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Novavax Update

Michelle made this Official Information request to Ministry of Health

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From: Michelle

Dear Ministry of Health,

I request current information about the likely availability timeline for when Novavax is going to be available in New Zealand. My current employment depends on it. Where exactly in the process is the Medsafe approval, and when are we expecting a shipment to arrive in New Zealand. I note the Indian government approved release of a shipment of 7 crore doses to New Zealand, Australia and Netherlands in late December however we are still awaiting an update here in New Zealand. Please release information pertaining to the expected timeline to me. Thank you.

Yours faithfully,

Michelle Matthews

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Kia ora Michelle,
Thank you for your email. Novavax started their rolling application to
Medsafe in August and the data has been under evaluation. Medsafe has
recently received a large amount of data from Novavax, however there is
more data and information yet to be provided. As with other COVID-19
vaccines, Medsafe will prioritise the review of this data. An announcement
will be made once Medsafe has made a decision on the application. 
 
Following Medsafe’s regulatory decision on the safety and effectiveness of
the Novavax COVID-19 vaccine and once delivery schedules have been
confirmed, we will consider the use of Novavax in New Zealand.   
 
So far, Medsafe has granted provisional approval for the Pfizer, Janssen
and AstraZeneca COVID-19 vaccines. 
 
Provisional approval means the pharmaceutical company must meet certain
conditions, including supplying more data from its clinical trials around
the world as they progress. Information about the approval process can be
found on the Medsafe
website: [1]https://www.medsafe.govt.nz/COVID-19/vac....

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: [2][email address] or by calling 0800
802 602. 

 

Ngâ mihi 

OIA Services Team 

  

[3]Ministry of Health information releases 

[4]Unite against COVID-19 

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From: Michelle <[FOI #18175 email]>
Sent: Wednesday, 12 January 2022 17:03
To: OIA Requests <[email address]>
Subject: Official Information request - Novavax Update
 
Dear Ministry of Health,

I request current information about the likely availability timeline for
when Novavax is going to be available in New Zealand. My current
employment depends on it. Where exactly in the process is the Medsafe
approval, and when are we expecting a shipment to arrive in New Zealand. I
note the Indian government approved release of a shipment of 7 crore doses
to New Zealand, Australia and Netherlands in late December however we are
still awaiting an update here in New Zealand. Please release information
pertaining to the expected timeline to me. Thank you.

Yours faithfully,

Michelle Matthews

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References

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Anil left an annotation ()

I would add supplementary questions to the above request

1. Answering the multiple OIA requests, the Ministry of Health replied;

“Medsafe has recently received a large amount of data from Novavax, however, there is
more data and information yet to be provided.”
Source
https://fyi.org.nz/request/18128-novavax...
https://fyi.org.nz/request/18175-novavax...

A. Is it true that there is still "more data and information yet to be provided” by Novavax?

B. Please provide a copy of the communication sent to Novavax requesting the missing “more data and information”.

C. Provide the date on which Medsafe received the latest data/information from Novavax regarding Novavax Vaccine.

D. If Medsafe already received all the relevant “data and information”,

a. If the answer to the above question "A" is NO. What are the reasons, Medsafe not updating its website regarding Novavax vaccine approval? https://www.medsafe.govt.nz/COVID-19/sta...

2. Provide the date on which Medsafe had received all the “data and information” from Pfizer before the approval of their Covid-19 vaccine?

3. How many working days Medsafe had taken to approve the Pfizer vaccine after receiving the “data and information”?

4. Did Medsafe evaluate the vaccine approval application during Christmas break?
As concerns were raised by doctors
https://www.newshub.co.nz/home/new-zeala...

5. Is Medsafe waiting for CDC approval before rubber-stamping the Novavax approval application?
As concerns were raised regarding the existence of Medsafe, itself https://www.stuff.co.nz/business/opinion...

6. Please provide the information without exposing the private information.
a. How many Medsafe Pfizer vaccine approving team members or their immediate family members own Pfizer stocks?

7. Does Pfizer Covid -19 vaccine contract in any way stop Medsafe to approve the non-Pfizer/mRNA vaccine?

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