Adverse reaction reporting process:

Full responses from the Ministry of

Health
- Can you please explain how the adverse reaction report data is gathered? What
portion of reports come through health professionals or health providers, and
what portion are self-reporting?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):

Regarding the COVID-19 vaccines, Medsafe and the National Immunisation Programme are
actively encouraging reporting of adverse events following immunisation (AEFI). Reports can be
made by either consumers/ members of the public or healthcare professionals. AEFI that occur
during the initial observation period after the vaccine, can be captured directly in the COVID
Immunisation Register (CIR). Reports for AEFI that occur once the consumer has left the
vaccine site can be submitted directly to the Centre for Adverse Reactions Monitoring (CARM).

We have seen good engagement from both consumers and healthcare professionals for the
reporting of the COVID-19 vaccines. The current reporting rate is 5.6 AEFI per 1000
vaccinations. For context the reporting rate in Australia for COVID-19 vaccines is 2.1 AEFI per
1000 vaccinations and in the United Kingdom this is 2 to 5 AEFI per 1000 vaccinations.

This information is within the Medsafe Safety Report under the summary of reports. For
Comirnaty, it states: “On average for every 10,000 people who are vaccinated 56 people report
an AEFI. It is also important to keep in mind that a report can be submitted for any cause and is
not necessarily associated with the vaccine.”

In addition, Table 5 in the report lists how many reports have been made by different types of
reporter, from Medsafe Safety Report #42:
https://www.medsafe.govt.nz/COVID-19/safety-report-42.asp

Consumer reporting is captured under ‘public patient’ and ‘public: on behalf of patient’

- What happens to that data before it is published in the weekly safety reports? Is it
reviewed? If so, what is being looked for in this process?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):
Each report that is received is linked to CIR entry to verify that the vaccination took place. It is
then checked by an analyst to make sure the events are all entered in our reporting database.

Significant reports are reviewed by Medical Assessors at CARM. If the report is significant it is
also presented to the COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) for
their expert input. The CV-ISMB review all reports with a fatal outcome with a view to
considering if any of the reported events prior to death were related to vaccination. The finalised
information is then collated into the AEFI report.

Some reports may not be able to be followed up on, for example if there is not enough
information provided in the report.

The Medsafe Safety Report for the COVID-19 vaccines is published on the Medsafe website
monthly: https://www.medsafe.govt.nz/COVID-19/vaccine-report-overview.asp

The most recent report was published on Wednesday 13 April, with the next report scheduled to
be published on Wednesday 11 May.

Details about the process for investigation of reported AEFI is available on the Medsafe website:
https://www.medsafe.govt.nz/COVID-19/monitoring-process.asp

The below link provides information on the follow-up process for significant adverse events,
including those with a fatal outcome:

https://www.medsafe.govt.nz/COVID-19/q-and-a-vaccine-safety.asp

- What efforts are made to explain/communicate that this data does not amount to
verified harm caused by the vaccine/the difference between correlation and
causation?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):

The Medsafe Safety report clearly defines that the information provided is reported AEFI.

An AEFI is defined as:

“An AEFI is an untoward medical event which follows immunisation and does not necessarily
have a causal relationship with the administration of the vaccine. The adverse event may be an
unfavourable or unintended sign, abnormal laboratory finding, symptom or disease.”

This is further qualified throughout the report including:

“It is also important to keep in mind that a report can be submitted for any cause and is not
necessarily associated with the vaccine.”

Under summary of reported deaths, it states:

“By chance, some people will experience new illnesses or die from a pre-existing condition
shortly after vaccination, especially if they are elderly. Therefore, part of our review process
includes comparing natural death rates to observed death rates following vaccination, to
determine if there are any specific trends or patterns that might indicate a vaccine safety
concern. See below for more information about these observed-versus-expected analyses.

To date, the observed number of deaths reported after vaccination is actually less than the
expected number of natural deaths.”

- What efforts are made to put this data into context regarding the risk v benefit
analysis of receiving the vaccine?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):

At the beginning of each Medsafe Safety Report, it is noted that:

Medsafe advises people NOT to make any decisions about vaccination based on information
contained in this report. If you have questions or concerns about receiving a vaccine, please
speak to a healthcare professional.

Within the report itself, we note that:

- “the protective benefits of vaccination against COVID-19 far outweigh the potential risks
of vaccination.”

- “Comirnaty: Up to 31 March 2022 a total of 10,941,275 doses of Comirnaty have been

administered and 60,972 AEFIs were reported. This means that more than 10.8 million
doses of Comirnaty were administered that did not result in a report of an adverse event.
On average for every 10,000 people who are vaccinated 56 people report an AEFI. It is
also important to keep in mind that a report can be submitted for any cause and is not
necessarily associated with the vaccine.”

- What, if anything, has been done differently in communicating the Covid-19

vaccine reaction reports data, versus how other vaccine reaction reports data? I'm
interested in if the approach was changed/considered in light of the
misinformation and anti-vax rhetoric around the Covid-19 (particularly mRNA)
vaccine. Obviously, NZ had the advantage of seeing how populations in other
 countries responded, before we began our vaccination programme - how was that
information used to mitigate the instrumentalisation of the data for
anti-vax/misinformation purposes?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):

For the COVID-19 vaccines we have proactively communicated safety data as it becomes
available. Most of this has been through the Medsafe Safety Report, which during 2021 was
published weekly and has now, due to the reduction in the number of vaccines being
administered, moved to monthly updates.

We reviewed the way other countries were presenting data before we designed the Medsafe
Safety Report. Over time, the report has changed in response to questions we received and any
concerns that needed to be addressed.

The report for COVID-19 vaccines it is a lot more detailed than for flu vaccine reports – see
example:
https://www.medsafe.govt.nz/safety/reports-and-promotion/Spontaneous-Reports-Influenza-Vac
cination-2020.asp

In addition to the reports, we have employed the use of enhanced safety surveillance
mechanisms such as observed versus expected analysis (detailed in the Medsafe Safety
Report), Post Vaccine Symptom Check (PVSC) an SMS based survey sent to up to 25% of the
vaccinated population. Results of PVSC are published on the Medsafe website here.

The COVID-19 Vaccine Independent Safety Monitoring Board (CV-ISMB) has provided expert
advice on the safety of the COVID-19 vaccines and where required there have been proactive
media releases from the Board/Ministry to communicate information around the safety of the
vaccines:
https://www.health.govt.nz/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-vaccine-strat
egy-planning-insights/covid-19-who-were-working#ismb

- Has anything been changed in this regard as the pandemic/vaccination campaign

has progressed?

Attribute to Rachel Mackay, Group Manager Operations, National Immunisation Programme:

As the rollout has progressed, we have continued to update and adapt our approach to take
advantage of lessons learnt here, as well as overseas. This includes for example the
development of new approaches to lift vaccination rates, such as drive through, pop up and
mobile clinics, as well as workplace vaccinations and other events, along with conducting and
building on research and other information and evidence to inform our approach.
Throughout the vaccination rollout, the Ministry and its partners have maintained a strong focus
on providing up to date, robust and accurate information about the vaccine and the virus to the
public.

The Ministry uses a rigorous process to compile and verify information regarding the Covid-19
outbreak and to support the vaccination roll-out. This involves drawing a complex range of
information from a variety of sources to determine infection and transmission rates, as well as
gauge vaccine effectiveness. This includes reviewing internationally published scientific
evidence and other information.

We have also continued to strongly encourage people to only go to trusted sources of

information when seeking to find out more about COVID-19 and the vaccine such as their GP,
the Ministry of Health’s website (health.govt.nz), covid19.govt.nz, karawhiua.nz, the Ministry for
Pacific Peoples, or health providers. It is important for people to protect themselves and others
from the disease by following the latest health advice.

This has been supported by a significant public information campaign, focussed on giving New
Zealanders accurate, timely and factual information at the right time. This approach, along with
a range of other public health measures, has also helped ensure New Zealand has become one
of the world’s most highly vaccinated countries.

- Are you able to tell me how many confirmed cases of pericarditis/myocarditis

have been caused by the vaccine in NZ? And how many deaths have been
attributed to the vaccines in NZ?

Attribute to Dr Tim Hanlon, Group Manager Post Event (Pharmacovigilance, Vaccine

Effectiveness and Population Protection):

Reports regarding adverse reactions (including Myocarditis and pericarditis cases) are regularly
reported, with the latest report published here:

https://www.medsafe.govt.nz/COVID-19/safety-report-41.asp

To date, three deaths following vaccination have been considered to be linked to the Pfizer
COVID-19 vaccine (Comirnaty). All three individuals were considered to have a
vaccine-mediated myocarditis. Myocarditis is a known and rare side effect of the Pfizer
COVID-19 vaccine.

The three cases are currently with coroners to determine the cause of death.

- Lastly, I see almost 1 million eligible Kiwis have not received their booster dose -
why do you think that is?
Attribute to Rachel Mackay, Group Manager Operations, National Immunisation Programme:

Research by the Ministry shows the main barriers to people who say they won’t get the booster
is because of concerns about the possible long term side effects, as well as testing of the
vaccine and questions regarding the immediate side effects potentially being worse than getting
Covid.

In cases where people say they are still likely to get the booster, most say they haven’t thought
about it or haven’t got around to it yet.

There will also be some people in this group who still intend to get their booster, but haven’t
been able to due to contracting Covid and who are following the recommended advice to wait
three months post recovery to get their booster.

In response, the Ministry of Health, the Centre for Adverse Reactions Monitoring, the Covid-19
Technical Advisory Group, Medsafe, and a number of other key bodies continue to monitor the
safety and efficacy of the Covid vaccine, which is one of the most closely studied medicines of
our time.

This also includes the Covid-19 Independent Safety Monitoring Board, which routinely reviews
adverse events that are reported following vaccination. These bodies regularly report their
findings to the public.

This work is also supported by targeted communications and public information campaigns, as
well as published research – including overseas evidence – to ensure people have access to
the latest information about the vaccine and the virus to support the vaccine rollout to New
Zealanders.

- Please add anything else you think is relevant/of importance.

Attribute to Rachel Mackay, Group Manager Operations, National Immunisation Programme:

We are continuing to strongly encourage all eligible New Zealanders to get their booster if it’s
been three months since their second dose – and also 16-17 year olds, who can now get their
booster six months after their second dose. We are also keen to ensure that as many tamariki
aged 5-11 are also vaccinated, which provides an important level of protection for them and their
whanau too.

This is because being boosted (in addition to fully vaccinated) will protect you significantly from
the more serious effects of Covid-19, meaning you are less likely to become severely ill, and
more likely to recover more quickly. It also reduces the chances of passing it on to family, friends
and loved ones, including those who cannot have the vaccine, such as young children.
A recent study shows that even when a vaccinated person was infected, they were far less likely
to infect unvaccinated people in their households. A vaccinated person who catches COVID
has got around a 63% less likely chance of transmitting the virus to the household. If you add in
the fact that most vaccinated people don't get the disease, the modelling suggests a more than
80% reduction in household transmission by vaccinated people.

The booster vaccine in particular also offers a very high level of protection against Omicron.
While vaccine effectiveness for Omicron against hospitalisation declines to around 45% from six
months after your second dose, it increases to about 90% after a booster dose. This is why
getting boosted is still so important to provide you with the highest possible level of protection.

ENDS