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The ongoing race for a coronavirus vaccine has raised several concerns regarding its efficacy and safe use. One particular concern that medical professionals are worried about is how the vaccine can potentially alter human DNA.
Internal medicine specialist Dr. Carrie Madej, who studied vaccine for about 20 years and trained in osteopathic medicine, explained the potential damages that a Covid-19 vaccine can cause in a video that she posted online. Throughout the pandemic, the genetic makeup of SARS-CoV-2 has been mutating, making it more complicated for scientists to develop a working vaccine.
Dr. Madej talked about how small alternations in the human genome result in rewriting the genetic code or DNA. DNA alterations can either help improve health or damage it. Since the vaccine will contain synthetic genetic code of coronavirus, it will be unlike traditional vaccines. Dr. Madej emphasized the fact that the DNA vaccines that are being developed have never been used on humans before until recent trials.
Fast Track Designation
Moreover, another danger of the potential vaccines is how the U.S. Food and Drug Administration (FDA) has granted several companies the Fast Track designation, allowing developers to skip over a few essential steps in vaccine development. Some have been 'skipping over the animal trials [and] going directly to human trials,' said Madej.
None of the companies are also comparing vaccine dosages to randomized placebo control trials which are a legal standard of the FDA, she continued, raising concern over standard protocols. The lack of randomized control trials vaccine trials has also been recently applied to other vaccines such as an altered vaccine for measles, mumps, and rubella (MMR).
Developer companies have also been exempt from product liability, meaning that any side effects caused by their vaccine, when released for public use, will not be held against the companies. With companies responsible for claiming that their vaccine produces antibodies is not enough proof that the dosages will be effective protection against coronavirus.
Recent developments in the development of COVID-19 vaccines include phase three of human trials. Moderna, one of the companies leading the race for a vaccine, has already given the dosages a price tag between $32 and $37.
Stéphane Bancel, Moderna's CEO, said, 'At Moderna, like many public health experts, we believe that the SARS-CoV-2 virus is not going away and that there will be a need to vaccinate people or give them a boost for many years to come.' Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases has been urging Americans to join the recent vaccine trials where the developers have aimed for 300,000 participants.
'We don't know if, really, it would work out in the population of people,' she said, pointing out that companies have been saying there's not enough time to do those kinds of studies. Recombinant vaccines may include a lot of foreign genetic code, Madej warns, which may result in permanent changes to a person's DNA.