Limitations of the Pfizer vaccine trials
Virginia Crawford made this Official Information request to Ministry of Health
The request was partially successful.
From: Virginia Crawford
Dear Ministry of Health,
"This trial and its preliminary report have several limitations. With approximately 19,000 participants per group in the subset of participants with a median follow-up time of 2 months after the second dose, the study has more than 83% probability of detecting at least one adverse event, if the true incidence is 0.01%, but it is not large enough to detect less common adverse events reliably. This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined. Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose. These data do not address whether vaccination prevents asymptomatic infection; a serologic end point that can detect a history of infection regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported later. Furthermore, given the high vaccine efficacy and the low number of vaccine breakthrough cases, potential establishment of a correlate of protection has not been feasible at the time of this report.
This report does not address the prevention of Covid-19 in other populations, such as younger adolescents, children, and pregnant women. Safety and immune response data from this trial after immunization of adolescents 12 to 15 years of age will be reported subsequently, and additional studies are planned to evaluate BNT162b2 in pregnant women, children younger than 12 years, and those in special risk groups, such as immunocompromised persons."
The above is an extract from an article describing, in detail, the Pfizer vaccine trials:
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
https://www.nejm.org/doi/full/10.1056/NE...
From the above, it is clear that the persons who received the placebo will NOT be followed up for the full two years indicated by the trial design, thus putting into question the validity of the trial as to the long term safety and efficacy of this vaccine.
Furthermore, in regard to pregnant women, Dr Bloomfield has stated that women should seek the advice of their doctor or specialist as to whether to they should take the vaccine. Most doctors have absolutely NO IDEA of the pros and cons of this vaccine for pregnant women and are relying on the Health Department to advise them. Already there are many reports (in the USA) of spontaneous abortions occurring after vaccination with BNT162B2.
Will the Health Department/Government make the public aware of the above issues?
How many pregnant women have been vaccinated so far? Is a record being kept of them?
Yours faithfully,
Virginia Crawford
Ministry of Health
Kia ora Virginia
Thank you for your request for official information received on 13 March
2021 for information pertaining to COVID-19 vaccines and pregnant women.
The Ministry's reference number for your request is: H202102874.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 13 April 2021, being 20
working days after the day your request was received.
If we are unable to respond to your request within this time frame, we
will notify you of an extension of that time frame.
If you have any queries related to this request, please do not hesitate to
get in touch.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: OIA Requests
Kia ora
Please find attached a letter regarding your request for official
information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: Virginia Crawford
Dear OIA Requests,
As already mentioned, most doctors would not be aware of the possible dangers of pregnant women taking the vaccine. There is no more risk for a woman contracting Covid, than there would be if she contracted flu.
Why is it that nine times out of 10, when links are provided for further information, they are neither clickable nor able to be copy/pasted?
If you could please correct the "links" you have provided, so that they can be easily accessed, it would be appreciated.
Yours sincerely,
Virginia Crawford
From: OIA Requests
Kia ora Virginia Crawford
Links below:
Immunisation Handbook on 15 March 2021:
https://www.health.govt.nz/our-work/immu...
Additional information about the Pfizer/BioNTech vaccine and pregnancy is available on the Immunity Advisory Centre (IMAC) website:
https://www.immune.org.nz/sites/default/...
https://www.immune.org.nz/sites/default/...
Please note that this response, with your personal details removed, may be published on the Ministry website at:
www.health.govt.nz/about-ministry/inform...
Ombudsman information:
[email address]
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
-----Original Message-----
From: Virginia Crawford <[FYI request #14914 email]>
Sent: Thursday, 1 April 2021 3:38 pm
To: OIA Requests <[email address]>
Subject: Re: Response to your request for official information (H202102874)
Dear OIA Requests,
As already mentioned, most doctors would not be aware of the possible dangers of pregnant women taking the vaccine. There is no more risk for a woman contracting Covid, than there would be if she contracted flu.
Why is it that nine times out of 10, when links are provided for further information, they are neither clickable nor able to be copy/pasted?
If you could please correct the "links" you have provided, so that they can be easily accessed, it would be appreciated.
Yours sincerely,
Virginia Crawford
-----Original Message-----
Kia ora
Please find attached a letter regarding your request for official information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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