Long term side-effects of Medsafe-approved Covid-19 vaccines
Greg Keen made this Official Information request to Ministry of Health
The request was partially successful.
From: Greg Keen
Dear Ministry of Health,
As at 18/02/21 your website states the following:
'Medsafe are doing robust assessments of COVID-19 vaccines so that we can be confident they're safe and effective before they can be used in New Zealand.'
1) Can you please provide details of robust assessments which were carried out on any COVID-19 vaccines prior to their approval in New Zealand (specifically by Medsafe) to ensure that there are no serious long-term effects on New Zealanders who are injected with any COVID-19 vaccine. For the purposes of clarity I will define 'long-term effects' as any adverse reaction to any COVID-19 vaccine which either persists beyond 6 months following the date of initial vaccination or first presents itself at least 6 months after the date of initial vaccination. To be clear, I am not requesting any information relating to any side effects which present themselves in the weeks following initial vaccination.
2) In the event that the long-term adverse effects of any approved COVID-19 vaccines are unknown or have not yet been assessed, what assurance can the Ministry of Health give New Zealanders that their regulatory business unit known as Medsafe is fit for purpose in its role of enhancing the health of New Zealanders by regulating medicines and medical devices to maximise safety and benefit, when there would appear to be a significant risk being taken with the long-term health of New Zealanders at stake?
Yours faithfully,
Greg Keen
From: OIA Requests
Kia ora
Thank you for your request for official information received 18 February
2021 for:
" 'Medsafe are doing robust assessments of COVID-19 vaccines
so that we can be confident they're safe and effective before they can be
used in New Zealand.'
1) Can you please provide details of robust assessments which were carried
out on any COVID-19 vaccines prior to their approval in New Zealand
(specifically by Medsafe) to ensure that there are no serious long-term
effects on New Zealanders who are injected with any COVID-19 vaccine. For
the purposes of clarity I will define 'long-term effects' as any adverse
reaction to any COVID-19 vaccine which either persists beyond 6 months
following the date of initial vaccination or first presents itself at
least 6 months after the date of initial vaccination. To be clear, I am
not requesting any information relating to any side effects which present
themselves in the weeks following initial vaccination.
2) In the event that the long-term adverse effects of any approved
COVID-19 vaccines are unknown or have not yet been assessed, what
assurance can the Ministry of Health give New Zealanders that their
regulatory business unit known as Medsafe is fit for purpose in its role
of enhancing the health of New Zealanders by regulating medicines and
medical devices to maximise safety and benefit, when there would appear to
be a significant risk being taken with the long-term health of New
Zealanders at stake?"
The Ministry's reference number for your request is: H202101531.
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
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
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From: OIA Requests
Kia ora,
Please find attached a letter regarding your request for information.
Ngā mihi
OIA Services
Government Services
Office of the Director-General
Ministry of Health
E: [email address]
show quoted sections
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