By Amit Kumar, Ph.D., CEO of Anixa Biosciences
October 22, 2020
President Trump’s recent positive Covid-19 diagnosis, as well as the more than 218,000 U.S. lives claimed by the virus underscore the need for a proper vaccine against the SARS-CoV-2 virus. While the biopharmaceutical industry is making dramatic progress in vaccine development, scientists, clinicians and the general public will need to evaluate several factors when a vaccine becomes available. Policy makers and the media have discussed and debated a number of issues, such as distribution and logistics, who gets the vaccine first, as well as safety and efficacy. However, there are a number of matters that should be discussed now, in anticipation of multiple vaccines reaching the market in the coming months.
- Limited Efficacy and Safety
Safety and efficacy are the two most important characteristics of any vaccine and will have a direct impact on an individual’s willingness to receive the inoculation, as well as post-vaccination social behavior. Because the U.S. Food and Drug Administration (FDA) is trying to authorize and/or approve a vaccine quickly, we will only have safety data for a few months, at most. While society has accepted this risk, will everyone? Also, the FDA has stated, that a vaccine with 50% efficacy, will be acceptable. Certainly, we hope for a vaccine that provides efficacy near 100%, yet the candidates now in late-stage clinical trials may not clear that hurdle. Though still beneficial, a vaccine that is only 50% efficacious, may not significantly change our social behavior. Since we will not know for whom the vaccine is effective, all of us will need to continue social distancing, wearing masks and making decisions about when to engage in social and business activities. This last point is critical for the economy and society as a whole. Underscoring this point is the fact that vaccine efficacy will probably vary among different demographics (elderly, underlying medical conditions, etc.). Unfortunately, too many pundits in the media believe that once a vaccine is available and properly administered, life will return to normal.
In addition, an individual in the U.S. was recently infected a second time with Covid-19. Worldwide, only a handful of patients have been re-infected after recovering from fully symptomatic disease. This is heartening, as it implies that immunity is conferred after the initial infection. If, however, large numbers of individuals demonstrate a second infection, then immunity is either not effectively conferred or it is conferred temporarily. If immunity proves to be unavailable or temporary, it will be difficult to create immunity through a vaccine, as a vaccine does not induce the immune system as aggressively as the actual disease. The scientific community is carefully monitoring re-infection rates.
- Multiple Vaccine Choices
There are several vaccine candidates in late-stage clinical trials, which should all report results in the next few months. Should several vaccines become available, individuals will have to decide which to take. Will the FDA, CDC or other government organization recommend one vaccine, and for which demographic group? If one vaccine is preferred, but not enough doses are available, should individuals take another vaccine rather than wait? Some demographic groups may want to wait, but some may want to take a different vaccine. How will individuals make that decision? And how will medical professionals advise their patients? If there are multiple vaccines with modest efficacies, should an individual take more than one? It is also possible that vaccine candidates that report later in 2021 may show better efficacy. Should individuals delay inoculation to see data for the next round of vaccines?
- Duration of Immunity
While vaccine trial participants will ultimately be followed for two years or more, approvals will occur only after a couple of months. Therefore, we will know little about duration of immunity. It is instructive to note that most who have recovered from symptomatic Covid-19, are not getting re-infected. While this may largely be due to mask wearing and other social measures we have taken, it appears that there is some sustained immunity after infection. This fact indicates that a vaccine may be able to provide long-term immunity. However, if we start seeing large scale re-infections after six months, a year, or even longer, then it is unlikely that any vaccine will provide longer term immunity. Should vaccine immunity be temporary, our social behavior will unlikely go back to normal, unless we provide repeated vaccinations.
Other challenges (vaccine nationalism, distribution, cold chain control and storage, etc.) with vaccines have been discussed, but the issues above need to be considered as well. While vaccines have been the primary focus of Operation Warp Speed, additional funding for developing therapeutics should also gain attention and funding. Specifically, we should target oral medications that can be administered outside a hospital setting. This type of therapeutic should be inexpensive, stable and easy to distribute through our pharmacy infrastructure. Since these medicines will be administered only to symptomatic, confirmed Covid-19 patients, many of the hurdles that arise with vaccines are not extant. The lack of a highly effective vaccine, should that situation arise, does not mean society is in trouble. The HIV story illustrates that an effective therapy could be as effective, especially for a disease that can be cleared with some help from a therapeutic. As a society, we will ultimately figure these things out, but it is important to understand that there may be a new normal, which may exhibit subtle as well as dramatic differences from the pre-pan
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