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PRAC finds no causal link between Comirnaty and Spikevax mRNA COVID-19 vaccines and autoimmune hepatitis

The April 4-7, 2022 Pharmacovigilance Risk Assessment Committee (PRAC) meeting noted no link between COVID vaccines and autoimmune hepatitis (AIH). The PRAC has concluded that...

Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

European Medicines Agency has published Meeting highlights from the Pharmacovigilance Risk Assessment Committee  (PRAC) 7-10 March 2022. COVID-19 Vaccine Janssen: small vessel vasculitis added as...

EMA recommends approval of Spikevax for children aged 6 to 11

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 6...

Moderna’s Covid-19 vaccine SPIKEVAX receives full FDA approval

Moderna, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to...

EMA: vaccine Moderna approved for children aged 12 to 17 in EU

The use of the Spikevax vaccine in children from 12 to 17 years of age will be the same as in people aged 18 and above.

Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis

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.

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