133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T +64 4 496 2000
W www.medsafe.govt.nz
01/02/2020
Virginia Crawford
By email:
[FYI request #14492 email]
Ref:
H202100277
Dear Virginia Crawford
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 20 January 2021
for information relating to Medsafe methods of assessing COVID vaccines.
You asked the following:
“If trials are still in progress, how can Medsafe be sure that these vaccines are "safe and
effective" by the time they are used in New Zealand? Already there are reports of very
serious side effects (and even deaths) from covid vaccines in various parts of the world.
As New Zealand’s medicines regulatory agency, Medsafe decides whether a medicine has
acceptable efficacy, safety and quality for use in New Zealand. You can find more information
about how this process works here:
www.medsafe.govt.nz/consumers/Safety-of-
Medicines/Vaccine-safety.asp.
When considering a medicine application, Medsafe reviews all safety aspects of the vaccine as it
may not be suitable for use by some people. Whilst Medsafe is prioritising COVID-19 vaccine
assessments, the review of safety of any vaccine will not be compromised. Following the
Medsafe process, the list of ingredients will be published in a datasheet and CMI on our website,
like all other medicines.
As well as following our usual approval processes, Medsafe will continue to monitor the safety
and effectiveness of vaccines and other medicines including taking action if it detects a safety
issue.
You may also be interested to know that information on the COVID-19 approval process for
medicines is available on the Medsafe website at
: www.medsafe.govt.nz/COVID-19/medicine-
approval-process.asp.
I trust this information fulfils your request. 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:
[email address] or by calling 0800 802 602.
Please note that this response, with your personal details removed, may be published on the
Ministry website.
Yours sincerely
Chris James
Group Manager
Medsafe
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