India’s First Indigenous COVID-19 Vaccine – COVAXIN

A vaccine based on whole inactivated coronavirus has an efficacy rate of 77.8% against symptomatic COVID-19 infections, phase 3 trial data suggest.

Covaxin, also known as BBV152, was authorised for emergency 

COVAXIN, Indias indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility.

The vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection

Covaxin COVID-19 Vaccine To Be Available In First Quarter Of Next Year,  Says Bharat Biotech

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Bharat Biotech’s Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid and 65.2 per cent protection against the new Delta variant.

The company on Saturday said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The efficacy analysis demonstrates Covaxin to be 93.4 per cent effective against severe symptomatic Covid cases while safety analysis shows adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side-effects and less than 0.5 per cent feeling serious adverse events.

The efficacy data demonstrates 63.6 per cent protection against asymptomatic Covid, a release from the city-based vaccine maker said.

Phase 3 clinical trials of the vaccine was an event-driven analysis of 130 symptomatic Covid cases, reported at least two weeks after the second dose, conducted at 25 sites across India.

The whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with Indian Council of Medical Research and National Institute of Virology in Pune.

Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccine’s trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global populations.”    

POSITIVE RESULTS

The Phase 3 trial involved 25,800 participants in India aged 18 to 98. Of these, 2,433 were over 60 years old, and 4,500 had pre-existing medical conditions (co-morbidities) such as cardiovascular disease, diabetes or obesity.

The study found that Covaxin had an efficacy of 93.4% against severe COVID-19 disease, and an overall vaccine efficacy of 77.8% against symptomatic infections confirmed by PCR tests. Against asymptomatic COVID-19, the efficacy was 63.6%. The vaccine also conferred 65.2% protection against symptomatic infection with the Delta variant, at least two weeks after the second dose.

As a rough comparison, recent figures from Public Health Scotland suggested that at least two weeks after the second dose, the Pfizer-BioNTech vaccine was 79% effective against the Delta variant, while the Oxford-AstraZeneca was 60% effective. However, different trial methodologies make it impossible to directly compare the relative efficacies of the various vaccines.

The main side effects from Covaxin were pain at the injection site, followed by headache, fatigue and fever. No severe or life-threatening adverse events were reported.

COVAXIN phase-1 trails completed

Coronavirus, Covid-19 Vaccine COVAXIN Latest Update: Rohtak PGIMS ...

Till now corona virus has affected more that 200 countries and has infected more than 16 million people. Due to the complications developed by this virus around 644k people have lost their lives. It not only causes fever and cold but also develops critical infections in the body which affects the lungs and makes breathing a difficult choice. So far many scientists are working on this virus and are trying hard to understand them. But in order to save the lives of people, many countries were forced to impose lockdown since there is no other option left to reduce the fatality rate.

Also many researchers have developed few medicines such as remdesiver to cure mild and moderate corona symptoms but they are still unable to treat the critical patients and sometimes such medicines also don’t work for mild symptoms as well. So basically there is no proper and fixed treatment for this virus. The only thing which can be game changer is a vaccine which yet to be developed.

Many countries including India is already in the race of producing a valid vaccine which can generate antibodies against the virus. India’s first indigenous covid-19 vaccine known as COVAXIN was developed by bharat biotech in collaboration with ICMR ( Indian council of medical research ) and NIV ( national institute of virology ). The vaccine initially got a nod from DCGI ( Drug controller general of India ) to perform phase I and II human clinical trails. Also the phase I trail started in the early month of july and successfully completed the first part of phase -I trail.

The first part of phase – I trail of COVAXIN was completed on saturday at the PG institute of medical sciences, Rohtak. And fortunately all the results were found to be encouraging which gave COVAXIN a positive nod to go froward for it’s 2nd part of phase – I trail.

Hope for the best, but expect less

I’m not in this world to live up to your expectations and you’re not in this world to live up to mine. -Bruce Lee

A friend’s status update on a social media site: ‘Who hurt you? My own expectations.’

Yes, we all have expectations in our lives: what we want out of life and who we want to become. I believe one of the keys to happiness lies within the management of your expectations of people and circumstances. If you do not have expectations, you can never be disappointed. Often we tend to believe that the way we treat others will be the way we are treated in return. But, unfortunately, this does not always happen.

The biggest disappointments in our lives are often the result of misplaced expectations. This is especially true when it comes to our relationships and interactions with others. You need to make sure you enter into relationship with someone who has as big of a heart as you do. If you do not, you may feel as if you are being taken advantage of. You need to find people who appreciate what you do for them and who will reciprocate those actions.

There are two ways to be happy: improve your reality or lower your expectations. Having realistic expectations will allow you to accept the flaws each person has. We need to learn how to take responsibility for our own lives and our own decisions before we can expect others to do the same.

One of the biggest challenges we face in life is learning to accept people for who they truly are. Once you realize that your expectations cannot change people, the better off you will be. Give without expectation, accept without reservation, and love with hesitation. Unrealistic expectations most often do lead to disappointment. Too many people are obsessed with finding the perfect career or the perfect spouse, and as a result become increasingly frustrated when this does not happen in reality.

Expectation is the root of all heartache. Try to remain confident while maintaining positive aspirations; just remember not to make the aspirations so high that they are impractical or unreachable.

Acceptance is an amazing trait that needs to be actively worked toward. When things do not work out the way we had planned, it is much more beneficial to realize that is how life works rather than becoming frustrated at the situation. Have hope rather than expectations and you will tend not to be as disappointed.

People rarely behave exactly the way you want them to. Hope for the best, but expect less. And remember, the magnitude of your happiness will be directly proportional to your thoughts and how you choose to think about things. Even if a situation or relationship doesn’t work out at all, it’s still worth it, if it made you feel something new, taught you something afresh.

SPUTNIK V COVID-19 VACCINE- MANUFACTURING IN KARNATAKA SOON

In the face of a vaccination shortage, Karnataka will house manufacturing plants for Covaxin and Sputnik V COVID-19 vaccines.

While Bharat Biotech’s Covaxin manufacturing facility in Malur, Kolar district, is under construction, Shilpa Medicare has signed a three-year definitive agreement with Dr. Reddy’s Laboratories (DRL) through its wholly-owned subsidiary Shilpa Biologicals Pvt. Ltd. (SBPL), for the production and supply of the Russia-made Sputnik V vaccine from its integrated biologics R&D-cum-manufacturing centre in Dharwad.

By the end of August, the Kolar vaccine manufacturing facility, according to state Health Minister Dr K Sudhakar, will be able to produce four to five crore doses each month.

Sudhakar claimed he attended a video conference with Bharat Biotech founder Dr Krishna Ella, his daughter Dr Jala Ella, and the rest of the team on May 17 in Bengaluru. Sudhakar said, “Dr Ella has assured me that their facility at Malur in Kolar will be able to produce one crore vaccines by June-end. By July-end it will be two to three crores, and their target by August-end is four crore to five crore vaccine doses.”

Dr. Krishna Ella and the directors of Bharat Biotech have also informed him that vaccination doses will be delivered to Karnataka as soon as possible, according to the minister. Sudhakar stated that he had requested a rollout timeline from them.

Meanwhile, SBPL said in a regulatory filing that it expects to produce 50 million doses of the dual vector Sputnik V in the first 12 months of commercial production.

On May 14, DRL soft-launched the imported COVID-19 vaccine Sputnik V. The vaccination is priced at Rs 948 per dosage, plus a 5% GST (retail price of Rs 995.40).

DRL, according to Shilpa Medicare, will help SBPL transfer technologies. SBPL will be in charge of manufacturing, while DRL will be in charge of distributing and promoting the vaccine doses throughout its marketing regions, according to the agreement.

In the near future, Shilpa Medicare stated, the businesses are looking into manufacturing Sputnik Light, a single-dose version of the Sputnik V vaccine.

Inoculations of the new coronavirus vaccines have been administered to nearly 1.13 crore people in Karnataka thus far. Both the first and second doses are included in this figure. However, due to a scarcity of dosages, the immunisation campaign for adults aged 18 to 44 has been halted.

India is experiencing a second wave of COVID-19 infection, and quick mass vaccination is being viewed as a viable approach to stop the pandemic from spreading further.

What is Covaxin, India’s COVID-19 vaccine candidate; how long before approval?

India’s Covid-19 vaccine candidate Covaxin: How does Covaxin compare to other vaccine candidates around the world? Where does it figure in the global race for a Covid-19 vaccine?

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India’s top drug regulator, the Central Drugs Standard Control Organisation, has allowed Bharat Biotech India (BBIL) to conduct human clinical trials for ‘Covaxin’, making it the first indigenous Covid-19 vaccine candidate to receive this approval, the firm said. These trials are scheduled to start across India in July.

What is ‘Covaxin’ and how was it developed?

Covaxin is a vaccine candidate to developed by BBIL against the novel coronavirus (Covid-19) in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).

As part of this collaboration, NIV isolated a strain of the virus from an asymptomatic Covid-19 patient and transferred it to BBIL early in May. The firm then used it to work on developing an “inactivated” vaccine–a vaccine that uses a the dead virus–at its high containment facility in Hyderabad.(Read Coronavirus Global Updates)

https://db57d942241899c441ca465c80cfbd92.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html “Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus,” said the company, adding that inactivated vaccines usually have a better safety record.

BBIL’s Covaxin then underwent pre-clinical testing, which is when the vaccine is tested on animals like guinea pigs and mice to see if it is safe, before the firm approached CDSCO for approvals to move on to the next stage of testing — human trials. https://www.youtube.com/embed/YHhHkhHIhVo?version=3&rel=1&fs=1&autohide=2&showsearch=0&showinfo=1&iv_load_policy=1&wmode=transparent

What does the approval mean for India?

The Drug Controller General of India, who heads CDSCO, has given Bharat Biotech approvals to begin testing its vaccines on humans through phase I and II clinical trials. This brings India a step closer to finalising a domestically developed Covid-19 vaccine for its population–a positive sign at a time when the country’s cases continue to surge, especially in the national capital.

The first phase, usually conducted on a small group of individuals, tries to find what dosage of the vaccine is safe for use, whether it is effective in building their immunity to the virus and whether there are any side effects. The second phase is conducted on a larger group comprising hundreds of persons fitting the description of those for whom the vaccine is intended using characteristics like age and sex. This phase tests how effective the vaccine is on the population group being studied.

Also Read: Covid-19 vaccine may be ready in 12-18 months, says WHO chief scientist

How many more stages of testing would the vaccine have to go through before approval?

Vaccines, like most new drugs, are meant to follow a clinical testing process spanning four stages, starting with pre-clinical tests and ending with phase III studies conducted on thousands of patients. After approval from the regulator, the firm has to continue monitoring the use of its vaccine on patients and submit post-marketing surveillance details, which checks for any long-term unintended adverse effects of the product.

Bharat Biotech plans to begin its phase I and II trials in July, but is unsure of the overall timeline for testing and approving its vaccine.

“At the moment we are not sure how the vaccine is going to perform in the humans, as clinical trials are about to commence. Based on the success results of phase I and phase II, we will progress to the larger clinical trials. Thereafter, the licensure timelines will be set out upon receiving regulatory approvals,” said BBIL.

What other Indian companies are working on a Covid-19 vaccine candidate? What stage are they at?

Other Indian firms engaged in the development of Covid-19 vaccines include Zydus Cadila, Serum Institute of India and, since earlier this month, Panacea Biotec.

While Panacea is still in the pre-clinical stage, it is not clear whether Zydus and Serum have completed their preclinical studies and have also applied to CDSCO for approval to conduct human trials yet.

How does Covaxin compare to other vaccine candidates around the world? Where does it figure in the global race for a Covid-19 vaccine?

Covaxin has reached a more advanced stage of testing than two other vaccine candidates that Bharat Biotech is developing through global collaborations — the first is in collaboration with Thomas Jefferson University, while the second is with the University of Wisconsin-Madison and vaccine maker FluGen. Both these candidates are currently in the pre-clinical stage, according to the World Health Organisation’s draft landscape of Covid-19 candidate vaccines.

However, it is still far behind in the global race for a Covid-19 vaccine. AstraZeneca, whose vaccine candidate “ChAdOx1-S” with the University of Oxford is already at phase III trials, is the frontrunner. Serum Institute has an agreement to manufacture this vaccine.

Moderna, which is also close to beginning phase III trials for its LNP-encapsulated mRNA vaccine candidate with the National Institute of Allergy and Infectious Diseases, is close behind.

Apart from Covaxin, which is not listed among the vaccines being tried globally, at least six other candidates are in Phase I/II trials and another five are in Phase I trials globally.

Globally, Zydus Cadila’s DNA plasmid and measles vector vaccines as well as Serum’s codon deoptimised live attenuated vaccine, which it is developing with Codagenix, are still in the pre-clinical stage, according to WHO.