Vaccine science is incredibly complex, and that makes mis-information way too easily effective to a disinterested or uninformed audience

I wrote a response recently to a (post claiming a criminal cover up by the FDA was underway)[https://steemit.com/hive-160342/@bntcamelo/the-fda-s-criminal-cover-up-of-vaccine-deaths-they-knew-it-was-killing-people-in-early-2021].

Here's what I responded:

What's interesting here is that the linked document neither supports the clickbait headline, nor the general sentiment of the article. Did you read it? Notably, the Alt Mind site presents it as some sort of smoking gun exposing criminal conspiracy. At face value, however, the document clearly and specifically lays out data and analysis related directly to the safety profile of the Pfizer vaccine.

Furthermore, the conclusion is that analysis "confirms a favorable benefit: risk balance for BNT162b2." There's also a note that "Pfizer will continue routine pharmacovigilance activities ... to assure patient safety." In fact, that continued activity is detailed rather comprehensively here: (Comirnaty EU Risk Management Plan (4.0) including Part I to Part VI (25Nov2021).pdf)[https://www.ema.europa.eu/en/documents/rmp-summary/comirnaty-epar-risk-management-plan_en.pdf]

This is either a relatively big misunderstanding of what was documented, or a gross misrepresentation of that information.

Note for instance that the Alternative Mind article linked here presents something called "Vaccine-associated enhanced diseases (VAED)" as a "surprise", alleging that the acknowledgement of such an effect indicates that the FDA was "up to its neck in a criminal conspiracy to conceal the truth about vaccine injuries and deaths". The truth is that scientists have learned how to mitigate the risks of this sort of vaccine-associated incident over the course of several decades.

Finally, the risk of such a thing is purely theoretical; a modified or more severe form of COVID hasn't been noted in an individual after (i.e. due to) prior vaccination.

I've since also posted (an interesting link to a paper from November 2020)[https://steemit.com/hive-160342/@primevaldad/prospects-for-a-safe-covid-19-vaccine]: scientists have been aware of both the potential risks of vaccination as well as both practices and methodologies that mitigate that risk and the need for ongoing evaluation. One interesting aspect of that link is that now that we're many months into public vaccination roll out, we will be able to begin to analyze data to help us understand the actual safety profile of the COVID-19 vaccines.

I researched a bit about VAED specifically in response to the mis-informative post, and I thought it would be worth sharing some of what I've learned:

First of all VAED, and specifically for SARS-COV-2, VAERD (which noted the association of the disease with the lower respiratory tract specifically), are indeed risks for individuals receiving the vaccine. The reason for that is the affinity between SARS-COV-2 and other similar diseases (SARS-COV-1 and MERS-COV) that have demonstrated VAED in the past (although it's important to note that in those cases, the occurrences of VAED were in animal models; and it's difficult to know for MERS specifically whether there is a risk for humans or not because of the relatively low volume of vaccinated individuals). As a side note, these effects were also observed for Polio, RSV, and dengue vaccines, and at least in some cases, vaccines were able to be reformulated to make inoculation safer and more effective.

So, is there a risk of VAED for COVID-19? Theoretically. However, VAED has not been documented for SARS-COV-2 thus far.

It is understood there is also a potential for higher risk of VAED in individuals with lower titer response to a vaccine, and so the continued evaluation is important since we do not know the effects of possibly waning titers over time, or the effects of variability between individuals (given that the mechanism(s) for any potential VAED is theoretical at this point, and therefore unknown). By mechanism, I mean that we know that coronaviruses infect cells in a number of different ways, and we know that the human body responds in a number of different ways to the presence of infection. It's this complex interplay between proteins, antibodies, and your body's cells and so on that define the mechanism(s) by which severity of disease would be determined. Scientists are also constantly refining their understanding of how each of those parts interacts with the others. The comprehensive picture is complex and ever developing.

Finally, it's important to note that these risks are not ignored. Calls like this to create well-defined clinical trials and follow up regimens did not go unheeded. For instance, Pfizer's own classification of VAED is as a "potential risk" because of the association with similar effects with the other coronaviruses (NOTE: vaccination methodology, and other variation in vaccine deployment do not impact the risk profile for VAED; i.e. the mRNA method nor the specific ingredients carry the same risk as other injection methods, etc.), but that terminology specifically differentiates it from their list of "identified risks", which have a history of actual reports unlike the theoretical nature of VAED.

Theoretical or not, there is a risk that a vaccine—and this goes for any inoculation—will cause you issues. In the end, we can seriously weigh the risks associated with a vaccine along with its benefits, and hopefully try to make an informed decision.

Here's hoping a little more information, and a little more accessible conversation about the intricacies of vaccine science can help!