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1st COVID-19 DNA vaccine: India ZyCoV-D vaccine effective against Delta
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1st COVID-19 DNA vaccine: India ZyCoV-D vaccine effective against Delta. The COVID-19 DNA vaccine is approved, and it is a great success against the Delta strain. It can be used for vaccination of adolescents.
On August 20, the Indian COVID-19 DNA vaccine ZyCoV-D was approved for emergency use (EUA) in India. This is the first worldwide approval for a DNA vaccine to be marketed.
ZyCov-D has shown excellent safety and effectiveness against DNA variants in Phase III clinical trials. Therefore, it has become the first COVID-19 vaccine approved by India that can be used for adolescent vaccination. Its developer is a large Indian pharmaceutical company “Zydus Cadila Healthcare“.
Following the success of the mRNA vaccine at the end of last year, the DNA vaccine was finally successful. This means that the main human vaccine technology routes have all been verified in the field of COVID-19 vaccines, and the era of nucleic acid vaccines has fully arrived.
Phase III clinical data show that DNA vaccines are effective against Delta variants
The COVID-19 DNA vaccine ZyCov-D has conducted the country’s largest Phase III clinical trial so far in India, involving more than 50 bases and a total of 28,000 subjects. The results of the study showed that during the phase III clinical trial, when the major new coronaviruses circulating in India were all Delta mutants, the effective rate of ZyCoV-D reached 67%, which is more than that in terms of the protective effect against the Delta strain. The vast majority of vaccines already on the market.
The Phase III clinical trial in India also proved that the COVID-19 DNA vaccine is very safe and tolerable. It is worth mentioning that in addition to adults and the elderly, 1,400 adolescent volunteers participated in the third phase of the trial, successfully verifying the safety and effectiveness of the DNA vaccine in the adolescent population. India’s inactivated vaccine, Covaxin, is only approved for adults over 18 years of age, and for teenagers over 12 years of age, India has stated that it has started to vaccinate ZyCov-D.
The principle of DNA vaccine is to design and synthesize a DNA plasmid carrying antigen sequence according to the Central dogma of molecular biology, which is transcribed into mRNA in human cells and then translated into protein to activate the human immune system. ZyCov-D uses a three-needle immunization program, and uses a needle-free syringe for vaccine delivery to enhance the effectiveness of the vaccine.
More than ten new coronavirus DNA vaccines are under development in the world. Why can India achieve a surpass?
According to the latest statistics of the WHO, there are 27 new coronavirus DNA vaccines in the world under development, 11 of which have entered the clinical stage. Prior to the approval of ZyCov-D, the fastest progress in clinical research was the COVID-19 DNA vaccine pGX9501/INO-4800 jointly developed by China Adiweixin (Suzhou) Biopharmaceuticals and Inovio Pharmaceuticals of the United States, as well as those developed by Anges Inc. and Takara Bio of Japan. AG0301, both of these projects have entered phase 2/3 clinical phase. In addition, Symvivo, which has cooperated with Merck to develop a DNA vaccine technology platform, has developed an oral COVID-19 DNA vaccine that has also entered the clinical stage. Companies such as China’s Kangtai Biology have also announced plans to explore the development of COVID-19 DNA vaccines.
In the face of many technological pioneers, why can India achieve a turnaround? The main reason is that the speed of the Phase III clinical trial of the COVID-19 vaccine is mainly determined by the incidence of the clinical research country. Academician Zhong Nanshan once pointed out: “Because of the effective prevention and control in China, we have no way to do it in China (for the COVID-19 vaccine). The third phase of the clinical trial is because there are no more patients.” While the epidemic in India is high, during the peak of the second wave of epidemics in India, the third phase of the vaccine can quickly collect enough effectiveness data, so the speed of development in the final phase of the clinical trial Realized the go-ahead.
It is worth noting that, according to ZyCov-D’s published technical information, it is highly consistent with the sequence design of pGX9501/INO-4800. Whether it will involve the intellectual property rights of other companies is still unknown. However, as a developing country, India has chosen a loose drug patent protection system in the process of drug supervision to facilitate the production of domestic generic drugs.
Development of DNA vaccine technology
Both DNA vaccine technology and mRNA vaccine technology were born in the early 1990s. The DNA vaccine technology was first invented by Chinese student Dr. Wang Bin and his supervisor Professor David B. Weiner during his work at the Perelman School of Medicine at the University of Pennsylvania. They then published a paper and successfully carried out the world’s first clinical trial of a DNA vaccine. At the same time, their colleague Katalin Kariko in the Perelman School of Medicine laboratory is working on mRNA vaccines.
In terms of the transformation of scientific achievements, Professor DavidB. Weiner and Dr. Joseph Kim founded Inovio Pharmaceuticals and served as the company’s co-founders and directors. After Wang Bin returned to China, he founded Ai Di Weixin Biopharmaceutical as the chief scientist and served as a distinguished professor at Fudan University School of Medicine.
In 2010 and 2013, Moderna and BioNTech successively obtained patent licenses related to mRNA synthesis from the University of Pennsylvania for vaccine development. Katalin Kariko joined BioNTech as the chief scientist. He led the team to develop the COVID-19 mRNA vaccine at the end of 2020. Obtained the FDA’s emergency use permit (EUA) in the United States.
DNA vaccines and mRNA vaccines, the future of nucleic acid vaccines
DNA vaccines and mRNA vaccines are called “third-generation” nucleic acid vaccine technologies. In recent years, rapid progress has been made in preclinical and clinical research in the field of infectious diseases and cancer, and it has become a powerful and versatile vaccine technology platform with broad commercial prospects.
At the end of 2020, two mRNA vaccines of BioNTech and Moderna were approved for the prevention of COVID-19 pneumonia. It was found that the mRNA vaccine can stimulate both humoral and cell-mediated immune responses. The third phase of Zydus Cadila’s COVID-19 DNA vaccine was successful and approved for marketing, and the data showed that it is effective against the Delta variant and safe and effective for adolescents, proving that the safety and effectiveness of the DNA vaccine has reached and partially exceeded the performance of the mRNA vaccine.
With the addition of DNA vaccines, the era of nucleic acid vaccines has come.
(source:internet, reference only)