RSS backs Narendra Modi as prime ministerial candidate

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. 

Idukki, Aug 7: Several people lost their lives and dozens of tea estate workers are feared trapped under soil in Kerala’s Munnar after torrential rains triggered a massive landslide on today. 

As many as five bodies have been recovered and rescue workers are fighting inclement weather to remove the debris.

According to rescue workers, four lanes of quarters and a church are buried under mud and around 80 people are feared trapped.

Seven people have been rescued so far and shifted to the hospital.

Sources said a portion of Pettimudi came crashing down on the workers colony with a deafening roar in the wee hours of Friday.

As people were sleeping in the quarters, there was little time to escape.

Further, with the Periyavara bridge being washed away, it became all the more difficult for rescue workers to reach the spot.

The construction of a new temporary Periyavara bridge however, is underway.

The bridge was previously destructed during the deluge of August 2018. Later during the north west monsoons and the south west monsoon of 2019, it suffered damage again.

The present bridge, which got damaged on Thursday after Kannimala river levels rose, was constructed under the leadership of Coir fed.

Although a new concrete bridge has been constructed near the temporary bridge in Periyavara, vehicle  movement has not been possible because the authorities are yet to build its approach via road.

The new bridge is to be constructed at a cost of Rs 4.75 crore from Devikulam MLA S Rajendran's fund.

The entire area has been cut off from outside world and communication networks have also crashed.

Teams of Fire and Rescue personnel, NDRF, revenue officials, estate workers and police are struggling to conduct rescue operations.

Meanwhile, District collector H Dhineshan said a team of rescue personnel was sent to Pettymudy after he was briefed about the mishap and search operations to locate and rescue people are underway.

Facilities have been arranged at the hospitals nearby to provide necessary treatment facilities to the people being rescued.