Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. Ruchika Chitravanshi takes you through this carefully drawn journey of vaccine development.
The Gam-COVID-Vac, called Sputnik V, is a two-part vaccine that includes two adenovirus vectors -- recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S).
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
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.
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'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.
Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
Justice Anup Jairam Bhambhani said that he was not "comfortable" with the present draft clarification given by the yoga guru, remarking that it seemed "more like a pat on the back" and a justification.
If the vaccine is safe and shows a promising immune response in humans, then larger trials would be planned for later in the year.
'We need to be proud of our Maratha history and should be ready to tell the world our stories and not just keep them limited to Maharashtra.'
The 'antisera' has been developed by the ICMR in collaboration with a Hyderabad-based bio-pharmaceutical firm. "With Biological E Limited we have developed an horse 'antisera' and we have just got clearance for conducting clinical trials for that," ICMR Director General Dr Balram Bhargava said at press briefing.
Almost 50% of young Internet users did not have any parental oversight over their online behaviour.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
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Affordable pricing, a variety of themes, and the ease of transacting are among key reasons that have made smallcases a hit among young investors.
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).
In the trial, the vaccine will be given by the intramuscular route in two doses on day 0 and day 28.
The move will help industries in pushing authorities for exemption under various labour laws at a micro-level, along with demanding changes to bring greater flexibility in their operations related to retrenchment, safety standards, and collective bargaining.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
However, Vaughan did not find any merit in the suggestion.
Chartered accountants are readying themselves for a higher onus on individuals to report violations that they come across as part of their work. There has been a scramble to understand the implications as the non-compliance with laws and regulations (NOCLAR) comes into effect in less than six months. It is applicable from April 1, 2022 after being deferred earlier because of the Covid-19 pandemic.
Early data from its vaccine candidate 'mRNA-1273' showed it produced protective antibodies in a group of eight healthy volunteers, Moderna said. The other closely watched COVID-19 vaccine is the one being developed by scientists at Oxford University.
'We expect to get the approval in the next few weeks,' says Deepak Sapra, CEO, API and pharmaceutical services, Dr Reddy's Laboratories (DRL).
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'This cannot be credibly explained away by referring to a "technical glitch".'
'I would go for Bharat Biotech's Covaxin and not Covishield, and that is my personal judgment since at least 11,500 have got at least one dose by now and it has proven to be safe.'
'They (the ransomware attackers) are not after any VVIP data.' 'Had that been the case, they would have quietly installed a different malware.'
The quick reaction surface-to-air-missile missile developed by DRDO was test launched from the Integrated Test Range at Chandipur near here at about 3.08 pm from a vertical launcher against an electronic target at a very low altitude.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
Join infectious disease specialist Dr Trupti Gilada on Rediff Chat and have all your queries on coronavirus answered.
Bibhu Prasad Routray explains why the US is supporting Japan's resolve to release 'treated' radioactive waste water into the Pacific Ocean. And what role China plays in the US decision.
There are 2,89,240 active cases of coronavirus infections in the country which comprises 2.86 per cent of the total caseload.
As the national transporter is planning to come out with semi-high speed routes where trains can clock an average speed of 160-200 kmph, dedicated testing becomes essential.
The UK's medicines regulator on Thursday approved a new antibody treatment against COVID-19, which it believes will also be effective against new variants such as Omicron.
The ministry of civil aviation on Wednesday said only two per cent of the passengers coming from countries that are not in the 'at-risk' list will be subject to random sampling for coronavirus and such passengers will be permitted to leave the airport after giving the samples.
The three students, two of them aged 20 and one 21, were also remanded in 14-day judicial custody by an Agra court, the officials said.
'We need to prove to the world that quality vaccines and R&D are possible in India.'
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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