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29-01-2021 12:28 |
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Marketing authorisation holder:
BioNTech Manufacturing GmbH Key Messages The latest safety data for this
vaccine are in line with the known side effect profile, and the related
reviews are presented in this update. Reports of suspected severe
allergic reaction have not identified new aspects regarding the nature of
this known side effect. No specific safety concern has been identified for vaccine use in frail elderly individuals. The benefits of Comirnaty in
preventing COVID-19 continue to outweigh any risks, and there are no
recommended changes regarding the use the vaccine. Safety updates provide the
outcomes of the assessment of emerging data since marketing authorisation for
COVID-19 vaccines. The assessments are carried out by EMA’s safety committee
(Pharmacovigilance
Risk Assessment Committee (PRAC)). The safety updates are published
regularly at Post-authorisation:
Safety updates. All published safety updates
for Comirnaty are available at Comirnaty:
safety updates. Updates on safety of Comirnaty On 28 January 2021, PRAC
concluded that the safety data reviewed for Comirnaty are in line with the
vaccine’s known benefit-risk profile. The review covered all new safety data
emerging since 21 December 2020, including the first Summary Monthly Safety
Report[1]
from the marketing authorisation holder. Specifically, the following was
concluded by PRAC in relation to: Severe allergic reaction (anaphylaxis) Anaphylaxis is a known side
effect of Comirnaty. The assessment of the reports of suspected anaphylaxis
to date did not identify new aspects regarding the nature of this side
effect. PRAC noted that a recent analysis in the United States estimated the
frequency of anaphylaxis as approximately 11 cases per million doses of
Comirnaty administered PRAC requested the marketing
authorisation holder to continue reviewing all anaphylaxis cases for further
assessment by the committee. Information on managing the
risk of anaphylaxis is already available in the product
information. Review of reports of suspected side effects with fatal outcome,
specifically in frail elderly individuals Given concerns which arose from
Norway about deaths reported in frail elderly individuals after vaccination
with Comirnaty, PRAC reviewed the current reports of suspected side effects
with fatal outcome in individuals of any age. This review did not suggest a
safety concern. In many cases concerning
individuals above 65 years of age, progression of (multiple) pre-existing
diseases seemed to be a plausible explanation for death. In some individuals,
palliative care had already been initiated before vaccination. Before Comirnaty was granted a
marketing authorisation in the EU, the safety of the vaccine was carefully
assessed through large clinical trials across age groups including study
participants that were 75 years of age and older, as detailed in the public
assessment report. PRAC concluded that based on
the current data there was no need to amend the product information regarding
how Comirnaty should be used, including in frail elderly individuals. PRAC
requested that the marketing authorisation holder continues reviewing all
reports of suspected side effects with fatal outcome thoroughly. Other information for Comirnaty Comirnaty is a vaccine that has
been authorised in the European Union (EU) for use in people aged 16 years
and older to protect against developing COVID-19 when infected with the
coronavirus SARS-CoV-2. COVID-19 is a potentially severe disease that may result
in death. Comirnaty contains a molecule
called mRNA, which the body uses to temporarily produce the SARS-CoV-2 spike
protein. The mRNA is broken down shortly after vaccination. The spike protein
does not cause COVID-19. Before Comirnaty was granted a
marketing authorisation in the EU, the efficacy and safety of the vaccine was
assessed through pre-clinical studies and large clinical trials. More than
18,000 participants have been given the vaccine in clinical trials. The most common side effects
known for Comirnaty will not be experienced by everybody, are usually mild or
moderate, and get better within a few days after vaccination. More information on how
Comirnaty works and its use is available in the medicine
overview for Comirnaty. This includes information on use in pregnant and
breastfeeding women and immunocompromised individuals. Information in all EU/EEA
languages is available in the product
information, which includes the summary of product characteristics and
the package leaflet. How safety is monitored As for all COVID-19 vaccines,
all relevant new information emerging on Comirnaty is collected and promptly
reviewed. This is in line with the pharmacovigilance
plan for COVID-19 vaccines of the EU regulatory network. Collecting suspected side effects The EU regulatory network
continuously monitors reports of suspected side effects observed in
vaccinated individuals. These reports are collected and recorded in EudraVigilance,
a system operated by EMA for managing and analysing information on suspected
adverse reactions to medicines. Vaccinated individuals and
healthcare professionals should report suspected side effects via the
national reporting systems. For more information, see Reporting
side effects. Information on how to report side effects in your Member
State is available in the package
leaflet and the list of national
competent authorities. You may visit EudraVigilance
– European database of suspected drug reaction reports and search for
“COVID-19 mRNA Vaccine PFIZER-BIONTECH (Tozinameran)” to see all suspected
side effects reported for Comirnaty in the EU. Please note that these reports
describe suspected side effects in individuals, i.e. these events may not
necessarily have been caused or otherwise be related to the vaccine. Planned and ongoing studies The company that markets
Comirnaty will continue to provide results from the main clinical trial,
which is ongoing for up to two years, and conduct additional studies to
monitor the safety and effectiveness of the vaccine as it is used in the
vaccination campaigns and other clinical practice. For the list of planned or
ongoing safety studies for Comirnaty, see the risk
management plan. A paediatric
investigation plan (PIP) for Comirnaty is in place. This describes how
the company will collect data on the vaccine’s efficacy and safety for its
potential use in children. In addition, EMA and European
authorities are coordinating observational
studies in EU Member States looking at real-world data from clinical
practice to monitor the safety and effectiveness of COVID-19 vaccines,
including in pregnant women. For more details on the ongoing projects,
see Treatments
and vaccines for COVID-19: post-authorisation. [1]
Summary Monthly Safety Reports will be compiled by the marketing
authorisation holders for COVID-19 vaccines to support timely and continuous
benefit-risk evaluations. The submission of such reports complements the
submission of periodic
safety update reports (PSURs). [2]
Centres for Disease Control and Prevention (CDC) COVID-19 Response Team, Food
and Drug Administration: Allergic Reactions Including Anaphylaxis After
Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine: United States,
December 14–23, 2020. MMWR. 2021; 70 (2): 46-52 (epub 6 Jan 2021). (MKY) |
