Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
By 2022, there is a plan to make an mRNA-technology vaccine, for which it has tied up with Canadian firm Providence Therapeutics.
Poonawalla, during an interaction with Odisha Chief Minister Naveen Patnaik through a video conference, expressed optimism that the COVID-19 vaccine could be ready by October-November this year and the next phase of the trial can start in mid-August in India. According to a press note released by the CMO, Poonawalla has informed that the Oxford University vaccine has shown promising results in the first phase trial.
Amid concerns over dangerous side-effects of the Oxford's COVID-19 vaccine, India is evaluating all serious adverse events post-vaccination to determine the causality aspects of Covishield and Covaxin, an expert associated with the process said on Saturday.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
Poonawalla said the price will be around USD 5-6 per dose with an MRP of around Rs 1,000 for the two necessary doses.
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
Several private hospitals across the country said they have no clarity on procuring COVID-19 vaccines under the new policy announced by Prime Minister Narendra Modi and that it has led to the vaccination being put on hold at their centres.
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
Britain has finalised 1 billion pounds worth of new trade and investment with India, creating over 6,500 jobs in the UK, to be signed off at a virtual summit between Prime Minister Boris Johnson and his Indian counterpart Narendra Modi on Tuesday. The investments confirmed by Downing Street on Monday evening form part of an Enhanced Trade Partnership (ETP), which will set the ambition to double the value of UK-India trade by 2030 and declare a shared intent to begin work towards a comprehensive Free Trade Agreement (FTA). "Like every aspect of the UK-India relationship, the economic links between our countries make our people stronger and safer," Johnson said.
The Union health ministry on Sunday clarified that already booked online appointments for second dose of Covishield vaccine will remain valid and the same will not be cancelled on Co-WIN platform.
The Hyderabad-based Bharat Biotech has fixed the price of its COVID-19 vaccine, Covaxin, at Rs 600 per dose for state governments and at Rs 1,200 per dose for private hospitals. The Pune-based Serum Institute of India, the world's largest vaccine maker in terms of volume, has announced a price of Rs 400 per dose for its COVID-19 vaccine, 'Covishield', for state governments and Rs 600 per dose for private hospitals.
Five labourers had died in the fire that broke out in a five-storey building in the SII's Manjari premises in Pune on January 21.
India is engaged with American entities for procurement of COVID-19 vaccines from the United States and their possible manufacturing in the country subsequently, the Ministry of External Affairs said on Thursday.
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
Maharashtra govt, California-based Zipline to launch the automated delivery service funded by Serum Institute.
Each vaccination session will cater to a maximum of 100 beneficiaries and the Union Health Ministry has advised states not to organise 'unreasonable numbers of vaccination per site per day'.
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.
50 lakh doses of 'Covishield' vaccine earmarked by the Serum Institute for export to the United Kingdom have now been made available for the inoculation of 18-44 age group in 21 states/UTs in India, amid a surge in COVID-19 cases, official sources said.
A 40-year-old man who was a volunteer in the third phase of the ''Covidshield'' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
Heads of fire departments of the Pune Municipal Corporation (PMC), Pune Metropolitan Region Development Authority (PMRDA) and Maharashtra Industrial Development Corporation (MIDC) are part of the joint probe team.
This follows a widespread criticism of its pricing policy as it sold Covaxin to the central government at Rs 150 per dose.
Covishield vaccine production won't be hit due to the fire, Serum Institute of India Chief Executive Officer Adar Poonawalla said. The Manjari facility is where the Covishield vaccine used in the nationwide inoculation drive against the pandemic is made.
The prime minister was happy that the assurance given by the Serum Institute that it will make India self-sufficient in vaccines at the lowest possible price in the world was fulfilled.
Bharat Biotech on Thursday said it plans to produce additional 200 million doses of COVID-19 vaccine 'Covaxin' at its subsidiary's Ankleshwar (Gujarat) based facility, taking the overall production volume of the vaccine to 1 billion (100 crore) dosages per annum.
Two men, aged 32 and 48, were given the first shot of the 'Covishield' vaccine, being manufactured by Pune-based Serum Institute of India, at Bharti Vidyapeeth's Medical College and Hospital on Wednesday. The dose will be repeated after one month, an official said.
The Serum Institute of India has informed the Centre that it will be able to supply around 22 crore doses of Covishield in October as the Union government has announced resuming export of surplus Covid vaccines in the coming fourth quarter under the 'Vaccine Maitri' programme, official sources said.
Experts, however, feel that given the intensity of the second wave and the high single dose coverage, India is in a good position to avoid any drastic wave in the near future.
Procurement of coronavirus vaccines and raw materials to boost domestic production is set to be a major focus area of External Affairs Minister S Jaishankar's five-day visit to the United States beginning Monday.
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.
Responding to another question, Choubey said that the phase-I of clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd, and now their immunogenicity testing is in progress. Their phase II clinical trials are ongoing.
India is not keen to 'bow down' to demands related to indemnity against legal liabilities in case any vaccine recipient develops severe adverse reactions post inoculation.
Phase-I clinical trials have revealed "excellent safety" of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd and their immunogenicity testing is now in progress, minister of state for health Ashwini Choubey informed the Rajya Sabha on Tuesday.
'Better to prevent than to wait for evidence. Protection delayed can also mean protection denied'
'I don't think anybody would want to be in my position today where every head of State has to be explained that I am prioritising my country because there is a surge in cases.'
British nationals arriving in India, irrespective of their vaccination status, will have to undergo 10 days of mandatory quarantine from October 4 as part of the reciprocal actions initiated by the government following the vaccine certification row between the two countries.
While the Indian government has been procuring Covid-19 vaccines at low prices so far, manufacturers have to declare the prices of vaccines they would supply to the open market (industries, private hospitals, etc) and state governments before May 1. Sohini Das reports.