Medsafe’s Clinical Evaluation report for Comirnaty (COVID-19 mRNA Vaccine) and communications with responsible authorities
John made this Official Information request to Ministry of Health
Currently waiting for a response from Ministry of Health, they must respond promptly and normally no later than (details and exceptions).
From: John
To whom it may concern at the Ministry of Health,
I am requesting details of communications from Medsafe and/or the Ministry of Health to responsible authorities which occurred from September 2019 to January 2025.
I am also requesting a copies of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine).
That report's title page has the following details:
"Applicant: Pfizer/BioNTech"
"TT Number TT50-10853"
"Application ID 109400"
These ten questions need to each be considered and answered individually.
1, Can your organisation release the full version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) dated January 2021?
2, Can your organisation release pages 59 to 64 of the January 2021 version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contains information on “adverse events”?
3, Can your organisation release pages 64 to 67 of the January 2021 version of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contains information on “Serious adverse events and deaths”?
4, Can your organisation release any emails sent from Ministry of Health and/or Medsafe email accounts related to the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase “Serious adverse events and deaths” in the email's text or subject line?
5, Can your organisation release any emails sent from Ministry of Health and/or Medsafe email accounts related to the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase “adverse events” in the email's text or subject line?
6, Can your organisation release any emails or documents sent from Ministry of Health and/or Medsafe email accounts related to the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which contain the phrase “public interest” in the email's text or subject line?
7, Can your organisation release any newer versions of the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) which were dated between February 2021 and February 2025?
8, Can your organisation release any emails sent from Ministry of Health and/or Medsafe email accounts which contain a reference to the Clinical Evaluation report for the Comirnaty (COVID-19 mRNA Vaccine) and were sent to any of the following "responsible authorities" (from the Health Practitioners Competence Assurance Act 2003)?
"Responsible authorities" from the Health Practitioners Competence Assurance Act 2003 include:
-Chinese Medicine Council of New Zealand
-Dental Council
-Chiropractic Board
-Dental Council
-Dietitians Board
-Medical Sciences Council of New Zealand
-Medical Radiation Technologists Board
-Medical Council of New Zealand
-Midwifery Council
-Nursing Council of New Zealand
-Occupational Therapy Board
-Optometrists and Dispensing Opticians Board
-Osteopathic Council
-Paramedic Council
-Pharmacy Council
-Physiotherapy Board
-Podiatrists Board
-Psychologists Board
-Psychotherapists Board
9, For each of the "responsible authorities" listed above, can your organisation provide the number of emails sent from the Ministry of Health and Medsafe email accounts to that "responsible authority" which contain both the phrase "adverse event" and the word "Comirnaty" in the email's text?
10, For each of the "responsible authorities" listed above, can your organisation provide the number of emails sent from the Ministry of Health and Medsafe email accounts to that "responsible authority" which contain both the phrase "adverse event" and the word "mRNA" in the email's text?
Sincerely,
John
Things to do with this request
- Add an annotation (to help the requester or others)
- Download a zip file of all correspondence