Michael Lehr headshotBy: Michael Lehr

Lehr is an Associate with Dunlap Bennett & Ludwig in our Richmond Office.

 

[05.07.2020 Richmond]   Vaccine development, in general, usually follows a standard pathway of exploratory research, pre-clinical research and development, clinical development and testing, regulatory review and approval, and finally, production.  This process takes many years, and occasionally, over a decade before a lab receives regulatory approval and production begins.  However, due to the ongoing global coronavirus pandemic, drug manufacturers are working with regulatory agencies around the world to bypass the years of regulatory approvals, which typically delay vaccines reaching the open market.  As a result, many pharmaceutical laboratories which first began working on a vaccine just several short months ago, are now entering the clinical development and testing stage.

Just this week, Pfizer, Inc. announced that it had administered the first round of its experimental coronavirus vaccines on patients in the U.S.  In doing so, Pfizer cut the typical timetable for new vaccine development of five to ten years to just four months.

Pfizer is working in tandem with German biotech company BioNTech SE to become the first to test and commence production on a coronavirus vaccine.  However, as the news media has widely reported, these two are not the only ones engaged in this quest.  Biotech and pharmaceutical giants across the globe, such as Johnson & Johnson, Moderna, and Roche, are desperately seeking to conclude successful human trials before their competitors.  While many have speculated that the first successful vaccine formula should be released to the world, the monetary benefit is all but guaranteed to the laboratory, which prevails.  Some pharmaceutical companies, such as Moderna and CanSino Biologics, have already started human trials. Moderna originally made headlines in early March as the first to conduct human trials in the U.S. Nonetheless, Pfizer’s announcement is still an impressive feat.  Furthermore, despite the “race” to complete their respective vaccines, each laboratory’s testing provides unquestionably valuable information to researchers looking to study every facet of the disease and how to combat similar viruses in the future.

At its core, the Pfizer trial is not particularly unique.  The study is limited to 360 patients in two age groups: 18-55 and 65-85; however, the testing on the older group is slated to begin once it can be established that a safe immune response occurs in the younger group.  Where Pfizer’s trial stands apart from the crowd, is that it will utilize four different vaccine varieties with varying dosage levels and timetables for completion.  Typically, a manufacturer would test only one variation of the vaccine and readjust in the future as it receives additional data.  However, Pfizer plans to run multiple trials at once, while looking for the most effective method as it analyzes the data.  Moreover, Pfizer has already pre-selected several European and U.S. sites for the production of the vaccine, should it be successful, thus cutting its production time even further.

The vaccine itself closely mirrors the Moderna vaccine, which utilizes a new method of ribonucleic acid (RNA) vaccination technology.  The vaccine takes RNA, stripped from the coronavirus, and injects into the patient so that it may enter the host patient’s cells.  From there, the RNA infects the host’s cells and prompts the cells to develop protective antibodies.  In theory, these antibodies should be resilient enough to defend healthy cells from active coronavirus pathogens in the future.  Currently, this type of RNA, based vaccination technology, has not been officially approved for widespread use in the United States.  However, given the global pandemic in which we are engulfed, U.S. regulatory agencies have allowed pharmaceutical companies to use this new method to develop a vaccine.  Not only will the RNA method likely prove a viable pathway to a successful vaccine, but it benefits researchers because they do not need to spend months brewing batches of proteins or inactivated viral particles, the traditional method for developing vaccines.  As such, the timetable from testing to production is further reduced.

While this is undoubtedly good news, the story ultimately buries the lead. In reality, Pfizer’s vaccine trials, along with the others currently in progress, will not result in a widely available vaccine for months, or longer. Pfizer touts its desire to produce emergency treatment, available for the most immunocompromised people, by fall of this year, but this leaves tens of millions of Americans waiting far longer.

While Pfizer has cut the testing period for their potential vaccine by years, the average American is still likely to be at least nine to twelve months, or more, away from being able to receive a vaccine. In the interim, Americans need to continue to wash their hands thoroughly, disinfect surfaces in their home or business, and continue to abide by recommended social distancing guidelines.

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