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. 

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
News Network
March 25,2020

New Delhi, Mar 25: The total number of confirmed coronavirus cases in India rose to 562, according to the Ministry of Health and Family Welfare on Wednesday.
This includes 512 active cases, while 40 infected people have already been cured or discharged.
The Union Health Ministry said that total deaths due to the disease now stand at 9, as the second death reported in Delhi is COVID-19 negative. One patient has also migrated due to the infection.
The Central government has taken several steps to contain the rapid spread of the virus including the screening 15,24,266 passengers at the airports.
Prime Minister Narendra Modi had on Tuesday announced a 21-day lockdown in the entire country effective from midnight to deal with the spread of coronavirus, saying that "social distancing" is the only option to deal with the disease, which spreads rapidly.
In a televised address to the nation, Prime Minister Modi said that it is vital to break the chain of the disease and experts have said that at least 21 days are needed for it.
The Prime Minister, who had also addressed the nation last week, said the lockdown has drawn a "Lakshman Rekha" in every home and people should stay indoors for their own protection and for that of their families. 

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
The wire
May 20,2020

Bhopal, May 20: Two months after Deepak Bundele, an advocate and former journalist, was brutally assaulted by the Madhya Pradesh’s Betul Police on March 23, an Assistant Sub-Inspector of Kotwali Police Station in Betul district, BS Patel, approached the victim to record his statement. However, he allegedly tried to convince Bundele to withdraw the case saying that the cops had mistaken him for a Muslim since he has a long beard and assaulted him. But, the cop added, they were ashamed of the incident after they came to know that they had beaten their ‘Hindu brother’.
Bundele was on his way to the government hospital for diabetes treatment, a day before the countrywide lockdown was announced, when the assault occurred. Miffed with the incident and after the district police denied to register the case, he wrote to the State Human Rights Commission; Chief Justice of Madhya Pradesh High Court; Chief Minister Shivraj Singh Chouhan; Vivek Johri, Director General of Police, Madhya Pradesh; and SP Betul to register an FIR against the police officials and take punitive action against them.
In the wake of COVID-19 pandemic outbreak, section 144 had been imposed in Betul district and public movement was restricted when the incident had occurred. 
Talking to Bundele, ASI Patel had said, “We seek an apology on behalf of those officials [who assaulted Bundele]. We are truly embarrassed because of the incident. If you want, I can bring those officials and make them apologise in person to you. They mistook you as a Muslim and assaulted you, since you had a long beard. And the man (who assaulted you) is a kattar (staunch) Hindu…In Hindu-Muslim riots whenever a Muslim is arrested, they beat them up brutally, always,” the police official can be heard saying in an audio recording shared by the victim.
In the 14 minutes long audio, he further said, “I request to you to withdraw the complaint. Please agree to our request; understand that we are living in Gandhi’s country; we are all Gandhi’s children…I have at least 50 friends from your caste.”
The cop continued, “All those people are ashamed that they did something like this to a Hindu brother without knowing his identity. We do not have any enmity against you. Whenever there is a Hindu-Muslim riot, police always supports the Hindus; even Muslims know this. But whatever happened with you was because of ignorance. For that, I have no words.” 
Refuting ASI Patel’s claim, Bundele claimed that there was no Hindu-Muslim riot that day, and asked whether he was beaten for being wrongly identified as a Muslim. The police officials agreed, and said: “Yes, exactly.”
“When I constantly declined to withdraw the compliant, he indirectly threatened me saying, ‘Agree to our request, else you and your advocate brother will face consequences’,” Bundele claimed. 
When contacted Betul SP DS Bhadoriya said, “I’m not aware of this audio clip. I will taken strict action, if I receive any such complain.”
Bundele said that he has written to the DGP and other senior police officials with details about the incident.   
THE ASSAULT
On March 23 evening, when Bundele was on his way to a hospital for the treatment, Betul Police allegedly thrashed him. The 32-year-old advocate had worked as a journalist for various dailies in Madhya Pradesh’s state capital for a decade. He moved to Betul in 2017 and started practising in the district court with his brother. “I have been a patient of diabetes and blood pressure for the last 15 years. On March 23, since I was not feeling well, I decided to visit the hospital and get some medicines. But I was stopped by the police midway,” Bundele had said. 
Even though the advocate, who sports a beard, said that he explained to police personnel that he had to get his medicines but one of them slapped him without trying to listen to what he was saying. “When I protested and said that police have no right to beat the public, they got anxious and within no time, many police officials came and started beating me up with sticks,” he added. 
"I need constant medication and lifesaving medicines to survive and I told the policemen everything while they were assaulting me. But, they kept hitting me, even after I fell,” he said, adding, "I bled for almost a 2-3 days after the incident.”
Bundele, sustained multiple injuries and his ear bled for almost two days after the incident, but, Betul police denied to file an FIR in the incident.
‘WILL MOVE TO THE HIGH COURT’
“Even after two months of the incident, no FIR has been registered and it seems that police is trying to sweep the matter under the carpet,” Bundele said, adding, “I have talked to the Supreme Court’s veteran advocate Vivek Tankha and Etasham Hashmi and will take this matter to the court.”
He also raised serious concerns about the communal angle of the incident, saying, “It’s a matter of grave concern that the police is turning communal and targeting a particular community.”

Source: https://www.google.com/amp/s/m.thewire.in/article/communalism/madhya-pr…

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.
Agencies
August 3,2020

New Delhi, Aug 3: President Ram Nath Kovind and Prime Minister Narendra Modi on Monday extended warm greetings and good wishes to the countrymen on the occasion of Rakshabandhan.

The President in his message said, "Greetings on Raksha Bandhan! Rakhi is the sacred thread of love and trust that connects sisters with brothers in a special bond. On this day, let us reiterate our commitment to secure the honour and dignity of women."

"Many wishes to all the countrymen on the auspicious occasion of Rakshabandhan," Prime Minister Modi tweeted in Hindi.

Rakshabandhan, which is being celebrated today, is a celebration of the unique bond between brothers and sisters. Tying of the Rakhi by sisters, symbolises love, affection and mutual trust between brothers and sisters. 

Comments

Add new comment

  • Coastaldigest.com reserves the right to delete or block any comments.
  • Coastaldigset.com is not responsible for its readers’ comments.
  • Comments that are abusive, incendiary or irrelevant are strictly prohibited.
  • Please use a genuine email ID and provide your name to avoid reject.