1982
Act
Information
Official
the
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1982
Act
Information
Official
the
under
Released
1982
Act
Information
Official
the
under
Released
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The application is being considered for provisional consent under section
23 of the Medicines Act 1981 for the following indications:
Active immunisation to prevent coronavirus disease 2019 (COVID-
19) caused by SARS-CoV-2, in individuals 16 years of age and
older.
The use of the vaccine must be in accordance with official
recommendations.
The application has been submitted via an expedited rolling review
process and has been assessed under urgency due to the significant
clinical need for a COVID 19 vaccine with a positive benefit risk profile.
The initial application was received on 13 November 2020, after which a
total of eight tranches of supporting information were submitted to
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Medsafe. Following assessment of these data packages, a request for
additional information was issued on 15 January 2021 and response from
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Pfizer was received on 22 January 2021. Additional responses and data to
support a change in the number of deliverable doses per vial were
received on 27 January 2021. All additional data has since been assessed
and a final recommendation has been made on 28 January 2021.
Given the rapid development of this medicine and the urgent clinical need
that exists in New Zealand, there are several aspects of the data required to
support quality, safety and efficacy that are not available at the time of
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completion of the evaluation. It is also proposed that any provisional
consent be granted for a period of nine months, before which time all
additional data should be received.
It was requested that the Committee focus on the specific aspects in their
consideration of the application:
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• The conditions and consent time period proposed for provisional
consent under section 23 of the Medicines Act 1981. Specifically,
the
whether these are appropriate and sufficient given the data
provided up to the time of referral, as well as whether any
additional conditions should be applied.
• Whether the proposed indications for the medicine are appropriate
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and supported by the clinical data available, as well as whether any
additional restrictions should be applied.
The following is the full list of evaluation reports and supporting
documentation that were provided:
• Final evaluation report - Quality (includes final recommendation)
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•
Final evaluation report - Novel excipients
• Final evaluation report - Non-clinical
• Final evaluation report - Clinical
• Final evaluation report - RMP ·
• Application dossier composed of iterative rolling review tranches
and RFI responses and additional data
• TGA assessment documentation
Medicines Assessment Advisory Committee
Minutes of the 109th meeting on 2 February 2021
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•
Advice from the Ministry of Health Science and Technical Advisory
Group (STAG) on new SARS-CoV-2 virus strains and the
implications for COVI D-19 vaccines
Pfizer New Zealand was informed of the referral on 29 January 2021.
Medsafe Presentation
Medsafe presented an overview of what is known about Comirnaty to the
Committee.
Pre-clinical discussion
The Committee considered the following documentation:
•
Final evaluation report Non-clinical
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The Committee noted that the pre-clinical questions raised in the report
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were addressed satisfactorily by the company. The Committee noted that
pre-clinical observations such as hepatoxicity are not apparent in the clinical
data. The reactogenicity seen in the clinical data does not appear to be a
concern in the pre-clinical data. The data on long terminal half-life of the
lipid nanoparticles was considered unusual but unlikely to be a safety
concern, as only two doses are intended to be administered. The pre-clinical
data did not suggest safety concerns in pregnancy.
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The Committee considers that generally the pre-clinical data has been
superseded by the clinical data. The Committee had no safety concerns
based on the preclinical data.
The Committee adopted the report and agreed with the conclusions.
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Evaluation
the
• Quality evaluation report (including Novel Excipients evaluation
report)
The Committee considered the following documentation:
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o Final evaluation report Quality (includes final
recommendation)
The Committee noted that the Medsafe evaluation report was detailed and
comprehensive. It was noted that many of the questions posed by Medsafe
had been resolved and unresolved questions were included as conditions
for the provisional consent.
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The number of quality conditions was noted and that these conditions
addressed instances where usual data was missing due to the developing
nature of the vaccine. The quality conditions align with those required by
other regulators, in particular the European Medicines Agency.
Medsafe noted that under Emergency Use Authorisation procedures,
product released to the US and UK markets are from smaller batch sizes.
Medicines Assessment Advisory Committee
Minutes of the 109th meeting on 2 February 2021
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The scale difference of the potential New Zealand batches was a focus of
the quality data assessment to ensure vaccine manufactured at commercial
scale is comparable to clinical trial batches.
Pfizer has demonstrated that final product specifications are sufficient to
ensure that product supplied to New Zealand will be comparable to clinical
trial batches. Any gaps in product characterisation would be covered in the
conditions of the provisional consent.
The Committee expressed confidence in the Medsafe quality and
manufacturing evaluation and were interested in being kept informed of
updates in this area.
• Clinical evaluation report
The Committee considered the following documentation:
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o Final evaluation report - Clinical
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The Committee considered the issue of efficacy data for subpopulations.
This subset included Maori, Asian, Pacific peoples, the elderly and groups
who are immunocompromised. The Committee commented that the
ethnicity subset data submitted was remarkably similar in efficacy and it is
not unreasonable to assume there is no genetic reason for different
responses in different ethnic groups in New Zealand.
The Committee agreed that it will be important to collect post-market safety
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data for Maori, Pacific peoples, elderly and immunocompromised subsets
as these are the people who are more likely to be at higher risk of
complications of COVID-19. However, the clinical picture on efficacy and
safety will become clearer over time as more people receive the vaccine.
The Committee discussed the lack of data
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the vaccine. Medsafe had asked the sponsor for an early cut-off time for
more data, which was not available. The sponsor had confirmed that the
the
next data analysis from the pivotal clinical trial will arrive in April 2021.
Overall, the Committee was satisfied with the clinical report and summary
presented. The Committee was satisfied with the efficacy data to date
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acknowledging that more data will be available over time.
• RMP evaluation report
The Committee considered the following documentation:
o Final evaluation report - RMP
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The Committee considered that the latest version of the Risk Management
Plan addresses many areas of concern raised by Medsafe. The need for
additional safety information regarding the elderly, children, people with
comorbidities and immunocompromised people was emphasised.
The Committee noted that patients with autoimmune diseases and patients
who are immunosuppressed were not well represented in clinical trials. The
planned clinical study in patients with rheumatoid arthritis receiving
Medicines Assessment Advisory Committee
Minutes of the 109th meeting on 2 February 2021
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immunomodulators was noted. The Committee expressed concern that
these individuals might be among those prioritised for vaccination before the
results of this study are available. It was noted that this issue is to be
managed as part of the Ministry of Health immunisation implementation
programme.
The need for more information on potential safety signals such as
reactogenicity, anaphylaxis, vaccine-associated enhanced disease and
facial paralysis was noted.
The Committee was satisfied with the updated Risk Management Plan,
noting that additional clinical studies, pharmacovigilance activities and
monthly safety reports are planned to address areas of missing information.
The Committee accepted the Risk Management Plan as written, noting that
it is a living document and there is the opportunity to add safety concerns as
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they emerge.
Discussion with Pfizer
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Pfizer representatives joined the meeting to respond to questions from the
Committee. The Committee had questions regarding finished product
testing, risk of transport to New Zealand, in use data in specific populations,
use in severe COVID-19, the emergence of new variants, unforeseen safety
signals after the doses given to date, update on duration of protection and
the new 6 dose proposal. All questions were suitably addressed by Pfizer.
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Discussion to finalise recommendation
Provisional Consent
The Committee unanimously agreed to Medsafe's
Official proposal to grant
provisional consent with a nine-month period. This period was proposed to
ensure that all post-approval data commitment deadlines were met. The
the
Committee agreed with this rationale.
Indications
The Committee agreed
under that the proposed indication wording for Comirnaty
is revised to the following:
Comirnaty has provisional consent (see section 5.1) for the
indication below:
Active immunisation to prevent coronavirus disease 2019 (COV/0-
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19) caused by SARS-CoV-2, in individuals 16 years of age and
older.
The use of this vaccine should be in accordance with official
recommendations.
Medicines Assessment Advisory Committee
Minutes of the 109th meeting on 2 February 2021
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The committee discussed the likely real world use in New Zealand and
acknowledged that the vaccine roll-out will be managed by the Ministry of
Health.
The Committee suggested that Section 5.1 of the data sheet to be revised
to include the following statement:
This medicine has been given a
provisional consent under Section
23 of the Act. This means that further evidence on this medicine is
awaited or that there are specific conditions of use. Refer to the
consent notice published in the New Zealand Gazette for the specific
conditions.
Conditions of provisional consent
The Committee reviewed each proposed condition of the provisional 1982
consent. The Committee agreed that Medsafe could make technical
amendments to the conditions of consent.
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The Committee agreed to the addition of the following condition:
Provide independent batch certification, such as UK National
Institute for Biological Standards and Control (NIBSC) certification,
EU Official Control Authority Batch Release (OCABR) certification,
Australian TGA batch release assessment, or any other certification
agreed with Medsafe, on request for all batches distributed in New
Zealand.
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The Committee raised concerns regarding the wording of the following
conditions.
Provide regular updates on the duration of efficacy and the
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requirement for booster doses. This should include the six months
analysis data from Study C4591001. Interim report due: April 2021.
the
Provide updates on efficacy including regarding asymptomatic
infection in the vaccinated group, vaccine failure, immunogenicity,
efficacy in population subgroups and results from post-marketing
studies, when these become available.
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Submit the final Clinical Study Reports for Study C4591001 and
. Study BNT162-01 once they available.
Inform Medsafe of all safety reviews they conduct or become aware
of and provide the completed review.
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The Committee recommended the following amendments to the conditions
to improve clarity of the requirements:
Provide regular reports on the duration of efficacy and the
requirement for booster doses within five working days of these
being produced.
Medicines Assessment Advisory Committee
Minutes of the 109th meeting on 2 February 2021
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