[Editor’s Note: This analysis is provided to WN&PR readers by Michael W. Yates, Pharm.D., R.Ph. Dr. Yates earned his degree in Pharmacology from Auburn University, and his Doctorate at the University of Florida. We publish this in the public interest in light of the many questions raised regarding the validity of infection rate, cases, and actual deaths as result of the Covid-19 outbreak]
To say this question is complicated is an incredible understatement. The discussion must be considered requiring an evaluation on individual bases, not a black-and-white/ all-or-none decision. To begin, there are currently 2 vaccines approved in the US via the FDA Emergency Use Authorization process, in an effort to make them available in record time to the public. These are both messenger RNA (m-RNA) vaccines that cause the ribosomes inside cells to produce fragments of the spike proteins surrounding the viruses, which then act as antigens to stimulate the protection of antibodies in large quantities, that will, in turn, attack other invading viruses. There are quite a number of other vaccines in development that work in multiple ways (including DNA based antivirals, viral vector versions, and protein subunit-based vaccines) that may get approval in the future. The current vaccines were pursued first because they were able to be developed quickly and be produced in large amounts, but they are still considered “experimental” because of several factors, including no animal studies. A significant benefit for these vaccines was the rapidity with which an effective tool could become available to a fairly large population at risk. This is not the first time m-RNA vaccines have been attempted, but this is the first time this type of vaccine has been approved.
These two vaccines (produced by Pfizer and Moderna) have seen similar efficacy in trials of 35-40,000 patients each with reductions of infection in the area of 95% vs patients given placebo. Also, these trials saw a highly significant reduction in patients who did become infected being designated as “severely ill”, so even if patients received the vaccine and subsequently contracted, their illness was much less severe. There have been some logistical problems, however, in the distribution and storage of these vaccines, especially as Pfizer’s version required storage of -70◦ C (or -94◦ F) which requires special freezers that are not commonly available. Cases of vaccine supplies having to be destroyed due to improper storage have been seen numerous times. This also requires 30 minutes or more to thaw out before administration. One report from the CDC showed 21 serious anaphylactic reactions had already occurred in the US between Dec 14-30, not to mention incidents of Bell’s palsy, injection site reactions, and other reactions. While still considered “rare”, these exceed the incidence seen with flu vaccines.
A more recent concern posed by some experts is one called ADE (antibody-dependent enhancement). This is a situation where the body’s normal defense system becomes detrimental to the individual. When viruses enter a body and encounter inadequate or less-than-effective antibodies that should destroy them, their ability to enter a host cell is actually enhanced and replication begins. This leads to increases in the virus now being produced and they are more infectious and virulent. This phenomenon can happen when a patient is reinfected with virus, or when one is given a vaccine and then subsequently infected by a virus. This latter issue was seen in animal studies for vaccines used to combat other Coronaviruses, including SARS-CoV and MERS, as well as vaccines for other viruses (Dengue fever, ebola, HIV, RSV, and Zika). How much slight mutations in these viruses into other variants increase this risk has yet to be completely understood, but most of these ADE events were seen in animal studies for other vaccines prior to approval, and thereby prevented those vaccines from being approved.
To emphasize the position of this article, NO ONE KNOWS the risk of ADE from any of these new vaccines. They may not ever occur, or if they do, is the risk any higher than that seen in patients whose natural immunity declines so that they are re-infected in the future. However, it must be studied and evaluated as we go forward in an effort to better understand this current pandemic.
Now the question of who should receive such vaccines must be asked. Remember, the survival rate for patients infected who are 69 or younger, according to the CDC, is greater than 99%, and 94.6% for those older than 69. While numerous authorities in the US have denounced the use of hydroxychloroquine, many groups have published data and articles showing efficacy of the drug. The question of safety has been recklessly made by some when it has been used for over 60 years without causing the issues raised by these fearmongers. It is widely used for rheumatoid arthritis patients and for malaria. In fact, rates of SARS-Cov 2 infection in sub-Saharan Africa have been far lower than most other places in the world, and use of hydroxychloroquine use there is common. As of Nov 14, only 46,000 deaths from this virus were seen in the entire continent of over 1 billion people, only 16% of that seen in the US. This latter statistic also should call into question the proposed increased risk of patients based on race, as Africa obviously has a majority population of black individuals. Ivermectin is another therapy that is now used as part of many hospital protocols for virus infected patients, and appears to be helping patients recover quickly and well. When you also see other therapies like Remdesivir, bamlanivimab, anti-inflammatory drugs, etc are now available for treating patients who do become ill, it now becomes reasonable to ask who then should get the vaccine. Given the data, one should look at a patient’s age, co-morbidities, and risk factors which include work environment (especially working in nursing homes or with other potentially sick patients), prior vaccine reaction issues, general health, etc. As with all drugs, every patient must weigh the risks vs the benefits expected from such vaccinations and decide for themselves, and for those not medically trained, include the input from your physician and or pharmacist in making that decision. Making such a decision based on what one sees on the internet or “heard” from some source (whether on some form of media or just from a neighbor or relative) is unwise and could be costly.
Michael W. Yates