• We kindly request chatzozo forum members to follow forum rules to avoid getting a temporary suspension. Do not use non-English languages in the International Sex Chat Discussion section. This section is mainly created for everyone who uses English as their communication language.

India’s first COVID-19 vaccine ‘COVAXIN’ gets DCGI approval for clinical trials

Wicked

Wicked

News Buff of ZoZo
Chat Pro User
Key Highlights
  • COVAXIN, developed by Bharat Biotech, is India’s first indigenous experimental vaccine against COVID-19
  • Human trials of the vaccine against the novel coronavirus will begin across India in July
  • The novel coronavirus has now killed at least 501,847 people in the world
  • 16D9E402-BE83-42B3-9CA2-7EAEB56C9035.jpeg
Hyderabad: COVAXIN, India’s first vaccine candidate against the novel coronavirus, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), has received approval from the Drug Controller General of India (DCGI) to conduct Phase I and 2 human trials. According to the vaccine maker, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine will be developed and manufactured by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India, the firm said in a release on Monday.
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

“We are proud to announce COVAXIN, India’s first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, announcing the vaccine development milestone.

The company accelerated its objective in completing the comprehensive preclinical studies. Results from these studies have been promising, showing extensive safety and effective immune responses.
“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling the future pandemics,” said Mrs Suchitra Ella, Joint Managing Director.

Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.
News Source-Times Now
 
The August 15 target for launching Covaxin, India’s Covid-19 vaccine, is being described as a fast-track effort. This is because the development of a vaccine is usually a long, uncertain process. It is also expensive, with funding playing an important role.

There is no fixed period but the process can typically run into decades — and still yield no results. For instance, after three decades of research, the vaccine for HIV is still in phase III of clinical trials. One of the fastest developed vaccines is the one used for mumps, which received approval in four years after trials began in 1963.

In general, a vaccine is developed and tested over a number of stages. For Covid-19, this has been fast-tracked in various ways.

1593857945946.png

Stage I: R&D

This typically takes two to four years. For Covid-19, this stage has been progressing fast for two reasons. First, a large number of candidates are based on the virus’s genetic code instead of its protein, and Chinese researchers globally shared the genetic sequence in January itself. The second reason is technology. For instance, Moderna is using m-RNA technology, which involves injecting genetic instructions to human cells for creating proteins to fight the virus. However, it is still unproven technology.

Stage II: Pre-clinical
This is when scientists test the vaccine on cell cultures and animals. They first inactivate the virus, pull out parts of the genetic sequence, and test if it triggers an immune response. More critically, they check if vaccine candidate continues to harm the cell. If there is no immune response and if the candidate harms the animals, the researchers return to stage 1. This stage can take two to three years.

For Covid-19, this stage is being shortened by performing various sub-stages simultaneously. However, most vaccine candidates are still in the pre-clinical stage.

Stage III: Clinical trials

On the basis of data submitted from the pre-clinical phase, regulators allow testing in humans. Very few candidates enter this stage. This phase consists of three phases and usually takes more than 90 months.

PHASE I: The vaccine is given to a small group of people — this takes about three months — and scientists measure antibodies in their blood.

PHASE II: If found safe, it moves to the next phase (6-8 months). The vaccine is given to several hundred people. Three aspects are assessed: reactogenicity (ability to produce common, adverse reactions), immunogenicity (ability to provoke an immune response) and safety. There is also a control to compare how the vaccine works in different variables.

This stage has been shortened in Covid-19 vaccine development. Moderna took just 63 days to reach clinical trials. The Oxford Vaccine Group researchers, which began phase I trials of Astra Zeneca’s vaccine in April, has now entered phase III.

PHASE III: Thousands of people are enrolled. This takes 6-8 months. This assesses how the vaccine works in larger populations.

Stage IV: Regulatory review

The manufacturer submits the data to receive a licence. In the US, approval typically comes after 10 months. However, this is fast-tracked during emergencies. The regulators allow a rolling review: the vaccine candidate submits sections of the application for review as and when they are completed.

Stage V: Manufacturing

This requires immense resources — funds running into millions of dollars, infrastructure, raw material, and scientific expertise. Pharma giants like Pfizer, Johnson & Johnson, Merck and Astra Zeneca, all trying to develop a vaccine, will have a clear advantage to scale up manufacturing if their product is found successful.

Stage VI: Quality control

The safety of the vaccine is monitored by both the regulator and the manufacturer.

Source : The Indian Express
 
@maya21f As per the covid19 vaccine candidates-
The last name in the table sinovac &and one more which i forgot the name haved failed in phase 3 as per yestrday news from a news article from china(M Waiting for the official global news for it )! :map:
 
@Wicked oops I have no idea about der test failure.
Hoping for best.
Read somewhere : corona is like a husband initial stage u might be scared n hide (lockdown) but can't escape from the bond n have to bare it for life time :Cwl:
 
You must log in or register to reply here.
Top