Dear Ministry of Health,

Would you please provide the studies that Jacinda Ardern, the Minister of Health and the Director General of Health refer to when they state the Comirnaty/Pfizer-BioNTech 'vaccine' is "safe and effective" for everyone 5 years and up, as well as pregnant women?
It appears this is still under provisional/emergency approval on your Medsafe site and
AEFI reports up to and including 28 February 2022 number 58,118 as well as 156 deaths. As most of the Covid death numbers in New Zealand are listed as death 'with' Covid rather than 'from' Covid;- and concurrently with our high vaccination rates, we now have one of the highest Covid case numbers per population in the world, please advise what scientific studies our Government is relying on to continue to make this 'safe and effective' statement to the New Zealand public.

Yours faithfully,

Debbie

Dear OIA Requests,

Thank you for your reply, but would you please answer this request specifically and provide a copy of the exact study/studies that the Prime Minister, Health Minister and the Director General of Health relied on in February 2021 to state unequivocally this "vaccine" is "safe and effective." For all of the New Zealand population, including children over 5 years of age, as well as pregnant woman. Not just the small group of at risk New Zealanders that Medsafe initially provisionally approved it for. There were no studies confirming this at both of the links you provided, only confirmation there is still much unknown and there is no long term study data to make this claim.

The Comirnaty data sheet at the link you provided does not confirm this Comirnaty/Pfizer-BioNTech 'vaccine' is completely "safe and effective" as the Prime Minister states. These include, but are not limited to; (direct cut and paste from link you sent me)

4.4 Special warnings and precautions for use
"Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported."
"Very rare cases of myocarditis and pericarditis have been observed following vaccination with COMIRNATY... 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 vaccination. Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition."
"Immunocompromised individuals
The efficacy, safety and immunogenicity of COMIRNATY has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy."
"Duration of protection
The duration of protection afforded by COMIRNATY is unknown as it is still being determined by ongoing clinical trials."
"Paediatric use
The safety and efficacy of COMIRNATY in children aged less than 5 years of age have not yet been established."

4.5 Interactions with other medicines and other forms of interactions
"No interaction studies have been performed.

Concomitant administration of COMIRNATY with other vaccines has not been studied."

4.6 Fertility, pregnancy and lactation
"Pregnancy
There is limited experience with use of COMIRNATY in pregnant women."
"Lactation
It is unknown whether tozinameran is excreted in human milk."

Adolescents 12 to 15 years of age – after 2 doses
"The safety evaluation in Study C4591001 is ongoing."

Children 5 to 11 years of age – after 2 doses
"The safety evaluation in Study C4591007 is ongoing."

Tabulated list of adverse reactions from clinical studies and post-authorisation experience.
Adverse reactions observed during clinical studies are listed below; (followed by a whole chart of adverse reactions that do not sound "safe")

Post-marketing experience
"Although the events listed in Table 3 were not observed in the clinical trials, they are considered adverse drug reactions for COMIRNATY as they were reported in the post-marketing experience. As these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known."

Table 3:Adverse reactions from COMIRNATY post marketing experience
These are very serious adverse drug reactions that are listed in the table.

The Vaccine efficacy data does not state the absolute risk reduction, which has been calculated as 0.84%. "Relative" risk is misleading to the general public.

Reading this document at the link you sent me it is clear that many conclusions are based on animal only trials, not human. It is also very clear that the study is ongoing and there is no way long term side effects can be evaluated .Which is why Medsafe only granted Provisional consent?

I note that in another OIA request the NZ Government confirmed earlier receipt of the recently ordered release of Pfizer study documents, but these also list a myriad of adverse reactions to be mindful of.

Thanks in advance for providing the exact study.

Yours sincerely,

Debbie