Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
"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.
'Just put a patch on your arm and the vaccine can be absorbed by the body.'
The teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddys Laboratories Ltd Hyderabad.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
This will also help test the effectiveness of preventing the entry of Nipah in target cells.
The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
Both manufacturers have sought funds in excess of Rs 150 crore under the department of biotechnology's Mission Covid Suraksha scheme. Announced last November, the scheme has an outlay of Rs 900 crore to help develop Covid vaccines, from the clinical development stage to setting up production sites.
The Sampark Foundation boasts of a $100 million outlay funded entirely by the Nayars and represents more than half of their wealth.
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.
Take a bow Natasha for looking so unignorable.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
Apart from the 1.1 crore doses of Covishield being procured from the Serum Institute of India, 55 lakh doses of indigenously developed Covaxin were being obtained from Bharat Biotech, Union Health Secretary Rajesh Bhushan said at a press conference.
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.
A massive pan-India inoculation drive against COVID-19 was set in process on Tuesday with more than 56 lakh doses of the Covishield vaccine flown to 13 cities across India from Pune and taken to designated national and state-level stores amid tight security.
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 CEO Aadar Poonawalla has said that the production of Covid-19 vaccine Covishield is in full swing in Pune and he will review the operations once he is back in the country in a few days. Poonawalla is currently in the UK to meet his family members.
Prior to the beginning of the nationwide vaccination drive against Covid-19 in India on January 16, the Pune-based Serum Institute of India has issued a factsheet to answer frequently asked questions that vaccine beneficiaries might have.
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.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
The move comes even as India's drug regulator has extended Covishield's shelf life from six to nine months from its manufacturing date.
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.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
The hospital, located in Parel area, on Tuesday got the approval of the Maharashtra ethics committee for conducting the vaccine trials.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India seeking emergency use authorisation for their COVID-19 vaccines.
Mukesh Ambani has raced ahead of Gautam Adani to become the richest Indian on a list of wealthiest people in the country. The 66-year-old chairman of the diversified Reliance Industries saw his wealth growing by a marginal 2 per cent to Rs 8.08 lakh crore, while Adani's fortune plummeted by 57 per cent to Rs 4.74 lakh crore, as per the 360 ONE Wealth Hurun India Rich List 2023. Anas Rahman Junaid, managing director and chief researcher at Hurun, attributed the decline in Adani's wealth to the Hindenburg report published in January. In January,
The Indian government and private firms have stepped up efforts to develop a vaccine to halt the spread of COVID-19 which has claimed over 3,700 lives with more than 1,25,000 cases in the country.
Poonawalla said booster vaccines have no demand as there is general lethargy among people and also because they are fed up with the pandemic.
Microsoft Chairman and CEO Satya Nadella along with Alphabet Inc and its subsidiary Google CEO Sundararajan Pichai are also among those from trade and industry who have been awarded the Padma Bhushan for their distinguished services.
The Serum Institute of India, the largest vaccine maker in the world, has been chosen by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready. Trials results for the first two phases were published earlier this month.
The DCGI arrived at the conclusion on Wednesday based on the recommendations of an independent expert committee which has also opined that compensation should not be paid to the volunteer, they said.
'It is admitted that the AZ vaccine can, in very rare cases, cause TTS.'
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
As India holds its breath for the Covid vaccination to be begin, Sudhir Bisht provides a quick checklist of what you must know about the vaccines that will be administered to citizens.
Serum CEO Adar Poonawalla posted a video of him playing tennis, with a message for the unvaccinated Novak Djokovic.
The Centre has accorded a security cover of armed Central Industrial Security Force (CISF) commandos for the Hyderabad premises of Bharat Biotech, one of the major COVID-19 vaccine manufacturers in the country, official sources said on Tuesday.
As of now, Gennova Biopharmaceuticals has launched a vaccine, Gemcovac-OM, which is based on the Omicron variant.
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