Railways to get 'next generation' e-ticketing system

New Delhi, Jul 31: With the highest single-day spike of 55,079 COVID-19 cases in the last 24 hours, India's coronavirus tally breached the 16 lakh mark on Friday, informed the Union Ministry of Health and Family Welfare.

With this latest spike, the total cases in the country stand at 16,38,871. Among these cases 5,45,318 are active. A total of 10,57,806 patients have been cured/discharged/migrated.

779 deaths due to COVID-19 have been reported in the country in the last 24 hours, taking the death toll to 35,747.

As per the Union Health Ministry, Maharashtra has a total of 1,48,454 active cases and recorded 14,729 deaths due to COVID-19.
Tamil Nadu has a total of 57,962 active cases and 3,838 deaths in the state.

Delhi has a total of 10,743 active cases and 3,936 deaths.

The Indian Council of Medical Research on Friday informed that a total number of COVID-19 samples tested up to 30th July is 1,88,32,970 including 6,42,588 samples tested yesterday.

Ayodhya, Aug 5: Prime Minister Narendra Modi on Wednesday recalled the significance of the path of 'maryada' associated with Lord Ram in the backdrop of the situation created by COVID-19 and emphasised the importance of social distancing and wearing face masks.

He said that the current situation demands 'maryada' should be 'do gaz ki doori, mask hai zaroori' and exhorted everyone to follow it.

In his speech after laying the foundation stone of the Ram Temple in Ayodhya, the Prime Minister said the temple of Lord Ram will inspire and guide humans for ages to come.

He said that the path of `maryada' followed by Lord Ram is all the more necessary today in the situation created by COVID-19.

"The `maryada' (need) today is do gaj ki doori, mask hai jaroori (keep distance of two yards, wear mask). The Almighty may keep all the citizens healthy and happy, this is my prayer. The blessings of Mother Sita and Shri Ram be always there on the citizens," he said.

The Prime Minister termed the occasion as historic and said that India is starting a glorious chapter when people across the country are excited and emotional to have finally achieved what they had been waiting for centuries.

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.