Comirnaty (COVID-19 mRNA vaccine) with active ingredient BNT162b2
Heather Darby made this Official Information request to Ministry of Health
The request was refused by Ministry of Health.
From: Heather Darby
Dear Ministry of Health,
Please provide any and all information that has been provided to the Ministry of Health or Medsafe pertaining to the product Comirnaty (COVID-19 mRNA vaccine) with active ingredient BNT162b2:
1. Certificates of Analysis for the first three batches of vaccine distributed in New Zealand.
2. Independent batch certification, such as UK National Institute for Biological Standards and Control (NIBSC) certification, EU Official Control Authority Batch Release (OCABR) certification, Australian TGA batch release assessment for all batches distributed in New Zealand.
3. Data to further characterise the truncated and modified mRNA species present in the finished product which addresses results from ion pairing RP-HPLC addressing 5’cap levels and presence of the poly(A) tail, and addresses the potential for translation into truncated S1S2 proteins/peptides or other proteins/peptides.
4. Relevant protein/peptide characterisation data for predominant species.
5. Evaluation of any homology between translated proteins (other than the intended spike protein) and human proteins that may, due to molecular mimicry, potentially cause an autoimmune process.
6. Analysis of the main peak of the RNA integrity test representing the full-length RNA that addresses 5’cap levels and presence of the poly(A) tail.
7. Reassessment of the active substance specification for the DNA template purity and impurities.
8. Active substance process validation data regarding the finalised indirect filter qualification assessment and the shipping validation between sites.
9. The capability of the next generation sequencing technology platform to detect lower amounts of RNA species of alternative sequence in the presence of the correct, more abundant RNA for the active substance.
10. The results and the assay suitability for the cell-based flow cytometry and the western blot method used for biological characterisation of protein expression for the active substance.
12. A summary of the validation/verification status of the immunoblot analytical procedure used to detect double stranded RNA (dsRNA) in the active substance.
13. Data comprising batch analyses of a suitable number of commercial batches as well as analyses of batches that have been used in the (ongoing) clinical trials.
14. Specifications and results of introducing an active substance to control poly(A) tail length and how it was controlled on each batch.
15. Data to support the suitability of the method used for %poly(A) tail in Q14 above.
16. Revised specifications of the mRNA integrity and polydispersity finished product.
17. Data to support the suitability of the method used for potency determination.
18. The finished product acceptance criteria for potency.
19. Control strategy assessment results for Lipid-related impurities.
20. The risk assessment with respect to the potential presence of elemental impurities in the active product based on the general principles outlined in Section 5.1 of ICH Q3D and Ph. Eur. monograph Pharmaceutical Preparations (2619).
21. Process development for ALC-0315 with emphasis on the identification and purge of impurities.
22. Specified impurities for ALC-0315 and appropriate specification limits for individual impurities.
23. Acceptance criteria for specified and un-specified impurities for ALC-0315.
24. Details about how the solvent residues that are used in the manufacture of the ALC-0315 excipient are controlled.
25. The ALC-0315 assay and impurities limits.
26. Method validation reports for assay, impurities, and residual solvents for ALC-0315.
27. ALC-0315 impurity standard information for any identified impurities reported.
28. The impact of the molecular weight and polydispersity of carboxy-MPEG on ALC-0159, including acceptance criteria, for these parameters in the starting material.
29. Reports on the duration of efficacy and the requirement for booster doses.
30. Reports on efficacy including asymptomatic infection in the vaccinated group, vaccine failure, immunogenicity, and efficacy in population subgroups.
31. The final Clinical Study Reports for Study C4591001 and Study BNT162-01.
32. The latest Safety Update Report.
Yours faithfully,
Heather
From: OIA Requests
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From: OIA Requests
Kia ora Heather,
Thank you for your request for official information. The Ministry's
reference number for your request is: H202204257.
As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 20 working days after
the day your request was received. If you'd like to calculate the
timeframe, you can use the Ombudsman's online calculator
here: [1]http://www.ombudsman.parliament.nz/
Due to the COVID-19 global pandemic response, the Ministry is experiencing
significantly higher volumes of queries and requests for information. 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: [2][email address]
-----Original Message-----
From: Heather Darby <[FOI #18947 email]>
Sent: Tuesday, 22 March 2022 12:04 pm
To: OIA Requests <[email address]>
Subject: Official Information request - Comirnaty (COVID-19 mRNA vaccine)
with active ingredient BNT162b2
Dear Ministry of Health,
Please provide any and all information that has been provided to the
Ministry of Health or Medsafe pertaining to the product Comirnaty
(COVID-19 mRNA vaccine) with active ingredient BNT162b2:
1. Certificates of Analysis for the first three batches of vaccine
distributed in New Zealand.
2. Independent batch certification, such as UK National Institute for
Biological Standards and Control (NIBSC) certification, EU Official
Control Authority Batch Release (OCABR) certification, Australian TGA
batch release assessment for all batches distributed in New Zealand.
3. Data to further characterise the truncated and modified mRNA species
present in the finished product which addresses results from ion pairing
RP-HPLC addressing 5’cap levels and presence of the poly(A) tail, and
addresses the potential for translation into truncated S1S2
proteins/peptides or other proteins/peptides.
4. Relevant protein/peptide characterisation data for predominant species.
5. Evaluation of any homology between translated proteins (other than the
intended spike protein) and human proteins that may, due to molecular
mimicry, potentially cause an autoimmune process.
6. Analysis of the main peak of the RNA integrity test representing the
full-length RNA that addresses 5’cap levels and presence of the poly(A)
tail.
7. Reassessment of the active substance specification for the DNA template
purity and impurities.
8. Active substance process validation data regarding the finalised
indirect filter qualification assessment and the shipping validation
between sites.
9. The capability of the next generation sequencing technology platform to
detect lower amounts of RNA species of alternative sequence in the
presence of the correct, more abundant RNA for the active substance.
10. The results and the assay suitability for the cell-based flow
cytometry and the western blot method used for biological characterisation
of protein expression for the active substance.
12. A summary of the validation/verification status of the immunoblot
analytical procedure used to detect double stranded RNA (dsRNA) in the
active substance.
13. Data comprising batch analyses of a suitable number of commercial
batches as well as analyses of batches that have been used in the
(ongoing) clinical trials.
14. Specifications and results of introducing an active substance to
control poly(A) tail length and how it was controlled on each batch.
15. Data to support the suitability of the method used for %poly(A) tail
in Q14 above.
16. Revised specifications of the mRNA integrity and polydispersity
finished product.
17. Data to support the suitability of the method used for potency
determination.
18. The finished product acceptance criteria for potency.
19. Control strategy assessment results for Lipid-related impurities.
20. The risk assessment with respect to the potential presence of
elemental impurities in the active product based on the general principles
outlined in Section 5.1 of ICH Q3D and Ph. Eur. monograph Pharmaceutical
Preparations (2619).
21. Process development for ALC-0315 with emphasis on the identification
and purge of impurities.
22. Specified impurities for ALC-0315 and appropriate specification limits
for individual impurities.
23. Acceptance criteria for specified and un-specified impurities for
ALC-0315.
24. Details about how the solvent residues that are used in the
manufacture of the ALC-0315 excipient are controlled.
25. The ALC-0315 assay and impurities limits.
26. Method validation reports for assay, impurities, and residual solvents
for ALC-0315.
27. ALC-0315 impurity standard information for any identified impurities
reported.
28. The impact of the molecular weight and polydispersity of carboxy-MPEG
on ALC-0159, including acceptance criteria, for these parameters in the
starting material.
29. Reports on the duration of efficacy and the requirement for booster
doses.
30. Reports on efficacy including asymptomatic infection in the vaccinated
group, vaccine failure, immunogenicity, and efficacy in population
subgroups.
31. The final Clinical Study Reports for Study C4591001 and Study
BNT162-01.
32. The latest Safety Update Report.
Yours faithfully,
Heather
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From: OIA Requests
Kia ora Heather
Please find attached a letter regarding your request for information.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [1][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
[2]www.health.govt.nz
[3]Ministry of Health information releases
[4]Unite against COVID-19
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From: Heather Darby
Dear OIA Requests,
Please unhide all the "acceptance criteria" that have been backend out.
Yours sincerely,
Heather Darby
From: OIA Requests
Kia ora Heather,
The Ministry stands by the decision made in response to your request for
information and as you have been previously informed under section 28(3)
of the Act, you have the right to ask the Ombudsman to review any
decisions made under your requests. The Ombudsman may be contacted by
email at: [1][email address] or by calling 0800 802 602.
Ngā mihi
OIA Services Team
[2]Ministry of Health information releases
[3]Unite against COVID-19
------------------------------------------------------------------------
From: Heather Darby <[FOI #18947 email]>
Sent: Tuesday, 24 May 2022 12:37
To: OIA Requests <[email address]>
Subject: Re: Response to your request for information, H202204257
Dear OIA Requests,
Please unhide all the "acceptance criteria" that have been backend out.
Yours sincerely,
Heather Darby
-----Original Message-----
Kia ora Heather
Please find attached a letter regarding your request for information.
Under section 28(3) of the Act you have the right to ask the Ombudsman to
review any decisions made under this request. The Ombudsman may be
contacted by email at: [1][email address] or by calling 0800
802 602.
Ngā mihi
OIA Services Team
[2]www.health.govt.nz
[3]Ministry of Health information releases
[4]Unite against COVID-19
References
Visible links
1. [4]mailto:[email address]
2. [5]http://www.health.govt.nz/
3. [6]https://www.health.govt.nz/about-ministr...
4.
[7]https://scanmail.trustwave.com/?c=15517&...
-------------------------------------------------------------------
Please use this email address for all replies to this request:
[FOI #18947 email]
Disclaimer: This message and any reply that you make will be published on
the internet. Our privacy and copyright policies:
[8]https://scanmail.trustwave.com/?c=15517&...
If you find this service useful as an Official Information officer, please
ask your web manager to link to us from your organisation's OIA or LGOIMA
page.
-------------------------------------------------------------------
****************************************************************************
Statement of confidentiality: This e-mail message and any accompanying
attachments may contain information that is IN-CONFIDENCE and subject to
legal privilege.
If you are not the intended recipient, do not read, use, disseminate,
distribute or copy this message or attachments.
If you have received this message in error, please notify the sender
immediately and delete this message.
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6. https://www.health.govt.nz/about-ministr...
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8. https://scanmail.trustwave.com/?c=15517&...
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Virginia Crawford left an annotation ()
Heather, this needs to be referred to the Ombudsman now. There is no good reason why the requested information can't be supplied, unless there is something to hide.
Athina Andonatou left an annotation ()
Great, intelligent questions.
Sadly, this is another example of corporate interests over people and money over morals
Things to do with this request
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Heather Darby left an annotation ()
This should read: Please unhide all the "acceptance criteria" that have been BLACKENED out.
Link to this