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Tag: Spikevax

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

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

Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

Regulatory Pharma -
European Medicines Agency has published Meeting highlights from the Pharmacovigilance Risk Assessment Committee  (PRAC) 7-10 March 2022. COVID-19 Vaccine Janssen:...

EMA recommends approval of Spikevax for children aged 6 to 11

Expert Opinion Pharma -
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include...

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

Global Markets Pharma -
Moderna, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for...

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

Regulatory Pharma -
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

Regulatory Pharma -
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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