I am a finance guy and not medically trained nor expert in clinical analysis and interpreting statistical inference of trial results or observations and I am trying to ascertain the risks of the Novavax vaccine in terms of the potential for myocarditis or pericarditis as well as thrombosis.
If there is anyone out there that can help me understand the observations regarding unsolicited adverse events as a result of the trials in the US and Mexcio.?
I quote from the and MedRxiv Preprint - Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico October 10, 2021:"Unsolicited AEs
Unsolicited AEs were slightly more frequent in vaccine than in placebo recipients (16.3% vs. 14.8%), although the imbalance appeared to include duplicate reporting of reactogenicity. There was a balanced frequency of MAAEs, SAEs, severe AEs, AESI related to Covid-19, and potential immune-mediated medical conditions between treatment groups (Table S9). There were no episodes of anaphylaxis, no evidence of vaccine-associated enhanced Covid-19, and no events that triggered prespecified pause rules. No episodes of Guillain Barr syndrome19 and no imbalance in myocarditis/pericarditis20 or thrombosis with thrombocytopenia syndrome (TTS)21 were observed (Tables S14-S16). All-cause mortality was balanced, nine (0.5%) among NVX-CoV2373 recipients and five (0.5%) in placebo recipients."
My novice (and I do mean novice) hypothesis before reading the above was that as the Novavax is a protein sub-unit vaccine using an inert lipid nanoparticle with 14 spike proteins expressed (even with a "secret sauce" adjuvant) as a opposed to a MRNA or viral-vector adenovirus vaccine which simply instruct your own body's cells to express the spike protein that it would present, by its mechanistic operation and presumably limited duration in the body, a much safer profile in terms of not only heart tissue and heart lining swelling, but also in terms of thrombotic events.
Underlying that hypothesis is a potentially simplistic view that assumes it is the spike protein and its dissemination throughout the body after vaccination, rather than staying localized at the injection site, can can cause clotting, even on a micro level, for which I fully understand that there is much debate on this matter.
However reading the above, even though only one case of myocarditis was noted in the population and an external review board determined that was more likely "viral myocarditis" it is very unclear to me as to whether my hypothesis is reasonable or not.
Anyone with some clinical insight willing to share their point of view would be very much appreciated.
Gig'em
If there is anyone out there that can help me understand the observations regarding unsolicited adverse events as a result of the trials in the US and Mexcio.?
I quote from the and MedRxiv Preprint - Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico October 10, 2021:"Unsolicited AEs
Unsolicited AEs were slightly more frequent in vaccine than in placebo recipients (16.3% vs. 14.8%), although the imbalance appeared to include duplicate reporting of reactogenicity. There was a balanced frequency of MAAEs, SAEs, severe AEs, AESI related to Covid-19, and potential immune-mediated medical conditions between treatment groups (Table S9). There were no episodes of anaphylaxis, no evidence of vaccine-associated enhanced Covid-19, and no events that triggered prespecified pause rules. No episodes of Guillain Barr syndrome19 and no imbalance in myocarditis/pericarditis20 or thrombosis with thrombocytopenia syndrome (TTS)21 were observed (Tables S14-S16). All-cause mortality was balanced, nine (0.5%) among NVX-CoV2373 recipients and five (0.5%) in placebo recipients."
My novice (and I do mean novice) hypothesis before reading the above was that as the Novavax is a protein sub-unit vaccine using an inert lipid nanoparticle with 14 spike proteins expressed (even with a "secret sauce" adjuvant) as a opposed to a MRNA or viral-vector adenovirus vaccine which simply instruct your own body's cells to express the spike protein that it would present, by its mechanistic operation and presumably limited duration in the body, a much safer profile in terms of not only heart tissue and heart lining swelling, but also in terms of thrombotic events.
Underlying that hypothesis is a potentially simplistic view that assumes it is the spike protein and its dissemination throughout the body after vaccination, rather than staying localized at the injection site, can can cause clotting, even on a micro level, for which I fully understand that there is much debate on this matter.
However reading the above, even though only one case of myocarditis was noted in the population and an external review board determined that was more likely "viral myocarditis" it is very unclear to me as to whether my hypothesis is reasonable or not.
Anyone with some clinical insight willing to share their point of view would be very much appreciated.
Gig'em
Horns down forever!