'Please don't read something which is not there in DG, ICMR's letter. The intent of the letter is only to expedite duly approved clinical trials without compromising on security and safety concerns'
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The NIH said results of two studies of blood serum from people who had received Covaxin suggest that the vaccine generates antibodies that effectively neutralise the B.1.1.7 (Alpha) and B.1.617 (Delta) variants of SARS-CoV-2, first identified in the United Kingdom and India, respectively.
The foreign envoys were taken to Hyderabad over a month after the ministry of external affairs briefed over 190 heads of diplomatic missions and representatives of leading international organisations on COVID-19 related issues.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
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.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
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.
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.
The needle-free vaccine will be available at private centres.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
Bharat Biotech's Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic COVID-19 and 65.2 per cent protection against the new Delta variant.
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.
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.
The ICMR-National Institute of Virology has been regularly undertaking studies to understand the protective efficacy of COVID-19 vaccines against emerging variants.
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.
The bench, which was critical of the Centre's stand on the issue, said "You (government) are so short of vaccines and you are not taking it through. May be it is an opportunity for you. Don't be so negative. It is like a raging fire and nobody is bothered. You people don't understand the larger picture or what.
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
The Indian vaccine industry largely feels there are two ways in which vaccine innovation can be spurred - one, get a high price for the product and two, have the government buy a few hundred million doses of the product at a certain price.
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.
Since India is one of the largest vaccine producers in the world, it is the country's 'moral responsibility' to fast-track vaccine development process to break the chain of coronavirus transmission, ICMR Director General Dr Balram Bhargava said referring to the two vaccine candidates developed indigenously.
As states grapple with a shortage of coronavirus vaccines, the Centre on Thursday said that over two billion doses will be made available in the country in five months between August and December, enough to vaccinate the entire population.
It will be unfair to put a date for any COVID wave as the behaviour of coronavirus is unpredictable and a disciplined and effective pandemic response can help the country get away from any significant outbreak, COVID Task Force chief V K Paul said.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
With the US education system operating independently from the government, universities are adopting varying strategies when it comes to Covid vaccination.
Dr Malhotra, who has demanded a full safety review into the use of AstraZeneca's Covid vaccine, told PTI Covishield "should never have been rolled out in the country in the first place".
Only half India's population has received the first shot of Covishield and Covaxin and the government's immediate task is to first vaccinate its adult population before placing its focus on children.
The prime minister in his intervention at the session on "global economy and global health" also flagged the issue of facilitating international travel and talked about the mechanism of mutual recognition of vaccine certification as a means of achieving this, according to the text of his intervention shared by his office.
India has purchased 500 million doses of the Oxford University-AstraZeneca vaccine candidate, one billion from the United States company Novavax and 100 million doses of the Sputnik V candidate from Russia's Gamaleya Research Institute, according to the US-based Duke University Global Health Innovation Center.
'I can say with confidence that any future SARS-CoV-2 vaccine, developed anywhere in the world, would have to be manufactured in India, if it is to be affordable and of high quality.'
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The modalities of COVID-19 vaccine delivery, distribution and administration were discussed during the meeting.
"The concrete actions are a stern indication that Government of India is making all out efforts to increase vaccine production in the country as well as attracting foreign vaccine manufacturers to supply the required vaccine doses for national Covid vaccination programme," the ministry in a statement.
According to the sources, there are limited prospects of J&J exporting its vaccine from the US to other countries in the near future and the "entire production" at the BE facilities in India, beginning July/August, will be handed over to the pharma giant under a contract between the companies.
These vaccines have not yet been approved by the World Health Organization
In a tweet, Prime Minister Narendra Modi said India is deeply honoured to be a 'long-trusted' partner in meeting the healthcare needs of the global community and that supplies of the vaccines to several countries will commence on Wednesday, and more will follow in the days ahead.
'Nobody is attacking the company or the vaccine.' 'The concerns are about the process and the lack of transparency.'
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