A recent article in the Wall Street Journal (WSJ) raises some concerns about a potential new vaccine by Pfizer. According to the Journal asiaone, the new vaccine, called Covid 19, may be just as dangerous as the current flu virus. The Wall Street Journal's story is based on research done by public-health researchers at the University of Minnesota. They have determined that Covid 19 may cause the development of a condition known as Guillain Barre Syndrome, or GBS for short. In other words, it is a condition which causes the involuntary movements and speech problems associated with an altered mental status.
So, what is this new vaccine all about? According to the Wall Street Journal, the Pfizer vaccine was developed through an exclusive agreement between the FDA and Pfizer's Worklife Biotech unit. According to the FDA, the company submitted a New Drug Application (NDA) to approve the vaccine. However, work on the vaccine was ongoing for more than a year prior to the submission of the NDA. This lengthy testing was due to the fact that Pfizer was working on another antiviral medication, called Tagamet, which was under the microscope of the FDA.
According to the Wall Street Journal, the NDA was only filed after Pfizer scientists raised safety concerns about the vaccine. In addition to this, the company did not notify the FDA of its earlier antiviral agents, nor did they submit data on any of the studies they had conducted to test their product's efficacy in terms of preventing disease. One of the studies concluded that Tagamet was not as effective as Pfizer's own Tagamet. Therefore, the FDA did not consider this NDA a valid filing for the new vaccine.
This raises questions as to why the FDA did not consider an NDA when approving medicine containing an antiviral compound as long as there was no study proving its effectiveness. If this is the case, then it is entirely possible that thousands of innocent people could be put at risk of contracting some form of disease as a result of that drug's use. While the effects of the vaccine on healthy adults are not known, studies have shown that young children who were administered the vaccine have been diagnosed with asthma, pneumonia, and other respiratory infections. There are also concerns about the effects on unprotected infants, especially those that are born to mothers who had previously given birth to children who suffered from these types of infections.
Now, that the patent on this vaccine has been issued, what does this mean for Pfizer? It means that any revenue generated through the sale of Tagamet will be tax-free, which means that it will not be passed onto consumers. Also, since this is not a patented drug, there is no point limit as to how many individuals you can give the vaccine to. The manufacturer can keep experimenting with the composition and dosage and could potentially come up with something even more harmful to humans, while concurrently trying to protect its patent rights. As you might expect, this could set the stage for fierce legal battles that could extend for years.
The bottom line is that the patent was issued because the Pfizer inventor, Dr. Robert M. Koche, did create an amazing product, but he did so before anyone else knew of his achievements. While the lack of a patent may restrict the public's access to this wonder medication, it should not prevent Koche from profiting from his creation. His hard work and dedication to ensuring that Tagamet is safe could ultimately land him in a position to greatly benefit from his invention. All he has to do is to ensure that he holds on to that patent and encourages others to do the same.