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Europe's medicines regulator said on Thursday it has issued new guidance for drug makers that modify their COVID-19 vaccines to protect against variants of the virus to speed up the approval process.
The EMA also initiated an assessment for all COVID‑19 vaccines used in the EU for immune thrombocytopenia (ITP), described as low blood platelet levels that could lead to bruising and bleeding, as a possible side effect, whilst also stating that up to this point no link with any COVID‑19 had been established. [12]
All RMPs for COVID‑19 vaccines will be published on the EMA's website. [136] The EMA published guidance for developers of potential COVID‑19 vaccines on the clinical evidence to include in marketing authorization applications. [137] In November 2020, the CHMP started a rolling review of the Moderna vaccine for COVID‑19 known as mRNA-1273 ...
In March 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) started a rolling review of data on regdanvimab. [10] [11] In October 2021, the EMA started evaluating an application for marketing authorization for the monoclonal antibody regdanvimab (Regkirona) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who ...
Europe's drug regulator said on Friday South Korean drugmaker Celltrion's COVID-19 treatment can be considered for patients at high risk of severe illness, but added that the monoclonal antibody's ...
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
In October 2024, the CHMP gave a positive opinion to update the composition of Nuvaxovid, a vaccine to target the SARS-CoV-2 JN.1 variant of the virus that causes COVID-19 following the recommendations issued by EMA's Emergency Task Force to update COVID-19 vaccines for the 2024/2025 vaccination campaign. [75]
Bebtelovimab is a neutralizing human immunoglobulin G1 (IgG1) monoclonal antibody, isolated from a patient who has recovered from the Coronavirus disease 2019 (COVID-19), directed against the spike (S) protein of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), that can potentially be used for immunization against COVID-19.
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