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COVID-19:Drug Controller General of India (DCGI) approved Covishield and Bharat Biotech”s Covaxin for restricted emergency use in India

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Srinagar, Jan 03: Expressing delight over the approval on restricted emergency use of its COVID-19 vaccine Covaxin, Bharat Biotech on Sunday said it has generated excellent safety data with robust immune responses to multiple viral proteins that persist and their goal is to provide global access to populations that need it the most.

The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India, Krishna Ella, Chairman and Managing Director of the Hyderabad-based pharmaceutical firm said in a statement.


Ella said it was a proud moment for the nation and a great milestone in India”s scientific capability, a kickstart to the innovation ecosystem in India.


“While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” he said.


On Sunday, Drug Controller General of India (DCGI) approved Covishield and Bharat Biotech”s Covaxin for restricted emergency use.


Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).


Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, he said.


The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in “26,000” volunteers across India, and this is India”s first and only Phase III efficacy study for a COVID-19 vaccine, Ella said.


It is the largest phase III efficacy trial ever conducted for any vaccine in India, he added.


Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals, Ella said.


This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech”s BSL-3 (Bio-Safety Level 3) bio-containment facility.


The evaluation of Covaxin has resulted in several unique product characteristics including long term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralising capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants, the statement said.


“It has also shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. Its most critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data,” it said.


The product development and clinical trial data thus far has generated five publications, which have been submitted to international peer reviewed journals, four of which have been accepted and will be published soon, it said adding the publication of phase II trial data is undergoing the peer review process.


Telangana IT Minister K T Rama Rao tweeted: “Many Congratulations to Dr. Krishna Ella, Suchitra Ella & the entire team of scientists @BharatBiotech on getting DCGI approval for Covaxin Hyderabad continues to shines on as the vaccine capital because of the pursuit of excellence of scientists & innovative entrepreneurs”. (With Agencies)

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In J&K, over six lakh children anaemic, reveals NITI Aayog

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(Asian News Hub) – In Jammu and Kashmir, over six lakh children have anaemia while more than two lakh children are stunted, reveals NITI Aayog State Nutrition Profile 2021.

According to the figures of NITI Aayog study titled State Nutrition Profile of Jammu and Kashmir accessed by the news agency—Kashmir News Observer (KNO), “Over 625,519 children are anaemic and 251,393 are stunted in J&K. The findings are based on data from the National Family Health Survey (NFHS) 3 (2005-2006), 4 (2015-2016), and 5 (2019-2020).”

Also Read: Poonch encounter: Bodies of two missing soldiers retrieved; toll 9

The anaemic data in the report reveals that in J&K 20 out of 20 districts shows public health concern.

As per the data, Anantnag is the highest-burden district with 69,576 numbers of anaemic children while Kupwara stands second with 62,491 number anaemic children. Budgam stands third with 54,203 numbers of anaemic children. In Srinagar, the numbers of anaemic children are 51,730 and in Baramulla, number of anaemic children are 48, 307.

Also Read: Amid high alert in Kashmir; gunmen kill two non-local residents in Sgr, Pulwama

“In Jammu, the numbers of anaemic children are around 47,000. In Rajouri, the numbers of anaemic children are around 34,000 while in Udhampur, the number of anaemic children are around 25, 000. In Poonch, the numbers of anaemic children are around 19,000”, the data reveals.

As per the NITI Aayog study report, 18 out of 20 districts show public health concern regarding the number of stunted children in J&K.

“Anantnag district has the highest number of 27, 578 stunted children. In Srinagar, there are 24, 680 stunted children and in Kupwara, there are 21, 982 stunted children, with Jammu having 20, 178 and in Budgam there are 19, 025 stunted children,” reveals the data.

Also Read: Following civilian killings, 13 militants killed in 9 encounters

It further reveals that in Rajouri there are more around 15, 000 stunted children. In Baramulla, there are 18,000 stunted children. In Kathua, there are around 8,000 stunted children. In Poonch, there are around 10,000 stunted children. In Ramban, there are around 7,000 stunted children. In Udhampur, there are around 15, 000 stunted children. In Doda, there are around 11,000 stunted children. In Kishtwar, there are around 5,000 stunted children.

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COVID19 vaccines effective enough, no need for third booster jab: Lancet

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(Asian News Hub) – Vaccines are effective enough at preventing severe cases of Covid-19 that there is no current need for the general population to be given third doses, according to a report in The Lancet published Monday.

Some countries have started offering extra doses over fears about the much more contagious Delta variant, causing the World Health Organization to call for a moratorium on third jabs amid concerns about vaccine supplies to poorer nations, where millions have yet to receive their first jab.

Also Read: Even after 5 decades, CRP Sgr hasn’t seen even 50 percent completion, reveals report

The new report by scientists, including from the WHO, concluded that even with the threat of Delta, “booster doses for the general population are not appropriate at this stage in the pandemic”.

The authors, who reviewed observational studies and clinical trials, found that vaccines remain highly effective against severe symptoms of Covid-19, across all the main virus variants including Delta, although they had lower success in preventing asymptomatic cases of the disease.

Also Read: Sgr turns COVID hotspot again; Admin mulls curbs

“Taken as a whole, the currently available studies do not provide credible evidence of substantially declining protection against severe disease, which is the primary goal of vaccination,” said lead author Ana-Maria Henao-Restrepo, of the WHO.

She said vaccine doses should be prioritised to people around the world still waiting for a jab.

“If vaccines are deployed where they would do the most good, they could hasten the end of the pandemic by inhibiting further evolution of variants,” she added.

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COVID-19: Samba becomes first district to complete vaccination for all above 18 years

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Instead of waiting for people to come, we reached out to them: DC Samba; LG congratulates for achieving milestone

(Asian News Hub) – Amid the ongoing Covid vaccination drive in Jammu and Kashmir Union Territory, Samba has become the first district in giving the first dose of Covid vaccine to all above 18 years of age.

A top health official told news agency—Kashmir News Observer (KNO) that there are around 241,000 persons in the district in between 18-44 age group and all of them have already got their first dose of Covid vaccine.

Also Read: DAK urges flu vaccination for children ahead of third Covid wave

He said that around 78,000 (33 percent) people have also got second dose of Covid vaccine and the process of vaccinating more and more people is going on. “It was possible only due to the efforts of health workers and front line workers who have worked tirelessly to achieve this milestone,” the official said.

District Magistrate Samba Anuradha Gupta said that since the beginning Samba district started the vaccination process strategically and Samba was among first few districts which completed vaccination process of all above 45 years of age.

“Instead of waiting for people to come to us, we went to them. We had constituted mobile teams to reach everyone. We were vaccinating above 45 age group the positivity and mortality rate started declining and people understood the importance of vaccination,” Gupta said.

Also Read: WHO says Covid will mutate like the flu and is likely here to stay

She said that then people above 18 years came on their own without need of any mobilisation and “our efforts are on complete second dose process at an earliest.”

Meanwhile LG Manoj Sinha has congratulated the Covid management team of Samba and health care workers for their tireless efforts in completing 100 percent vaccination of above 18 years of age. He hoped that other districts will catch up soon and complete this process as well.

“Congratulations to Covid mgmt team of Samba & health care workers for their tireless effort to ensure 100% vaccination of above 18 yrs of age.Samba becomes first distt. of J&K to achieve this milestone & I am sure other districts will catch up soon,” Office of LG tweeted.

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