26th May 2021

Submission to Office of the Gene Technology Regulator (OGTR) re Assessment of the Janssen-Cilag COVID-19 vaccine

Office of the Gene Technology Regulator
MDP 54 GPO Box 9848
CANBERRA ACT 2601
E-mail: ogtr@health.gov.au
 
cc: Therapeutic Goods Administration
 
RE: SUBMISSION DIR-182 Assessment of the Janssen-Cilag COVID-19 vaccine
 
To Whom it May Concern,
 
As per your invitation to comment on the assessment of the Janssen-Cilag COVID-19 vaccine [1], we provide our concerns as follows:
 
1. The viral vector (non-replicating) Ad26.COV2.s that is used
 
From time to time, even after many thousands or millions of vaccinations, some vaccines used have been found to be contaminated with live viruses. And in spite of attempts to produce “germ free” vaccines, contamination with live viruses may still occur, as stated by FDA [2].
 
A quote from peer reviewed journal: “Although testing is a key component of viral safety in biotechnology products, the data presented here indicate that testing alone is not enough to ensure that a given product is free of a viral contaminant, and that a holistic, multifaceted approach must be taken. This is never more true than when faced with a previously unknown emerging virus, such as SARS-CoV-2, where the capacity of the virus to infect production cell lines or be detected in existing assays is not initially known.” [3].
 
What testing will Jansen do to ensure that vials of vaccine are not contaminated with genetic disease causing material?
 
2. Potential Adverse Events
 
According to completion date of Phase 3 of their clinical trials, i.e.
  • Start: January 22, 2021 | End: January 2, 2023 [4].
  • Start: May 10 2022 | End: May 11, 2023 [5].
As stated in Johnson & Johnson Protocol “Until 1-year post-vaccination, each participant will be asked at least twice a week, through the electronic clinical outcome assessment (eCOA),if they have experienced any new symptoms or health concerns that could be related to infection with SARS-CoV-2. As of 1-year post-vaccination, until the end of the 2-yearfollow-up period, the frequency of this (suspected) COVID-19 surveillance (symptom check) through the eCOA will decrease to once every 2 weeks.” [6]
 
How can this vaccine be considered when clinical trials have either recently commenced or yet to commence and require two years monitoring duration for adverse events, immune persistence and effectiveness?
 
3. Primers for Diagnosis of SARS-CoV-2
 
What part of the SARS-CoV-2 have been targeted with primers for the diagnosis of SARS-CoV-2 in suspected individuals?  Are the regions targeted by the primers specific to SARS-CoV-2 and is such spike protein used in the Janssen vaccine specific for SARS-CoV-2?  If this question cannot be answered by Janssen then this raises implications for targeting a virus that potentially may not even exist hence there are no requirements for such genetically engineered vaccine material to be administered into humans.
 
Because previous vaccines developed to prevent SARS actually created more severe disease when vaccinated animals were deliberately infected, hopefully, Johnson & Johnson avoid such a disaster.  But uncertainty remains. As explained in the Expert Review of Vaccines: “As the world is rushing for a COVID-19 vaccine, the possibility of vaccine-mediated disease enhancement has been flagged as a potential safety concern.” [7]. 
 
Should this vaccine be released on emergency approval, the variety of consequences following SARS-Cov-2 infection in vaccinees is not known. 
 
 
Kind Regards
Michael O’Neill | Secretary
Informed Medical Options Party
 
 
 
REFERENCES:
         Investigating Viruses in Cells Used to Make Vaccines US FDA: https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/investigating-viruses-cells-used-make-vaccines-and-evaluating-potential-threat-posed-transmission “Some of these tumor-forming cell lines may contain cancer-causing viruses that are not actively reproducing. Such viruses are hard to detect using standard methods. These latent, or "quiet," viruses pose a potential threat, since they might become active under vaccine manufacturing conditions.”
[3]     Viral contamination in biologic manufacture and implications for emerging therapies:   https://www.nature.com/articles/s41587-020-0507-2.pdf?origin=ppub  Retrieved August 10, 2020.
[7]     Vaccination against SARS-CoV-2 and disease enhancement – knowns and unknowns:  
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