|
09-07-2021 16:44 |
|
Comirnaty
and Spikevax: possible link to very rare cases of myocarditis and
pericarditis |
|
EMA’s safety committee (PRAC)
has concluded that myocarditis and pericarditis can occur in very rare cases
following vaccination with the COVID-19 vaccines Comirnaty and Spikevax
(previously known as COVID-19 Vaccine Moderna). The
Committee is therefore recommending listing myocarditis and pericarditis as
new side effects in the product
information for these vaccines, together with a warning to raise
awareness among healthcare professionals and people taking these vaccines. Myocarditis and pericarditis are inflammatory conditions of the heart. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain. In
reaching its conclusion, the Committee took into consideration all currently
available evidence. This
included an in-depth review of 145 cases of myocarditis in the European
Economic Area (EEA) among people who received Comirnaty and 19 cases among
people who received Spikevax. PRAC also reviewed reports of 138 cases of
pericarditis following the use of Comirnaty and 19 cases following the use of
Spikevax. As of 31 May 2021, around 177 million doses of Comirnaty and 20
million doses of Spikevax had been given in the EEA. In
addition, the PRAC also looked into cases received worldwide. The
Committee concluded that the cases primarily occurred within 14 days after
vaccination, more often after the second dose and in younger adult men. In
five cases that occurred in the EEA, people died. They were either of
advanced age or had concomitant diseases. Available data suggest that the
course of myocarditis and pericarditis following vaccination is similar to
the typical course of these conditions, usually improving with rest or
treatment. Healthcare
professionals should be alert to the signs and symptoms of myocarditis and
pericarditis. They should tell people receiving these vaccines to seek
immediate medical attention if symptoms indicative of myocarditis or
pericarditis occur. These include breathlessness, a forceful heartbeat that
may be irregular and chest pain. Healthcare
professionals should consult applicable guidance and/or consult specialists
(e.g. cardiologists) to diagnose and treat these conditions. At this
point in time, no causal relationship with myocarditis or pericarditis could
be established with two other COVID-19 vaccines authorised in the EEA,
COVID-19 Vaccine Janssen and Vaxzevria[1],
and the Committee has requested additional da ta from the companies
marketing these vaccines. EMA
confirms that the benefits of all authorised COVID-19 vaccines continue to
outweigh their risks, given the risk of COVID-19 illness and related
complications and as scientific evidence shows that they reduce deaths and
hospitalisations due to COVID-19. As for all
vaccines, EMA will continue to monitor the vaccines’ safety and effectiveness
and provide the public with the latest information, particularly as more
adolescents and young adults are vaccinated and more second doses are given.
The agency will take necessary action if any new safety issues are
identified. Information for the general public
Information for healthcare
professionals Following
a review of very rare cases of myocarditis and pericarditis in people who
received Comirnaty and Spikevax (formerly COVID-19 Vaccine Moderna),
healthcare professionals should:
The
product information will be updated to include myocarditis and pericarditis
as side effects with unknown frequency. A direct
healthcare professional communication (DHPC) will be sent in due course to
healthcare professionals prescribing, dispensing or administering the
medicine. The DHPC will also be published on a dedicated
page on the EMA website. More about the medicine Comirnaty and
Spikevax (COVID-19 Vaccine Moderna) contain a molecule called mRNA which has
instructions for making the spike protein. This is a protein on the surface
of the SARS-CoV-2 virus which the virus needs to enter the body’s cells. When a person
is given one of these vaccines, some of their cells will read the mRNA
instructions and temporarily produce the spike protein. The person’s immune
system will then recognise this protein as foreign and produce antibodies and
activate T cells (white blood cells) to attack it. If, later on,
the person comes into contact with SARS-CoV-2 virus, their immune system will
recognise it and be ready to defend the body against it. More about the procedure This review of
Comirnaty and Spikevax was carried out in the context of a safety
signal. A safety
signal is information on a new or incompletely documented adverse
event that is potentially caused by a medicine such as a vaccine and
that warrants further investigation. The review was
carried out by EMA's Pharmacovigilance
Risk Assessment Committee (PRAC),
the Committee responsible for the evaluation of safety issues for human
medicines. The PRAC’s
recommendations will be submitted to EMA’s human medicine committee, CHMP,
for endorsement. The PRAC
reviewed data for Vaxzevria and COVID-19 Vaccine Janssen as part of its
review of pandemic summary safety reports submitted monthly by the marketing
authorisation holders. [1]
As of end of May 2021, cases of myocarditis reported in the EEA from the
EudraVigilance database were: 38 for Vaxzevria and 0 for COVID-19 Vaccine
Janssen. Cases of pericarditis were: 47 for Vaxzevria and 1 for COVID-19
Vaccine Janssen. The exposure in the EEA for each vaccine was around 40
million for Vaxzevria and 2 million for COVID-19 Vaccine Janssen. (MKY) |
