TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variants
The TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the United Kingdom. The guidance lays out what information the medicines regulators would need in order to approve any modifications to authorised COVID-19 vaccines, should virus mutations make them less effective at preventing the disease. This guidance is in addition to the earlier Access Consortium statement on COVID-19 vaccines evidence
ACCESS CONSORTIUM
Points to consider for strain changes in authorised COVID-19 vaccines in an ongoing SARS-COV-2 Pandemic
KEY NOTES
Access Consortium stated, in an ongoing pandemic, it is desirable to test the updated vaccine directly in humans and generate adequate clinical data on immunogenicity and safety.
No requirement for large clinical studies or trials
Only 'Correlates of protection' is mentioned in the document. this means protection is coincidental
Standardised documentation regarding virus variants definitions and regulatory requirements are not required to gain vaccine approval
Clinical safety data is not required prior to approval
No requirement to provide immunogenicity data on humans
Influenza Vaccines aare being made before the virus is circulating in humans and without knowing the strain
Flu vaccines are updated and approved annually without underlying clinical and non-clinical data
Pharmaceutical companies are currently creating and getting Government approval for 'mock-up' flu vaccines before they know the strain and before the strain has been identified in the population. Once they know the strain, they are just submitting a variation but keeping all the safety data of the first strain.
The Government is comfortable to approved influenza vaccines without ANY Immunogenicity data
The government is recommending that the COVID-19 vaccines be delivered at the same time as, or close to Influenza vaccines
Absence of non-clinical data on toxicology, including reproductive toxicology needs to be justified, but approval is likely if the antigen is tbe only change to the vaccine
What does this mean for the future?
Based on all available information, it is possible to likely the following will happen:
Covid-19 disease will turn endemic
The TGA has accepted LESS DATA for future jabs for COVID-19 even though the manufacturers haven't completed the trials on the initial covid-19 jabs
The TGA will approve future COVID-19 jabs based on clinical or non-clinical data of DIFFERENT virus strains not in human circulation
The TGA will approve new COVID-19 Jabs WITHOUT TOXICOLOGY DATA being provided
The TGA will approve new COVID-19 Jabs WITHOUT ANY EFFICACY DATA AND RECOMMENDS MANUFACTURERS COLLECT THE EFFICACY DATA ONCE RELEASED TO THE POPULATION
DOES THIS SOUND LIKE RIGOROUS VACCINE TESTING TO YOU?
Below is the full doc with highlighted points of interest:
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