Covishield
Serum Institute seeks DCGI's approval for Covishield as booster dose
Serum Institute of India has sought from India's drug regulator approval for Covishield as a booster dose citing adequate stock of the vaccine in the country and a demand for a booster shot due to the emergence of new coronavirus variants, reported The Economic Times quoting official sources.
In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine, they said.
Singh is learnt to have said in the application that as the world continues to face the pandemic situation, many countries have started administering booster dose of COVID-19 vaccines.
"People of our country as well as citizens of other countries who have already been fully vaccinated with two doses of Covishield are also continuously requesting our firm for booster dose," an official source quoted Singh as having said in the application on Tuesday.
Also read: Govt decides to administer Covid booster dose to above-60 citizens
"You are aware that now there is no shortage of Covishield in our country and the demand for a booster dose is increasing day by day from the people who have already taken two doses in view of the ongoing COVID-19 pandemic and emergence of new strains."
It is the need of the hour and a matter of right to health of every individual that they should not be deprived of third dose/booster dose to protect themselves in this pandemic situation, Singh stated.
The Union government has informed Parliament that the National Technical Advisory Group on Immunization and National Expert Group on Vaccine Administration for COVID-19 are deliberating and considering scientific evidence for the need and justification for a booster dose.
Also read: Nasal vaccine booster dose may be used with Covaxin
Recently, Kerala, Rajasthan, Karnataka and Chhattisgarh have urged the Centre to decide on allowing booster doses of COVID-19 vaccine diseased amid concerns raised by 'Omicron', the new variant of SARS-CoV-2.
The Delhi High Court on November 25 directed the Centre to clarify its stand on administering booster doses to those who are fully vaccinated against coronavirus, saying it does not want a second-wave-like situation on account of being conservative.
3 years ago
Serum Institute of India to start Covishield supply to COVAX countries
The Serum Institute of India (SII) will start COVID-19 vaccines supply to COVAX countries soon, sources said on Monday.
Serum Institute of India was supposed to start Covishield vaccine supply to COVAX countries from Monday, after it received approval from the government of India, to supply COVID vaccines to other countries, reports ANI.
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"The first consignment from the Pune facility of Serum Institute of India was scheduled to leave for Nepal today. However, due to some reason, it has been delayed by two to three days," said SII sources.
"However the clarity on the exact date of the consignment dispatch is still awaited," sources added.
Earlier, the government of India has allowed the SII to start the supply of vaccines to other countries in the world. The supply of COVID vaccines to other countries was banned by the government in April this year.
Read:Indian PM scraps three contentious farm laws
Earlier, in a tweet Serum Institute of India's chairman, Adar Poonawala had said that around 200 million doses of Covishield are stockpiled with the states in India.
Being the world's largest manufacturer of vaccines, SII now produces over 120 million doses of Covishield every month, and according to some sources, there are over 150 million doses stockpiled in the manufecturer'sshalini bhardwaj Pune facility.
3 years ago
India hits 1 billion Covid vaccination milestone
India Thursday scripted history by hitting the milestone of one billion Covid-19 vaccinations in just nine months after it began its ambitious inoculation drive.
India is the second country in the world to achieve the feat in such "a short period of time". China, however, touched the one billion mark of Covid vaccinations in June.
Prime Minister Narendra Modi hailed the milestone as "historic" and described it as "the triumph of Indian science, enterprise and collective spirit of 130 crore Indians".
Read: FDA OKs mixing COVID vaccines; backs Moderna, J&J boosters
"Congrats India on crossing 100 crore vaccinations. Gratitude to our doctors, nurses and all those who worked to achieve this feat," he said in the national capital.
According to the Indian Health Ministry, around three-quarters of the country's adults have had one dose of a Covid vaccine while 30 percent are fully jabbed.
And the government aims to get all the country's adults inoculated by this year-end.
India took 85 days to touch the 10-crore vaccination mark, 45 more days to hit the 20-crore mark and 29 more days to reach the 30-crore mark, as per the Ministry data.
The country took 24 days to reach the 40-crore mark and 20 more days to surpass the 50-crore vaccination mark on August 6. It then took 76 days to hit the 100-crore mark.
"Congratulations India! This is the result of the leadership of our visionary Prime Minister Narendra Modi," Health Minister Mansukh Mandaviya tweeted.
Read: Covid vaccine: India's Covaxin gets emergency use approval for kids aged 2-18
India's daily case count has also been dropping -- from less than 30,000 new daily cases in the past month to below 20,000 cases in the past 10 days.
India rolled out the world's largest Covid vaccination drive on January 16, with Oxford-AstraZeneca vaccine Covishield and state-owned Bharat Biotech's Covaxin.
India also sent Covid jabs to neighbouring countries. And Bangladesh was the first to receive two million doses of Covishield as a gift from India.
3 years ago
India warns of tit-for-tat action against UK's Covid vaccine policy
India Tuesday warned of a tit-for-tat action if Britain did not recognise Covishield as a legitimate anti-corona vaccine for its nationals travelling to the UK.
Terming Britain's new Covid vaccine policy as "discriminatory", Foreign Secretary Harsh Vardhan Shringla made it clear that India could "take reciprocal measures" if the matter was not resolved at the earliest.
"The non-recogition of Covishield is a discriminating policy and impacts our citizens travelling to the UK," Shringla told the media in the Indian capital.
"The External Affairs Minister has raised the issue strongly with the new UK foreign secretary. I am told that certain assurances have been given that this issue will be resolved," the Foreign Secretary added.
His warning came on a day Indian Foreign Minister S Jaishankar tweeted about raising the issue with his British counterpart Liz Truss on the sidelines of the 76th session of the UN General Assembly in New York.
"Pleased to meet new UK Foreign Secretary @trussliz... Urged early resolution of quarantine issue in mutual interest," Jaishankar tweeted earlier in the day.
As per the new vaccine rules, Indian nationals travelling to the UK will have to undergo self-isolation for 10 days even if they have received both doses of Covishield -- the Oxford-AstraZeneca vaccine produced by the Serum Institute of India.
3 years ago
Better immune response from mixing Covaxin, Covishield, says ICMR study
A GROUP of 18 people, who had “inadvertently received Covishield as the first jab and Covaxin as the second”, showed better immunogenicity — the ability to generate an immune response — than those who received two doses of the same vaccine, according to a new study by the Indian Council of Medical Research (ICMR), reports The Indian Express.
In May, 18 villagers in Siddarthnagar, Uttar Pradesh, had received Covaxin as the second dose, six weeks after they got Covishield. The study compared their reaction to 40 recipients of two doses of Covishield and 40 recipients of two doses of Covaxin.
Read:India approves Johnson & Johnson COVID-19 vaccine for emergency use
“We compared the safety and immunogenicity profile of them (the group of 18) against that of individuals receiving either Covishield or Covaxin. Lower and similar adverse events following immunisation in all three groups underlined the safety of the combination vaccine-regime,” said the study which is yet to be peer reviewed.
“Immunogenicity profile against Alpha, Beta and Delta variants in the heterologous group was superior; IgG antibody and neutralising antibody response of the participants was also significantly higher compared to that in the homologous groups,” it said.
“Overall, this study demonstrates that immunisation with a heterologous combination of an adenovirus vector platform-based vaccine followed by an inactivated whole virus vaccine is safe and elicits better immunogenicity than two doses of homologous vaccination, using the same vaccines,” it said.
While Covishield is built on a viral vector vaccine platform and uses a weakened version of adenovirus, a common cold virus that causes infection in chimpanzees, Covaxin is built on an inactivated whole virus vaccine platform.
Read: BMRC clears Indian Covaxin’s clinical trials in Bangladesh
The study is the first scientific evidence emerging from India on superior immunogenicity profile demonstrated in mixed-vaccine doses. However, the researchers have underlined that to conclusively prove these preliminary findings, “multi-centre” randomised control trials need to be carried out. They have also flagged the study’s limitations: the sample size of 18 participants is small; follow-up period is only 60-70 days after first dose; baseline serological and immunological data of participants is not available.
According to the study, the findings have an “important implication” for the Covid-19 vaccination programme wherein “heterologous immunisation will pave the way for induction of improved and better protection against the variant strains of SARS-CoV-2”.
“This is the first report of heterologous immunisation with an adenovirus vector based and an inactivated whole virion vaccine in humans demonstrating safety and significantly improved immunogenicity… Immunogenicity profile studied against the variants of concerns, Alpha, Beta and Delta variants, demonstrates significantly higher titers in the heterologous group,” it said.
The researchers have said such mixed regimens will help to “overcome the challenges of shortfall of particular vaccines” and “remove hesitancy around vaccines in people’s mind that could have genesis in programmatic ‘errors’ especially in settings where multiple Covid-19 vaccines are being used”.
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On safety, reactogenicity analysis showed that in the heterologous group, 11 per cent reported pain at the injection site; however, during the second dose, no such local adverse event was reported, it said.
The most commonly reported systemic adverse event was pyrexia (raised body temperature) and malaise (discomfort): 33.3 per cent reported this during the first dose, and 5.5 percent during the second dose. “No other systemic AEFI like, urticaria, nausea, vomiting, arthralgia or cough was reported,” said the study.
Currently, the Indian drug regulator has granted permission to CMC Vellore to conduct Phase 4 clinical trials to assess the efficacy of a combination of Covishield and Covaxin doses as compared to the current protocol of using two doses of the same vaccine.
3 years ago
Covid-19: Government orders 66 crore vaccine doses worth RS 14,505 crore
The government is placing its largest order yet of Covid vaccines at 66 crore doses worth Rs 14,505 crore to procure Covishield and Covaxin shots that will help it to substantially meet the vaccine availability projections it had made in the Supreme Court, reports Times of India.
The order is in line with the Centre's estimate of 135 crore doses being available between August-December as stated in its affidavit submitted to the Supreme Court on June 26. Apart from the order for 66 crore doses, the government has made an advance payment to reserve 30 crore doses of Hyderabad based Biological-E's Corbevax vaccine, official sources said.
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This means a total of 96 crore doses are expected to be available on account of government procurement during August December. While the 96 crore doses comprises Centre's share of 75% of the total manufactured doses, the private sector will also have another 22 crore doses of Covishield and Covaxin available during the period.
The order and other anticipated supplies, said officials, will help India remain on track to ensure vaccination for the 18+plus population by the year-end.
The total production of Covishield and Covaxin in August-December is placed at 88 crore doses. Despite a shortfall of around 3.5 crore doses in July, Covaxin production is put at 38 crore in this period, slightly less than the 40 crore mentioned in the SC affidavit. The glitches in its production are understood to have been sorted out.
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Apart from Covishield, Covaxin and Corbevax, the government's estimate of 135 crore doses also included Sputnik V and Zydus Cadila's vaccine. While Sputnik V locally manufactured supplies are yet to start, Cadila's approval is pending. Ten crore Sputnik and five crore Cadila are estimated to be available this year, according to the Centre's affidavit.
"Government has already made an advance payment 96 doses and another 22 crore doses will be available for the private sector, thus securing a large bulk of the expected supply well in advance," said an official source.
The order assumes significance as it assures a supply of jabs to ensure ramping up of vaccination drive amid fear of a third wave. The government aims to inoculate the entire adult population above 18 years age by December. A total of 39.49 crore doses have been administered across the country till Thursday 7pm.
Read: Sputnik V's commercial roll-out in India in coming weeks: Dr Reddy's Laboratories
The Centre has indicated availability of 13.5 crore doses during July, which would translate into an average 50 lakh doses per day. While daily vaccinations have been modest in July so far with a little over 5 crore doses given so far in the month, the states have been asked to ramp up sessions along with that in the private sector where pick up has been slow so far.
While some states have raised concerns about irregular supplies of jabs, the health ministry has emphasised on advance planning and logistics management to ensure that neither people are turned away nor doses are wasted. The health ministry indicates availability of doses to states 15 days in advance to enable planning of vaccination centres and sessions accordingly.
3 years ago
Serum gets govt nod to produce Sputnik vaccine in India
The Indian government on Friday gave permission to Serum Institute to produce Russian Covid-19 jab Sputnik V in the country, a development that could also help end vaccine shortage in neighbouring Bangladesh.
The permission from India's drugs controller came two days after the country's leading vaccine maker sought its nod to manufacture the Russian Covid jab here.
"We have got preliminary approval for Sputnik V. But actual manufacturing will take several months. In the meantime, our focus remains Covishield," a spokesperson for Serum Institute told the local media.
Also read: Sputnik V production starts in India; 100 million doses to be produced annually
Serum's Covishield is being widely used in both India and Bangladesh's mega inoculation drives. Bangladesh has inked a deal with Serum to buy 30 million doses of Covishield, but a recent surge in Covid cases in India has now made the delivery of the remaining doses uncertain.
"However, if Serum manages to plug the gap in vaccine shortage in India, it will also be able to resume supply of the Covid jabs to Bangladesh. In that case, there will be no impediment from any official channel," government sources told UNB.
On Thursday, Serum said that it sought permission from India's drugs controller to produce Sputnik V in this country as well as indemnity against legal proceedings linked to the use of its vaccines here.
Also read: Sputnik V's Limited Rollout Begins In Hyderabad, Visakhapatnam Tomorrow
"SII put up an application to the Drugs Controller General of India on Wednesday, seeking permission to manufacture Sputnik V in India," a company official had said.
Another company official had told the media that all vaccine companies in India should get indemnity protection against liabilities "if foreign companies are granted the same".
Serum's demand came in wake of media reports that Prime Minister Narendra Modi's government could grant legal protection to foreign Covid vaccine makers Pfizer and Moderna.
Also read: Russian Vaccine Sputnik V: Things we should know to fight COVID-19
In a recent interview with a British daily, Serum's chief executive officer Adar Poonawalla had said that the company would increase the vaccine production capacity from the existing 2.5 billion to 3 billion doses a year within six months.
India is currently witnessing a ferocious second wave of Covid-19. At the same time, an acute shortage of Covid vaccines has seriously hampered the country's mass inoculation drive.
Prime Minister Modi rolled out the world's largest Covid vaccination drive in India on January 16. Covishield and local company Bharat Biotech's Covaxin are currently being given to citizens.
3 years ago
India's Reliance developing a tapeworm drug to treat Covid
India's richest man Mukesh Ambani-owned oil-to-telecom conglomerate Reliance Industries is working to develop a new anti-Covid formulation -- a tapeworm drug -- as the country grapples with a devastating second wave of the pandemic.
Reliance has disclosed the information about the drug 'Niclosamide' as a possible cure for coronavirus in its annual report for the financial year 2020-21, filed with markets regulator, the Securities and Exchange Board of India (SEBI).
India has recorded over 28 million cases to date -- second only to the US -- and is now the epicentre of the global pandemic. The country has also recorded more than 300,000 deaths, the third-highest fatality count in the world, behind the US and Brazil.
Though Prime Minister Narendra Modi rolled out the world's largest Covid vaccination drive on January 16, the country is currently facing an acute shortage of jabs.
Serum Institute-produced Oxford-AstraZeneca vaccine Covishield and local company Bharat Biotech's Covaxin are currently being given to citizens. Covishield is also being used in Bangladesh's mega inoculation drives.
Moreover, in view of the ongoing pandemic, Reliance has decided to pay full salaries for five years to the families of employees who succumbed to Covid-19, and put in place a liberal leave policy for the serving staff affected by coronavirus.
In a statement, the conglomerate has said that under the 'Reliance Family Support and Welfare Scheme', it would fully fund tuition fees, hostel accommodation and books of all the children of the deceased employees, up to graduation.
Reliance has also promised 100 percent payment of premium for hospitalisation coverage for the spouse, parents and children of those employees."Further, all colleagues affected by Covid-19 personally or within their family can avail the special Covid-19 leave for the full duration of their recovery, both physically and emotionally," according to the statement signed by Mukesh and his wife Nita.
The second richest person in Asia and the 14th richest in the world, Mukesh's current net worth is around USD 78 billion. His Reliance Group is now India's most valuable company by market capitalisation.
UNB had earlier reported about Mukesh's rumoured plans to hand over three core business areas of Reliance Industries to his three children -- Akash, Isha and Anant -- and also about his aggressive fundraising spree to make his conglomerate debt-free amid the pandemic.
The fundraising spree was aimed at reducing Reliance's dependence on the flagship oil sector to diversify into telecom and e-commerce. Last year, Reliance raised USD 15.2 billion by selling stakes in its telecom unit Jio and another USD 7 billion through rights issue.
The digital news outlet had also reported about Reliance's plans to take its telecom arm Jio public in the 2021-22 fiscal, riding on the increased digital adoption across the world, in the wake of Covid. India's internet users are likely to grow to 850 million by 2022.
3 years ago
India's COVID-19 tally rises to 28,441,986
India's COVID-19 tally rose to 28,441,986 on Thursday with 134,154 new cases recorded in the past 24 hours, said the federal health ministry.
Besides, 2,887 deaths were reported since Wednesday morning, taking the death toll to 337,989.
Read:7 die in gas cylinder blast in India
There are still 1,713,413 active cases in the country, with a decrease of 80,232 in the past 24 hours. The number of daily active cases has been on the decline over the past few days, after a continuous surge since mid-April.
A total of 26,390,584 people has been cured and discharged from hospitals across the country, showed the latest data from the federal health ministry.
Read: India to start trials on safety, efficacy of mixing Covid vaccine doses
India kicked off a nationwide vaccination drive in January, and so far over 221 million vaccination doses have been administered across the country, and 2,426,265 doses were given on Wednesday alone.
Presently the third phase of vaccination is going on, covering all people aged 18 years and above. However, an acute shortage of vaccines is being seen across the country.
Read: India's COVID-19 tally reaches 28,175,044 with 127,510 new cases
Meanwhile, the federal government has ramped up testing capacities, as 353,782,648 tests were conducted till Wednesday, out of which 2,159,873 tests were conducted on Wednesday alone, said the latest data issued by the Indian Council of Medical Research on Thursday.
Three types of vaccines are being administered in India, including Covishield, Covaxin and Russia-made vaccine Sputnik-V.
3 years ago
India to start trials on safety, efficacy of mixing Covid vaccine doses
India will soon start trials to test the safety, immunogenicity and efficacy after mixing doses of different brands of Covid-19 vaccines, reported The Tiimes of India on Tuesday.
The trials will currently include Covaxin, Covishield and Sputnik-V, which currently have emergency use authorisation in the country, going forward the trials may also include jabs that are in the pipeline, senior officials said.
Some studies in the UK and Spain have shown mixing of Pfizer and AstraZeneca vaccines to be safe and immunogenic. However, officials in India maintain that though the concept is scientifically feasible, it cannot be allowed without adequate evidence and therefore, a study has to be conducted.
Also read: India's COVID-19 tally reaches 28,175,044 with 127,510 new cases
The Indian Council of Medical Research, along with the Chennai-based National Institute of Epidemiology, has launched a nationwide study to determine vaccine effectiveness in preventing severe Covid-19 infection. The study will be carried out at 11 sites across 10 cities. A senior scientist with the
“It is scientifically possible and it is a good thing, especially in a country like ours, such a thing (mixing of doses) will really help boost the vaccination programme. But it is currently not allowed under the vaccination protocol and there is no question of allowing it to happen without adequate evidence generated through trials. Therefore, we have decided to have studies to test the same,” a senior official said.
The decision has also been endorsed by the National Technical Advisory Group on Immunisation (NTAGI). The study — expected to start soon and likely to take about two months — will be conducted by the government in collaboration with vaccine manufacturers.
Also readIndia fought first wave of Covid-19 courageously, will be victorious in second round: PM Modi:
Jabs for all by December, says govt as Supreme Court quizzes it on vaccine policy
The Centre on Monday told the Supreme Court that it expects the country's entire population above 18 years to be vaccinated against Covid-19 by the end of the year, but the court remained sceptical of the claim citing impediments in the form of dual pricing and allocation of vaccines at different
Jabs for all by December, says govt as Supreme Court quizzes it on vaccine policy
Apart from testing the safety and feasibility of mixing doses of different vaccines, the study will also evaluate whether mixing of doses of different vaccines help boost immune response to the virus.
3 years ago