According to a Reuters article citing CNBC-TV18, the topic expert committee at India’s pharmaceutical regulator has approved licensing Zydus Cadila’s three-dose COVID-19 vaccine (ZyCoV-D) for emergency use authorization (EUA). CNBC-TV18 reports that the committee also mentioned that Zydus needs more data on the 2-dose schedule of their vaccine.
So, how exactly does this vaccination prevent disease?
Zika virus DNA vaccine (ZyCoV-D). The body’s immune system is genetically programmed to respond to the virus. The vaccine contains a plasmid DNA vector carrying the SARS-CoV-2 spike protein gene. Like other DNA vaccinations, this one causes the recipient’s cells to produce the spike protein, activating the immune system. The plasmid contains unmethylated CpG patterns to enhance its capacity to stimulate the immune system. E. coli cells are used to produce the plasmid. Intradermal shots are given using a spring-powered jet injector.
After receiving an injection of the vaccine, the plasmid DNA is taken up by skin cells. When the plasmid DNA reaches the cell’s nucleus, it expresses the spike protein gene. The spike protein is then secreted and covers the cell’s surface.
The spike protein is recognized as foreign and hence triggers an immune response. As part of this immune reaction, antibodies can bind to the spike protein and prevent it from binding to cells. Virus-infected cells can also be eliminated thanks to T cells produced by the immune system. A person who has received the vaccine will have an immune system that can swiftly identify and resist the SARS-CoV-2 virus if exposed. They will be less likely to get sick as a result of this.
Below are some more data about ZyCoV-D:
Because it is based on DNA, it trains the immune system to recognize and destroy the virus. Tropis is injected using a device that does not require a needle. This makes it a less invasive and more convenient replacement for traditional vaccines. Clinical tests have proven to be secure and efficient.
It is currently being manufactured in large quantities and will soon be available in India. If you’re thinking about getting the ZyCoV-D vaccine, talk to your doctor about it. They can help you decide if you should get the vaccine or not. Zydus Zycov D, a needle-free vaccine for coronavirus:
On July 1, generic pharmaceutical manufacturer Cadila Healthcare Ltd. applied for clearance of its ZyCoV-D vaccine, citing a 66.6% efficacy rate in a late-stage trial involving more than 28,000 participants nationwide. Following the approval of Covishield, a vaccine developed locally, Bharat Biotech’s Covaxin, Russia’s Sputnik V, and the United States Moderna, ZyCoV-D would become the country’s sixth vaccine. It will be the first DNA vaccination of its kind worldwide when approved. A pharmaceutical company in Ahmedabad, India, requested an EUA for their three-dose COVID-19 vaccine, ZyCoV-D, on July 1.
The company only recently handed in a research protocol for the shot, which includes two doses. The SEC will undoubtedly examine the evidence and conclude. The largest clinical trial ever conducted in India involved testing the company’s COVID-19 vaccine in more than 50 sites nationwide. Additionally, this study was the first time that COVID-19 immunization had been tried out on Indian adolescents (12-18).
The following are some benefits of DNA vaccines:
- DNA vaccines may be stored at room temperature and have a longer shelf life than traditional vaccines. They have improved portability and accessibility.
- DNA vaccines are effective because they can stimulate an immunological response even in those with impaired immune systems. Therefore, they can be an option for people who cannot get immunizations the traditional way.
- DNA vaccinations are safe to use and have minimal side effects. Those who have doubts about the security of vaccinations should consider them.
- DNA vaccines are a practical option for large-scale immunization drives due to their low production costs.
- DNA vaccines are still in the research and development phase, but they can potentially revolutionize how we immunize humans. They could be a cheap and easy way to protect people from numerous illnesses.
What are the downfalls of the DNA vaccine, if any?
DNA vaccines have great promise, but there are still some significant obstacles to overcome. Some major drawbacks of DNA vaccines include the following:
- DNA vaccines may not induce an immune response as strong as traditional immunizations elicit. This could make it harder for them to stay healthy.
- DNA vaccines have not been subjected to the same scrutiny regarding their safety as more traditional immunizations. This suggests that there is little risk of experiencing adverse effects.
- Since DNA vaccines are still in the research and development phase, they are more expensive than traditional vaccines.
- DNA vaccines may be less effective if they cause the immune system to develop a tolerance to the encoded antigen.
- The vectors used to administer DNA vaccinations can cause their own set of problems. Some vectors, for instance, have been linked to cell death and inflammation.
- Concerns have been raised about potential unintended consequences, such as cancer development, when using DNA vaccines because of their ability to transfer genetic material to cells.
Vaccination against ZykV:
Protecting against SARS-CoV-2 infection, ZyCoV-D is a plasmid DNA vaccine that activates the human immune system’s cellular (T lymphocyte immunity) and humoral (antibody-mediated immunity) arms. Immunization effectively prevented COVID in 100% of cases of asymptomatic disease and 66.6% of cases of mild disease. A ‘needle-free injector’ is used for the intradermal administration of this vaccine. Zydus asserts that its needle-free method significantly lessens adverse effects. The following section delves more into ZyCoC-D data.
What to Do:
The novel coronavirus SARS-CoV-2 causes COVID-19, and the first immunization against it is ZyCoV-D, the first ‘plasmid DNA’ vaccine. This plasmid DNA immunization is the first one safe enough for human use. In the company’s proposal, Patel wrote that the vaccine “has proven its safety and efficacy profile” against COVID-19. Reports indicate that Zydus Cadila spent between 400Cr and 500Cr on developing vaccines.
Can only adults get the Zydus Cadila Covid vaccine?
Sources said that the government’s national anti-coronavirus immunization strategy will initially only distribute the Zydus Cadila COVID-19 vaccine, licensed by India’s pharma regulator for those aged 12 and up, to adults. The health ministry has given the green light to begin planning the needle-free shot for the upcoming national Covid vaccination campaign.
The government has already placed an order with the Ahmedabad-based business for one billion vaccination pills. “As of now, under the national Covid vaccination campaign, only adults will receive ZyCov-D, which India’s drug regulator has approved for those aged 12 and older,” an official said. The cited source.
The government intends to take its time distributing Covid vaccines to children, Union Health Minister Mansukh Mandaviya said on Thursday, adding any decision will be based on expert opinion. Despite some progress in a few countries, he maintains that youngsters’ global immunization rates against COVID-19 remain dismally low.
Based on the advice of professionals, we have decided against vaccinating the kids. We’re taking a moment to reevaluate whether or not to vaccinate our children because they are the future of our nation. “We need to move with caution,” Mandaviya advised. In the meantime, the National Technical Advisory Group on Immunisation (NTAGI) is establishing a thorough child immunization program, including compiling a priority list of co-morbidities.
The Indian pharmaceutical regulatory body has authorized ZyCov-D, the first vaccine against Covid for youngsters 12 and older. According to government documents, Bharat Biotech’s Covaxin has been given emergency use authorization by the Drugs Controller General of India (DCGI) for patients aged two to eighteen.
Before administering ZyCov-D to adults, frontline workers, and vaccine providers will get brief instructions on using the needle-free applicator in real-world field situations. Currently, anyone over the age of 18 can get the Covid vaccine. One crore doses of ZyCoV-D would be provided to the government by Zydus Cadila for Rs 265.
The Government of India has made an order with Cadila Healthcare for one crore doses of its Covid-19 vaccine ‘ZyCoV-D’ at Rs 265 per dose and the needle-free applicator at Rs 93 per dose, exclusive of GST, as disclosed today in a regulatory filing.
On August 20, 2021, the Drugs Controller General of India approved ZyCoV-D, a three-dose injection developed by Zydus Cadila and the first plasmid DNA vaccination in the world, for emergency use in adults and children over the age of 12. It’s the first time a Covid-19 vaccination has been developed that doesn’t require a needle.
Vaccine campaigns in India have not yet used ZyCoV-D. We expect that the needle-free application of the immunization will encourage many more people to become vaccinated and protect themselves from COVID-19, particularly children and young adults aged 12 to 18 years old,” said Sharvil Patel, the company’s managing director. “We are pleased to support the Government’s vaccination program with ZyCoV-D.”
Each of the three ZyCoV-D injections will be administered 28 days apart. Phase III clinical trial interim data shows primary effectiveness of 66.6% for symptomatic RT-PCR-positive cases from more than 28,000 volunteers.
Cost of Zydus Cadila:
After lengthy negotiations with the government, Zydus Cadila reportedly settled on a price of Rs 265 per dose for its COVID-19 vaccine. No final deal has been reached. The Indian drug regulatory agency has given Zydus Cadila’s ZyCov-D vaccine the green light to vaccinate people aged 12 and up. The needleless vaccination costs Rs 358 for each dose, with an additional Rs 93 per dose for a disposable frictionless jet applicator.
Insiders said the Ahmedabad-based pharmaceutical company had recommended pricing its three-dose regimen at Rs 1,900. The cost of a single dose has been cut to Rs 358 thanks to the firm, which now includes the price of a disposable jet applicator (Rs 93). A source knowledgeable about the situation has said that a decision on the matter is expected this week.
The three injections will be given 28 days apart, and each arm will receive treatment. On August 20, the drug regulation authorized the urgent use of ZyCoV-D, the first DNA-based vaccination against COVID-19.
Corona Vaccine without Needle by Zydus Dosing:
The PharmaJet needle-free applicator is used for the three-shot series of intradermal vaccines to provide painless administration. Zydus Cadila is “evaluating” a two-dose schedule at 3 mg/dose after finding that it is equivalent to the current three-dose schedule.
The business projected the vaccine’s release date to be between July 45 and August 6, pending regulatory approval and production increases. The new ZyCoV-D production facility is anticipated to be completed by the end of July. Additionally, the current production capacity is 4.5 million doses. Zydus Cadila claims its annual output will be 10-12 crore doses. The company hopes to increase annual production by 60-70 million doses through future partnerships, bringing the total to 200 million.
ZyCoV-D uses the DNA from SARS-CoV-2 proteins to direct human cells to produce antigens that the immune system recognizes as belonging to SARS-CoV-2. The vaccine may be stored in India’s cold-chain infrastructure because it is stable between 2 and 8 degrees Celsius. Intradermal (between the layers of the skin) injections are simpler to give than intramuscular ones. Potentially helpful in protecting against ever-evolving infections, DNA vaccines like those developed by Cadila might be updated fast.
On July 1, Zydus Cadila announced that it had applied for a EUA from the DCGI for its three-dose COVID-19 vaccine marketed under “ZyCoV-D.” On June 27, the Centre informed the Supreme Court that immunizations against COVID-19, including Zydus Cadila’s candidate, “will be available for the 12-18 age group soon, subject to the statutory permissions.”
ZyCoV-D, a DNA-based vaccine against COVID-19, is safe and effective in clinical trials. This is the first emergency application of a DNA-based vaccination in India. The vaccine is administered using the needle-free Tropis injection device.