Printed from https://fyi.org.nz/request/14712-appropriate-vaccine-warnings on November 05, 2024 13:18

Appropriate vaccine warnings

Virginia Crawford made this Official Information request to Ministry of Health

The request was partially successful.

From: Virginia Crawford

Dear Ministry of Health,

The FDA has stated the following:

All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:

This product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older; and

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

https://www.fda.gov/media/144412/download

Could you please confirm that a similar protocol will be instituted in New Zealand, i.e. that all recipients of the vaccine will be given a leaflet or other documentation to indicate that this vaccine has been given temporary approval only in New Zealand and is not yet fully licensed for use in this country.

Yours faithfully,

Virginia Crawford

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From: Megan King

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Kia ora

 

Thank you for your request for official information received 18 February
2021 for:

 

            "The FDA has stated the following:

 

All descriptive printed matter, advertising, and promotional material
relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and
conspicuously shall state that:

 

This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 16 years of age and older;
and

 

The emergency use of this product is only authorized for the duration of
the declaration that circumstances exist justifying the authorization of
emergency use of the medical product under Section 564(b)(1) of the FD&C
Act unless the declaration is terminated or authorization revoked sooner.

 

https://scanmail.trustwave.com/?c=15517&...

 

Could you please confirm that a similar protocol will be instituted in New
Zealand, i.e. that all recipients of the vaccine will be given a leaflet
or other documentation to indicate that this vaccine has been given
temporary approval only in New Zealand and is not yet fully licensed for
use in this country."

 

The Ministry's reference number for your request is: H2021001468.

 

As required under the Official Information Act 1982 we will endeavour to
respond to your request no later than 18 March 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

 

Megan King

Advisor | OIAServices

Office of the Director-General

Ministry of Health

E: [1][email address]

L1 North, Yellow, 113 Molesworth St, Wellington

 

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Kia ora Virginia,

 

On behalf of Nick Allan, Manager OIA Services, please see attached the
response to your OIA request.

 

 

Ngā mihi

OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [1][email address]

 

 

 

 

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