Where is the Medsafe report stating the Comirnaty BNT162b2 product is safe and effective?
If only I could put my references on the OIA request form... so I'll have to do it here instead.
The proposed replacement for the Medicines Act, the Therapeutic Products Bill is a hydra. As a trustee of the Physicians and Scientists for Global Responsibility, we’ve put together a massive submission to the consultation.
If the Ministry of Health is to act in such a way as to protect health, the Ministry should respond to long-understood public health principles which help guide decision-making to ensure that where human biology and capacity meets a medical product - a synthetic chemical or biotechnology - that risk appropriately reflects age, developmental stage, the presence of multiple morbidities, and what other stuff is going on.
One of the big concerns is the magical idea of risk-benefit analyses - that they will pop out of thin air and assure us that any medicine, be it a pharmaceutical medicine, a biotechnology or a medical device, will be safe and effective.
However, risk-benefit analyses designed to achieve the purpose of an Act that states it will protect health, must be able to ensure babies, kids, teens, twenty-somethings, me (undisclosed) and the grandparents - will benefit.
An important component of decision-making is the precautionary principle - how do we make judgement in uncertainty, when harm is plausible, and could lead to irreversible harm?
I’ve had my share of one-sided poxy risk benefit analyses through years of reviewing pesticides policy and regulation which all too often, pivot back to economic rationale rather than judgement based on exposures and risk to your farmer neighbour. Pesticides risk assessment methodologies studiously avoid a requirement that regulators scrutinise the latest data in the peer reviewed literature via magical protocols. These keep regulators depending on the industry that they are supposed to regulate and avoiding any obligation to look outside hallowed regulatory enclaves.
Risk-benefit analyses are important tools for industry. So we need to be very sceptical of their integration in legislation.
So, if we’ve got the Therapeutic Products Bill in process, deadline for submission is in a couple of days - what is the likelihood risk-benefit analyses would be comprehensive and judgement will follow constitutional and administrative law principles, if, ummmmm no really big requirements are locked in?
Let’s look at the case study of BNT162b2 - that is safe and effective.
Wait. I can’t find Medsafe’s report where they undertake a risk-benefit analysis to confirm the product is safe and effective.
Right, but, well. They would have undertaken a later risk-benefit analysis to confirm the product was safe and effective for Tier 4, the generally healthy population, who were never at risk of hospitalisation and death from Sars-Cov-2.
Of course, the data was changing all the time. The Ministry of Health knew that ‘Compared to a person aged 20-39, a person who is 85 years or older has a risk which is 600 times higher’. JP Ioannidis’ work, which was persistently ignored by the Ministry, was clear from the get-go.
Officials recognised that antibodies weren’t everything and thought the spike protein that was produced from the instructions injected into Kiwi arms, would only last two weeks.
The whole point was that the entire population would be immune, but it was contradicted by the fact that many people could already be immune, as asymptomatic transmission by healthy people was normal and vaccine efficacy was limited.
Wouldn’t the Director General Ashley Bloomfield and Minister for Covid-19 the Hon Chris Hipkins be required to consider these facts by age and health status?
Because officials are required to protect individual health. They’re granted powers based on the obligation that they will protect health. That’s how we trust the officials and Ministers.
The Ministry of Health was well aware that from 2000-2018 a total of 48 deaths from vaccines were reported, so I’m guessing, Pfizer’s February 28, 2021 post-marketing report which revealed 1223 deaths and thousands of adverse events would have sent officials into a frenzy of revision as to safety. Because on signing the contract with Pfizer around, December 17 2020, the government signalled that even healthy groups would be injected.
Pfizer was legally required to provide post-marketing reports within 5 working days of them being produced. We assume the disclosure of such massive adverse events would have triggered a risk-benefit calculation, particularly for the healthy groups that were not at risk of hospitalisation and death.
Therefore, in the public interest, here is my Official Information Act Request. It was just going to go through FYI, but unfortunately it appears my Notes/references were too long. So I’ve put the request here with the references to help officials understand why I am so confused.
OFFICIAL INFORMATION ACT REQUEST
Where is the Medsafe report stating the Comirnaty BNT162b2 product is safe and effective?
Dear Ministry of Health and Medsafe,
Please supply the following information under the Official Information Act.
a) Medsafe safe and effective reports and statements prior to March 31, 2021. Please provide copies of briefings, submissions, aide memoire or advice where Medsafe states that the Comirnaty BNT162b2 product is safe and effective prior to March 31, 2021.
b) Please supply risk-benefit notes and reports produced by Medsafe for presentation to the 109th Meeting of the Medicines Assessment Advisory Committee (MAAC).
c) Re: Benefit-risk reports produced after provisional consent granted, and during the staged rollout. Please supply report numbers and dates of all benefit-risk reports published by the Ministry of Health after provisional consent was granted, to support the staged rollout to Tiers 2, 3 and 4 of the population as per the COVID-19 Vaccine and Immunisation Programme (and the Sequencing Framework)(1) and ensure that the response was proportionate to health risk, that respected individuals and was not undertaken in an arbitrary manner.
d) Re: Staged rollout of the COVID-19 Vaccine and Immunisation Programme and the Sequencing Framework. Please supply a list of all briefings, submissions, aide memoire, or advice provided by the Ministry to the Hon Chris Hipkins and Director General Ashley Bloomfield, from 1 October 2020-1 January 2021 including the dates and title of each document. Information required is in relation to scheduling of the staged rollout to all of the COVID-19 Vaccine and Immunisation Programme and the Sequencing Framework overseen by Hipkins and Bloomfield.(2)
NOTES TO THE OIA REQUEST
[1] In January 2021 the Ministry of Health stated: Medsafe decides whether a product such as a vaccine is safe and effective enough to be approved for use in New Zealand.(3)
[2] The public have been told that the vaccine is only approved after Medsafe confirms that the Comirnaty product is safe and effective, and your Vaccine Evaluation and Approval Process page shows a diagram of how benefits and risks are explored.(4)
[3] Your Spotlight on Comirnaty vaccine, 3 June 2021, Prescriber Update 42(2): 16–17 page states: Comirnaty vaccine has provisional approval for use in individuals aged 16 years and older, based on a favourable benefit risk profile.(5)
[4] The Health Act 1956 Part 3A, Management of Infectious Diseases overarching principles require Ministry of Health and Medsafe officials to respect individuals and ensure that measures are proportionate to the health risk, and not be made or taken in an arbitrary manner.(6)
[5] An October 2021 OIA H20211151 request asked for information on risk and benefit. When asked what the relative and absolute risk reduction was, the Ministry of Health referred the requestor to the MoH site How Covid-19 Vaccines Work. This site does not contain this information.(7)
[6] Medsafe’s January 2021. Clinical Evaluation (CE). TT50-10853 (Doc. No. 10, 80pp. 86/162) SECTION VI. Benefit Risk Assessment. P.71 (PP 94/162) Summary stated: The benefit risk balance of Comirnaty (COVID-19 mRNA Vaccine) for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older, is not clear.(8)
[7] In Medsafe’s Evaluation of a New Medicine Application, the agency listed the product as a higher risk medication, and confirmed as a new biological entity that a data protection period would apply for 5 years from the age of gazette. There was no mention of the Comirnaty product being safe and effective.(9) Instead, the Evaluation stated:
a. Due to the unresolved concerns and additional quality, safety and efficacy data to be provided at the time of completion of the evaluation, Medsafe is unable to recommend that this product be granted consent. It is therefore recommended that the application be referred to the Medicines Assessment Advisory Committee (MAAC) under section 22(2) of the Medicines Act 1981 for their consideration. In referring the application, it is requested that the MAAC focus on the specific aspects in their consideration of the application:
- The conditions and consent time period proposed for provisional consent under section 23 of the Medicines Act 1981. Specifically, whether these are appropriate and sufficient given the data provided up to the time of referral, as well as whether any additional conditions should be applied.
- Whether the benefit risk balance of Comirnaty vaccine for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older is positive.
[8] A Memo on January 28, 2021 to the MAAC Secretary, Product regulation: MAAC required to focus on: Whether the benefit risk balance of Comirnaty vaccine for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older is positive.
[9] On January 28, 2021 Chris James of Medsafe sent a letter to Pfizer and stated:
‘Having reviewed the information supplied in your initial application and in your further response, I am not satisfied that I should give my consent to the distribution of the product.’ (10)
[10] On February 2, 2021 the Minutes of the 109th meeting of the MAAC stated that they: ‘Recommend that the Minister of Health grant provisional consent to distribute the medicine under Section 23 of the Medicines Act, and impose the conditions proposed by Medsafe as amended by the Committee.’ (11)
[11] MAAC do not appear to have considered the benefit risk balance.(12) The committee do not state that the medicine has a positive risk profile – they allude to the need for a positive profile, this is not the same thing.
‘The application has been submitted via an expedited rolling review process and has been assessed under urgency due to the significant clinical need for a COVID 19 vaccine with a positive benefit risk profile.’
[12] The Minutes of the 109th meeting state that
‘The Committee unanimously agreed to Medsafe's proposal to grant provisional consent with a nine-month period.’
[13] There is no description by the MAAC or Medsafe stating the product is safe and effective.
[14] In a letter from Chris James dated February 1, 2021, he states that Medsafe will monitor the safety and effectiveness of the vaccines. James does not say the Comirnaty product is safe or effective.(13)
[15] In a February 3 letter to Chris James, unnamed Acting Manager Product Regulation (Medsafe) (14) requests Chris James, Group Manager's signature to confirm provisional consent is granted:
‘The MAAC has recommended that you grant provisional consent to the distribution of the following medicine: Comimaty (COVID 19 mRNA vaccine) (Pfizer BioNTech) 0.5mg/ml concentrate for injection ( TT 50 10853). Medsafe supports this recommendation and you are therefore asked to sign the attached letter to the applicant company to advise them of the outcome of the MAAC recommendation.’
[16] Pfizer’s New Zealand Data Sheet for Comirnaty does not state that the vaccine is safe and effective. It summarises safety profile but does not state the technology is safe.(15)
[17] In February 2021 the Ministry of Health was assuring the public: Medsafe only grants consent for a vaccine to be used in New Zealand once they are satisfied it’s safe and effective enough to use. All COVID-19 vaccines will go through the same safety test and must meet the same robust standards.(16)
[18] An October 2021 OIA H20211151 request asked for information on risk and benefit. When asked what the relative and absolute risk reduction was, the Ministry of Health referred the requestor to the MoH site How Covid-19 Vaccines Work. This site does not contain this information.(17)
References.
1. https://www.health.govt.nz/system/files/documents/information-release/updated_approach_to_the_sequencing_framework_for_covid-19_vaccines.pdf
2. https://www.health.govt.nz/system/files/documents/information-release/updated_approach_to_the_sequencing_framework_for_covid-19_vaccines.pdf
3. https://www.health.govt.nz/system/files/documents/information-release/h202008610_19_jan_2021.pdf
4. https://www.medsafe.govt.nz/Consumers/Safety-of-Medicines/Medsafe-Evaluation-Process.asp
5. https://www.medsafe.govt.nz/profs/PUArticles/June2021/Spotlight-on-Comirnaty-vaccine.html
6. https://www.legislation.govt.nz/act/public/1956/0065/latest/whole.html#DLM307296
7. https://www.health.govt.nz/system/files/documents/information-release/h202111151_response.pdf
8. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view (page 96/162)
9. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view (pp45-76/162)
10. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view Doc.14. Pages119-120/162
11. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view Doc.15 p131/162
12. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view Doc.15 p123-131/162
13. https://www.health.govt.nz/system/files/documents/information-release/h2020100314_1_feb_2021_covid_vaccine_safety.pdf
14. https://drive.google.com/file/d/1wuxQMUgjuKubaSIXFBZLj4_vAzg0PF5S/view Doc.15 p121-131/162
https://www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf
14. https://www.health.govt.nz/system/files/documents/information-release/h202101370_12_march_2020_covid_vaccine_information_to_recipents.pdf
15. https://www.health.govt.nz/system/files/documents/information-release/h202111151_response.pdf
Note to the public, as the large 162 document is apparently unavailable on the Ministry of Health site I have linked to a citizens copy.