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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March 24,2020

New Delhi, Mar 24: Thirty-two states and Union Territories (UTs) have announced complete lockdown to check the spread of the coronavirus in the country, informed the Central government on Tuesday.
There is a complete lockdown in as many as 560 districts of the country affecting several hundred million people.
Earlier, the complete lockdown was imposed in 30 districts, as of now, almost the entire country is in lockdown to restrict public movement in an attempt to break the chain of transmission of coronavirus.
Three states -- Uttar Pradesh, Madhya Pradesh and Odisha -- have announced lockdown in select districts with the governments continuously monitoring the situation and ready to extend the restrictions to other districts as well.
The Union Territory of Lakshadweep has announced restrictions on certain activities.
The Indian Railways has suspended all passenger train operations till March 31 in view of coronavirus.

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News Network
May 2,2020

New Delhi, May 2: With 2,293 new cases in the last 24 hours, the highest number of cases in a single day, India's COVID-19 tally reached 37,336 on Saturday, including 1,218 deaths, according to the Ministry of Health and Family Welfare.
As many as 71 deaths were reported in the last 24 hours.

Out of the total number, 9,951 people have been cured/discharged/migrated.

In the state of Maharashtra, the number of coronavirus positive cases has crossed the 10,000-mark with at least 485 deaths.

The positive cases in Maharashtra has reached 11,506, including 1,879 discharged cases.

After Maharashtra, Gujarat has the most number of COVID-19 cases (4,721). The state has reported 236 deaths, while 735 people have been discharged.

The Centre on Friday extended the ongoing nationwide lockdown for two more weeks with effect from May 4 till May 17 while allowing different sets of relaxations in red, orange and green zones.

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News Network
July 22,2020

New Delhi, Jul 22: Congress leader Rahul Gandhi termed the BJP-led Uttar Pradesh government as 'goonda raj' (rule by hooligans), hours after Ghaziabad-based journalist Vikram Joshi succumbed to bullet injury he received from a group of men, who had allegedly harassed the scribe's niece.

"Journalist Vikram Jashi was killed after he protested against the harassment against his niece. My condolence to the family. They promised Ram Raj, but gave Goondaraj," Gandhi tweeted.

"Is it the same Ram Rajya that BJP promised after it came to power? This is complete 'Goondaraj'. Neither journalist, nor those who protect the law are safe in UP, so how can the common man expect justice," tweeted his party colleague Randeep Surjewala.

Expressing his shock over the incident, party leader and lawyer Abhishek Singhvi said, "Shocking jungle raj in #Ghaziabad area with journalist #Joshi, already known as the complainant in #FIR, being shot on a scooter while with his daughters, struggling in a coma with a bullet in the skull! Thank God daughters not hit. Shocking, scary, disgusting lack of fear of law & order! #UP."

Ajay Kumar Lallu, Congress president in the state added, "The Ghaziabad incident has shocked the entire state. It's a tragic incident. Nobody is safe in Uttar Pradesh. If it is not jungle raj then what is. The government remains silent while criminals are becoming more active. While leaving home in the morning, people in the state worry whether they will be able to return in the evening or not."

In the meantime, the Station in-charge has been suspended and a departmental inquiry has been ordered after the journalist's family accused the police of inaction. A total of nine accused have been taken into the custody, while efforts are on to nab another accused.

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