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The #Moderna and #Pfizer #COVID #vaccine numbers are not necessarily the solution to the #pandemic that the media are making them out to be. There are several important factors here that aren't being talked about. [thread...]
(1) Adverse reactions are common after the second shot of both these #RNA vaccines. I personally experienced an adverse reaction at least 50x worse with the Moderna vaccine than any other vaccine I have received, and I have received almost every vaccine. https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
(2) It's up to vaccine companies as far as what they define to be a Grade 3 vs. Grade 4 adverse reaction. The grades are defined by the FDA; however, the questionnaires asked of participants have to be properly written, and staff trained, to align responses with FDA intent.
(3) As a data scientist, I can tell you that in the case of the Moderna vaccine, the followup questions that are asked of participants by a tracking app, for at least 8 days after each shot, are extremely badly written. Consequently, their data is bad (mostly incomplete).
(4) There are other confounding factors in grade level assessment. My adverse reaction was so bad that I sat by my phone all night ready to dial 911 if I felt I would lose consciousness. I didn't call, because it would cost hundreds of dollars out of pocket for the ambulance, ...
... and therefore, I couldn't positively answer the question the next morning, "Did you seek medical attention for any medical symptoms in the last 24 hours" (which is a contributing criterion for Grade 4). This is an example of how a badly-written question leads to bad data.
(5) Even if (conservatively speaking) the adverse reaction incidence rate is "only" say 10% (in keeping with the below Science editorial), then for the expected 40 million people to be vaccinated by the end of January, that's 4 million adverse reactions. https://blogs.sciencemag.org/pipeline/archives/2020/11/16/modernas-vaccine-efficacy-readout
Four million adverse reactions *will* be a media fiasco. People will tell their stories. Anti-vaxxers will be ecstatic. This is why I decided to speak up as a whistleblower in the CNBC story. RNA vaccines, though extremely easy to develop, may present significant challenges.
It is extremely important to give people time to adjust to the idea that upon receiving the second shot, there's a significant possibility that they're going to have one of the worst nights of their life -- but that it might be worth it, because COVID can be much worse.
But also, even though they're better than traditional vaccines (e.g. attenuated virus vaccines), RNA vaccines may not be our best option here. Protein-based vaccines (e.g. Novavax and COVAXX) elicit higher immunogenicity with lower reactogenicity.
Furthermore, on the Science editorial, comparing the Moderna and Pfizer adverse reaction prevalence to that of Shingrex is hardly a high bar, given that Shingrex is notorious for triggering adverse reactions that can last 2 years or more.
(6) The population to be initially vaccinated will be front-line workers, and those most at risk of severe COVID symptoms or death (those with diabetes, heart conditions, the elderly, etc.). I am very concerned about severe adverse reactions in the latter group.
(7) The adverse reaction I experienced was an interferon response, triggered by the body recognizing the RNA as viral. Interferon responses are elevated in kids, so both these vaccines may be intolerable for kids. (Pfizer just added kids to their trial, so we shall see!)
(8) Antibodies and T-cell responses induced by natural infection to coronaviruses don't last long. SARS-CoV-1 antibodies attenuated by 50% in the first 12 months, and by 70% in the first 24 months... https://pubmed.ncbi.nlm.nih.gov/16423201/
...but SARS-CoV-2 antibodies attenuate much faster than that. In the largest study to date, four cases of reinfection were confirmed by viral RNA sequencing in Qatar. Median time to reinfection was only 64.5 days! https://bnonews.com/index.php/2020/09/qatar-confirms-4-coronavirus-reinfection-cases-in-largest-study-to-date/
(9) Many people point to the T-cell response as potentially providing immunity even after antibody levels fall; however, the reinfection data seem to indicate that we can't rely on T-cells saving us here.
There is very little good data on T-cell immune response for SARS-CoV-2 at this point. However, we know from decades of failed attempts to create vaccines that are safe, effective, and long-lasting, for any coronavirus, for any species, that this is not going to be easy.
(10) My guess: most SARS-CoV-2 vaccines will last 3-6 months, depending on the type of vaccine, before a booster is needed. But we don't know how bad the interferon response will be for the 3rd or 4th or shot. If the Moderna trial required a 3rd shot, I would have dropped out!
If it turns out that boosters trigger more severe reactions each time, if they are not spaced far apart (leaving a person susceptible to the virus between shots), then nobody will get their boosters, and/or we won't eradicate the virus.
I don't mean to be a naysayer; however, there are some potentially serious issues with RNA vaccines to which we need to pay heed. Surely a severe adverse reaction is not as bad as dying of COVID or being incapacitated for life. But will everybody reach that conclusion? TBD.
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