The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
A Chennai-based man has demanded a compensation of Rs 5 crore from the SII after his health worsened allegedly after volunteering for the clinical trials for a COVID-19 vaccine.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
The Union Health Ministry on Friday announced that those above the age of 18 years who have completed nine months after the administration of the second dose will be eligible for the precaution dose.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
'Our client is suffering due to the ill-effects of the vaccine. He has to be compensated for his suffering. Further, a detailed investigation has to be done on the Covishield vaccine and its side-effects,' says the volunteer's advocate.
"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," Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe said.
Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
Serum Institute along with other vaccine producers have agreed with the government to sacrifice profits. There is no vaccine industry on the planet that has agreed to provide vaccines at such a subsidised price, he added.
In a recent letter to Union Home Minister Amit Shah, SII said its employees have been working round the clock in spite of various challenges because of the pandemic.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
The company has set an affordable ceiling price of USD 3 (around Rs 225) per dose, it added.
Recalling how the industry used to face "hardships" in securing permissions and "harassment from bureaucrats" 50 years ago, chairman of the Pune-based vaccine maker Serum Institute of India (SII), Dr Cyrus Poonawalla, on Friday hailed the Modi government saying that red-tapism and licence raj have come down under its rule.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
Serum Institute of India plans to make 300 million doses of AZD1222 by December, and will begin phase-2 trials soon. It has also tied up with Novavax for development and commercialisation of its candidate.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
A source closely involved in logistical arrangements said the movement of vaccine doses is likely to start from early Tuesday morning through road and air routes amid elaborate police security.
COVAX, 'the global COVID vaccine equity scheme', has so far delivered 65 million doses to 124 countries and economies but it is dependent on countries and manufacturers honouring their commitments.
The Serum Institute of India has stockpiled 40 mn-50 mn doses and is adding more every week. Most of these will come to India.
Maharashtra Chief Minister Uddhav Thackeray on Friday said that whether the fire at the Serum Institute of India (SII) was an accident or sabotage will be known only after the probe gets over.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
"The initial supply price of Covishield for all government immunization programme, including India, has been the lowest", SII said.
SII's CEO Adar Poonawalla took to Twitter to announce the "philanthropic" gesture.
The economics and pricing of the Covishield vaccines and the government's own decision to pay higher prices raise more than a few questions, observes Prosenjit Datta.
The show-cause notice was issued following reports that human trials of the most promising COVID-19 vaccine candidate, being developed by the University of Oxford, have been put on hold after a United Kingdom participant had an adverse reaction to it.
SII executive director Suresh Jadhav on Friday alleged that the government began inoculating people from multiple age groups without taking into account the available stock of vaccines and the WHO guidelines.
"There is no sufficient supply of vaccine vials by the Centre for inoculation of above-45 age group people. Hence, the state cabinet decided to divert the stock, purchased for the 18-44 age group, for the above-45 age group," Health Minister Rajesh Tope said.
By January-February, it's expected to have at least 100 million doses for the Indian government, reports Sohini Das.
Pune-based Serum Institute of India (SII) is sitting on 200 million doses of Covishield that were manufactured in December and are set to expire in September. The company is likely to destroy these vaccines if nothing works out, Sohini Das reports.
The DCGI also directed Serum Institute of India to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.
"The Serum Institute of India (SII) has informed the state government that it can supply the 'Covishield' vaccine only after May 20," Maharashtra Health Minister Rajesh Tope said.
The Centre on Wednesday placed a second purchase order with the Serum Institute of India for the supply of one crore doses of Oxford-AstraZeneca COVID-19 vaccine 'Covishield', each costing Rs 210, including GST, sources said.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
SII said it will address the limited capacity by scaling up the vaccine production over the next two months.
The comments came after AstraZeneca and Oxford University acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.
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