The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'The ICMR and Biological E Limited, Hyderabad, have developed highly purified antisera (raised in animals) for prophylaxis and treatment of COVID-19,' the apex health research body said on Thursday. The 'antisera' is yet to undergo human clinical trials to establish its safety and efficacy and Drugs Controller General of India would be approached soon in this regard, Dr Samiran Panda, the head of epidemiology and communicable diseases at the ICMR said.
September witnessed 24,33,319 people recuperating from coronavirus infection contributing to around 46.15 per cent of the total 52,73,201 recoveries registered so far in the country.
SII has been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events.
As tensions between the armies of India and China at the LAC show no sign of ebbing, both sides have significantly ramped up the presence of their troops.
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 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.
They stressed that classification of cases into mild, moderate and severe categories based just on respiratory symptoms should be relooked to include other organ involvement.
The aim of the mission is to accelerate the development of at least six vaccine candidates and ensure that they are licenced and introduced in market for emergency use at the earliest.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
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.
In phase I, the vaccine would be tested on 375 volunteers and the maximum of 100 of them would be from AIIMS.
The Director General of Health Services (DGHS) in the ministry of health, in a letter to the Principal Secretaries of health and medical education of states, said it has been observed that there is 'inappropriate use' of N-95 masks, particularly those with valved respirators, by the public other than designated health workers.
With these states imposing lockdowns anew, the health ministry emphasised that the restrictions should be utilised to focus on containment, surveillance and testing in the containment and buffer zones as the key strategy for early detection of cases and fatality management.
The vaccine candidate, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said. The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.
The lockdown, which was first clamped on March 25 and spanned for 21 days, had registered 10,877 cases, while the second phase of the curbs that began on April 15 and stretched for 19 days till May 3, saw 31,094 cases.
'Now, the government will have to ensure even stronger surveillance to curb the infection but if that will be done is something to be observed'
'Children need milk. If there is no money, how can one buy it'
Officials said the study would have started earlier as it was planned to be conducted with the rapid antibody test kits brought from China.
The nation in a post-coronavirus future could well look back on the pandemic period as a 'blessing in disguise' if Indians imbibe hand, respiratory and environmental hygiene and practise it in their everyday lives, the minister said.
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