Darryl Ward
From:
Tim Strabala <[email address]>
Sent:
Thursday, 4 February 2021 11:42 am
To:
Kerry Laing; Julie Everett-Hincks
Subject:
DMC_Cover_Letter.docx REF:0526695
Attachments:
DMC_Cover_Letter.docx
Good morning both,
Please find attached a cover letter with a few explanatory points for the documents you received on Board
Books.
Thanks once again for agreeing to consider this application.
Kind regards, Tim
Tim Strabala, PhD
Principal Scientist, New Organisms
s 9(2)(a) OIA – this information is withheld to protect
+64 4 474 5470 | a person or persons’ privacy
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1
Cover letter – APP204176: Pfizer SARS-CoV-2
vaccine BNT162b2 (COMIRNATYTM)
4 February 2021
Dear Kerry and Julie,
The section 26 statutory determination APP204176 to on the new organism status of the Pfizer SARS-
CoV-2 vaccine BNT162b2 (COMIRNATYTM) is now ready for your review and should now be on Board
Books. As I’m sure you’re aware, Medsafe granted provisional approval to the vaccine yesterday,
February 3, so it would be appreciated if you could let me know your comments as soon as possible.
However, there is no statutory time frame regarding a s26 determination.
Because we think this determination is relatively straightforward, and in the interests of expediency, I
have provided a draft decision for your perusal. Please note that this is exactly what it is stated to be –
a draft – you may alter it as you see fit. I am of course available for a teleconference or a Zoom
meeting to discuss the application and advice with you, if you wish. If I receive no comment from either
of you regarding the draft decision, I will assume that you find it acceptable in its current form (barring
addition of dates and other administrative aspects).
You should have received an e-response form from Matina Ma via a separate email. Please indicate
your decision using this form to Matina, also cc’ing me.
Please feel free to contact me directly if you require more information or would like to discuss
anything.
Thank you,
Tim Strabala, PhD
Principal Scientist, New Organisms
[email address]
+64 4 474 5470 | s 9(2)(a) OIA
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From: Tim Strabala
Sent: Thursday, February 11, 2021 12:34 PM
To: Julie Everett-Hincks s 9(2)(a) OIA
; Kerry Laing s 9(2)(a) OIA
Diane Totton
<[email address]>
Cc: Miriam Robertson <[email address]>; Christopher Hill
<[email address]>; Erina Marwick <[email address]>
Subject: RE: APP20476 - revised draft decision (changes tracked) REF:0596254
Thank you, Julie. Thanks to both you and Kerry for your diligent work on this determination.
Kind regards, Tim
Tim Strabala, PhD
Principal Scientist, New Organisms
+64 4 474 5470 | s 9(2)(a) OIA
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Our New Zealand Business Number Is 9429041901977
This email message and any attachment(s) are intended for the addressee(s) only.
If you receive this message in error, please notify the sender and delete the message and any attachment(s).
From: Julie Everett-Hincks s 9(2)(a) OIA
Sent: Thursday, 11 February 2021 12:13 pm
To: Tim Strabala <[email address]>; Kerry Laing s 9(2)(a) OIA
Diane Totton
<[email address]>
Cc: Miriam Robertson <[email address]>; Christopher Hill
<[email address]>; Erina Marwick <[email address]>
Subject: RE: APP20476 - revised draft decision (changes tracked) REF:0596254
Dear Kerry, Tim and Diane
I have reviewed the attached document pertaining to the Section 26 statutory determination of
APP204176.
I accept the changes made herein.
Following the discussion this morning, I have resolved that BNT-162b2 is not an organism as
defined by the HSNO Act (s2).
My E-Response is copied here:
E-RESPONSE
APP204176 To determine whether Pfizer SARS-CoV-2 vaccine is a new organisms for the
purpose of the HSNO Act.
I determine that BNT-162b2 vaccine is not a new organism under section 26 of the HSNO Act.
Kind regards
Julie
Dr Julie Everett-Hincks
s 9(2)(ba)(i) OIA – release of this information would be likely to would be likely to
prejudice the supply of similar information or information from the same source
From: Kerry Laing s 9(2)(a) OIA
Sent: Wednesday, 10 February 2021 1:25 pm
To: Diane Totton <[email address]>; Julie Everett-Hincks s 9(2)(a) OIA
Cc: Tim Strabala <[email address]>
Subject: RE: APP20476 - revised draft decision (changes tracked) REF:0596254
Hi Diane
I am satisfied with the current Decision Report. Subject to hearing Julie’s approval, I give
approval for the use of my electronic signature.
Kind regards
From: Diane Totton [mailto:[email address]]
Sent: Wednesday, 10 February 2021 9:47 a.m.
To: Kerry Laing s 9(2)(a) OIA
Julie Everett-Hincks s 9(2)(a) OIA
Subject: FW: APP20476 - revised draft decision (changes tracked) REF:0596254
Good morning Kerry and Julie,
I don’t expect that the below link will work for you, so I’ve attached the decision
document for your further consideration.
(I’ve told Tim many times that he shouldn’t work so late but he just won’t listen to me.)
Kind regards,
Diane Totton (she/her)
Applications Administrator
+64 4 474 5571
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This information is intended to provide general guidance as to the requirements of the HSNO Act, based on the information
you have provided. It should not be relied on as a substitute for independent advice. The EPA accepts no liability whatsoever
for claims arising out of reliance on the information contained in this record.
This email message and any attachment(s) are intended for the addressee(s) only. The contents may be confidential and are not necessarily the
opinions of EPA New Zealand. If you receive this message in error, please notify the sender and delete the message and any attachment(s).
From: Tim Strabala
Sent: Tuesday, 9 February 2021 11:45 pm
To: Kerry Laing s 9(2)(a) OIA
Julie Everett-Hincks s 9(2)(a) OIA
Cc: Diane Totton <[email address]>; Miriam Robertson
<[email address]>
Subject: APP20476 - revised draft decision (changes tracked)
Hello Kerry and Julie,
Please find below the link to the revised draft decision for APP204176, statutory
determination regarding the new organism status of the SARS-CoV-2 vaccine
BNT162b2. I have tracked Kerry’s requested changes for your ease of examination.
http://epa/edrms/apps-2020/1/APP204176/c/APP204176_Decision_FINAL.docx
This is an intranet link that cannot be externally accessed.
If you are both satisfied with the way the decision reads in its current form, please
simply advise us of that via email. Kerry, if you could also advise that you authorise the
use of your electronic signature on the document, then Diane can proceed with
preparing the final documents for publication on the EPA website, and initiating
processes for publication of the decision in the New Zealand Gazette.
Please note that the determination does not take effect until the Gazette notice is
published. This should take place within one or two days after you authorise your
decision with us.
Please let me know if you have any further questions or comments.
Kind regards, Tim
Tim Strabala, PhD
Principal Scientist, New Organisms
+64 4 474 5470 | s 9(2)(a) OIA
Follow us on Facebook, Twitter, Instagram, and LinkedIn.
Our New Zealand Business Number Is 9429041901977
This email message and any attachment(s) are intended for the addressee(s) only.
If you receive this message in error, please notify the sender and delete the message and any attachment(s).
ReplyReply al Forward
s 9(2)(ba)(i) OIA – release of this information would be likely to would be likely to prejudice the supply of similar
information or information from the same source
Darryl Ward
From:
Tim Strabala
Sent:
Wednesday, 10 February 2021 2:20 pm
To:
Julie Everett-Hincks; Kerry Laing; Diane Totton
Cc:
Miriam Robertson; Christopher Hill; Erina Marwick
Subject:
RE: APP20476 - revised draft decision (changes tracked) REF:0596254
Attachments:
APP204176_Decision_FINAL_changes_tracked.docx
Hi Julie,
Diane would have sent you this as well, but please find the requested document attached.
Kind regards, Tim
Tim Strabala, PhD
Principal Scientist, New Organisms
+64 4 474 5470 | s 9(2)(a) OIA
Follow us on Facebook, Twitter, Instagram, and LinkedIn.
Our New Zealand Business Number Is 9429041901977
This email message and any attachment(s) are intended for the addressee(s) only.
If you receive this message in error, please notify the sender and delete the message and any attachment(s).
From: Julie Everett-Hincks s 9(2)(a) OIA
Sent: Wednesday, 10 February 2021 2:14 pm
To: Kerry Laing s 9(2)(a) OIA
Diane Totton <[email address]>; Tim Strabala
<[email address]>
Cc: Miriam Robertson <[email address]>; Christopher Hill <[email address]>; Erina
Marwick <[email address]>
Subject: Re: APP20476 - revised draft decision (changes tracked) REF:0596254
Dear Tim
Can you please email the document to me, with Kerry's changes? I am unable to access the document
through the link provided.
Many thanks
Julie
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s 9(2)(ba)(i) OIA – release of this information would be likely to would be likely to prejudice the supply of similar
information or information from the same source
Document Outline
