In a move that heaps still further controversy on the field of Covid-19 vaccines, India has approved the world’s first DNA-based injection against the coronavirus. Manufactured by Indian drug company Zydus Cadila and requiring three doses per patient, the vaccine is claimed to have 66.6 percent efficacy against symptomatic Covid-19 and to be safe for children aged over 12. In reality, however, there are no publicly available data supporting these claims, either in an official published study or a preprint interim analysis. Faced with receiving this new experimental vaccine, many Indian citizens will doubtless therefore be left wondering what exactly it is that their country’s drug regulator is trying to hide.
The only information currently available about this DNA vaccine is published in the form of a press release. Dated 1 July 2021 and published by Zydus Cadila, the product’s manufacturer, the press release states that over 28,000 volunteers have received the injections, including around 1,000 children over the age of 12. While claiming the results supposedly demonstrate safety and efficacy, no scientific evidence whatsoever is provided in order to prove this. Instead, the press release parades a 117-word statement from Dr. Sharvil Patel, Zydus Cadila’s Managing Director, who claims that the vaccine “has proven its safety and efficacy profile.” Apparently, the more than 1 billion citizens of India who are being targeted with receiving the shots are simply expected to take Dr. Patel’s word on this.
As has similarly been the case with other Covid-19 vaccines, the approval granted by India’s drug regulator was issued in the form of an ‘emergency use authorization’. The issuing of emergency use authorizations essentially bypasses the requirement for companies to conduct full clinical trials, thus enabling the ultra-rapid rollout of new medicinal products with minimal regulatory interference. Indian citizens have a right to be concerned that the world’s first DNA-based Covid-19 vaccine was approved in such a hasty and non-transparent fashion.
One of the basic building blocks of life, DNA (deoxyribonucleic acid) is a molecule that carries genetic information for making the proteins and molecules that are necessary for the growth, development, functioning, and reproduction of all known organisms, including many viruses. DNA is organized into thread-like structures known as chromosomes, found in the nucleus of each cell.
Zydus Cadila’s vaccine is what is known as a plasmid DNA vaccine. Plasmids are small molecules of DNA, usually circular, that can replicate independently of a cell’s chromosomal DNA. The basic idea behind using plasmid in a Covid-19 vaccine is that it carries genetic information enabling the body’s cells to make copies of the SARS-CoV-2 ‘spike protein’, the part of the coronavirus that binds to specific receptors on a cell membrane and facilitates viral entry and infection. This should result in the body’s immune system producing antibodies, thus enabling it to recognize and fight the virus if confronted with it in future.
The potential long-term risks of DNA-based vaccines deserve serious consideration. As Dr. Matthias Rath and Dr. Aleksandra Niedzwiecki explain in their in-depth analysis of Covid-19 vaccines published earlier this year, many aspects of the immune response generated by DNA vaccines are still not fully understood. The possibility that genes controlling cell growth might be affected, potentially causing cancer, or that antibody production against DNA might be induced, thus resulting in autoimmune diseases, cannot be excluded. Nor can we be certain that the genetic makeup of humankind won’t be altered irreversibly, for generations to come.
These days, many, perhaps even most, people have strong reservations about consuming genetically modified foods. Aware that the seeds for such foods are developed and owned by multinational corporations whose primary motivation is the accumulation of profit, people are instinctively aware that the safest and healthiest foods are those that are grown naturally. This same commonsense thinking also needs to be applied to the field of genetically engineered vaccines, the patents for which are owned by multinational pharmaceutical companies. Just as with genetically modified foods, the primary motivation fueling the development of gene-based vaccines is the accumulation of shareholder profits.
Research conducted by scientists at the Dr. Rath Research Institute has shown that combining vitamin C with other natural compounds impedes key mechanisms of coronavirus infection. Doctors in China have similarly documented that high-dose vitamin C greatly reduces mortality from Covid-19. Based on this and other research, it is now a scientific fact that natural alternatives to genetically engineered vaccines already exist. Faced with accepting such vaccines, we therefore need to apply the same crystal-clear logic that we already apply to genetically modified foods. From a risk management perspective, genetically engineered vaccines with no long-term safety data are definitely best avoided.