The first batch of DRDO-developed anti-Covid drug 2-DG (2-deoxy-D-glucose) was launched on Monday to treat patients suffering from the deadly disease. The medicine comes in powder form and can be taken with water.
Defence Minister Rajnath Singh and Health Minister Harsh Vardhan released the first batch of the 2-DG, an anti-Covid-19 therapeutic application of the drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of Defence Research and Development Organisation (DRDO) in collaboration with Dr Reddy's Laboratories (DRL).
Rajnath Singh handed over the anti-Covid drug to his cabinet colleague Harsh Vardhan who handed over it to Delhi All India Institute of Medical Sciences (AIIMS) director Randeep Guleria at an event here.
The Defence Minister would be later distributing around 10,000 doses of the drug to a few hospitals in the national capital.
The Drugs Controller General of India (DCGI) granted emergency use nod for the drug last week. The drug could be a game-changer in the battle against pandemic as it helps in faster recovery of hospitalised patients and reduces oxygen dependence.
Clinical trial results have shown that the drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in Covid patients.
The medicine was found to be safe for Covid-19 patients in phase 2 trials, conducted between May and October last year. It was found to be effective in cutting short the hospital stays of Covid patients and reducing their supplemental oxygen dependence.
During the first wave of the pandemic in April last year, INMAS-DRDO scientists conducted laboratory experiments with the help of Centre for Cellular and Molecular Biology (CCMB), Hyderabad, and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth.
Based on these results, the Drugs Controller General of India (DCGI) Central Drugs Standard Control Organisation (CDSCO) permitted Phase-II clinical trial of 2- DG in Covid-19 patients in May 2020. The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients.
In Phase-II trials (including dose ranging) conducted during May-October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery. Phase-II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients.
A team of US researchers has found that delaying the second dose of Covid-19 vaccines, at least for people aged under 65, could result in up to 20 per cent lower mortality, but only under certain conditions.
These conditions include a one dose vaccine effectiveness (efficacy) of 80 per cent or higher and vaccination rates of 0.1 per cent to 0.3 per cent of the population per day, according to the study, published by The BMJ.
If these conditions apply, the strategy could prevent between 47 and 26 deaths per 100,000 people, respectively, the study noted.
"Decision makers will need to consider their local vaccination rates and weigh the benefits of increasing these rates by delaying a second dose versus the risks associated with the remaining uncertainty in this strategy," write researchers including Thomas C. Kingsley, Assistant Professor of Medicine at Mayo Clinic, Minnesota.
"These decisions should continue to be re-evaluated as new data become available," the researchers added.
Both the Pfizer and Moderna covid-19 vaccines in a standard two dose schedule are highly effective at preventing symptomatic infections and death. But immunity worldwide remains low, partly owing to low vaccination rates.
The longer it takes to effectively vaccinate the global population, the greater the likely risk of vaccine resistant strains developing. This has led to calls to prioritise single dose vaccination for as many people as possible, even if this means delaying a second dose beyond the studied time frame.
"The justification for this relies on the assumption that meaningful protection against Covid-19 can be achieved after a single dose of vaccine, but this is the subject of intense debate," the team said.
To explore this further, they set out to measure the impact of delayed second dose vaccine policies on infections, hospital admissions, and deaths compared with the current on-schedule two dose regimen. Using a simulation model based on a "real-world" sample population of 100,000 US adults, the team ran a series of scenarios over a six-month period.
The results suggest that a delayed second dose strategy is optimal for vaccination rates at or lower than 0.3 per cent population per day if the vaccine efficacy from one dose is 80 per cent or greater.
Hyderabad, May 12 (IANS) Pharma major Dr. Reddy's Laboratories Ltd on Wednesday announced that it has entered into a royalty-free, non-exclusive voluntary licensing agreement with Eli Lilly and Company for the manufacture and commercialization of baricitinib in India.
The drug baricitinib has received restricted emergency use approval from the Central Drugs Standard Control Organization (CDSCO), Ministry of Health, India, for use in combination with remdesivir for the treatment of suspected or laboratory confirmed Covid-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
This partnership comes at a critical juncture in the fight against the pandemic in India and adds to the company's existing range of Covid-19 therapeutics covering the full spectrum from mild to moderate and severe conditions of the disease, and a vaccine, the Hyderabad-based company said.
"From the start, we have been determined to explore every possible avenue against COVID-19. Our collaboration with Lilly will help us make yet another treatment option available to patients in India," said Deepak Sapra, Chief Executive Officer, API and Services, Dr. Reddy's Laboratories.
In another development, Dr Reddy's announced the launch of Ertapenem for Injection, 1 g/vial, a therapeutic equivalent generic version of INVANZ(ertapenem for injection) for injection, 1 g/vial, approved by the U.S. Food and Drug Administration (USFDA).
"We are pleased to bring this important product to market at this time," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories. "We're excited to extend our strategic partnership with Gland Pharma whose hard work, in collaboration with the team at Dr. Reddy's, has enabled the execution of this launch."
"We are delighted about this collaboration, as it brings together Dr. Reddy's experienced marketing and distribution capabilities and Gland Pharma's robust development and manufacturing capabilities. Gland Pharma has an exclusive API supply arrangement for this product and a dedicated manufacturing facility in Hyderabad for Ertapenem Injection. With the launch of this product we see increased capacity utilization of this dedicated Penem facility," said Srinivas Sadu, MD and CEO of Gland Pharma Ltd.
One in every nine adults consistently had very poor or deteriorating mental health during the first six months of the Covid-19 pandemic, according to new research.
Those living in the most deprived neighbourhoods along with ethnic minority groups were severely affected, said the team based at The University of Manchester, King's College London, Cambridge, Swansea and City University.
The researchers also found that infection with Covid-19, local lockdown, and financial difficulties all predicted a subsequent deterioration in mental health.
However, two thirds of adults were in groups whose mental health was largely unaffected by the pandemic, finds the study published in The Lancet Psychiatry.
"We are increasingly aware that social and economic advantages have an important influence on how well people are able to cope with challenges that appear to have affected everyone equally," said Kathryn Abel, Professor from Manchester University.
"The health and social inequalities we already know about for women and for people in poverty relate to different burdens of stressful life events and different resources to deal with them.
"These remain relevant and are important reasons for the differences we are seeing in the mental health trajectories across the pandemic," Abel said.
The team analysed monthly surveys between April and October 2020 on 19,763 adults to identify typical patterns of change in mental health, revealing five distinct groups.
The unaffected groups were more likely to be older, white, and from the least deprived areas, with men being especially likely to have consistently very good mental health. Women and parents of school-aged children were particularly affected, but experienced significant improvements in mental health around the time schools' reopened.
Those who experienced a sustained decline or consistently very poor mental health were more likely to have had pre-existing mental or physical conditions. They were also more likely to be Asian, Black or mixed ethnicities, and live in the most deprived areas, according to the research.
The Indian Medical Association (IMA) on Saturday slammed the Union Health Ministry, saying it is "astonished to see the extreme lethargy and inappropriate actions" from the department in combating the agonizing crisis caused by the devastating second wave of the Covid-19 pandemic.
Noting that the collective consciousness, proactive cognizance, and requests made by the IMA and other professional learned colleagues are put into the "dustbin", the association said the decisions are taken "without realizing the ground realities".
In the last 20 days, an IMA statement said, the association has been insisting on the need for complete, well- planned pre-announced national lockdown rather than few states declaring lockdown ranging for 10 days to 15 days - so as to getting breathing time for the health care infrastructure to recoup and replenish both the material and manpower.
"Lockdown will break the chain of devastating spread," said the IMA, a national voluntary organisation of Doctors of Modern Scientific System of Medicine in India.
However, it said, the Central government had refused to implement the lockdown resulting in mounting of new patients beyond four lakhs every day and the number of moderate to severe cases are increasing to nearly 40 per cent.
Mentioning that "sporadic night curfews have not done any good", the IMA stressed: "Life is precious than the economy."
"Wake up from slumber and respond to mitigate the growing challenges in covid pandemic," the IMA said.
The equitable, accessible, and affordable vaccination for all above 18 years were demanded by the IMA based on scientific facts from April 6 onward and after persistent call of Prime Minister Narendra Modi with his innovative qualities assured the nation, the vaccination drive was started from May 1, it said.
"It is unfortunate, the ministry has failed to make the necessary required roadmap and ensure vaccine stock, resulting in the majority of the places where vaccination could not be rolled out for people above 18 years," the IMA said.
"When the Prime minister notification is not implemented scrupulously, who is to be blamed?"
Considering differential Covid vaccine pricing system as "unhumanistic", the IMA said the people of the age group between 18 and 45 years are forbidden to get the free vaccination from the central share of 50 per cent and they are placed under the mercy of the state governments.
"The jeopardy of private practitioners and states to negotiate with manufacturers for pricing and stock resulted in exorbitant price rise and vaccine shortage."
Giving example of eradication of smallpox and polio in 1997 and 2014, the IMA said it could only happen by adopting the universal free vaccination and not by differential pricing system.
When Rs 35,000 crore were allotted in the budget, the IMA said, with which the maximum required 200 crore vaccine dozes are purchasable.
"Why the central government is shedding its responsibility?," asked the IMA, adding "unless the government comes out and implements with willingness and steadfastness for equitable distribution, we will not be able the achieve the goal".
Today for the last seven days, the IMA said, "no vaccine is available in small and medium private hospitals".
"The crisis of oxygen is deepening every day and scores of people are succumbing to Oxygen mismatch supply and it is creating panic both among patients and fraternity. Though there is enough production, it is often the distribution which is not proper," said the IMA.
Even after 15 days of the crisis, the IMA said: "The government is not seen at the forefront to solve these issues and resulting in people knocking at the doors of courts to get justice, resulting in judicial activism.
"Health care professional oganisations are neither consulted nor the honourable Health minister in this whole pandemic had time to interact with modern medicine professional organisations to solve this issue. Imported oxygen concentrators and oxygen plants are yet to reach the beneficiaries."
The IMA later appealed saying, "as the time is running out with the impending crisis lest we deepen the crisis, solve it on a war footing".
"Though various mutants are identified yet the real hazard is not explained in actual terms. Dedicated experts shall be designated to study this and propose mitigation measures at the earliest," the IMA suggested.
The IMA also raised question over the government hiding actual Covid deaths. "Why are we trying to hide actual deaths? If the public comes to know about the actual deaths, their seriousness to adopt Covid-appropriate behaviours will rise."
The IMA demanded to revamp the entire health care administration with Indian Medical Service (MS) cadets who are "well versed with the technical and administrative skill for effective execution of health care".
"We also demand to establish a new integrated Ministry to serve in this pandemic with a dedicated, proactive, vibrant, innovative, and altruistic Minister and alleviate the fear of people by leading from the front.
"We propose for augmentation of infrastructure, materials, and manpower by enhancing health care budget to be raised from 1 per cent of GDP to minimum 8-10 per of GDP, and judiciously use the earmarked budget amount for ensuring equitable and affordable Universal vaccination."
Double-mutant variant of severe acute respiratory syndrome SARS-CoV-2 -- B.1.617 -- that has emerged in India, entered certain types of lung and intestine cells with slightly increased efficiency compared with the original wild-type strain, say researchers.
The researchers, including Markus Hoffmann from German Primate Center, also reported that the entry of B.1.617 into the lung and intestinal cells was blocked following treatment with soluble angiotensin-converting enzyme 2 (ACE2) or the serine protease inhibitor Camostat.
However, this host cell entry was not blocked by the monoclonal antibody Bamlanivimab, which has received emergency use authorisation (EUA) as a Covid-19 treatment.
Finally, B.1.617 also partially evaded neutralisation by the antibodies induced through natural infection or immunisation with the Pfizer-BioNTech BNT162b2 vaccine, a study that appeared in the pre-print repository medRxiv, suggested.
The researcher said that antibody evasion by B.1.617 may contribute to the rapid spread of this variant.
The sharp rise in Covid-19 cases and deaths in India over recent weeks is thought to be caused by the novel variant B.1.617, which harbours eight mutations in the spike protein.
These include the RBD mutations L452R and E484Q, which are known to modulate antibody-mediated neutralisation.
However, the researchers said it is not currently known whether B.1.617 resists this antibody-mediated neutralization.
To test whether B.1.617 is more adept at entering cells, the researchers infected eight cell lines with pseudotyped virus particles expressing spike protein from the original wild-type virus, the B.1.617 variant, or the B.1.351 variant.
Of the eight cell lines tested, the spikes of B.1.617 and B.1351 mediated entry into Calu-3 lung cells and Caco-2 colon cells with slightly increased efficiency, compared with the original strain.
Collectively, the study reveals that antibody evasion by B.1.617 may contribute to the rapid spread of this variant, the team noted.
New Delhi, May 3 (IANS) Debunking news reports that India has not placed fresh orders for Covid vaccines with the Serum Institute of India (SII) and Bharat BioTech since March, the Union government on Monday said such reports are completely incorrect and are not based on facts.
The media reports suggested that the last order placed with the two vaccine makers (100 million doses with SII and 20 million doses with Bharat Biotech) was in March.
"It is clarified that 100 per cent advance of Rs 1,732.50 crore was released to Serum Institute of India (SII) on April 28 for 11 crore doses of Covishield vaccine during May, June and July, and was received by them on April 28. As on date, against the last order of 10 crore doses for supplies of Covishield vaccine, 8.744 crore doses have been delivered till May 3," the Ministry of Health and Family Welfare said in a statement.
Additionally, 100 per cent advance of Rs 787.50 crore was released on April 28 to Bharat Biotech India Ltd (BBIL) for 5 crore Covaxin doses during May, June and July, and was received by them on the same day.
"As on date against the last order of 2 crore doses for supplies of Covaxin vaccine, 0.8813 crore doses have been delivered till 03.05.2021. Hence to say that fresh orders have not been placed by Government of India is not correct," the ministry said.
Serum Institute of India CEO Adar Poonawalla also issues a statement, saying that his company has received orders for 26 crore doses.
"As of today, we received total orders of over 26 crore doses of which we supplied more than 15 crore doses. We have also got 100 per cent advance of Rs 1,732.50 crore by GoI for the next tranche of 11 crore doses in the next few months. Another 11 crore doses would be supplied in the second channel for states and private hospitals in the next few months," Poonawalla said in a statement.
Earlier, the Financial Times reported Poonawalla as saying that vaccine shortage could continue in India till July.
The production is expected to increase from about 60 million-70 million doses a month to 100 million in July, Poonawalla was quoted as saying in the report.
When the number of new infections began declining in January, "everybody really felt that India had started to turn the tide on the pandemic". The authorities did not expect to confront a second wave," the report quoted him as saying.
Poonawalla said that his comments may have been "misinterpreted".
"First of all, vaccine manufacturing is a specialised process, it is therefore not possible to ramp up production overnight. We also need to understand that the population of India is huge and to produce enough doses for all adults is not an easy task. Even the most advanced countries and companies are struggling in relatively smaller populations," he explained.
At least 23 patients died at a government hospital in Chamarajanagar district in Karnataka in the wee hours of Monday after the oxygen supply dropped, officials said.
"The deaths were reported after there was a fall in oxygen supply level between 12 a.m. and 2 a.m. on wee hours of Monday, where at least 144 patients are being treated," a senior official at the hospital said.
A statement released by the Chief Minister's office here, stated that Chief Minister B.S. Yediyurappa has spoken to the district collector over the incident and called an emergency Cabinet meeting on Tuesday.
Home Minister Basavaraja Bommai, meanwhile, has asked the DGP Praveen Sood to investigate the matter and submit a comprehensive report for further action.
Chamarajanagar district in charge minister, S. Suresh Kumar said that it was not proper to attribute all deaths due to oxygen shortage as the state government was investigating the matter. "I am visiting there to find out about the matter," he said this before leaving from Bengaluru to Chamarajnagar.
Health Minister, K. Sudhakar too left from Bengaluru for Chamarajnagar, to take stock of the situation. "It is very saddening to know about such incident. We do not have complete information yet," he said.
Mysuru MP, Pratap Simha, said, "Last night, when media people drew my attention to the situation of oxygen shortage in Chamarajnagar district, I myself contacted DC Ravi and took a conference call with ADC who is in charge of oxygen. At night itself I contacted Southern Gas and they provided 15 cylinders. Despite all this, this sad incident occurred. Chamarajnagar is not some far away place. We feel it is a part of us. We are part of their sorrow."
The district has recorded a total of 11,928 cases of COVID-19 infection since the beginning of the pandemic. At least 167 people have died due to the virus until Sunday.
New Delhi, May 1 (IANS) Amid the raging second wave of the Covid-19 pandemic in India, White House's chief medical adviser Anthony Fauci has suggested a complete lockdown for a few weeks to curb transmission of the Covid-19, the media reported.
According to Fauci, a temporary lockdown in India is the need of the hour as it could have a significant impact on the dynamics of the outbreak. "You can shutdown temporarily to put an end to the cycle of transmission. So one of the things to be considered is to temporarily shut down," Fauci told The Indian Express.
"We are very pained to see India suffering so much. And that's the reason why the rest of the world needs to chip in and help," he added. Alongside lockdown, Fauci emphasised that the most important thing is to get oxygen, supplies, medication, PPE and vaccinations.
"To have a country like India, where two per cent of people are vaccinated, is a very serious situation. You absolutely have to get more people vaccinated," according to Fauci. "There is suffering now but I guarantee that we will get it back to normal. Hang in there, help each other," Fauci added. India on Saturday started the third phase of the vaccination drive covering those above the age of 18 years.
However, the exercise began mainly in six states -- Maharashtra, Rajasthan, Uttar Pradesh, Chhattisgarh, Gujarat and Odisha. All other states and Union Territories (UTs) have either deferred vaccination for the age group of 18-44 by a few days due to a shortage of vaccine.
India has so far administered 15,49,89,635 doses since January 16 when the world's largest inoculation exercise started.
The Ministry of Health and Family Welfare (MoHF) on Saturday said that India witnessed the highest spike of 4,01,999 fresh cases of Covid-19 and 3,523 fatalities due to Covid-19 infection in the last 24 hours.
Telangana reported 7,754 new Covid-19 cases and 51 deaths during the 24-hour period.
The number of infections saw a slight increase from 7,646 on Friday.
The number of cases has been on decline for last few days as the authorities brought down the daily testing to less than one lakh.
Government and private laboratories tested 77,930 samples during the 24-hour period till 8 p.m. Friday.
The fresh cases pushed the state's cumulative tally to 4,43,360 while the toll rose to 2,312.
The case fatality rate increased to 0.52 per cent but was still lower than national average of 1.1 per cent.
The number of active cases mounted to 78,888. A total of 6,542 people recovered from the virus during the last 24 hours, taking the overall number of recoveries to 3,62,160. The recovery rate stands at to 81.68 per cent as compared to the national average of 81.8 per cent.
During the last 24 hours, the health authorities tested 77,930 samples, taking the total number of tests to more than 1,29,83,784 crore. Samples tested per million population improved to 3,48,838.
The daily count of cases in Greater Hyderabad once again crossed 1,500 after dropping to 1,441 on Friday.
Medchal Malkajgiri and Rangareddy district adjoining Hyderabad reported 630 and 544 cases, respectively.
Out of 33 districts in the state, only five reported cases in double digits.
Sangareddy district reported 325 cases, followed by 281 in Karimnagar, 279 in Siddipet, 267 in Nizamabad, 255 in Jagtiyal, 242 in Suryapet, 242 in Vikarabad, 231 in Nalgonda, 230 in Khammam, 216 in Mancherial and 208 in Warangal Urban.
Amid a deteriorating Covid-19 situation, the national capital on Thursday recorded its highest ever single-day toll from the disease in 24 hours as 395 deaths were reported.
The situation in Delhi has been quite alarming, with many patients not getting bed in hospitals, along with a widespread shortage of medical oxygen.
The city has recorded its highest single-day Covid toll even as Delhi Chief Minister Arvind Kejriwal said there was "no more panic on availability of oxygen".
On Thursday, while 395 patients died, 24,235 new cases were reported.
During the last 24 hours, 73,851 tests were done. Out of them, 32.82 per cent were found to be corona positive. Besides, since Wednesday, 25,615 corona patients in Delhi have also recovered.
So far, a total of 15,772 people have died due to corona virus in Delhi. There are currently 97,977 active corona patients.