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<ul><li><keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> is the first <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">COVID-19</keyword> vaccine to get DGCI’s (Drug Controller General of India) nod. </li><li>The drug regulatory body allowed the pharma company to conduct phase I and phase-II clinical trials. </li><li>The vaccine was developed in collaboration with the National Institute of Virology, <keyword id="9487562" type="COMPANY" weightage="20" keywordseo="indiancouncil-of-medical-research">IndianCouncil of Medical Research</keyword> (<keyword id="6364396" type="UNKNOWN" weightage="20" keywordseo="ICMR">ICMR</keyword>). </li><li>The human trials of Covaxin are likely to begin in July. </li><li>According to the World Health Organisation (WHO), there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase. </li></ul>India, on Monday (June 29) got the approval for conducting human trials of a potential coronavirus vaccine. Covaxin — developed by the Indian vaccine and bio-therapeutics manufacturer Bharat Biotech — is the first COVID-19 vaccine to get DGCI’s (Drug Controller General of India) nod. The drug regulatory body allowed the pharma company to conduct phase I and phase II clinical trials. <div type="twitter" handle="BharatBiotech" handlename="BharatBiotech" image="http://pbs.twimg.com/profile_images/1100655759069720576/FTMGdOoj_normal.png" favoritecount="1314" retweetcount="677" status="COVAXIN™, India's 1st indigenous Covid-19 vaccine, developed by Bharat Biotech successfully enters human trials.… https://t.co/Q6X8uJVrHK" createdat="1593453110000" id="1277661065002676224"></div> The human trials of the vaccine — which was developed in collaboration with the National Institute of Virology, IndianCouncil of Medical Research (ICMR) — are likely to begin in July. The development comes after Bharat Biotech showed the results of pre-clinical studies of the potential vaccine, ensuring safety and immunity response. The company says that they completed pre-clinical studies in two months — after the regulatory approval. “The collaboration with and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project,” Krishna Ella, Chairman and MD of Bharat Biotech <a href="https://indianexpress.com/article/india/bharat-biotechs-covid-vaccine-1st-in-india-to-get-approval-for-human-trials-6482403/">told</a> the Indian Express. The drug manufacturer said that the vaccine has been developed in a high containment facility in Hyderabad. “Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling the future pandemics,” Ella <a href="https://www.timesnownews.com/health/article/india-s-first-covid-19-vaccine-covaxin-gets-dcgi-approval-for-clinical-trials/613790">added</a>. Scientists across the globe are now working towards a vaccine faster than ever. As many as 86 teams are presently working to come up with a Covid-19 vaccine including those undergoing clinical trials. <a href="https://www.hindustantimes.com/india-news/vaccine-by-bharat-biotech-first-to-get-human-trials-nod/story-Ha2bWTuHXIgh7xPDr6AyfN.html">According to</a> the World Health Organisation (WHO), there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase. Coronavirus infection has already cost over 16,475 lives in India and the world is now waiting with bated breath for a vaccine. Zydus Cadila, Serum Institute of India and other Indian pharma giants are also working to develop COVID-19 vaccines. According to the Ministry of Health and Family Welfare, the total COVID infections spiked to 548,318, as on June 30. See also: <a href="https://www.businessinsider.in/international/news/who-says-the-coronavirus-pandemic-is-far-from-over/articleshow/76702071.cms">WHO says the coronavirus pandemic is far from over</a> <a href="https://www.businessinsider.in/india/news/unlock-2-no-bar-pass-for-inter-state-travel-home-secretary-to-states/articleshow/76701922.cms">Unlock 2: No bar, pass for inter-state travel, Home Secretary to states</a>

An Indian COVID-19 vaccine made by Bharat Biotech is set to enter human trials

<ul><li>ICMR, on Sunday (July 5) said that it has not set any deadline for the <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword>. </li><li>The aim is to conduct clinical trials as quickly as possible, given the urgency and uncertainty of the global pandemic, it said. </li><li>Experts believe that vaccine development takes a lot of time as it undergoes several phases and clinical trials — and it is nearly impossible to adhere to the deadline. </li><li>This was after the DCGI approved to conduct human trials of <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> — developed jointly by <keyword id="149108" type="COMPANY" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>, National Institute of Virology and the IndianCouncil of Medical Research (ICMR).</li></ul>Much like the rest of the world, India too is waiting with bated breath for a COVID-19 vaccine. Drug Controller General of India’s (DCGI) approval to conduct human trials of Covaxin — developed jointly by Bharat Biotech, National Institute of Virology and the IndianCouncil of Medical Research (ICMR) ⁠— has sparked hopes but then a circular last week turned that hope into fear of rushed process. The biomedical research body told the trial centres that it wanted to<a href="https://www.businessinsider.in/science/health/news/icmr-aims-to-launch-covaxin-covid-19-vaccine-by-august-15/articleshow/76765732.cms"> launch the vaccine </a>by August 15, 2020. It was an audacious target and ICMR faced much flak from experts. <div type="twitter" handle="BiIndia" handlename="Business Insider India🇮🇳" image="http://pbs.twimg.com/profile_images/1232926719016718336/sfffJHNV_normal.jpg" favoritecount="13" retweetcount="3" status="#WATCH | India’s #ICMR wants to launch a vaccine by August 15, risking rushed trials and approvals. @kiranshaw ex… https://t.co/McwlQcUMwr" createdat="1593958856000" id="1279782320153587713"></div> However, ICMR, on Sunday (July 5) said that it has not set any deadline for the vaccine. The idea is to conduct clinical trials as quickly as possible, given the urgency and uncertainty of the global pandemic, it said. “Our internal communication is being misinterpreted. We only said that we envisage to have a vaccine by 15 August and it is not a deadline. We have not said that we will launch a vaccine by then. The process can be expedited but the vaccine still will have to undergo all safety clinical trials," Mint<a href="https://www.livemint.com/news/india/haven-t-set-15-aug-as-deadline-for-covid-19-vaccine-says-icmr-11593996663185.html"> reported </a>citing an ICMR official. “Our trials will be done following the best practices and will be reviewed by a data safety monitoring board," ICMR added. The path ahead for COVAXIN On July 2, ICMR Director Balram Bhargava, in a letter, asked Bharat Biotech to accelerate the clinical trials of Covaxin. It also directed companies to grant approvals related to trials quickly. According to reports, as many as 1,125 people will undergo Covaxin trials — and the recruitment of these candidates will begin from July 7. Gillurkar Multispeciality Hospital in Nagpur, which is one of the selected 12 institutes to conduct the trials, said that they haven’t got the vaccine yet to start the process. Even the candidates for human trials have not been selected yet. “We will start screening patients from Tuesday. Their samples will be sent to a Delhi laboratory and the report will come in three days. We will then recruit healthy volunteers,” <a href="https://www.business-standard.com/article/current-affairs/august-15-deadline-for-covaxin-impossible-to-achieve-say-trial-sites-120070600041_1.html">said </a>Dr Chandrasekhar Gillurkar of Gillurkar Multispeciality Hospital. The human trails will happen in two phases. Gillurkar said that, after the first dosage is given, the waiting period will be around 14 days before the second dose can be given to those candidates. They will again be checked after 14 days to assess the immune system and if they have developed antibodies. So, the entire process will be completed in over 28 days. According to the Union Science &amp; Technology Ministry, six Indian pharma companies are working to develop a COVID vaccine. It also said that these vaccines may not be ready for use until 2021 — and later <a href="https://timesofindia.indiatimes.com/india/no-coronavirus-vaccine-before-2021-science-ministry-says-in-release-deletes-it/articleshow/76804617.cms">backtracked the mention of the deadline</a>. Globally, there are 13 vaccines undergoing clinical trials as of now. While 129 are in the pre-clinical evaluation phase, a<a href="https://www.hindustantimes.com/india-news/vaccine-by-bharat-biotech-first-to-get-human-trials-nod/story-Ha2bWTuHXIgh7xPDr6AyfN.html">ccording to</a> the World Health Organisation (WHO). See also: <a href="https://www.businessinsider.in/science/health/news/icmr-aims-to-launch-covaxin-covid-19-vaccine-by-august-15/articleshow/76765732.cms">India wants a COVID-19 vaccine by August 15 at the risk of rushing trials and approvals</a> <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-may-hit-the-indian-market-by-the-end-of-the-year-if-successful-says-ceo-of-worlds-largest-vaccine-manufacturer/articleshow/76763833.cms">Oxford COVID-19 vaccine may hit the Indian market by the end of the year if successful, says CEO of world’s largest vaccine manufacturer</a> <a href="https://www.businessinsider.in/india/news/an-indian-covid-19-vaccine-made-by-bharat-biotech-is-set-to-enter-human-trials/articleshow/76702286.cms">An Indian COVID-19 vaccine made by Bharat Biotech is set to enter human trials</a>

ICMR ‘clarifies’ that August 15 was not a deadline for COVID-19 vaccine after experts called out how impossible it was

Thiruvananthapuram, Apr 23 () The premier Sree ChitraTirunal Institute for Medical Sciences and Technology here hasdeveloped an innovative technology to isolate RNA from swabsamples and enhance the chances of identifyingCOVID-19positive cases, days after it announced a cheaper and fasterdiagnostic test kit to confirm the disease.The "Chitra Magna" kit uses mangentic nanoparticle tocapture and concentrate the ribonucleic acid (RNA) from thepatient's swab sample and the institute has filed for patentfor this technology which is simpler than imported ones, itsaid.Barring a few domestic manufacturers, the majority of RNAisolation kits are imported and its non-availability oftenbecomes a severe bottleneck for RT-PCR (Reverse transcriptase-Polymerase chain reaction) testing in large numbers across thecountry, a release from the institute said.The kit can be deployed for both PCR and Chitra GeneLAMP-N, the much cheaper and faster diagnostic kit developedby it recently, for tests to detect COVID-19 which has claimedover 700 deaths in the country.Dr Anoop Thekkuveettil and his team, which came up withChitra GeneLAMP-N, has developed Chitra Magna, SCTIMST, anInstitution of National Importance under the Union Departmentof Science and Technology, said. It said the SARS-COV-2, the causative virus of coronaviruspandemic, is a virus that uses RNA, a long single strandedpolymeric substance present in all living cells and carriesthe genetic information of the organism necessary for life.One of the critical steps in detectingthis virus is byconfirming the presence of the RNA of the virus in the sampletaken from the throat or nose.In the lab, the RNA of SARS-CoV-2 is extracted, convertedinto DNA and amplified using the PCR technique or LAMPtechnique, the release said. "Chitra Magna" would give a significant advantage in theextraction as even if some viral RNA disintegrates duringstorage and transportation of the samples, all of it iscaptured by the magnetic bead-based extraction technology. The magnetic nanoparticle beads bind to the viral RNA andwhen exposed to a magnetic field, gives a highly purified andconcentrated level of RNA.As the yield of PCR or LAMP test is dependent on gettingadequatequantity of viral RNA, this innovation enhances thechances of identifying positive cases, the release said. 'Chitra Magna' can be usedto extract high purity RNAfrom patient samples not only for LAMP testing, but also forRT-PCR test, the release said.The technology of 'Chitra Magna' has been transferred tothe Agappe Diagnostics Ltd at Kochi.The company has already taken the Chitra GeneLamp foridentification of the N gene of SARS-COV-2, a potentialconfirmatory test with accuracy matching RT-PCR in its initialvalidation at National Institute of Virology by the IndianCouncil of Medical Research.The test kits are now being validated in larger testsamples for ICMR approval, followed by commercialmanufacturing license from authorities concerned.Last week, the institute has announced it has developedthe Chitra Gene LAMP-N test kit which is highly confirmatoryfor the diagnosis of COVID-19 using reverse transcriptaseloop-mediated amplification of viral nucleic acid (RT-LAMP).The test kit which is highly specific for SARS-CoV-2N-gene can detect two regions of the gene which will ensurethat the test does not fail even if one region of the viralgene undergoes mutation during its current spread, it hadsaid adding the ICMR approval for it was awaited. UDVS VS

Premier medical institute in Kerala develops RNA extraction kit for COVID-19

Amaravati (AP), Apr 8 (): Rapid testing kits beganrolling out from the state-run Andhra Pradesh Medi-Tech Zone(AMTZ) as demand for these grew exponentially consequent tothe spread of the novel coronavirus in the country, the stategovernment said on Wednesday. Chief Minister Y S Jagan Mohan Reddy formally launched thekits at his camp office on Wednesday. AMTZ is an enterprise under the Andhra Pradesh government,dedicated for medical device manufacturing and the IndianCouncil of Medical Research has recently approved the kits tobe manufactured at the zone in Visakhapatnam. Special Chief Secretary (Industries and Commerce) RajatBhargava handed over the first set of 1,000 rapid testingkits, manufactured at the AMTZ, to his counterpart in thehealth department K S Jawahar Reddy in the presence of theChief Minister and Industries Minister M Goutham Reddy. Later, the Industries Minister told reporters that theAMTZ started manufacturing 2,000 testing kits per day and itwould soon be scaled up to 25,000 units a week from nextmonth. The Minister said about 20 tests could be carried out witheach kit daily and would cost Rs 1,200 for the government.DNA, RNA, PCR tests could also be performed using thesekits and the result obtained in 55 minutes.From April 15, for the first time in the country,assembling of ventilators would also commence at the AMTZ,with an initial capacity of 3,000 per month.It would later be increased to 5,000 a month, GouthamReddy added.The Central government has already placed an order for3,500 ventilators, the Minister said. DBVVS VS

AP govt-owned AMTZ rolls out rapid COVID-19 test kits

Panaji, Apr 14 () Goa Health Minister VishwajitRane on Tuesday said air travellers will not be allowed toenter the coastal state without a health certificate, afterthe Centre opens up airports once the COVID-19 lockdown iseased or lifted.Speaking to , Rane said he had already urged ChiefMinister Pramod Sawant to take up the issue with the UnionCivil Aviation ministry to not allow air travellers to enterthe state without a COVID-19 certificate.The Civil Aviation Ministry can inform the airlinesabout this condition."Each state has powers to enforce its own rules tocontain the spread of COVID-19," he said.Even if all COVID-19 patients in Goa are cured of theinfection, the authorities will not relax, he said, addingthat the state plans to ramp up its testing facilities intalukas to widen the scope. As many as 10 rapid testing booths will be set up atindustrial estates and state borders, the health ministersaid."Even if the number of positive cases comes to zero inthe state, the challenge will not end. In keeping with theguidelines of the Epidemic Act, we will make masks compulsoryin public spaces," he said.Goa may not detect new cases, but this lean periodwill be used to ramp up testing facilities, he said.Rane further said that he had directed the healthsecretary to formulate a protocol for random testing."We have to ensure that the guidelines of the IndianCouncil of Medical Research are followed," he added. RPSARU ARU

Tourists will need COVID-19 certificate to enter Goa: Minister

(Eds: Adding more inputs)Kolkata, May 11 () An association of doctors inWest Bengal has shot off letters to the Union health ministryand Chief Minister Mamata Banerjee, making a case for a relookat the revised policy for discharge of coronavirus patientsand setting up dedicated critical care units in COVID-19hospitals of the state.Noting that different strains of the coronavirus areprevailing across the country with non-identical morbidity andmortality profile, the Left-backed Association of HealthService Doctors (AHSD) said in its missive to Union healthminister Harsh Vardhan that the Centre's discharge guidelinescannot be uniformly exercised everywhere.The revised discharge policy for COVID-19 casesannounced by the ministry in consulation with the IndianCouncil of Medical Research (ICMR) had said coronavirus-infected patients developing severe illness or havingcompromised immunity will have to test negative through thereverse transcription polymerase chain reaction (RT-PCR)before being discharged by a hospital. However, moderate cases of COVID-19 and pre-symptomatic, mild and very mild cases need not undergo testsbefore being discharged after resolution of symptoms."As Gujarat, Maharashtra, Delhi are flooded with caseswith perceived scarcity of beds and apparatus, and too highbed occupancy rate, the ICMR's recentmost discharge protocoland advisory on quarantine stay may be applicable there havingno other alternative."But in West Bengal and many other states wheregeographical spread is not yet established, dischargingconfirmed cases without.... sampling can't be the choice.Asymptomatics may potentially transmit the virus," the letter,dated May 10, said.According to the previous set of rules, a COVID-19patient was considered fit to be discharged upon testingnegative on day 14 and then again in a span of 24 hours.The AHSD urged the central government to take upstate-specific focused intervention with the ICMR.In its communication to Banerjee, the associationvoiced concern that the coronavirus situation may spin out ofcontrol in the state if appropriate steps such as dedicatedcritical care units (CCUs) for serious coronavirus patientsare not developed in all COVID-19 hospitals."COVID hospitals in Kolkata and Howrah are alreadyoverflowing with patients. Reports are coming that not enoughspace is available for even properly keeping the corpses," theletter said.While "lack of infrastructure and human resources" inthe district-level COVID-19 hospitals is worrying, "The CCUfor serious patients has not been developed in most of thehospitals except Beleghata ID and MR Bangur Hospital. Thenumber of beds in these two hospitals is limited, too," thegovernment service doctors' body said.The association said that non-COVID services inhospitals have almost collapsed with OPDs, cancer and dialysistreatment having "practically stopped" or continuing "on ameagre scale."The AHSD, in its letter to the Union health ministry,added that "it has been experienced that coronavirus patientswith mild symptoms or no symptoms are not encouraged for homeisolation by their family and close relatives". SUS MM SBNRBT RBT

Doctors' body urges Centre to reconsider revised COVID-19 discharge policy

Kolkata, Apr 17 () The Calcutta High Court onFriday asked the West Bengal government to give a deeper lookinto the requirement of more samples being tested on "warfooting" for identification and treatment of COVID-19patients, as the state told it that more than 300 samples arebeing tested daily at present.Hearing a PIL in connection with the situation in WestBengal over the COVID-19 pandemic spread, a division benchcomprising Chief Justice T B N Radhakrishnan and JusticeArijit Banerjee directed the state government to report to iton the acceleration of the rate of sample collection andtesting in adherence to the ICMR testing protocol and WHOguidelines."We are of the view that it is necessary that theofficial respondents (West Bengal government) give a deeperlook to the requirement of more number of samples beingcollected and subjected to tests on war footing," thedivision bench said.In a report placed before the high court on Friday asper its direction, the state health secretary said that as thenumber of testing laboratories in West Bengal increased, therehas been a steady rise in the number of tests being conducted. The bench noted that neither the report indicates, northe petitioner claims that there has been any community spreadof the disease in the state, observing that such spread of thevirus "has to be prevented at all costs." The report stated that this figure is expected toincrease in the days ahead.On allegations made by senior counsel Bikash RanjanBhattacharya, representing the petitioner, about the manner ofcertification and the auditing of the reason for death beforeissuing the death certificate, the court said that it expectsthe government to place their response in this regard with theviews of the health personnel concerned.The report placed by the health secretary said thatthere are seven testing laboratories - five government and twoprivate - for sample testing for the virus and that there areseveral more which are in the process of being developed.The report said that currently, as a result of therise in the number of ICMR-approved laboratories in the statefrom one to seven, more than 300 samples are being testeddaily and that "this figure is expected to increase in thedays ahead.The state was also asked to place a report on thepetitioner's allegation that there is deficit in facilitiesfor the protection and safety of doctors, nurses, paramedicalpersons and other health service-oriented persons coming intoregular close contact with COVID-19 patients and with thosesuspected to have contracted the disease.The state was also directed to file its response onwhether WHO (World Health Organisation) and ICMR (IndianCouncil of Medical Research) guidelines and advisories arebeing followed by all stakeholders, including the stateadministration. The report by the state government said that it hasissued an advisory on April 13 in which all symptomaticcontacts, whether primary or secondary, and all asymptomaticprimary contacts of COVID-19 positive patient, have beenadvised to be tested as per ICMR guidelines.The report placed by the state Health secretary deniedalleged deficiency in the supply of personal protectiveequipment (PPEs). "As of April 16, a total of 2,58,805 PPEs, 1,52,460N95 masks, 4,53,775 two-layered masks, 9,17,750 three-layered masks, 4,75,000 gloves and 53,769 litres of sanitizerhave been supplied to the health facilities in the state," thereport said. The division bench directed the state government tofurnish the details and information asked for by it in theform of an affidavit by the next date of hearing, which itscheduled on April 23.Senior counsel Bikash Bhattacharya, appearing forpetitioner Fuad Halim had on Thursday told the court that theguidelines issued by the WHO and the ICMR for tackling theissue of COVID-19 are not being adhered to by the state ofWest Bengal.The division bench had then directed the West Bengalgovernment to file a report within a day on the allegations. AMRNN NN

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An Indian COVID-19 vaccine made by Bharat Biotech is set to enter human trials

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ICMR ‘clarifies’ that August 15 was not a deadline for COVID-19 vaccine after experts called out how impossible it was

Prerna Sindwani

Premier medical institute in Kerala develops RNA extraction kit for COVID-19

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AP govt-owned AMTZ rolls out rapid COVID-19 test kits

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Tourists will need COVID-19 certificate to enter Goa: Minister

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Doctors' body urges Centre to reconsider revised COVID-19 discharge policy

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HC wants WB govt to look into need for raising COVID-19 tests on war footing

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