Understanding COVID vaccines manufactured in India

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India's first COVID-19 vaccine, Covaxin, was developed in-house. Bharat Biotech's Bio-Safety Level 3 high containment facility designed and manufactured this inactivated vaccine.Covaxin vaccine production is currently at six crore doses per month, according to the government.

Meanwhile, India is anticipating the release of its first homegrown messenger or mRNA vaccine, which is currently in phase 3 clinical trials. Genova Biopharmaceuticals, based in Pune, is producing the vaccine.

India has also developed ZyCoV-D, the world's first DNA-based COVID-19 vaccine. Zydus Cadila was the one who came up with the idea. The Drug Controller General of India granted it an Emergency Use Authorization (EUA) on August 20, 2021. (DCGI). The primary efficacy of this medicine was 66.6 percent in symptomatic RT-PCR positive cases, according to interim results from phase 3 clinical trials.

Covaxin is an inactivated vaccine, which means it is made up of dead coronaviruses that are subsequently injected into the human body.

Zyvox-D is a COVID-19 vaccine made from DNA plasmids. It was created in collaboration with the Department of Biotechnology and deployed by BIRAC as part of the 'Mission COVID Suraksha.' The vaccination causes the cell to create a coronavirus spike protein, which triggers an immune response against the virus.

The messenger RNAs in the mRNA vaccination cause an immunological response in our bodies, which generates antibodies and thereby protects us against the disease. While Covaxin employs dead coronaviruses to develop antibodies, mRNA vaccines will use synthetically manufactured mRNA to instruct human cells how to make a protein—or even just a portion of a protein—to activate the immune response and antibody creation, while ZyCoV-D uses DNA plasmid to fight coronavirus.

The firm explains why it produced an inactivated vaccine: "Inactivated vaccinations have been around for decades in the traditional sense. Seasonal influenza vaccinations, polio vaccines, pertussis vaccines, rabies vaccines, and Japanese encephalitis vaccines all employ the same technique to manufacture inactivated vaccines with a safe track record of over 300 million doses of supply to date. In the realm of vaccine technology, it is the most well-known and time-tested platform."Like all vaccinations, mRNA vaccines benefit people who get vaccinated by giving them protection against diseases like COVID-19 without facing the potentially devastating consequences of getting sick," the US Centers for Disease Control and Prevention (CDC) said of mRNA vaccines.

"We are convinced that this would be a significant vaccine for both India and the globe," Dr. Renue Swarup, Secretary, DBT, and Chairperson, BIRAC, said after the world's first DNA-based vaccination was approved for emergency use. This is a significant step forward in our Indigenous Vaccine Development Mission, putting India on the map for novel vaccine development around the world."

What is the mechanism of action of these vaccines?

When the body is infected, covaxin instructs the immune system to generate antibodies against live coronaviruses using dead coronaviruses. Large quantities of coronaviruses are sprayed with beta-propiolactone, a chemical that disables the coronaviruses and robs them of their ability to multiply while leaving the proteins and spike intact. These are then combined with an adjuvant, which is an aluminum-based substance. "Vaccine adjuvants, also known as immune-potentiators, are added to the vaccine to improve and boost its immunogenicity," according to Bharat Biotech.

Jonas Salk was the first person to employ inactivated viruses to treat an illness. He treated polio with vaccinations. Meanwhile, mRNA vaccines deliver synthetic mRNAs to cells, instructing them to generate a fragment of the spike protein seen on the COVID-19 producing coronavirus's surface. The mRNA is broken down and eliminated by the cells after the protein is created. The immune system recognizes that the cells in our bodies have protein spikes on them and that they do not belong to us. As a result, an immune response is elicited, and antibodies are created to combat the protein surges. As a result, the body has learned how to recognize and fight against a coronavirus infection.

A genetically modified, non-replicating variant of DNA plasmids is administered into the human body in ZyCoV-D vaccinations. The spike protein of the plasmids is programmed for production.

The immune system responds to these spike proteins because they are perceived as threats by the body. The government claims that this vaccination will be effective in combating the virus's mutation. According to a government statement, "the plug-and-play technology on which the plasmid DNA platform is built may be simply changed to deal with alterations in the virus, such as those presently happening."

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Clinical trials:

In July 2020,Covaxin gained DCGI permission for phase I and II human clinical studies. It conducted the third clinical trial with 25,800 volunteers, more than 2400 of whom were over 60 years old and more than 4500 of whom had comorbid diseases.

Human clinical studies for Genova Biopharmaceuticals' mRNA vaccines are currently in their third phase.

The ZyCoV-D vaccine was tested on 28,000 participants in phase 3 clinical trial. "This is the largest COVID-19 vaccine experiment ever conducted in India. In previous adaptive Phase I/II clinical trials, this vaccine had demonstrated strong immunogenicity, tolerance, and safety profile "according to an official statement.

Efficacy:

Efficacy refers to a drug's capacity to provide the desired consequences.

In 77.8% of cases, covaxin is effective against symptomatic COVID-19 disease. The vaccination has a 93.4 percent effectiveness against severe symptomatic COVID-19 illness. The firm claims that the efficacy data shows 63.6 percent protection against asymptomatic COVID-19.

Although Genova Biopharmaceuticals' mRNA is currently in the third phase of clinical trials, other mRNA vaccines have shown the efficacy of more than 90% in research investigations. The Phase 3 trial of the Moderna mRNA-1273 vaccination

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