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References

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2. https://www.health.govt.nz/about-ministr...
3. mailto:[email address]

Kia ora Mary/Megan,
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...
Medsafe has granted provisional approval of the Janssen Pharmaceutical
vaccine, however provisional approval does not mean that there is a
commitment to using the vaccine in New Zealand
([2]www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-strategy-planning-insights/covid-19-purchasing-vaccines).
New Zealand has secured two million doses of the Janssen vaccine through
an Advance Purchase Agreement and officials are working with Janssen to
confirm vaccine delivery schedules. 

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

 

Ngâ mihi 

OIA Services Team 

  

[4]Ministry of Health information releases 

[5]Unite against COVID-19 

--------------------------------------------------------------------------

From: Mary Hobbit <[FOI #18348 email]>
Sent: Thursday, 27 January 2022 09:57
To: OIA Requests <[email address]>
Subject: Official Information request - Novavax Vaccine and Information on
Cabinet Approval
 
Dear Ministry of Health,

I am enquiring about the availability of the Novavax vaccine:

- Once it is approved by MedSafe, what timeline is expected for approval
by Cabinet?
- Is it possible that is approved by MedSafe, but that Cabinet does not
make a decision on its use in New Zealand?

- In term of the Janssen vaccine, this has been granted provisional
approval by MedSafe but Cabinet still is yet to decide on its use. Why is
that?

Yours faithfully,
Megan Fox

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References

Visible links
1. https://www.medsafe.govt.nz/COVID-19/vac...
2. http://www.health.govt.nz/our-work/disea...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/
6. https://scanmail.trustwave.com/?c=15517&...
7. https://scanmail.trustwave.com/?c=15517&...