Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
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.
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.
A number of European countries have banned flights from the UK as the British government warned that the potent new strain of the virus was "out of control" and imposed a stringent new stay-at-home lockdown from Sunday.
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.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
According to the health ministry, the block task force would be tasked with resolving bottlenecks, thus de-centralising planning and preparedness for vaccine introduction.
Five vaccine candidates are in advanced stages of development in India, out of which four are in Phase II/III and one is in Phase-I/II trials.
In a letter to states and union territories, Union Health Secretary Rajesh Bhushan has suggested setting up of a state steering committee chaired by the chief secretary, a state task force led by additional Chief Secretary or principal secretary (health), and a district task force to be headed by the district magistrate.
The Israeli ambassador said the efficiency of the agriculture sector as a whole will increase with the new legislations and consumers will also enjoy better and fresh crops.
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.
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.
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