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.
Agencies
September 27,2020

01142147.jpg

Chandigarh, Sept 27: The Shiromani Akali Dal has quit the BJP-led National Democratic Alliance (NDA) over the farm Bills issue, SAD chief Sukhbir Singh Badal announced Saturday night.

He made the announcement after holding a core committee meeting of the party in Chandigarh.

The highest decision-making body of the Shiromani Akali Dal core committee at its emergency meeting here tonight decided unanimously to pull out of the BJP -led NDA alliance, he said.

According to a party statement issued here, he said the decision to quit the NDA was taken because of the Centre's stubborn refusal to give statutory legislative guarantees to protect assured marketing of farmers crops on MSP and its continued insensitivity to Punjabi and Sikh issues like excluding Punjabi language as official language in Jammu and Kashmir.

The SAD becomes the third major NDA ally to pull out of the grouping after the Shiv Sena and the TDP.

Badal said the SAD will continue to stand by its core principles of peace, communal harmony and guard the interest of Punjab and Punjabi in general, and Sikhs and farmers in particular.

He said the decision has been taken in consultation with the people of Punjab, especially party workers and farmers.

Badal said the Bills on agricultural marketing brought by the BJP-led government are lethal and disastrous for the already beleaguered farmers.

He said the SAD was the oldest ally of the BJP, but the government did not listen to it in honouring the sentiments of farmers.

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
September 13,2020

293d3268a57.jpg

New Delhi, Sept 13: Union Health Ministry has announced guidelines for the conduct of teaching activities in the classrooms.

Union Minister of State for Health and Family Welfare, Ashwini Kr. Choubey shared a picture of the guidelines on his Twitter handle on Sunday.

The health ministry issued the Standard Operating Procedures (SOP) for Skill training institutes, Higher Education Institutes conducting courses in technical programs requiring lab work to be permitted from September 21.

As per the guidelines, the seating arrangement should be done in an order to ensure a distance of 6 feet between chairs, desks.

"The staggering of classroom activities, with separate time slots, to allow adequate physical distancing and disinfection of classroom premises. Academic scheduling to have intermix of regular classroom teaching and online assessment. Teaching faculty to ensure that they and students ear masks throughout teaching activities. Sharing of items like laptops, notebook, stationery amongst students to not to be allowed," the guidelines said.

The Health Ministry had on September 8 issued a standard operating procedure (SOP) for a partial reopening of schools for students of classes 9 to 12 for taking guidance from their teachers on a voluntary basis.

The SOP follows Unlock 4 guidelines of Home Ministry which came into effect from September 1.

The Home Ministry had said that states and Union Territories may permit up to 50 per cent of teaching and non-teaching staff to be called to the schools at a time for online teaching or tele-counselling and related work from September 21.

It said that students of classes 9 to 12 may be permitted to visit their schools, in areas outside the containment zones only, on a voluntary basis, for taking guidance from their teachers and this will be subject to the written consent of their parents or guardians.

Students from Class 9th to 12th will have the option of attending the classes remotely/virtually or physically only on a voluntary basis for guidance from their teachers subject to written permission of parent/guardian.

The guidelines said that cleaning and regular disinfection (using 1 per cent sodium hypochlorite) of frequently touched surfaces (doorknobs, elevator buttons, handrails, chairs, benches, washroom fixtures, etc.) will be made mandatory in all classrooms, laboratories, lockers, parking areas, other common areas before the beginning of classes and at the end of the day.

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
September 16,2020

upsc.jpg

New Delhi: At a time when Sangh Parivar backed media targeting Muslim institution for encouraging students from the oppressed community to crack the Civil Services Examination, an RSS-backed coaching institute has claimed a 61 per cent success rate in this year’s exam.

Samkalp Foundation has claimed that out of the 759 candidates picked by the Union Public Service Commission (UPSC) to enter the civil services this year, 466 had undertaken its Interview Guidance Program (IGP).

According to Sankalp's website, 649 candidates had enrolled for the IGP, out of the 990 candidates chosen by the UPSC in 2018. In 2017, 2016, and 2015, the numbers were 689, 648, and 670 against the total recruitment of 1,099, 1,078, and 1,236, respectively.

Meanwhile, senior journalist Vijaita Singh shared a picture of an invitation card from the foundation, wherein Union Petroleum Minister, Dharmendra Pradhan, and Nagaland Governor RN Ravi will interact with the successful candidates as Chief Guests of the Webinar meeting.

The webinar meeting is scheduled for September 20 at 11:00 am where several other Guests of Honors will address the candidates along with Pradhan and Ravi.

Last year, Home Minister Amit Shah and senior RSS functionary Krishna Gopal had delivered a lecture on national security to retired and serving civil servants at an event organised by Samkalp. Gopal is one of the senior-most 'mentors' at the foundation.

The foundation's photo gallery on its website is filled with photographs of its students with BJP ministers such as Smriti Irani, Prakash Javadekar and Ramesh Pokhriyal.

About Sankalp Foundation

Samkalp started as an organisation engaged in running schools in several towns and cities of north India in 1986. As an organisation which gives training to school teachers to inculcate "rashtriya bhawna" in its early age, it morphed into one of the leading institutes training civil service aspirants in the 1990s.

It had reportedly trained 26 aspirants in its first batch, 14 of whom qualified for the civil services. No one made it to the IAS but one aspirant joined the IPS while others joined other Central services.

The next year, Samkalp breached the IAS barrier, and 13 of their alumni qualified for this prestigious service. The number of aspirants who approached the institute was 84, and 59 of them qualified for different services.

By 1999-2000, more than 100 interviewees had reportedly approached Samkalp as its success rate went up to 90 percent. Over the years, the foundation started centres in different cities like Agra, Ludhiana, Bhopal, and Bhilai, apart from its first centers in Delhi.

While the claim of the foundation has created little controversy and public discussion on the telecast of a program by Sudarshan TV News about the entry of Muslims into the All-India Services after clearing the UPSC exams has created much furore.

On Tuesday, Supreme Court made some strong oral remarks taking objection to the show, which had portrayed the large entry of Muslims into UPSC as "UPSC Jihad".

Comments

Athul kiran
 - 
Saturday, 19 Sep 2020

I like to study IAS COACHING. I AM PLUS 2 STUDENTS. APPLY FOR DEGREE COURSE.

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.