India urgently authorizes the world's first DNA-based COVID-19 vaccine in response to the third wave of outbreaks

On August 20, the Indian government stated in a statement that the first DNA-based COVID-19 vaccine developed by Ahmedabad-based Cadila Healthcare Ltd.
was granted emergency authorization this Friday .
In clinical trials, the vaccine is 67% effective in preventing symptomatic infections
.

The statement said that the vaccine is "the world's first and locally developed new coronavirus vaccine based on DNA technology in India, which can be used in humans, including children and adults 12 years of age and older

In a clinical trial in July, the vaccine was 67% effective in preventing symptomatic infections

This is India's second approved self-developed new coronavirus vaccine.
Cadila claims that this vaccine can be used against the latest mutant strains, including the highly infectious Delta variant, increasing the country's ability to fight the virus
.

To date, India’s new crown cases have exceeded 32.

According to a BBC report on the 18th, the World Health Organization confirmed that India’s Covishield Covid-19 vaccine was fake and issued a medical warning to the world
.

As India’s main Covishield vaccine, it is the most widely used in India, with more than 486 million doses already injected

Currently, only 9% of India’s population has completed the complete vaccination of the vaccine, and a total of six vaccines have been approved for use in the country
.

At present, the main DNA new crown vaccines and mRNA new crown vaccines

According to information on the WHO’s official website, there are many teams around the world that are engaged in the research and development of DNA new crown virus vaccines, including Inovio Pharmaceuticals in the United States , Ai Weixin Biotechnology in China, Takis , an Italian biotechnology company, and the United States Applied DNA Science Corporation.
Cadila Indian pharmaceutical companies
.

Inovio Pharmaceuticals, China Ai Di Weixin Biological,

Among them, Inovio Pharmaceuticals and Chinese vaccine company Beijing Aidiweixin Biotechnology have begun to jointly develop INO-4800/pGX9501 as early as January 2020
.

Ai Di Weixin initiated Phase 1 and Phase 2 clinical trials of the vaccine in China, and Inovio completed Phase 1 and Phase 2 clinical trials in the United States

INO-4800 is a plastid DNA vaccine delivered by electroporation, containing the S1 and S2 subunits of the SARS-CoV-2 spike protein
.

INO-4800 is composed of optimized DNA plasmids, which are directly delivered to cells in the body through proprietary technology and intelligent devices to produce a reliable, safe and tolerable immune response

DNA vaccines and mRNA vaccines are both nucleic acid vaccines.
After traditional attenuated vaccines, inactivated vaccines and genetic engineering subunit vaccines, nucleic acid vaccines are called "third-generation vaccine technology" in the industry
.

In the early 1990s, John Wolf of the University of Wisconsin in the United States unexpectedly discovered that after intramuscular injection of foreign recombinant plasmids containing foreign genes in mice, the plasmids can stably express the encoded Protein for at least 2 months
.

DC.

In 2018, China approved the DNA vaccine developed by the Harbin Veterinary Research Institute of the Chinese Academy of Agricultural Sciences for the prevention of H5 subtype avian influenza, and obtained the national first-class veterinary drug certificate.
This is also the first DNA vaccine product approved in China
.

The Jinxiang review article of Fudan University pointed out that after more than ten years of improvement, the delivery efficiency of DNA vaccines has been greatly improved, especially in response to severe acute respiratory syndrome (SARS), highly pathogenic influenza, Middle East respiratory syndrome (MERS), and In terms of sudden infectious diseases such as ZIKA and Rift Valley fever, the preliminary clinical effects of DNA vaccines have been verified
.

DNA vaccines are characterized by good safety, inducible humoral and cellular immunity, short research and development and production cycles, fast supply and high stability, suitable for strategic storage and delivery to remote areas with low production costs

After more than ten years of improvement, the delivery efficiency of DNA vaccines has been greatly improved, especially in response to severe acute respiratory syndrome (SARS), highly pathogenic influenza, Middle East respiratory syndrome (MERS), Zika fever (ZIKA), and Rift Valley With regard to sudden infectious diseases such as fever, the preliminary clinical effects of DNA vaccines have been verified

https:// August 2020, the WHO updated the guidelines for DNA vaccine development (WHO/BS/2020.
2380), fully affirming the importance of DNA vaccines, and believes that the most prominent advantages of DNA vaccines are:① Preparation of DNA vaccines only requires nucleic acid The reorganization of substances does not need to deal with biomolecules such as proteins, so the preparation is fast and simple, and there is no need to consider factors such as protein antigen structure, modification, stability, and changes brought about by the process
.
② The use of encoded gene fragments does not replicate or integrate, and there are very few adverse reactions
.
③ The encoded gene fragments are expressed in the cells of the body and can activate both the cellular immune response and the humoral immune response
.
④ Stable at room temperature and easy for mass production
.
⑤ Preparation after rapid modification of virus mutation sites
.

① The preparation of DNA vaccines only requires the recombination of nucleic acid materials and does not need to deal with biomolecules such as proteins.
Therefore, the preparation is fast and simple, and there is no need to consider factors such as protein antigen structure, modification, stability, and changes brought about by the process
.
② The use of encoded gene fragments does not replicate or integrate, and there are very few adverse reactions
.
③ The encoded gene fragments are expressed in the cells of the body, which can activate both the cellular immune response and the humoral immune response
.
④ Stable at room temperature and easy for mass production
.
⑤ Preparation after rapid modification of virus mutation sites
.
① The preparation of DNA vaccines only requires the recombination of nucleic acid materials and does not need to deal with biomolecules such as proteins.
Therefore, the preparation is fast and simple, and there is no need to consider factors such as protein antigen structure, modification, stability, and changes brought about by the process
.
② The use of encoded gene fragments does not replicate or integrate, and there are very few adverse reactions
.
③ The encoded gene fragments are expressed in the cells of the body, which can activate both the cellular immune response and the humoral immune response
.
④ Stable at room temperature and easy for mass production
.
⑤ Preparation after rapid modification of virus mutation sites
.

We believe that DNA vaccines have the potential to become another focus after mRNA vaccines, and their industrialization will be greatly accelerated
.
However, there are still many problems with DNA vaccines that need to be resolved.
For example, antibiotics frequently used in DNA vaccines produced by Escherichia coli may remain in DNA vaccine products.
Although most of them can be removed through purification steps, trace residues are still a problem.
Risk factors
.
Its safety, effectiveness, and ethical risks remain to be seen
.

We believe that DNA vaccines have the potential to become another hot spot after mRNA vaccines, and their industrialization will be greatly accelerated
.
However, there are still many problems with DNA vaccines that need to be resolved.
For example, antibiotics frequently used in DNA vaccines produced by Escherichia coli may remain in DNA vaccine products.
Although most of them can be removed through purification steps, trace residues are still a problem.
Risk factors
.
Its safety, effectiveness, and ethical risks remain to be seen
.
We believe that DNA vaccines have the potential to become another focus after mRNA vaccines, and their industrialization will be greatly accelerated
.
However, there are still many problems with DNA vaccines that need to be resolved.
For example, antibiotics frequently used in DNA vaccines produced by Escherichia coli may remain in DNA vaccine products.
Although most of them can be removed through purification steps, trace residues are still a problem.
Risk factors
.
Its safety, effectiveness, and ethical risks remain to be seen
.
DNA vaccines have the potential to become another hot spot after mRNA vaccines, and their industrialization will be greatly accelerated
.
However, there are still many problems with DNA vaccines that need to be resolved.
For example, antibiotics frequently used in DNA vaccines produced by Escherichia coli may remain in DNA vaccine products.
Although most of them can be removed through purification steps, trace residues are still a problem.
Risk factors
.
Its safety, effectiveness, and ethical risks remain to be seen
.

 

references:

references:

Smith, TRF, Patel, A.
, Ramos, S.
  et al.
 Immunogenicity of a DNA vaccine candidate for COVID-19.
  Nat Commun 11,  2601 (2020).
  https://doi.
org/10.
1038/s41467-020- 16505-0 

Smith, TRF, Patel, A.
, Ramos, S.
  et al.
 Immunogenicity of a DNA vaccine candidate for COVID-19.
  Nat Commun 11,  2601 (2020).
  https://doi.
org/10.
1038/s41467-020- 16505-0 https://doi.
org/10.
1038/s41467-020-16505-0 

Jin Xiang,Yu Qingling,Zhang Lunan,He Yue,Cheng Xin,Liu Xiaoyan,Wang Bin.
Research progress of DNA vaccine against new coronavirus[J].
Chinese Journal of New Drugs,2020,21:2425-2433.

Jin Xiang,Yu Qingling,Zhang Lunan,He Yue,Cheng Xin,Liu Xiaoyan,Wang Bin.
Research progress of DNA vaccine against new coronavirus[J].
Chinese Journal of New Drugs,2020,21:2425-2433.

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