Kia ora Scott,

 

Thank you for your request for official information received by Medsafe on
24 June 2021  for:

 

 "I would like to make a request for information relating to the
first-in-human safety, reactogenicity and immunogenicity trial of the
Covid-19 vaccine ReCOV. "

I request a copy of the approval letter sent by Medsafe to the study
applicant. If earlier applications were declined or received only
provisional approval, I request copies of Medsafe's letters apprising the
applicant of these outcomes.

 

I further request copies of all other correspondence between Medsafe and
the investigators and sponsors of this study which relates to the
application (and any earlier applications for the same study, if any),
namely correspondence with:

1) Jiangsu Rec-Biotechnology

2) New Zealand Clinical Research (and/or its subsidiaries Auckland
Clinical Studies and the Christchurch Clinical Studies Trust)

3) Principal Investigator Dr Paul Hamilton

4) Principal Investigator Dr Chris Wynne"

 

The Ministry's reference number for your request is: H202107630.

 

As required under the Official Information Act 1982, the Ministry will
endeavour to respond to your request no later than 22 ^ July 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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Kia ora Scott,

 

Thank you for your request for official information which was transferred
from the Health Research Council of New Zealand and received by Medsafe on
02 July 2021.

You requested:

 

1. I would like to make a request for information relating to the
first-in-human

safety, reactogenicity and immunogenicity trial of the Covid-19 vaccine

ReCOV.

2. My request is motivated by the public interest and curiosity
surrounding this

first-of-its-kind study.

3. I request copies of all recommendations or advice provided by HRC to
the

Ministry of Health and/or Medsafe upon HRC's consideration of the

application for performing the study.

4. This should include recommendations or advice for the application which
was

approved, as well as any earlier applications for the same study that were

declined or only given provisional approval (if any).

5. I also request copies of the minutes of all Standing Committee on

Therapeutic Trials meetings where the application (or any earlier
applications

for the same study) was discussed.

6. I also note that SCOTT's consideration of applications for this study

presents some apparent conflicts of interest, insofar as:

 SCOTT Chair Assoc Prof Richard Robson is an advisor to the Board

of, and has a financial stake in, New Zealand Clinical Research; and

 SCOTT member Dr Chris Wynne is the Chief Operations Officer of New

Zealand Clinical Research,

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where New Zealand Clinical Research is the company contracted to

conduct the study. I request information about how these and any other

conflicts were managed.

7. Note that the above is derived from my reading of the SCOTT membership

list published on the HRC website and dated September 2019:

https://www.hrc.govt.nz/sites/default/fi...

(https://www.hrc.govt.nz/sites/default/fi... TT.pdf)

If this is now out of date, I would like to request a copy of the current

membership list.

 

 

As you have an open OIA request with Medsafe currently, we have decided to
consolodate the two requests together under the same reference number:
H202107630

If you need to contact us at any stage about your request, please quote
this reference number in your correspondence.

 

Your request has been logged and you can expect a reply no later than 22
July 2021 as required under the Official Information Act 1982.

 

Ngā mihi

 

OIA Services

Government Services

Office of the Director-General

Ministry of Health

E: [1][email address]

 

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References

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