Informed Consent #28 - Inconsistent information on Pfizer vaccine
From: Annie Weston
Dear Ministry of Health,
Regarding a comparison between the New Zealand Data Sheet on Comirnaty https://www.medsafe.govt.nz/profs/Datash...
And the US Package Insert - Comirnaty https://www.fda.gov/media/151707/download
There are several discrepancies between the information on Pfizer’s vaccine presented to the citizens of the two different countries:
4.4 Special warnings and precautions for use
Myocarditis and pericarditis
Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often in younger men. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vacination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
5 WARNINGS AND PRECAUTIONS
5.2 Myocarditis and Pericarditis
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/cl...).
Table 5. Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants With or Without* Prior SARS-CoV-2 Infection Based on Food and Drug Administration (FDA)† Definition After Dose 1 or From 7 Days After Dose 2 in the Placebo-Controlled Follow-up
Table 6: Vaccine Efficacy – First Severe COVID-19 Occurrence in Participants 16 Years of Age and Older With or Without* Prior SARS-CoV-2 Infection Based on Protocol† or Centers for Disease Control and Prevention (CDC)‡ Definition From 7 Days After Dose 2 – Evaluable Efficacy (7 Days) Population During the Placebo-Controlled Follow-up
The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (>80%), fatigue (>60%), headache (>50%), myalgia (>40%), chills (>30%), arthralgia (>20%), pyrexia and injection site swelling (>10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
6 ADVERSE REACTIONS
In clinical studies, the most commonly reported (≥10%) adverse reactions in participants 16 through 55 years of age following any dose were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
In clinical studies, the most commonly reported (≥10%) adverse reactions in participants 56 years of age and older following any dose were pain at the injection site (78.2%), fatigue (56.9%), headache, (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
1) Why is myocarditis and pericarditis downplayed in the NZ version ie: “Very rare cases of myocarditis and pericarditis have been observed” vs the US version “Postmarketing data demonstrate increased risks of myocarditis and pericarditis”.
2) Why does NZ use the FDA definition and the US the CDC definition of “severe illness from Covid-19”.
3) Why does the NZ version round down adverse reaction percentages to the nearest ten? Even if you average the US version across both age groups it doesn’t equate to the NZ version.
4) What is the reason for not replicating the US document in its entirety except for the NZ specific title.
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