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A three-month-old baby in <keyword id="1706444" type="PERSON" weightage="20" keywordseo="Basti-district">Basti district</keyword> of <keyword id="6357713" type="LOCATION" weightage="20" keywordseo="Uttar-Pradesh">Uttar Pradesh</keyword> has tested positive for the <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>, becoming the youngest patient in the state. The baby's sample, along with that of his mother, was sent for testing to <keyword id="390728" type="COMPANY" weightage="20" keywordseo="Gorakhpur-Medical-College">Gorakhpur Medical College</keyword> and the reports were received on Monday night in which the baby has tested positive for the virus while the mother's report is awaited. Both have been put in the isolation ward in the hospital. The mother and child are related to the youth who had died due to coronavirus in Gorakhpur on March 30 and live in Millat Nagar area which has been marked as a Covid-19 hotspot. District Magistrate <keyword id="2886175" type="PERSON" weightage="20" keywordseo="Ashutosh-Niranjan">Ashutosh Niranjan</keyword> said that the tally of corona positive cases in Basti is now 14. SEE ALSO: <a href="https://www.businessinsider.in/india/news/data-of-coronavirus-patients-state-wise-in-india/articleshow/74669748.cms">Coronavirus cases in India state wise</a> <a href="https://www.businessinsider.in/topic/coronavirus">Coronavirus News and Updates</a> <a href="https://www.businessinsider.in/india/news/how-to-check-coronavirus-symptoms-at-home/articleshow/74960334.cms">What are the Coronavirus symptoms and how to check for them at home</a>

A three-month-old baby among Coronavirus patients in Uttar Pradesh

After two cases of the <keyword id="11445972" type="UNKNOWN" weightage="20" keywordseo="delta-plus">Delta plus</keyword> strain were found in Deoria and Gorakhpur, a patient has now tested <keyword id="6439681" type="UNKNOWN" weightage="20" keywordseo="positive">positive</keyword> to the <keyword id="2139218" type="ENTERTAINMENT" weightage="20" keywordseo="Kappa">Kappa</keyword> strain of Covid-19 in Sant Kabir Nagar. The patient, a 66-year-old man, has died. The strain was detected during the genome sequencing exercise. His sample was collected on June 13 as a routine and sent to CSIR's Institute of Genomics and Integrative Biology, <keyword id="6358777" type="UNKNOWN" weightage="20" keywordseo="New-Delhi">New Delhi</keyword> that has confirmed the Kappa strain in the sample. Like <keyword id="6383835" type="ORGANIZATION" weightage="20" keywordseo="delta">Delta</keyword> plus, Kappa too has been declared as a variant of concern. Head of microbiology department at <keyword id="6355646" type="UNKNOWN" weightage="20" keywordseo="BRD-Medical-College">BRD Medical College</keyword>, Amresh Singh, said the patient had tested Covid positive on May 27 and was brought to the medical college on June 12. The sample was taken on June 13. "The patient died in the course of treatment on June 14. He had no travel history," Singh said. Health officials said more than 2,000 samples have been sent for genome sequencing from the state. Two cases of Delta Plus strain were recorded for the first time in <keyword id="6357713" type="COMPANY" weightage="20" keywordseo="Uttar-Pradesh">Uttar Pradesh</keyword> this week. Officials said that since none of the three patients had a travel history, it suggests the virus was mutating in the state. SEE ALSO - <a href="https://www.businessinsider.in/tech/news/google-calendars-new-rsvp-option-will-let-you-specify-how-you-want-to-attend-a-meeting/articleshow/84237490.cms">Google Calendar’s new RSVP option will let you specify how you want to attend a meeting</a> <a href="https://www.businessinsider.in/business/corporates/news/tcs-hires-over-20000-in-june-quarter-its-highest-ever-quarterly-addition/articleshow/84240423.cms">TCS has loaded up half a million peeps as it expects many to move on</a>

After Delta Plus, now coronavirus Kappa variant found in Uttar Pradesh

Gorakhpur (UP), Apr 30 () A 34-year-old woman has tested positive for coronavirus in the district, a senior health official said on Thursday. This is the second case in the district after a 50 year-old-man was found positive for the virus, Chief Medical Officer Srikant Tiwari said. The woman had been attending to her ailing father in Delhi's Safdarjung hospital along with her mother and sister. The family returned in an ambulance to Bansgaon village in Gorakhpur on Tuesday and were asked by the village head to report to the district hospital. The ambulance driver left the family at the gate of the district hospital and fled from the spot, officials said. The family was kept in quarantine at the hospital and their samples sent for testing. While the woman has tested positive for coronavirus, the other family members are negative.Gorakhpur Comissioner Jayant Narlirkar said since the woman came directly from Delhi to the district hospital, there is no threat of the virus spreading in the village. The entire family is quarantined since Tuesday and the woman has been admitted to the BRD medical college. Both the cases in the district are connected to Safdarjung Hospital. The man, who had earlier tested positive for coronavirus, was admitted to Safdarjung Hospital and had returned to the district recently. COR SAB DVDV

Gorakhpur records another case of coronavirus

Gorakhpur, Apr 26 () A three-month-old boy who had tested positive for coronavirus and undergoing treatment at a hospital here was on Sunday discharged from the facility, officials said. "The baby and his mother were tested twice for COVID-19 on their arrival at the hospital on April 12. While the mother tested negative, the baby was confirmed positive for the disease," Principal, Baba Raghav Das (BRD) Medical College, Dr Ganesh Kumar said. He said the major challenge before the doctors was not only to cure the baby but also make sure that the infection does not get transmitted to the mother. "The mother was taking care of the baby in an isolation ward and she followed instructions like wearing masks and gloves while breastfeeding the baby and cleaning him," Kumar said. "The baby had no serious complications except fever for which he was initially given medicine. The infant recovered without any medication due to self immunity, which was boosted by feeding of mother's milk only," he said. Kumar said the tests conducted on both the mother and the baby on April 25 and April 26 respectively came negative. The mother has been advised to undertake certain precautions back at home, he said. The mother and the son received a standing ovation from officials, including District Magistrate Vijyendra Pandiyan, Commissioner Jayant Narlirkar, Kumar and others, while leaving the hospital. Corr NAV AQSAQS

Three-month-old boy recovers from COVID-19 in UP's Gorakhpur

Gorakhpur (UP), Jun 20 () The superintendent incharge of the Uttar Pradesh government-run Baba Raghav Das (BRD) Medical College here has tested positive for COVID-19, officials said on Saturday. He had high fever and difficulty breathing for the last four days, Principal Ganesh Kumar said. People who came in his contact are being tracked, Kumar said. According to sources, samples of more than 40 people, including doctors and health workers, have been taken for testing. Meanwhile, Chief Medical Officer Srikant Tiwari said a COVID help desk will be set up at community health centres in the district as per directives of the state government. Paramedical staff will be deployed at the help desks all patients visiting the health facility will be screened with an infrared thermometer. He said strict action will be taken if any case of COVID-19 treatment under an untrained person comes into cognizance. CORR SAB DPB

UP: BRD College's superintendent incharge tests COVID-19 positive

<ul><li>Serum Institute of India will begin human trials of Oxford-AstraZeneca’s COVID-19 vaccine candidate in India today. </li><li>The hospital has been given a target of enlisting 300 to 350 volunteers. Those chosen for receiving a dose of vaccine will be in the age group of 18 to 99 years. </li><li>The other site for phase 2 trial in Pune, BJ Medical College, is ready and waiting for the vaccine candidate to arrive. The human trials there are set to begin there next week. </li><li> On successful completion of the trials at all sites, the vaccine will be launched under the brand name “Covishield” </li></ul>Serum Institute of India will begin human trials of Oxford-AstraZeneca’s COVID-19 vaccine candidate in India today at Bharti Vidyapeeth Medical College and <a href="https://indianexpress.com/article/cities/pune/pune-first-dose-of-covishield-to-be-given-at-bharati-hospital-today-6569763/">Hospital in Pune. </a> "To start with we have identified five volunteers who will undergo COVID-19 and antibodies tests. Those whose reports are negative will be shortlisted for vaccination on Wednesday," told Dr Sanjay Lalwani, Medical Director, Bharti Vidyapeeth''s Medical College and Hospital and Research Centre PTI. The hospital has been given a target of enlisting 300 to 350 volunteers. Those chosen for receiving a dose of vaccine will be in the age group of 18 to 99 years. The other site for phase 2 trial in Pune, BJ Medical College — to which the Sassoon General Hospital is attached — is ready and waiting for the vaccine candidate to arrive. The human trials there are set to begin there next week. SII has selected 14 locations for the trial — <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">The ICMR-Regional Medical Research Centre, Gorakhpur </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Bharti Vidyapeeth''s Medical College and Hospital and Research Centre. </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;"> Jehangir Clinical Development Centre </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Andhra Medical College in Visakhapatnam </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">JSS Academy of Higher Education and Research in Mysuru. </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;"> BJ Medical College </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">AIIMS in Delhi </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Nehru Hospital in Gorakhpur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">PGIMER in Chandigarh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">ABJ Medical College in Pune </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">AIIMS in Jodhpur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">The King Edward Memorial (KEM) in Mumbai </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Nair Hospital in Mumbai </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;"> </td></tr></tbody></table> The vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. The Oxford University vaccine candidate has received permission to start phase-two and three trials in India earlier this month. The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute <a href="https://www.hindustantimes.com/india-news/serum-institute-ties-up-with-bill-gates-foundation-gavi-to-speed-up-covid-19-vaccine-manufacture-process/story-h20YRO9mdooYA8ysqenE9L.html">partnered with </a>Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. According to SII, <a href="https://www.businessinsider.in/science/health/news/serum-institute-may-begin-human-trials-of-oxford-astrazenecas-covid-19-vaccine-candidate-from-august-25/articleshow/77540739.cms">the vaccines will be available as early as the first half of 2021</a> after gaining approvals and qualifications from the World Health Organization (WHO). If successful, Novavax's candidate will be available to all 92 countries, while AstraZeneca's candidate vaccine will be available to 57 Gavi-eligible countries. SEE ALSO: <a href="https://www.businessinsider.in/education/news/heres-a-list-of-instructions-neet-and-jee-aspirants-have-to-follow-during-exam-this-year-according-to-nta/articleshow/77735246.cms">Here’s a list of Instructions NEET and JEE aspirants have to follow during exam this year, according to NTA</a>

Oxford-Astrazeneca COVID-19 Vaccine: Phase II trials will begin in India today

Lucknow, Jul 5 () Uttar Pradesh recorded the highest single-day jump of 1,153 coronavirus cases on Sunday, pushing the infection tally to 27,707, while the death toll in the state reached 785 with 12 fresh fatalities, officials said. A total of 18,761 COVID-19 patients have recovered and discharged from hospitals, Additional Chief Secretary (Home and Information) Awanish Awasthi said. There are now 8,161 active cases in the state, he added. As many as 29,117 samples were tested for coronavirus on Friday, Awasthi said. In Lucknow, samples were tested at King George Medical University and Sanjay Gandhi Post Graduate Institute of Medical Sciences. Tests were also done at Institute of Medical Sciences - Banaras Hindu University in Varanasi, Lala Lajpat Rai Memorial Medical College in Meerut, Baba Raghav Das Medical College in Gorakhpur, Moti Lal Nehru Medical College in Prayagraj, RML hospital in Lucknow, National Institute of Biologicals in Noida and Ganesh Shankar Vidyarthi Medical College in Kanpur, he said. Besides, as many as 2,703 antigen tests were done, the official said. NAV AQS AQS

Highest single-day spike of 1,153 COVID-19 cases in UP; 12 more die in state

<keyword id="6357713" type="LOCATION" weightage="20" keywordseo="Uttar-Pradesh">Uttar Pradesh</keyword> reported its first coronavirus-related death on Wednesday after test reports of a 25-year-old man, who died two days ago, came COVID-19 positive. The man was admitted to the BRD Medical College here on Sunday and he was suffering from kidney and liver problems, the institute's principal <keyword id="251515" type="PERSON" weightage="20" keywordseo="Ganesh-Kumar">Ganesh Kumar</keyword> said. "The sample of the patient was found positive for the <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword>," an official of the <keyword id="188869" type="COMPANY" weightage="20" keywordseo="King-George">King George</keyword>'s Medical University (KGMU) said in Lucknow. The man hailed from Basti in Uttar Pradesh. "Here, six people, including doctors and paramedical staff, who came in contact with the man have been quarantined. The driver of the ambulance and the deceased's brother-in-law in Gorakhpur are also quarantined," District Magistrate <keyword id="8990179" type="PERSON" weightage="20" keywordseo="vijyendra-pandiyan">Vijyendra Pandiyan</keyword> told reporters. The deceased was suffering from liver and kidney ailments for the last three months, college principal Kumar said. "The man was admitted here (BRD Medical College) on Sunday at 3.15 pm and after his death, it was confirmed that he was coronavirus positive," Pandiyan told reporters. "He was being treated at the Basti district hospital and other places for the last three months. He had renal failure and he was immuno-compromised. He was having some breathing problems and as per protocol, his blood sample was taken and sent for test in Gorakhpur and he was found COVID-19 positive," he said. Later, his sample was sent to KGMU Lucknow for a second opinion and there too it was confirmed that he was COVID-19 positive, Pandiyan said. "We have alerted the Basti administration and they are also tracking each person who came in contact or attended the funeral to be send to quarantine. We are trying to establish all links with CCTV camera footage and mobile phone call details to know who came in the contact with the man," he said. SEE ALSO:<a href="https://www.businessinsider.in/india/news/data-of-coronavirus-patients-state-wise-in-india/articleshow/74669748.cms">Coronavirus cases in India state wise</a> <a href="https://www.businessinsider.in/science/health/news/coronavirus-myths-and-facts-here-are-some-rumours-about-covid-19-that-arent-true/articleshow/74487962.cms">Coronavirus myths and facts</a> <a href="https://www.businessinsider.in/science/health/news/coronavirus-dos-and-donts-for-protection-against-convid-19/articleshow/74475858.cms">Do’s and Don’ts for protection against COVID-19</a>

Coronavirus claimed its first victim in Uttar Pradesh

<ul><li>The pharma giant will be meeting principal investigators at 17 different sites across the country. </li><li>Once these formal procedures are completed, SII <a href="https://www.financialexpress.com/lifestyle/health/covid-19-human-trials-of-oxford-vaccine-set-to-begin-in-2-weeks-serum-institute-icmr-members-to-meet-today/2054835/">will begin human trials anytime after August 25. </a> </li><li>The trials will be held at PGIMER Chandigarh, AIIMS in Delhi, ABJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, and 13 other sites in the country. </li></ul>Serum Institute of India is likely to begin human trials of <keyword id="9605255" type="COMPANY" weightage="20" keywordseo="oxford-astrazeneca">Oxford-AstraZeneca</keyword>’s COVID-19 vaccine candidate in India in the next few weeks. The pharma giant is expected to meet principal investigators on August 14 at 17 different sites across the country. The trials will be held at PGIMER Chandigarh, AIIMS in Delhi, ABJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysuru. The virtual meet is going to establish a standard operating procedure for conducting phase 2 and phase 3 clinical trials of the vaccine candidate in India. Once these formal procedures are completed, SII <a href="https://www.financialexpress.com/lifestyle/health/covid-19-human-trials-of-oxford-vaccine-set-to-begin-in-2-weeks-serum-institute-icmr-members-to-meet-today/2054835/">will begin human trials anytime after August 25. </a> SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. The Oxford University vaccine candidate has received permission to start phase-two and three trials in India earlier this month. The Serum Institute of India would introduce candidate vaccines from <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword> and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute partnered with Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. According to SII, the vaccines will be available as early as the first half of 2021 after gaining approvals and qualifications from the World Health Organization (WHO). If successful, Novavax's candidate will be available to all 92 countries, while AstraZeneca's candidate vaccine will be available to 57 Gavi-eligible countries. (With inputs from IANS) SEE ALSO: <a href="https://www.businessinsider.in/india/news/heres-how-indias-74th-independence-day-celebrations-will-take-place-this-year/slidelist/77523536.cms">Here’s how India’s 74th Independence Day celebrations will take place this year</a> <a href="https://www.businessinsider.in/careers/news/how-much-deloitte-kpmg-ey-and-pwc-accountants-and-consultants-make-from-entry-level-to-executive-roles/articleshow/77533447.cms">How much Deloitte, KPMG, EY, and PwC accountants and consultants make, from entry level to executive roles</a> <a href="https://www.businessinsider.in/science/news/a-dwarf-planet-between-mars-and-jupiter-has-a-salty-ocean-beneath-its-surface-making-it-a-contender-for-alien-life/articleshow/77495476.cms">A dwarf planet between Mars and Jupiter has a salty ocean beneath its surface, making it a contender for alien life</a>

Serum Institute may begin human trials of Oxford-AstraZeneca’s COVID-19 vaccine candidate from August 25

Mahrajganj (UP), Apr 30 () A man who had recently returned from Delhi tested positive for novel coronavirus in Uttar Pradesh's Mahrajganj district, which had not reported any infection for over three weeks, an official said. District Magistrate Ujjwal Kumar said the sample of the man, who had returned from Delhi six days ago to his native Ratanpurwa village in Paniyara area, tested positive in the report received from the Gorakhpur medical college late on Wednesday. "The family members and all those who came in contact with him will be quarantined. The entire area has been sealed and sanitised," Kumar said. The district had not reported any new COVID-19 case after six people had tested positive on April 4. Maharajganj was declared having zero active cases after the recovery of the six patients. COR SABHMB

New COVID-19 case in Maharajganj

Santkabirnagar (UP) Apr 25 () Nineteen people including 18 members of an extended family have tested positive for coronavirus in the district and have been admitted to hospital, a senior administrative officer said on Saturday.A student of the Darul Uloom Deoband seminary who had come to the district last month had tested positive for coronavirus earlier this week. His family members and close relatives were subsequently kept in quarantine and their samples were sent for testing, of which 18 have been found to be positive, District Magistrate Ravish Kumar Gupta said.One person from Tilathi village in Bakhira police station area has also tested positive for the virus, Gupta said.This patient had recently returned from Mumbai. His sample was sent to Gorakhpur medical college and the report was received Saturday, the DM said, adding that his family members have been quarantine and their samples sent for testing.The District Magistrate said with these new cases, the number of coronavirus positive patients in the district was now 21.The areas from where these cases have been reported have been sealed off, he added. COR SAB RDMRDM

18 family members, another person test positive for coronavirus

By Payal Banerjee (Eds: Adds details) New Delhi, Aug 3 () The Drugs Controller General of India (<keyword id="172241" type="ORGANIZATION" weightage="20" keywordseo="DCGI">DCGI</keyword>) has given nod to the <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword> candidate in the country. Government officials told that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on <keyword id="8763838" type="UNKNOWN" weightage="20" keywordseo="covid-19">COVID-19</keyword>. "The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said. "As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said. As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India, the officials said. Currently, phase 2 and 3 clinical trials of the <keyword id="8973295" type="COMPANY" weightage="20" keywordseo="oxford-vaccine">Oxford vaccine</keyword> candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa. The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information. The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India. According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore. "According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said. The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for COVID-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said. To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. PLB ANB ANB

DCGI gives nod to Serum Institute of India for phase 2 and 3 human clinical trials of the Oxford COVID-19 vaccine candidate

By Rana Ajit New Delhi, Apr 20 (): A recent assessment by the Uttar Pradesh government termed the state of the lockdown "unsatisfactory" in 40 of the 75 districts and called for stricter enforcement there of the restrictions to fight coronavirus. The districts in the "unsatisfactory" category include capital Lucknow, Gautam Buddh Nagar, Ghaziabad, Bulandshahr, Allahabad, Varanasi and Kanpur. Sources said Additional Chief Secretary (Home) Awanish Awasthi sent the assessment to district magistrates and police chiefs of all 75 districts in the state on April 18, two days before the planned implementation of a set of relaxations in the nationwide lockdown. An annexure listed all districts, describing the lockdown there as "unsatisfactory" or "satisfactory". The table also carried remarks, giving an indication of the reasons why a district got the "unsatisfactory" rating. These included the number of COVID-19 patients in the district, law and order violations, lack of coordination between different agencies and the detection Tablighi Jamaat members who might have spread the virus after their congregation in Delhi . "Satisfactory" districts in eastern Uttar Pradesh included Chief Minister Yogi Adityanath's stronghold Gorakhpur, Ballia, Deoria and Maharajganj. "In this list, the lockdown situation in many districts of the state has been described as unsatisfactory, which makes it clear that the lockdown is not being enforced strictly in those districts," Awasthi's letter said. It called for "stricter enforcement" of the lockdown on the basis of the remarks made in the list. The 35 districts where lockdown and slowing down of COVID-19 spread have been found satisfactory include Aligarh, Etah, Hathras, Kasganj, Pilibhit, Shahjahanpur and Hardoi. Lucknow is in the "unsatisfactory" category. Remarks mention a large number of COVID-19 patients (93 when the assessment was made) and Jamaat participants (159). The letter also said there was lack of coordination in policing there. In Gautam Buddh Nagar, it mentioned 67 confirmed cases, 82 Jamaatis, lack of coordination in policing and the suicide by a suspected coronavirus patient. In "unsatisfactory" Agra, there was lack of coordination between the principal and doctors at the S N Medical College. When the note was prepared, 152 people had tested positive for coronavirus there and 60 Tablighi Jamaat members were detected. In Mathura, the list flagged an agitation by migrant labourers staying at a cold storage facility. RAX ASHASH

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