thevaccinereaction--2020-10-05--20 Volunteers Suffer Serious Reactions to Johnson & Johnson’s COVID-19 Vaccine

On Sept. 23 , 2020 , U.S. pharmaceutical and medical devices company Johnson & Johnson , Inc. announced the start of the Phase 3 human clinical trial for its experimental Ad26.COV2.S vaccine for COVID-19 .
The New Jersey-based company , which is partnering with its subsidiary Janssen Pharmaceutica NV of Belgium on development of the vaccine , is planning to enroll 60,000 volunteers to participate in the trial.1 2 3 Johnson & Johnson recently announced the results of the Phase 1/2a clinical trial for the Ad26.COV2.S vaccine .
The double-blind , randomized , placebo-controlled trial included 796 participants divided into @ @ @ @ @ @ @ 18 to 55 years of age in one group and 394 healthy elderly individuals 65 years of age and older in the other .
The first group was broken out into cohort 1a and cohort 1b .
The second group was cohort 3.4 5 Each of the participants were given a single entramuscular injection of Ad26.COV2.S at dose levels of either 5×1010 or 1×1011 viral particles ( vp ) per dose of vaccine .
After four weeks of observation , 99 percent of all the participants developed antibodies to the SARS-CoV-2 virus.4 5 @ @ @ @ @ @ @ Adverse Events After Getting Ad26.COV2.S About 58 percent of participants in cohorts 1a and 1b experienced local adverse events , while 64 percent of them also suffered systemic adverse events .
Of the participants in cohort 3 , 27 percent of them experienced local adverse events , while 36 percent suffered systemic events .
Of the healthy adults aged 18 to 55 years old in cohorts 1a and 1b , 19 percent of them came down with fevers , while four percent of the adults aged over 65 years old in cohort 3 @ @ @ @ @ @ @ were considered mild or moderate and resolved within one to two days after vaccination .
However , five percent ( 20 ) of the participants in cohorts 1a and 1b suffered from Grade 3 fevers of over 101.3°F .
Grade 3 adverse events are considered to be serious reactions .
They are only one grade removed from “ life-threatening ” ( Grade 4 ) and just two grades from “ death ” ( Grade 5 ) .4 5 6 7 According to a news report on Johnson & Johnson ’ s Phase 1/2a @ @ @ @ @ @ @ were two severe adverse events recorded .
One participant had hypotension ; however , this effect is not related to vaccination as the participant had a history of hypotension .
Another participant with fever was hospitalized as a suspected case of COVID-19 ; however , the fever resolved within 12 hours.
” 5 The most common adverse events experienced by trial participants were pain the injection site , fatigue , headaches and myalgia ( muscle pain ) .4 5 Ad26.COV2.S Uses AdVac Technology to Carry SARS-CoV-2 Genetic Code into Cells On Mar .
@ @ @ @ @ @ @ had been given $ 1B by the U.S. Biomedical Advanced Research and Development Authority ( BARDA ) in the Department of Health and Human Services ( HHS ) to develop an advenovirus vectored COVID-19 vaccine using J & J ’ s AdVac technology and PER.C6 , a cell line derived by transformation of embryonic retinal epithelial cells with human adenovirus type5 E1 region gene , for production.8 The Ad26.COV2.S vaccine combines the genetic material from the SARS-CoV-2 virus that causes COVID-19 with an adenovirus that causes the common cold but has reportedly been @ @ @ @ @ @ @ longer replicate and cause disease .
The “ disarmed ” adenovirus acts as a vector , carrying the SARS-CoV-2 virus ’ s genetic code into human cells and is supposed to teach the immune system to create antibodies to attack the SARS-CoV-2 ’ s “ spike proteins ” that enable the virus to infect cells .
J & J ’ s Ad26.COV2.S vaccine combines the genetic material from the SARS-CoV-2 virus that causes COVID-19 with an adenovirus that causes the common cold but has reportedly been genetically modified so that it can no @ @ @ @ @ @ @ “ disarmed ” adenovirus acts as a vector , carrying the SARS-CoV-2 virus ’ s genetic code into human cells and is supposed to teach the immune system to create antibodies to attack the SARS-CoV-2 ’ s “ spike proteins ” that enable the virus to infect cells.1 3 9 This recombinant adenovirus technology , known as AdVac , was used to produce Johnson & Johnson ’ s Ebola vaccine , which was approved by the European Commission ( EC ) on July 1 , 2020.J & J officials have stated the first @ @ @ @ @ @ @ available for emergency use authorization in early 2021.9 10 11