Tēnā koe Garry, 

 

Thank you for your request under the Official Information Act 1982 (the
Act) on 18 September 2022. You asked:  

 

“(1) Please advise whether the Ministry will be procuring the Pfizer
Bivalent COVID-19 vaccine and if yes 

(2) when will it be available and 

(3) who will be eligible for it.” 

 

As you may be aware, for COVID-19 vaccinations to be administered in New
Zealand, a pharmaceutical company must submit an application to Medsafe,
New Zealand’s medicine safety authority. Medsafe assess all COVID-19
vaccine applications before granting approval. For your information, the
status of all COVID-19 vaccine applications is publicly available on the
Medsafe website
here: [1]www.medsafe.govt.nz/COVID-19/status-of-applications.asp. 

 

It is important that Medsafe conduct its own evaluations and approvals of
COVID-19 vaccines in a fair and impartial manner that is free from any
potential conflicts of interest. More information about Medsafe’s approval
process can be found on Medsafe’s
website: [2]www.medsafe.govt.nz/COVID-19/vaccine-approval-process.asp. 

 

At present, Pfizer has applied to Medsafe for its Omicron BA.1
(Pfizer-BioNTech) vaccine to be approved for those aged 12 years and over.
Medsafe is currently assessing the clinical and manufacturing data
provided by Pfizer, which is being done as a priority. It is important to
note that Medsafe has not received an application for the Omicron BA.4/5
(Pfizer-BioNTech) vaccine, but this application is to be expected once
more data is available. 

 

As you may be aware, the Australian Therapeutic Goods Administration (TGA)
recently provisionally approved the use of Moderna’s bivalent COVID-19
vaccine (SPIKEVAX Bivalent original/Omicron) for use as a booster dose in
adults 18 years and over. It is important to note that the TGA approval
does not remove the need for Medsafe approval. Please note, it is up to
the individual company to choose to apply, which results in different
countries having access at different times. 

 

Please note that if Medsafe approves an application, the New Zealand
Government then considers advice and makes decisions on when and who a
particular vaccine will be used for as part of the COVID-19 immunisation
programme. Advice is provided by the COVID-19 Vaccine Technical Advisory
Group (CV TAG), who review international literature and make
recommendations for use of COVID-19 vaccines. 

 

We are unable to provide a date for when the Omicron BA.1
(Pfizer-BioNTech) vaccine may be available in New Zealand for those aged
12 years and over. Please be assured that the National Public Health
Service, Te Whatu Ora and the New Zealand Government continue to closely
monitor emerging scientific evidence and research from around the world in
relation to COVID-19 vaccines. Any changes will be communicated publicly. 

 

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. 

Ngā mihi  

     

OIA Services Team 

M[4]inistry of Health information releases 
U[5]nite against COVID-19 

 

 

 

 

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References

Visible links
1. http://www.medsafe.govt.nz/COVID-19/stat...
2. http://www.medsafe.govt.nz/COVID-19/vacc...
3. mailto:[email address]
4. https://www.health.govt.nz/about-ministr...
5. https://covid19.govt.nz/