133 Molesworth Street
PO Box 5013
Wellington 6140
New Zealand
T+64 4 496 2000
20 October 2021
Tess M
By email: [FYI request #16788 email]
Ref:
H202112578
Tēnā koe Tess
Response to your request for official information
Thank you for your request under the Official Information Act 1982 (the Act) on 18 September
2021 for information relating to Pfizer COVID-19 vaccine Comirnaty data. You specifically
requested:
“1. I need you to provide me the Pfizer COVID-19 vaccine Comirnaty data that shows:
A. The effectiveness in stopping or slowing the transmission of covid-19
B. The effectiveness in reducing symptoms of covid-19
C. The effectiveness of the Pfizer vaccine against other strains preferably the Delta
strain.”
Whilst initial trials of the Pfizer vaccine did not measure efficacy against transmission, it is
important to note that subsequent studies carried out by other researchers (independent of
Pfizer) have evaluated the effect of vaccination on transmission of the virus. Preliminary results
from these studies have shown that two doses of the Pfizer vaccine can substantially reduce
transmission of the virus. Further information, with links to the relevant studies, can be found at:
www.health.govt.nz/system/files/documents/pages/science_updates_7_may_2021.pdf.
Likewise, more data are required to understand the extent of the effect that vaccination has on
transmission of the Delta variant. A summary of currently available data can be found on the
United States Centers for Disease Control (CDC) science brief page:
www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
Additional information about the safety and effectiveness of the vaccine can be found on the
Ministry of Health (the Ministry) website at the following links:
• The Coronavirus Immunisation handbook:
www.health.govt.nz/our-work/immunisation-
handbook-2020/5-coronavirus-disease-covid-19. This also provides references to
scientific studies conducted regarding COVID-19 and the vaccine.
• The Vaccine datasheet
: www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf
• Ministry webpage regarding vaccine safety and efficacy:
www.health.govt.nz/our-
work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-
vaccine-effectiveness-and-protection.
• Scientific and technical information available on the Ministry website at:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-
19-resources-and-tools/covid-19-science-news.
“2. Please provide the information that has shown the Pfizer COVID-19 vaccine Comirnaty
to be safe in the 12 year to 16 year old age group that has been used in the decision
making to allow 12 to 16 year olds to get it.”
Pfizer submitted clinical trial data with the application to change the indication of the Pfizer
vaccine to cover 12- to 16-year-olds. This information is withheld under section 9(2)(b)(ii) of the
Act, where its release would likely unreasonably prejudice the commercial position of the person
who supplied the information. However, the safety, immunogenicity, and efficacy of the
BNT162b2 Covid-19 Vaccine in adolescents for Comirnaty is publicly available at:
www.nejm.org/doi/full/10.1056/NEJMoa2107456.
“3. Please provide the information that provided evidence to award the decision of the
face covering mandate and shows its safety and effectiveness against contraction and
transmission of a virus.”
The Ministry does not conduct scientific research or studies. Please refer to online scientific
studies for further information:
https://pubmed.ncbi.nlm.nih.gov/. The Ministry constantly reviews international studies and evidence on mask wearing in the
community setting. Our current advice aligns with that of the World Health Organization
(WHO):
https://www.who.int/publications/i/item/advice-on-the-use-of-masks-in-the-community-
during-home-care-and-in-healthcare-settings-in-the-context-of-the-novel-coronavirus-(2019-
ncov)-outbreak. As part of reviewing international evidence, the Ministry considers other advice from
international organisations including Centres for Disease Control and Prevention, Public Health
England, the European Centre for Disease Control and Prevention, Australian jurisdictions and
a range of scientific and medical journals.
The information is collated through Ministry specialist technical advisory groups whose
membership include a variety of expert professions such as infection prevention and control,
public health, infectious diseases, microbiology and primary care. When reviewing evidence, we
ensure it is applicable to the current New Zealand situation and can be applied in our context.
Please refer to the below previously released responses regarding face coverings:
•
www.health.govt.nz/system/files/documents/information-
release/h202006250_20_oct_2020.pdf.
•
www.health.govt.nz/system/files/documents/information-
release/h202008732_15_dec_2020_0.pdf.
Maintaining the requirement for face coverings provides wider benefits that support the overall
response to the pandemic. Face coverings are a constant reminder of the ongoing threat posed
by COVID-19 and will help prompt people to be more vigilant about other important behaviours,
such as physical distancing, scanning using the New Zealand COVID Tracer App, hand hygiene
and coughing and sneezing etiquette. Familiarity with using face coverings also supports
community preparedness and may help to limit transmission of COVID-19 in the event of any
subsequent community outbreak where transmission may have been undetected for a time.
You may wish to request information from the Department of the Prime Minister and Cabinet
directly as they may hold information relating to this part of your request.
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On 19 September 2021 you requested further information relating to PCR COVID-19 tests.
Please find a response to each part of your request below. You asked:
“1. Please provide the evidence that the PCR test for COVID-19 is effective at detecting
SARs-COV-2.”
Evidence contributing to the Ministry’s confidence in the efficacy of COVID-19 tests used
includes:
• robust validation of the tests used, both internationally and within New Zealand;
• participation of the laboratories in both internal and external quality assurance
programmes, with acceptable performance, as required by the laboratory accreditation
standard;
• the additional validation of positive results provided by whole genome sequencing.
COVID-19 virus delta variant genetic material has been found in PCR testing of samples, which
confirms the presence of the virus in the community.
“2. At what cycle threshold (ct) value do false positives begin to occur? Please provide the
percentage of false positives including the mentioned ct value and each ct value thereafter
that is used here in New Zealand.”
The Ministry does not hold data for the reporting of false positive results. All COVID-19 testing
of people done as part of the public health response in in New Zealand is undertaken in
laboratories that are accredited to international laboratory standards (ISO 15189) by
International Accreditation New Zealand. The requirements of accreditation mean there are
documented quality assurance and result validation processes which must be followed for every
test performed.
To ensure that any incidences of false positives are identified and corrected, all positive results
are quality assured by the laboratory where the sample is tested by using a different method or
a different gene target. Subsequently, all positive results are confirmed once more when Whole
Genome Sequencing is completed for every positive sample.
No laboratory test provides 100 percent certainty of the result. The viral test for COVID-19 is not
100 per cent sensitive or able to correctly identify individuals with the disease every time. This is
the reason individuals are tested more than once, for example, in managed isolation facilities.
While false positives may have occurred in New Zealand, as in other countries, it is believed to
have occurred only a handful of times. If a false positive result has been released and actioned,
the patient is informed as soon as possible of the error. The Ministry does not hold data about
how many times a false positive has been actioned, for example, through quarantining.
“3. When testing for COVID-19 will it pick up other variants of COVID-19, other
coronavirus’s and other bacterial infections?”
The PCR Test used in New Zealand can, for example, differentiate between SARS-CoV-2 and
influenza. Presumably this question has been prompted by misinformation about the CDC
decision to withdraw the FDA Emergency Use Authorisation for a PCR test it developed early in
the pandemic. There is more information about this issue at:
www.factcheck.org/2021/07/scicheck-viral-posts-misrepresent-cdc-announcement-on-covid-19-
pcr-test/.
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The withdrawal of the PCR test developed by the CDC does not affect the PCR testing
undertaken by New Zealand diagnostic laboratories. The CDC’s RT-PCR test was only looking
for SARS-CoV-2 and ignoring genetic material from other viruses. The changes to testing
procedures were to encourage labs to switch to tests that can look for flu viruses at the same
time. The CDC’s announcement about the changes to RT-PCR testing for COVID-19 can be
found at:
www.cdc.gov/csels/dls/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-
PCR_SARS-CoV-2_Testing_1.html. On 21 September 2021 you requested further information relating to COVID-19. Please find a
response to each part of your request below. You asked for:
“Please provide the studies or research that show social distancing reduces the spread of
COVID-19?
Please only provide evidence that was used by the government to implement social
distancing.”
As advised above, the Ministry does not conduct scientific research or studies. Therefore, these
parts of your request are refused under section 18(g) of the Act as the information requested is
not held by the Ministry and there are no grounds for believing it is held by another agency
subject to the Act.
However, modelling studies performed by Te Pūnaha Matatini, a centre of research excellence
hosted by the University of Auckland, demonstrate the value of lockdowns in reducing the
spread of COVID-19:
https://cpb-ap-se2.wpmucdn.com/blogs.auckland.ac.nz/dist/d/75/files/2017/01/technical-report-
7-september.pdf, and for the original outbreak the evidence can be found following this link:
www.tepunahamatatini.ac.nz/2020/04/22/effect-of-alert-level-4-measures-on-covid-19-
transmission/. The Ministry has published information regarding how COVID-19 is spread. This information can
be found on the public facing website. Scientific reviews of the method of spread have also
been undertaken (link to RFA 213). The current evidence suggests SARS-CoV-2 is spread by
both airborne and droplet spread, and that physical distancing is effective against the former but
less effective against airborne spread. Computer simulations generally use real world estimates
to inform the model wherever possible and are often fitted to the known data to date for a
specific scenario such as an outbreak. Modelling studies usually state explicitly which values
(including ranges) they have used, the source of these values study would normally specify the
data sources on which the model is fitted, and any assumptions used in the model.
Real world data that lock-downs decrease the R value have been presented above.
Please provide evidence that the Pfizer COVID-19 vaccine Comirnaty reduces any
serious outcomes and hospital admissions of COVID-19.
The Ministry does not treat patients, therefore it cannot provide guidance regarding specific
treatment protocols that are the responsibility of district health boards, hospitals and medical
and other health professionals. General guidance for health professionals is available at:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-
information-health-professionals/covid-19-advice-all-health-professionals.
As advised above, the Ministry does not undertake scientific research. A wealth of scientific
information about COVID-19 is publicly available on PubMed, a service of the National Library
of Medicine in the United States at:
https://pubmed.ncbi.nlm.nih.gov/. Likewise, the Ministry
publishes summaries of a range of scientific information at:
www.health.govt.nz/our-
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work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-resources-and-tools/covid-
19-science-news.
However, the Ministry has published vaccination data of all cases people infected in the August
2021 outbreak, including their vaccination status. Of the 158 people hospitalised in this outbreak
as at 9am on 11 October 2021, just three were fully vaccinated (two doses and more than 14
days since the second dose) Likewise, of the 1622 infected, just 66 were fully vaccinated (two
doses and more than 14 days since the second dose). This information is publicly available and
regularly updated at:
www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-
coronavirus/covid-19-data-and-statistics/covid-19-case-demographics#vaccinations-details. 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 at:
www.health.govt.nz/about-ministry/information-releases. Nāku noa, nā
Gill Hall
Group Manager COVID-19 Science and Insights
COVID-19 Health System Response
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