Serum Institute of India gets nod for phase 2,3 trials of Oxford covid vaccine

Agencies
August 3, 2020

The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said 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 Covid-19.

"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 Oxford vaccine 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. 

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News Network
March 25,2020

Chennai, Mar 25: Tamil Nadu reported its first Covid-19 death at the Rajaji Government Hospital in Madurai this morning. The 54-year-old man from Madurai had no history of travel to any coronavirus-affected state or country.

However, he did have contact with two Thai nationals who had tested positive for Covid-19 and are undergoing treatment in isolation in Erode.

"Despite our best efforts, the #COVID-19 +ve Pt at MDU, #RajajiHospital, passed away few minutes back. He had medical history of prolonged illness with steroid-dependent COPD, uncontrolled Diabetes with Hypertension,” Tamil Nadu health minister C. Vijayabaskar tweeted.

The patient tested positive for the coronavirus on March 23. Yesterday the minister had disclosed that the patient had not responded well to treatment due to his medical condition. “He has a medical history of prolonged illness with steroid dependent COPD, uncontrolled diabetes with hypertension,” he said.

As of Wednesday morning, the total number of Covid-19 infected patients in Tamil Nadu was 18, including one patient who has recovered.

The latest patients include a 65-year-old man who returned from New Zealand and is currently in isolation at a private hospital, a 55-year-old woman from Saidapet who is currently in quarantine Kilpauk Medical College Hospital, and a 25-year-old who returned from London and is undergoing treatment at the Rajiv Gandhi Government General Hospital.

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News Network
April 4,2020

Kochi, Apr 4: France on Saturday evacuated 112

French citizens stranded in Kerala and Tamil Nadu in a special Air India flight, official sources said here.

The Embassy of France had made a request to the Kerala government to facilitate the journey of the French citizens stranded due to the lockdown announced by the central government to prevent the spread of novel coronavirus.

The French citizens, mostly tourists and those who came for Ayurvedic treatment, were brought here by the state tourism department 24 days ahead of their trip.

They underwent a medical examination before boarding the flight for Paris from Cochin International Airport at 08.13 am on Saturday, officials said.

The Air India flight was chartered by the French government for evacuating its citizens in various cities in India including Kochi, Bengaluru and Mumbai.

On Friday, Gulf nation Oman had evacuated its 46 citizens stranded in Kochi in an Oman Air flight.

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Agencies
March 12,2020

The Ministry of Health and Family Welfare has prepared a draft for guidelines for home quarantine, as well as for the use of masks by public, in view of coronavirus.

What to do in Home Quarantine?

The government says, for those taking refuge to home quarantine should stay in a well-ventilated single-room preferably with an attached or separate toilet. It adds that if another family member needs to stay in the same room, it's advisable to maintain a distance of at least 1 metre between the two.

The government advised, coronavirus patients to stay away from elderly people, pregnant women, children and persons with co-morbidities within the household as their immune system may be low. The health minister also suggested to restrict the patient's movement within the house. "Under no circumstances attend any social/religious gathering e.g. wedding, condolences, etc, said the guideline.

It also instructed the corona virus infected person to avoid sharing household items like dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with others at home. The guideline also demanded that even though home quarantine, the patient should wear a surgical mask at all times. "The mask should be changed every 6-8 hours and disposed off. Disposable masks are never to be reused, it added.

"Masks used by patients/ caregivers/ close contacts during home care should be disinfected using ordinary bleach solution (5 per cent) or sodium hypochlorite solution (1%) and then disposed of either by burning or deep burial," instructs the government.

Even for family members of a patient, the health ministry clearly instructs to use disposable gloves when cleaning the surfaces or handling soiled linen. No visitors, under any circumstances will be allowed, said the guideline.

"In case the person being quarantined becomes symptomatic, all his close contacts will be home quarantined (for 14 days) and followed up for an additional 14 days or till the report of such case turns out negative on lab testing," states the draft.

How to wear & dump masks?

There is a specific and elaborate do's and don'ts also released by the ministry. For those unsure in which mask to choose, it says, "Medical masks of different sizes and shapes are available in the market. The common ones are flat pleated masks of woven fabric which covers the nose and mouth and affixed behind the head with straps/ elastic fasteners. There are also conical or duck bill shaped masks with valves (or without valves) that fit in the contour of face over the nose and mouth, but are costlier."

However, the ministry warns, medical masks should not be used by healthy persons who are not having any symptoms "because it creates a false sense of security". Instead, it suggests to refrain from touching face, mouth, nose and eyes as well as washing hands regularly with soap for 20 seconds each time.

However, when a person develops a cough or fever, the suspected patient needs to switch to medical masks. "Use of medical three layer masks when ill, will prevent your infection from spreading to others. However you also need to wash your hands frequently to avoid spreading infection to others," read the guideline.

Even if one is not tested positive but showing symptoms, they are advised to wear masks while visiting a healthcare facility. "Close family contacts of such suspect/confirmed cases undergoing home care should also use Triple layer medical mask," it warns.

The ministry has also given point by point guideline on how to use a mask like to make sure that they are facing down while unfolding or for that matter to ensure there are no gaps on either side of the mask.

It even warns, "Fit flexible nose piece (a metallic strip that can easily be located) over nose-bridge" to ensure no one else are infected. The government also warns against simple dumping of the masks once used. Instead one should disinfect "using ordinary bleach solution (5 per cent) or sodium hypochlorite solution (1 per cent) and then disposed of either by burning or deep burial," says the Health Ministry.

COVID-19 emerged in early December 2019 in China's Wuhan province and has now spread to over 100 countries. As on March 9, 2020, India has reported 42 cases mostly among those who had travelled from affected countries.

However the government says, "It causes a minor illness in majority of patients with symptoms of fever and or cough. A small proportion of such persons may progress to severe disease with difficulty in breathing."

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