Connect with us

Medical Science

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)

Continue Reading

Medical Science

Serosurvey would determine impact of possible 3rd Covid wave on children: DAK

(Asian News Hub) – Doctors Association Kashmir (DAK) on Saturday said serosurvey of pediatric population in the valley would determine the impact of possible third Covid-19 wave on children.

Serosurvey of children will give us a fair estimate of their vulnerability in predicted third wave,” said DAK President and influenza expert Dr Nisar ul Hassan.

“Serosurvey involves testing blood samples of individuals for antibodies that are developed after an infection,” he said.

“This will give us an idea about the percentage of pediatric population who might have developed natural immunity.”

Dr Hassan said recently, a serosurvey of general population including children aged 7 to 17 years has been completed in Kashmir, the results of which are awaited.  The sample size per district in the age group 7 to 11 was 40 and it was 80 in 12-17 age group.

“The survey needs to be extended to the age group of 0 to 6 years and the sample size per district should be 500 to 1000 to get a clearer picture of the actual percentage of children who have developed immunity against Covid-19,” he said.

Dr Hassan said there are speculations that children would be affected more than adults in possible third wave as this is the population group in which there is no vaccine yet.

“However, various serosurveys have dismissed the claim that the next wave will be affecting children exclusively,” he said.

“A pediatric serological study conducted by AIIMS, New Delhi at five different sites found that 55.7 percent children had developed antibodies,” DAK President said.

“The study found that seroprevalence of children and adults in the same regions were almost similar.”

“Another study conducted by PGI Chandigarh revealed that 69 percent of children had antibodies against Covid-19,” he said.

“These children had remained either asymptomatic or mildly symptomatic during the infection.”

“The data of the two surveys prove that children have acquired natural immunity against the virus and it is highly unlikely that the third wave will affect children more than adults,” said Dr Nisar.

“This is a big relief. Because the apprehensions expressed by several health experts about the third wave primarily targeting children had left people worried,” he said.

“But, we can’t derive conclusions on the data from other regions. We need to have our own data based on which decisions can be made ahead of the feared third wave,” he added.

Continue Reading

Medical Science

Israel reports Pfizer COVID-19 vaccine effectiveness against infection down to 40%

(Asian News Hub) – The Health Ministry said Thursday that the effectiveness of the Pfizer COVID-19 vaccine in preventing infection and mild symptoms has dropped to 40%, according to new data collected over the past month as the delta variant spreads in Israel.

In a televised address, Prime Minister Naftali Bennett meanwhile called on Israelis who haven’t been vaccinated to do so as soon as possible.

“The Israeli government is investing billions so that there is a vaccine available in every location in the country, and there are still a million Israelis who simply refuse to be vaccinated,” he said. “The vaccine refusers are endangering their health, their surroundings and all Israeli citizens. If a million Israelis continue to be unvaccinated, this will force the others to shut themselves in at home.”

The effectiveness of the vaccine in preventing hospitalizations and severe symptoms stands at 88% and 91%, respectively, the ministry said.

With inputs from Haaretz

Continue Reading

Medical Science

Scientists discover more than 30 viruses frozen in ice, most never seen before

(Asian News Hub) – A group of scientists discovered ancient viruses frozen in two ice samples taken from the Tibetan Plateau in China, and most of them are unlike anything ever seen before.

The findings, published Wednesday in the journal Microbiome, came from ice cores taken in 2015 that scientists said began to freeze at least 14,400 years ago.

“These glaciers were formed gradually, and along with dust and gases, many, many viruses were also deposited in that ice,” Zhi-Ping Zhong, lead author and researcher at the Ohio State University Byrd Polar and Climate Research Center, said in a statement. “The glaciers in western China are not well-studied, and our goal is to use this information to reflect past environments. And viruses are a part of those environments.”

When researchers analyzed the ice, they found genetic codes for 33 viruses. Of the 33, genetic codes for four of them showed they are part of virus families that typically infect bacteria. Up to 28 were novel, meaning they had never before been identified.

The group said it doesn’t believe the viruses originated from animals or humans but came from the soil or plants. The scientists said roughly half of them survived because of the ice.

“These are viruses that would have thrived in extreme environments,” said Matthew Sullivan, co-author of the study and director of Ohio State’s Center of Microbiome Science.

“These viruses have signatures of genes that help them infect cells in cold environments – just surreal genetic signatures for how a virus is able to survive in extreme conditions.”

Sullivan said the technology used to study microbes and viruses inside the ice would lead to looking for similar genetic sequences in other extreme ice environments, possibly on Mars.

Senior author of the study Lonnie Thompson said the discovery of the viruses in glaciers of ice will help researchers understand how they respond to climate change.

“We know very little about viruses and microbes in these extreme environments and what is actually there,” Thompson said. 

“The documentation and understanding of that is extremely important.”

AGENCY

Continue Reading

Trending