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Dr. John Campbell | Viral Vaccine Paper

Batch-dependent safety of the BNT162b2 mRNA COVID-19 vaccine

2023-07-05 23:00:00 - Dr. John Campbell

71% of the suspected adverse reactions occurred in 4.2% of the vaccine batches


Numbers of suspected adverse events (SAEs),


after BNT612b2 mRNA vaccination in Denmark.


27 December 2020–11 January 2022, (population 5.8 million)


(According to the number of doses per vaccine batch) 


Each dot represents a single vaccine batch. 


By 11 November 2022 (European area)


701 million doses of Pfizer given


971,021 reports of suspected adverse effects (SAEs)


Clinical data on individual vaccine batch levels have not been reported


(batch-dependent variation in the clinical efficacy and safety of authorized vaccines would appear to be highly unlikely)


We therefore examined rates of SAEs between different BNT162b2 vaccine batches administered in Denmark


Data on all SAE cases, Danish Medical Agency (DKMA)


SAE seriousness was classified as non-serious, serious 


(hospitalization or prolongation of existing hospitalization, life-threatening illness, permanent disability or congenital malformation) or SAE-related d****


Anonymized data


SAEs were counted on a batch level by linking individual SAEs to the batch label(s) of BNT162b dose(s)


10,793,766 doses administered


4,026,575 persons


52 different BNT162b2 vaccine batches


(2,340–814,320 doses per batch)


43,496 SAEs were registered in 13,635 persons


61,847 batch-identifiable SAEs,


of which 14,509 (23.5%) were classified as severe,


579 (0.9%) were SAE-related d*****


Unexpectedly


Rates of SAEs per 1000 doses varied considerably between vaccine batches


From 1 SAE per 20 doses given to I in many thousands to zero


Variabilities


Vaccine manufacturing


Storage


Transportation


Clinical handling and control


Administration technique





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