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Spikevax

Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19)

Spikevax contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Spikevax does not contain the virus itself and cannot cause COVID-19.

Regulatory News

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

Techno -
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...
Regulatory News

Pharmacovigilance risk assessment committee: Spikevax and Comirnaty mRNA vaccines

Techno -
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...
Expert Articles

EMA recommends approval of Spikevax for children aged 6 to 11

Techno -
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...
World Pharma News

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

Techno -
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...
Regulatory News

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

Techno -
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.
Regulatory News

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

Techno -
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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Expert Articles

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