US FDA will rapidly update fact sheets with information on myocarditis/pericarditis occurring primarily in young men and adolescent males following the second dose, agency's Doran Fink tells the CDC’s Advisory Committee on Immunization Practices, which said benefit-risk of the Pfizer/BioNTech and Moderna vaccines remains favorable.
The US Food and Drug Administration will add warning language to COVID-19 mRNA vaccine fact sheets about the risk of myocarditis and pericarditis, an agency official told a Centers for Disease Control and Prevention panel on 23 June.
The CDC’s Advisory Committee on Immunization Practices convened to discuss reports of myocarditis/pericarditis following administration of the Pfizer Inc./
Create an account to read this article
Already a subscriber?
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad using an unproven theory to help explain his COVID-19 vaccine decisions and the impact of the recently finalized reduction-in-force at the FDA.
In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
The Senate Health, Education, Labor and Pensions Committee voted to advance Monarez's nomination to lead the CDC as the agency announced the largest US measles outbreak in 22 years.
The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.
