thevaccinereaction--2020-07-06--81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That

81 Percent of Clinical Trial Volunteers Suffer Reactions to CanSino Biologics’ COVID-19 Vaccine That Uses HEK293 Human Fetal Cell Lines

An experimental vaccine for COVID-19 is being developed by CanSino Biologics , Inc. of Tianjin , China , in partnership with China ’ s Academy of Military Medical Sciences ’ Institute of Biotechnolog .
A Phase 1 human clinical trial of the COVID-19 vaccine ( adenovirus type-5 Ad5-nCoV ) has been completed in China involving 108 volunteers , ranging in age from 45–60 years old.1 2 3 4 In that trial , 87 ( 81 percent ) of the 108 participants suffered at least one adverse reaction within seven days after vaccination .
Of these , 30 ( 83 percent @ @ @ @ @ @ @ the low dose group , 30 ( 83 percent ) were in the middle dose group , and 27 ( 75 percent ) were in the high dose group .
Overall , 10 ( nine percent ) of the participants experienced Grade 3 adverse reactions .
Of the 36 participants in the high dose group , six ( 17 percent ) of them had Grade 3 adverse reactions.1 2 Pain , Fever , Fatigue , Headache Most Common Reactions to CanSino ’ s Ad5-nCoV Vaccine for COVID-19 According to researchers conducting the study @ @ @ @ @ @ @ the Ad5-nCoV vaccine : The most common injection site adverse reaction was pain , which was reported in 58 ( 54 % ) vaccine recipients .
Pain was reported in 17 ( 47 % ) participants in the low dose group , 20 ( 56 % ) participants in the middle dose group , and 21 ( 58 % ) participants in the high dose group .
The most commonly reported systematic adverse reactions overall were fever ( 50 [ 46 % ] ) , fatigue ( 47 [ 44 % ] ) @ @ @ @ @ @ @ ] ) , and muscle pain ( 18 [ 17 % ] ) .
Fever was reported in 15 ( 42 % ) participants in the low dose group , 15 ( 42 % ) participants in the middle dose group , and 20 ( 56 % ) participants in the high dose group .
Headache was reported in 14 ( 39 % ) participants in the low dose group , 11 ( 31 % ) participants in the middle dose group , and 17 ( 47 % ) participants in the high @ @ @ @ @ @ @ in seven ( 19 % ) participants in the low dose group , three ( 8 % ) participants in the middle dose group , and eight ( 22 % ) participants in the high dose group.2 Nine of the participants , including two in the low dose group , two in the middle dose group and five in the high dose group developed Grade 3 fevers of over 101.3°F .
One of the participants in the high dose group reported “ severe fever along with severe symptoms of fatigue , dyspnoea , @ @ @ @ @ @ @ the high dose group experienced “ severe fatigue and joint pain.
” The reactions happened within 24 hours after vaccination.1 2 Like in the Phase 1 Ad5-nCov vaccine trial conducted by CanSino , some participants in the Phase 1 trial of the mRNA-1273 COVID-19 vaccine conducted by Moderna , Inc. earlier this year also experienced Grade 3 reactions .
Of the 45 volunteers who participated in the Moderna clinical trial during March-May 2020 , nine percent of them experienced severe adverse reactions to the mRNA-1273 vaccine , including 29-year-old Ian Haydon of Seattle @ @ @ @ @ @ @ reactions 12 hours after getting the second of two 250 µg doses of the mRNA-1273 vaccine .
He developed a fever of over 103 degrees and eventually fainted.1 2 Grade 3 reactions are described by the U.S. Department of Health and Human Services ( HHS ) as , “ severe or medically significant but not immediately life-threatening ; hospitalization or prolongation of hospitalization indicated ; disabling ; limiting self care ” such as “ bathing , dressing and undressing , feeding self , using the toilet , taking medications.
” The only thing @ @ @ @ @ @ @ classified as Grade 4 , which is “ life-threatening ” and “ Grade 5 , which is “ death.
” 5 6 7 Can Sino Now Running Phase 2 Human Clinical Trials on Ad5-nCoV Vaccine for COVID-19 CanSino Biologics has reportedly begun a Phase 2 human clinical trial of Ad5-nCoV vaccine using the HEK293 cell line that involves testing on 500 healthy volunteers .
On May 12 , the National Research Council of Canada ( NRC ) announced a collaborative agreement with the Chinese company to “ advance bioprocessing and clinical development in @ @ @ @ @ @ @ 9 10 In a press release , the NRC stated , “ This collaboration will allow the NRC to advance a scale-up production process for the vaccine candidate , using its proprietary HEK293 cell line.
” 9 10 To facilitate this work , the Canadian government announced it would provide $ 44 million to upgrade the NRC facilities in Montreal to “ enable compliance with Good Manufacturing Practice ( GMP ) standards ” and to “ ensure readiness for Canadian bioprocessing of potential vaccine candidates as they become available.
” 9 “ It @ @ @ @ @ @ @ and resources from both sides that are critical to the development of Ad5-nCoV , ” said Xuefeng Yu , CEO of CanSino Biologics.10 Can Sino Ad5-n-CoV Vaccine Uses HEK-293 Human Fetal Cell Lines for Production Life Site News reported on June 26 , 2020 that CanSino ’ s Ad5-n-CoV vaccine employs a chimpanzee adenovirus vector that uses the HEK293 cell lines derived from tissue of an aborted fetus.11 The HEK293 human fetal cell line , which was designed , developed and is licensed by Canada ’ s National Research Council ( NRC ) @ @ @ @ @ @ @ the AZD1222 COVID-19 vaccine developed by the University of Oxford ’ s Jenner Institute .
The May 12 , 2020 joint press release issued by Canada ’ s NRC and CanSino Biologics , Inc. stated , “ The relationship between the NRC and CanSinoBIO was first established in 2013 .
The NRC ’ s HEK293 cell line was later licensed to CanSinoBIO and used in the development of an approved vaccine against the Ebola virus.
” 12 The HEK293 cell line was initially produced in 1973 by a team led by Alex van @ @ @ @ @ @ @ from normal fetal human embryonic kidney cells .
These cells were created following transfection with sheared adenovirus 5 DNA , leading to the incorporation of some of the adenoviral genome into the human chromosome 19 of the fetal cell ’ s genome .
The name 293 comes from the fact that it was Frank Graham ’ s ( one of van de Eb ’ s postdoc ) 293rd experiment .
These cells were initially thought to originate from an endothelial , epithelial , or fibroblastic cell from the fetal kidney .
However , @ @ @ @ @ @ @ HEK293 cells has led to the suggestion that they may actually originate from a neuronal fetal kidney cell .
Following sequencing studies , it has also been identified that these cells have a very complicated karyotype , with multiple copies of chromosomes .
For example , these cells have four copies of chromosome 17 .
It has also been established that these cells do not have a single Y chromosome—but have three X chromosomes—suggesting that the fetus from which they were obtained was a female.13 The HEK293 cell is described by Creative Biolabs @ @ @ @ @ @ @ 293 ( HEK293 ) cell line is a predominant host for both stable expression and transient expression of various research grade proteins and protein therapeutics , and more recently , five therapeutic agents produced in HEK293 cells have been approved by the FDA or the European Medicines Agency ( EMA ) for therapeutic use .
Since being generated over 40 years ago , the HEK293 cell line has been extensively used as a robust and reliable platform to produce plenty of recombinant antibodies , antibody fusion proteins and proteins important to the neuropharmacologist @ @ @ @ @ @ @ , ligand-gated ion channels , and voltage sensitive ion channels .
The HEK293 cell line was originally generated by the transformation of normal human embryonic kidney ( HEK ) cells following exposure to sheared fragments of human adenovirus type 5 ( Ad5 ) DNA .
The E1A adenovirus gene is expressed in these cells and participates in transactivation of some viral promoters , allowing these cells to produce very high levels of protein.14