thevaccinereaction--2020-10-19--Johnson & Johnson Pauses Phase 3 COVID-19 Vaccine Trial Following ‘Unexplained Illness’

Just weeks after Johnson & Johnson ( J & J ) announced that its COVID-19 Ad26.COV2.S vaccine trial ENSEMBLE had reached the final phase of testing , the company has paused the study after one participant developed an ‘ unexplained illness.
’ 1 The company released a statement saying , “ Following our guidelines , the participant ’ s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board ( DSMB ) as well as our internal clinical and safety physicians , ” 2 According to Mathai Mammen , the global head of Janssen research and @ @ @ @ @ @ @ It ’ s not at all unusual for unexpected illnesses that occur in large studies over their duration.
” 3 ENSEMBLE is a placebo-controlled , double blind study and it is not yet clear whether the participant received the active vaccine or a placebo .
No details have been released about the illness and the company said it would be at least a few days before details are known .
It is not the first indication of potential safety issues associated with J & J ’ s experimental Ad26.COV2.S vaccine for COVID-19 .
@ @ @ @ @ @ @ than half of the participants experienced an adverse reaction .
Most were local reactions or mild and transient fevers , but 20 ( five percent ) volunteers in one of the study groups reportedly developed Grade 3 fevers of over 101.3°F.5 The J & J study is projected to enroll 60,000 people .
This is the Second Pause for a COVID-19 Vaccine Trial This is the second late-stage vaccine trial to be temporarily suspended due to safety concerns .
In early September , AstraZeneca ’ s Phase 3 COVID-19 vaccine trial was twice @ @ @ @ @ @ @ neurological complication called transverse myelitis.6 Though the first patient is believed to have previously undiagnosed multiple sclerosis , William Schaffner , MD , an infectious disease specialist at the Vanderbilt University School of Medicine in Nashville , Tennessee , is quoted as saying that two neurological incidents “ would make any independent reviewer anxious… If I were on that data safety monitoring board , that would give me a chill.
” 7 That trial has been restarted now in other participating countries including Britain , Brazil , India and South Africa , but @ @ @ @ @ @ @ results of a U.S. Food and Drug Administration ( FDA ) investigation .
Globally , approximately 18,000 people have received AstraZeneca ’ s vaccine so far.8 The J & J and the AstraZeneca vaccines are both adenovirus-based .
Adenoviruses are “ non-enveloped , double-stranded DNA viruses ” that generally cause mild respiratory or gastrointestinal infections like the common cold in humans , though an adenovirus infection can be serious in someone with a compromised immune system or preexisting respiratory or cardiac issues .
Several characteristics are cited as advantages to using an adenoviral @ @ @ @ @ @ @ including the ability to stimulate both an innate ( cell-mediated ) and humoral ( adaptive ) immune system response and because adenoviral vectored vaccines are easy to manipulate genetically.9 Another feature is that the adenovirus itself triggers the vaccine ’ s inflammatory immune response , so it is not necessary to add an adjuvant to the vaccine to provoke an inflammatory response that stimulates immunity.10 Several of the current frontrunners in the race for a COVID-19 vaccine are using genetically modified adenoviral-vectored vaccine protocols , on the theory that they use a more @ @ @ @ @ @ @ some of the newer vaccine types , like Moderna ’ s mRNA vaccine .
However , despite more than 30 years of experience with the advenovirus vector technology , no adenoviral-vector vaccine has yet been shown to be effective in human beings , and the only adenoviral-based vaccine currently in use is a rabies vaccine used in wild animals.11 Other potential drawbacks to the adenoviral-vector vaccines have to do with the way the healthy immune system reacts to adenoviruses in nature .
People may not respond appropriately to a vaccine based on a @ @ @ @ @ @ @ already been exposed .
People develop immunity not only to natural adenoviruses but also to the modified adenoviruses used in the vaccine and so may neutralize any boosters given.12 The J & J trial is using “ adenovirus 26 , ” an uncommon human adenovirus in hopes most people will not have been exposed and already developed immunity to it .
AstraZeneca is using a chimpanzee virus.13 Both Vaccines Are Part of Operation Warp Speed Another thing the J & J and AstraZeneca vaccines have in common is that they are both being @ @ @ @ @ @ @ public-private business partnership between government and the pharmaceutical industry aiming to rapidly move an experimental COVID-19 vaccine through the approval and distribution process .
Operation Warp Speed has come under fire after an NPR report showed that “ at least $ 6 billion in US funding was awarded to various pharmaceutical companies , including J & J , through a third party , a defense contract management firm .
This side-step of the established acquisitions process , which details how federal contracts are to be awarded , allows the awarding process to be @ @ @ @ @