Memo CV TAG Medical Exemption.pdf

Memo
Temporary  Medical  Exemptions  for  the  COVID-19  Vaccine:  COVID-19
Vaccine Technical Advisory Group (CV TAG) recommendations

Date:
3 November 2021
To:
Dr Juliet Rumball-Smith, General Manager Clinical Quality & Safety, COVID-19
Vaccine Immunisation Programme (CVIP)
Joanne Gibbs, Director of National Operations, CVIP
From:
Dr Ian Town, Chief Science Advisor, Ministry of Health
For your:
Consideration
Purpose of report
1.  To outline the COVID-19 Vaccine Technical Advisory Group’s (CV TAG) recommendations on
the clinical criteria for medical exemptions to the first or second dose of the Pfizer COVID-19
vaccine.
Background and context
2.  COVID-19 Vaccine Certificates (CVCs) are an important potential tool to help support the
broader public health response to COVID-19, being particularly important in settings where there
is greater risk of community transmission. In this context, CVCs, either in paper form or the digital
equivalent, will allow people to demonstrate that they have been fully vaccinated or are medically
exempt from vaccination for a defined period.
3.  Evidence of medical exemption for vaccination is also important for people who are
mandated to be vaccinated in certain roles due to their employment, such as border workers,
teachers, healthcare workers, and employees of businesses where CVCs are mandatory.
4.  To date, the Pfizer COVID-19 vaccine has shown an excellent safety and efficacy profile[1] and
is recommended for all New Zealanders 12 years of age and over.[2]
5.  The only contraindication to the Pfizer vaccine is hypersensitivity to the active substance or to
any of the excipients, for example anaphylaxis to a vaccine component, such as polyethylene
glycol (PEG).[3] Such reactions are rare and, even people with this history can usually receive the
Pfizer vaccine after specialist assessment under supervision.[3]
6.  Well-defined clinical criteria for a temporary medical exemption from full vaccination are
needed for both the health professionals who will be asked to provide the exemption and for the
people applying for an exemption, especially where CVCs are mandatory.

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Medical Exemptions
7.  Overall, the number of people in New Zealand estimated to be eligible for a medical
exemption is expected to be small, and includes those who may be waiting for an alternative
vaccine for their second dose, for example due to an adverse reaction following the first dose of
the Pfizer vaccine.
8.  The Australian Technical Advisory Group on Immunisation (ATAGI) have released guidance on
medical exemptions.[4] ATAGI states that “Vaccinations may reasonably be temporarily deferred for
individuals with some acute major medical conditions (e.g. undergoing major surgery or hospital
admission for a serious illness). Typically, these are time-limited conditions (or the medical
treatment for them is time limited) and therefore temporary exemptions are considered appropriate.
These exemptions are only to be given where a suitable alternative COVID-19 vaccine is not readily
available for the individual.” Furthermore, the ATAGI guidance recommends a maximum duration
of 6 months, with review as the individual recovers from their acute major medical illness.
First dose
9.  The Pfizer data sheet provided to Medsafe documents the following contraindications only:
‘Hypersensitivity to the active substance or to any of the excipients’.[5] PEG is an excipient in the
vaccine that is potentially associated with hypersensitivity reactions, but these are rare.[3, 6] It is
possible for the Pfizer vaccine to be successfully administered despite a history of PEG allergy.[7]
10. It is difficult to estimate the number of people affected by these contraindications, due in part
to the rarity of the events. However, the incidence of anaphylaxis following administration of the
Pfizer vaccine is estimated at 8 cases per million doses administered in the US.[3] The current
reporting rate for anaphylaxis (reports meeting levels 1-3 of the Brighton Collaboration case
definition) in New Zealand is approximately 11 per million doses administered.[8]
11. Fewer people should request a medical exemption to the first dose of the Pfizer vaccine when
a second class of vaccine becomes available, such as a vector-based vaccine (Janssen or
AstraZeneca) for the population aged 18 and over.
Second dose
12. Myocarditis and/or pericarditis is a known rare side effect of the Pfizer vaccine and such
events occurring after the first Pfizer dose may provide the basis for an exemption to the second
dose.
13.  Other adverse events that have been reported to the Centre for Adverse Reactions
Monitoring (CARM), the Immunisation Advisory Centre (IMAC), or have been observed
internationally[9] include: shingles, appendicitis, lymphadenopathy with or without fever,
exacerbation of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), regional pain
syndrome, and neurological events with localised arm pain. These events may or may not be
related to the vaccine and it is generally advised to defer the second dose until the symptoms
have fully resolved.
14. The number of people with medical exemptions to the second dose of the Pfizer vaccine
should also decrease in size when a second class of vaccine becomes available, such as a vector-
based vaccine (Janssen or AstraZeneca) for the population aged 18 and over.

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Proposed principles of medical exemption
15. There are very few situations where a vaccine is contraindicated and, as such, a medical
exemption is expected to be rarely required.
16. Vaccinations may reasonably be temporarily deferred for individuals with some acute major
medical conditions, such undergoing major surgery or hospital admission for a serious illness.
Typically, these conditions are considered time-limited, and therefore a temporary exemption is
considered appropriate.
17. Exemptions are only to be given where a suitable alternative COVID-19 vaccine is not readily
available for the individual.
18. Exemptions should be for a specified time, reflecting, for example, recovery from clinical
conditions or the availability of alternate vaccines.
19. It is likely that most people who are not medically exempt can be safely vaccinated with extra
precautions.
Recommendations
20. CV TAG recommends that the clinical criteria given in Table 1 below be used as the basis for
temporary exemptions:

Table 1 Criteria for temporary COVID-19 vaccine exemption

Type of vaccine
Criteria for temporary exemption
1.  Pfizer
1. Anaphylaxis to the first dose of the vaccine or
known severe allergy to the excipients of the
vaccine as per the datasheet provided to
Medsafe.a, b

2. Myocarditis/pericarditis following the first dose
of the vaccine.
2.  mRNA COVID-19 vaccine
1. Inflammatory cardiac illness within the past 6
e.g. Pfizer, Moderna
months including: myocarditis, pericarditis,
endocarditis, acute rheumatic fever or acute
rheumatic heart disease (i.e., with active
myocardial inflammation).

2. Acute decompensated heart failure. Although
myocarditis and/or pericarditis is very rare
following vaccination, if such an event were to
occur, then it may exacerbate a patient’s pre-
existing heart failure.
3.  All COVID-19 vaccines
1. PCR-confirmed SARS-CoV-2 infection until
complete recovery from the acute illness. Chronic
symptoms following COVID-19 ("Long COVID”) is
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not a contraindication to COVID-19 vaccine but
does warrant a clinical discussion with the patient
regarding the benefits and risks.

2. Serious adverse eventc attributed to a previous
dose of the same COVID-19 vaccine with no
other cause identified.

3. Unable to tolerate vaccine administration with
resulting risk to themselves or others (e.g., due to
severe neurodevelopmental condition such as
autistic spectrum disorder). This may warrant a
temporary exemption while additional resources
and support to facilitate a safe administration of
a second dose are arranged.
Notes for table above:
a.  This criterion will be removed as an exemption when there is an alternative vaccine
available in New Zealand.
b.  Many of these individuals will be able to be safely vaccinated in a controlled
environment, and we recommend clinical immunologist/specialist assessment.
c.  An adverse event is considered serious for the purposes of these criteria1 if it:
i) requires in-patient hospitalisation or prolongation of existing hospitalisation OR
results in persistent or significant disability/ incapacity.
AND
ii) has been reported to CARM.
AND
iii) has been determined following review by, and/or on the opinion of, a relevant
medical specialist to be associated with a risk of recurrence of the serious adverse
event if another dose of the same vaccine is given.
Note that if a serious adverse event to a previous dose of a COVID-19 vaccine is
used as a reason for the exemption, then this may require discussion with a suitably
qualified health professional, such as a Medical Doctor or Nurse Practitioner, who is
registered with the relevant responsible authority, and holds a current Annual
Practising Certificate (APC) issued by that authority.

21. The CV TAG also recommends:
a.  Those who are confirmed as having a non-placebo vaccine in any COVID-19 vaccine
trial in New Zealand (for example, the Valneva COVID-19 vaccine trial NCT04956224)
should be offered a temporary exemption. Note that this exemption does not equate

1 Examples of serious AEFIs may include but are not limited to: a medically significant illness (e.g., immune thrombocytopenia
purpura (ITP), myocarditis, potentially life-threatening events (e.g., anaphylaxis), severe ME/CFS, or persistent or significant
disability (e.g., Guillain-Barré Syndrome). These reactions do not include common expected local or systemic reactions known
to occur within the first few days after vaccination.
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to determining them to be adequately vaccinated for the purposes of a CVC or
fulfilment of the Vaccination Order.
b.  A maximum duration of 6 months for the exemption, with the ability to apply for a
new exemption if required. This time limitation will allow individuals who can safely be
vaccinated, with either the same vaccine or an alternative vaccine, as appropriate, to
be protected against COVID-19 in a timely way.
c.  Those who are not medically exempt include the following:
i.  People who had an otherwise negative experience that is not mentioned above,
with other vaccines in the past.
ii.  People with disabilities, once adequate resources are available to support safe
delivery. People with disabilities are generally at higher risk from COVID-19, and
therefore are a priority for vaccination.
iii.  Pregnant people. Pregnancy is not a valid reason for exemption in the absence of
any of the criteria listed in the above table. Pregnancy is associated with higher
risk from COVID-19 compared to the general population and therefore this group
are a priority for vaccination.
22. CV TAG will continue to monitor all relevant information and will update their
recommendations as further evidence becomes available.



Dr Ian Town
Chief Science Advisor and Chair of the COVID-19 Vaccine Technical Advisory Group

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References

1.
Polack, F.P., et al., Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. New
England Journal of Medicine, 2020. 383(27): p. 2603-2615.
2.
Medsafe. Approval status of COVID vaccines applications received by Medsafe. 2021 25
August 2021 [cited 2021 18 October]; Available from:
https://www.medsafe.govt.nz/COVID-19/status-of-applications.asp.
3.
Greenhawt, M., et al., The Risk of Allergic Reaction to SARS-CoV-2 Vaccines and
Recommended Evaluation and Management: A Systematic Review, Meta-Analysis,
GRADE Assessment, and International Consensus Approach. The Journal of Allergy and
Clinical Immunology: In Practice, 2021. 9(10): p. 3546-3567.
4.
ATAGI. ATAGI expanded guidance on acute major medical conditions that warrant a
temporary medical exemption relevant for COVID-19 vaccines. 2021; Available from:
https://www.health.gov.au/sites/default/files/documents/2021/10/atagi-expanded-
guidance-on-temporary-medical-exemptions-for-covid-19-vaccines.pdf.
5.
Medsafe - New Zealand Medicines and Medical Devices Safety Authority. New Zealand
Data Sheet, Comirnaty Covid-19 Vaccine. 2021; Available from:
https://www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf.
6.
Sellaturay, P., et al., Polyethylene glycol (PEG) is a cause of anaphylaxis to the
Pfizer/BioNTech mRNA COVID-19 vaccine. Clinical & Experimental Allergy, 2021. 51(6):
p. 861-863.
7.
Krantz, M.S., et al., Safety Evaluation of the Second Dose of Messenger RNA COVID-19
Vaccines in Patients With Immediate Reactions to the First Dose. JAMA Internal
Medicine, 2021.
8.
Medsafe. Adverse events following immunisation with COVID-19 vaccines: Safety Report
#31 – 2 October 2021. Available from: https://medsafe.govt.nz/COVID-19/safety-
report-31.asp.
9.
Barda, N., et al., Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide
Setting. New England Journal of Medicine, 2021. 385(12): p. 1078-1090.

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