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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

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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Second vaccine dose must if you get Covid after first jab: DAK

(Asian News Hub) – If you have received first dose of Covid-19 vaccine and got infected with the virus, you should go for the second shot soon after the recovery,”said Doctors Association Kashmir (DAK) on Tuesday in a communiqué.

“People who contract Covid after the first dose still need to get the second jab,” said DAK President and influenza expert Dr Nisar ul Hassan.

“However, you shouldn’t get the vaccine while sick,” he said.

Dr Hassan said you should get your second dose as soon as your isolation is over.

“One should take the second shot 2 weeks after all the symptoms of Covid have been resolved,” he said.

“I am aware of several cases where someone tested positive for Covid-19 after getting their first dose,” Dr Hassan said.

“They should get their second dose of the vaccine after they get over with their quarantine to gain its full protective benefits,” he said.

The DAK President said you are fully protected against the Covid only after the second dose.

“It is vitally important to get both doses for best protection against the Covid,” he said.

“First dose primes the body with an initial immune response,” Dr Nisar said.

“Second dose is the one that really gives the boost to the immune system. It induces a level of virus neutralizing antibodies about 10-fold greater than the first dose,” he said.

“Also, second dose induces cellular immunity, which predicts not only longer protection, but better protection against variant strains,” he added.

Dr Nisar said there are two Covid-19 vaccines that are being used in Kashmir right now – Covaxin and Covishield which have two-dose schedule.

He said doses are spaced depending on which vaccine you get. ​ ​

“The time interval between two doses of Covaxin is 4-6 weeks, while second dose of Covishield can be taken 4-8 weeks after the first. But, there is some data that delaying the second dose of Covishield up to 12 weeks gives a better immune boost,” he informed.

“It is imperative to take the same vaccine for both doses and mixing of the two should not be done,” he added.

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India could see 10 Lakh Covid-19 deaths by August 01: Lancet

(Asian News Hub) – India could see a staggering 10 lakh deaths from Covid-19 by August 1, according to an editorial in the British medical journal Lancet. If that outcome were to happen, Prime Minister Narendra Modi’s government would be responsible for presiding over a self-inflicted national catastrophe, the top peer reviewed journal said on Friday.
 
So far, 2,50,025 have died of Covid-19 in the country so far.

The Lancet editorial quoted the Institute for Health Metrics and Evaluation, an independent global health research organisation, in giving its projection for a million (10 lakh) deaths by August 1. “India squandered its early successes in controlling Covid-19. Until April, the government’s Covid-19 taskforce had not met in months,” the editorial said.
 
The science journal said that India must now restructure its response while the crisis rages. “The success of that effort will depend on the government owning up to its mistakes, providing responsible leadership and transparency, and implementing a public health response that has science at its heart.”

Lancet, in its editorial, has suggested that India should adopt a two-pronged strategy. It said that the “botched vaccination” campaign must be rationalised and implemented speedily. For this, it should increase the vaccine supply and set up a distribution campaign that can cover not just urban but also rural and poorer citizens.
 
Secondly, India needs to control transmission of the virus, publish accurate data in a timely manner and explain to the public what is happening and what is needed to bend the epidemic curve, including the possibility of a new federal lockdown.  “Modi’s actions in attempting to stifle criticism and open discussion during the crisis are inexcusable,” Lancet said. 

Genome sequencing too needs to be expanded to better track, understand, and control emerging and more transmissible SARS-CoV-2 variants, it said.
 
In a sharp criticism of the government strategy, Lancet said despite warnings about the risks of superspreader events, the government allowed religious festivals to go ahead, drawing millions of people from around the country, along with huge political rallies—conspicuous for their lack of Covid mitigation measures.
 
It also noted that modelling suggested falsely that India had reached herd immunity, encouraging complacency and insufficient preparation. “At times, Modi’s government has seemed more intent on removing criticism on Twitter than trying to control the pandemic.”

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WHO classifies triple-mutant Covid variant from India as global health risk

(Asian News Hub) – A World Health Organization official said Monday it is reclassifying the highly contagious triple-mutant Covid variant spreading in India as a “variant of concern,” indicating that it’s become a global health threat.

Maria Van Kerkhove, the WHO’s technical lead for Covid-19, said the agency will provide more details in its weekly situation report on the pandemic Tuesday but added that the variant, known as B.1.617, has been found in preliminary studies to spread more easily than the original virus and there is some evidence it may able to evade some of the protections provided by vaccines.

“And as such we are classifying this as a variant of concern at the global level,” she said during a press conference. “Even though there is increased transmissibility demonstrated by some preliminary studies, we need much more information about this virus variant in this lineage in all of the sub lineages, so we need more sequencing, targeted sequencing to be done.”The WHO said last week it was closely following at least 10 coronavirus variants across the world, including the B.1.617.

The variant was previously labeled a “variant of interest” as more studies were needed to completely understand its significance, Van Kerkhove said.

“What it means for anybody at home is any of the SARS-CoV-2 viruses circulating can infect you and spread and everything in that sense is of concern,” she said Monday. “So, all of us at home, no matter where we live, no matter what virus is circulating, we need to make sure that we take all of the measures at hand to prevent ourselves from getting sick.”

A variant can be labeled as “of concern” if it has been shown to be more contagious, more deadly and more resistant to current vaccines and treatments, according to the WHO.

The group issued a clarification Monday to their earlier remarks, saying that current data shows the existing Covid-19 vaccines “remain effective at preventing disease and death in people infected with this variant.”

The international organization has already designated three other variants with the classification: B.1.1.7, which was first detected in the U.K. and is the most prevalent variant currently circulating throughout the U.S.; B.1.351, first detected in South Africa, and the P.1 variant, first detected in Brazil.

B.1.617 has three sublineages, Van Kerkhove said, that will be described in the situation report Tuesday.

The variant is believed by some to be behind the latest wave of infections in India.

The country is averaging about 3,879 Covid deaths per day, according to data compiled by Johns Hopkins University, though media reports indicate the official figure is being understated.

It has reported an average of about 391,000 new cases per day over the past seven days — up about 4% from a week ago, Johns Hopkins University data shows.

The variant has since spread to other countries, including the United States.

CNBC

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