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29-01-2021 12:23 |
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Today EMA has released its
first safety
update on a COVID-19 vaccine – Comirnaty. It concludes that safety data
collected on Comirnaty use in vaccination campaigns is consistent with the
known safety profile of the vaccine, and no new side effects were identified. The safety update reflects data collected and assessed since Comirnaty’s authorisation, including data from EudraVigilance (the EU’s centralised database of suspected side effects) and data received from other sources, including the company’s monthly safety report required for COVID-19 vaccines. EMA will publish monthly safety updates for all authorised COVID-19 vaccines, in line with exceptional transparency measures for COVID-19. This safety update includes the
assessment by EMA’s safety committee (PRAC) of deaths reported after
vaccination with Comirnaty, including deaths in frail, elderly people. PRAC
carried out an analysis of the cases and took into account the presence of
other medical conditions and the death rate for corresponding age groups in
the general population. PRAC concluded that the data did not show a link to
vaccination with Comirnaty and the cases do not raise a safety concern.
Further reports will continue to be carefully monitored. The safety and effectiveness of
Comirnaty will continue to be monitored as it is used across the Member
States and globally, through the EU
pharmacovigilance system, additional studies by the company and independent
studies coordinated by European authorities. These measures will allow
regulators to swiftly assess data emerging from a range of different sources
and take appropriate regulatory action to protect public health, if needed. More about the vaccine Comirnaty is a vaccine for
preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and
older. It contains a molecule called
messenger RNA (mRNA) with instructions for producing a protein from
SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing
the body to attack the spike protein on the surface of SARS-CoV-2. More information is available
on the vaccine’s
page on EMA website. Reporting side effects Vaccinated individuals and
healthcare professionals should report suspected side effects via national
reporting systems. These reports help regulators understand more about
Comirnaty and complement the knowledge already generated by clinical
trials and other studies. Information on how to report
side effects in individual Member States is available in the package leaflet.
For a full list, see National
competent authorities. For more information, see Reporting
side effects. (MKY) |
