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Vaccine Passports & Temporary Authorisation

Comparing CoViD jab passports to existing vaccine passports

One of the common justifications for CoViD-19 vaccine passports I've heard are comparisons to Yellow Fever and Smallpox vaccine possports, however I struggle to see the comparison...

  1. Both of these are one-time vaccines, using tried and tested vaccine methods... CoViD-19 jabs are already being followed up by boosters and use an untried and still being tested vaccine method.
  2. Treatments for Yellow Fever and Smallpox remain elusive... for Smallpox a quick response by vaccine following exposure can help, but other than that only supportive or palliative care can be given.  However, there are now known, tried and tested treatments for CoViD-19, different ones for various stages of infection, but already proving to either prevent serious illness if treated early, or preventing death if already ill.
  3. The death rates are vastly different:
    1. Similar to CoViD-19 there is disparity among age groups, but different sources give various death rates for Small Pox from an average death rate of 7.6% to as high as 30%.  With less options for reporting over the periods of time affected, these are more likely to be underestimates.
    2. Yellow Fever appears to be between 46% and 60%.  Due to the areas greatest afffected, these could well be underestimates.
    3. The death rate for CoViD-19 varies greatly between ages, however even the worst affected demographics, those over 65 years of age and/or with existing co-morbidities,  are no where near these death rates, or even rates of serious illness.


Emergency Use Authorisation vs Temporary Authorisation

In USA, the FDA grants "Emergency Use Authorisation" under the following conditions:

Prior to leaving the EU, the EMA (European Medical Association) granted Temporary Authorisation, but since January 2021, the CoViD vaccinations are being rolled out in the UK under "temporary Authorisation under Regulation 174" from the MHRA (Medicines and Healthcare Products Regulatory Agency)

  • The Medicines and Healthcare Products Regulatory Agency gave temporary authorisation to the supply of specific batches of Pfizer and BioNTech’s vaccine on 2 December,1 on the basis of efficacy data submitted between 1 October and 2 December 2020.
  • A temporary use authorisation is valid for one year only and requires the pharmaceutical companies to complete specific obligations, such as ongoing or new studies, says the law firm Brodies.3 Once comprehensive data on the product have been obtained, standard marketing authorisation can be granted. 
  • In guidance to healthcare professionals the MHRA said that “no interaction studies have been performed.”
  • The vaccine manufacturer "must promptly provide to MHRA any further data that is generated by them, or which otherwise come into their possession, which is relevant to the risk / benefit profile of the product";
  • The vaccine manufacters "must operate a comprehensive pharmacovigilance system for this product in accordance with UK legislation for licensed products, as if they were market authorisation holders",
Interestingly whereas the FDA EUA requires that no alternative treatment is available, the MHRA Temporary Authorisation doesn't:
174.  The prohibitions in regulation 46 (requirement for authorisation) do not apply where the sale or supply of a medicinal product is authorised by the licensing authority on a temporary basis in response to the suspected or confirmed spread of—
(a)pathogenic agents;
(b)toxins;
(c)chemical agents; or
(d)nuclear radiation,
which may cause harm to human beings.

 See this response to the FDA approval of Pfizer CoViD jab, and watch this video expanding on it.

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