thevaccinereaction--2020-09-14--Novavax’s Adjuvanted COVID-19 Vaccine Caused Severe Adverse Reactions in Clinical Trials

Biotechnology company Novavax , Inc. of Gaithersburg , Maryland recently made public the results of the Phase 1 part of a Phase 1/2 human clinical trial for its experimental NVX-CoV2373 vaccine for COVID-19 .
According to Novavax , “ NVX‑CoV2373 was created using Novavax ’ s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike ( S ) protein and contains Novavax ’ s patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
” 1 The clinical trial involved 131 healthy adults between 18-59 years of age .
The results were @ @ @ @ @ @ @ Medicine ( NEJM ) on Sept. 2 , 2020.2 Of the 131 participants in the clinical trial , , which began on May 26 , 2020 , 83 were given the NVX-CoV2373 vaccine containing the Matrix-M1 adjuvant to help stimulate an immune response to produce a strong antibody response .
Matrix-M1 contains nm ( nanometers ) of nanoparticles composed of Quillaja saponins , cholesterol and phospholipid .
Quillaja saponins are chemical compounds extracted from the soapbox tree .
They are used by the food industry as “ emulsifiers in beverages and food additives.
@ @ @ @ @ @ @ the cosmetics industry , Quillaja saponins ( from the Latin “ sapo , ” meaning soap ) are used as “ antidandruff , cleansing , emulsifying , foaming , masking , moisturizing , skin conditioning , and surfactant agents.
” 6 Of the remaining trial participants , 25 were given the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant and 23 participants were given a placebo of sterile 0.9 percent normal saline .
Each participant received two intrasmuscular injections in the deltoid muscle .
The injections were given three weeks apart.2 Trial participants were divided @ @ @ @ @ @ @ group B , group C , group D and group E. The 23 participants in group A received two doses of the placebo ; 25 participants in group B received 25-μg ( microgram ) doses of the NVX-CoV2373 vaccine without the Matrix-M1 adjuvant ; 29 participants in group C received 5-μg doses of NVX-CoV2373 with Matrix-M1 ; 28 participants in group D received 25-μg doses of NVX-CoV2373 with Matrix-M1 ; and 26 participants in group E received a single 25-μg dose of NVX-CoV2373 with Matrix-M1 followed by a single dose of placebo.2 According @ @ @ @ @ @ @ , two of the 83 participants ( one each in groups D and E ) suffered “ severe adverse events ” ( headache , fatigue and malaise ) after the first dose .
Two participants—one each in groups A and E—had “ reactogenicity events ” ( fatigue , malaise and tenderness ) .
A reactogenicity event is an “ expected ” adverse event following vaccination.7 8 Following administration of the second dose , one participant in group D had a “ severe local event ” ( tenderness ) and eight participants—one or two @ @ @ @ @ @ @ ” The most common of these severe systemic events were joint pain and fatigue .
One participant in group D developed a fever of 100.58°F.2