that an around 1,600 participants of more than 18 years would be enrolled in the study,” a source said.

Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.

To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.

On the partnership with AstraZeneca, Serum Institute of India CEO Adar Poonawalla had said: “Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University”. These vaccines will be for India and middle and low income countries across the world (GAVI countries), he had said.

The firm plans to start the phase 2 and 3 human trials in India in August.               

Oxford University on Monday announced satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world. 

According to a report in the Lancet, the initial trial results showed that the  vaccine is safe and prompts protective immune response.

Import licenses cancelled, suspended

DGCI has cancelled the rapid diagnostic kit import licenses of three firms and suspended that of 16 others saying the USFDA has removed the manufacturers from their list of coronavirus serology test kits with directions that they should not be distributed.

The three firms are Cadila Healthcare, MDAAC International and NW Overseas while the 16 companies include Transasia Bio-Medicals, Cosmic Scientific, Inbios India, S D Biosensor, Accurex Biomedicals, Biohouse Solutions and Trivitron Healthcare among others.          

 The companies were issued a show cause notices on July 17 asking why their import licenses shall not be cancelled since the diagnostic kits of the manufacturers have been removed by USFDA with direction that it should not be distributed from the list of product of serology test kits for COVID-19 disease, according to an official order by the Drug Controller General of India (DCGI).

They were directed to submit their reply by July 20, failing which it would be presumed they have nothing to say in the matter and action deemed fit will be initiated under provisions of the Drugs and Cosmetics Act.

“Your response to the show cause notice has not been found satisfactory with respect to removal of said kit, by USFDA from their list mentioning not to distribute,” the DCGI order issued to the 16 companies on July 21 stated.

“However, it has been mentioned by you to not to cancel your said import license for the above product. Therefore, in public interest, your import license for above product becomes inoperative and stands suspended, till further orders,” it said.

As for the three companies whose licenses were cancelled, the orders said: “Your response to the show cause notice has not been found satisfactory with respect to the removal of said kit, by USFDA from their list mentioning not to distribute”.

“Further, it has been mentioned by you that you intend to surrender your license for the above product. Therefore, in public interest, your import license for above product becomes inoperative and stands cancelled with immediate effect,” the order issued on July 21 read. PTI