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.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said vaccine effectiveness will be seen only after 14 days.
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.
The Union Health Ministry on Friday announced that those above the age of 18 years who have completed nine months after the administration of the second dose will be eligible for the precaution dose.
Serum Institute of India, the world's largest vaccine manufacturer, has a licence to produce the shot and has already manufactured close to 50 million doses.
A bench of Justices L Nageswara Rao and B R Gavai said bodily autonomy and integrity are protected under Article 21 of the Constitution.
The teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddys Laboratories Ltd Hyderabad.
The Centre on Tuesday placed orders for 44 crore doses of Covishield and Covaxin, a day after Prime Minister Narendra Modi announced that the Centre would take over the state procurement quota and provide free jabs to state governments for inoculation of all above the age of 18.
The US Food and Drug Administration had in February approved Johnson & Johnson's COVID-19 vaccine that works with just one dose for emergency use.
'he Centre has not issued any mandate, the stand of centre is that it should be 100 per cent but it is not a mandate'
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
Lauding the scientists and technicians for the 'Made in India' vaccines, he said the country is proud of them.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
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 production of Covaxin will increase from the current 10 million doses per month to 60 million-70 million by July-August.
'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'
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.'
'We are trying to salvage 50-100 million doses of Covishield with the latest drive on booster doses.'
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.
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.
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.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
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.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
"The Serum Institute of India (SII) has informed the state government that it can supply the 'Covishield' vaccine only after May 20," Maharashtra Health Minister Rajesh Tope said.
Two weeks after the vaccination programme started, about 37 per cent of the targeted 10 million healthcare professionals had received the first shot. This slow rate may prompt the government to allow vaccines in the private market sooner, to use up the doses before they expire, Sohini Das reports.
Senior Congress leader Manish Tewari and Union Health Minister Harsh Vardhan sparred on Twitter on Saturday with the Opposition leader raising questions over the emergency use approval given to the indigenously developed vaccine Covaxin and the Bharatiya Janata Party leader hitting back alleging that Tewari was only passionate about spreading rumours.
There was the mistaken belief that there was no risk of a second wave anytime soon.
No decision on granting indemnity to any foreign or Indian Covid vaccine-manufactures has been taken yet, the government said Friday, underlining these decisions are to be taken 'in the interest of nation and people'.
'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.'
The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS in New Delhi on Thursday, with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.
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.
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.
During the meeting, scheduled to be held through video conference at 6 pm on Tuesday, the Department of Biotechnology will make a presentation and also coordinate with all the participants, sources added.
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