EMA recommends approval of fourth COVID-19 vaccine

Genéricos/Novedades | Posted 19/03/2021 post-comment

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11 March 2021 saw the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the fourth COVID-19 vaccine. After a thorough evaluation, EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data on the Janssen vaccine were robust and met the criteria for efficacy, safety and quality.

EMA COVID-19 vaccine approvals
The Janssen clinical trial involved over 44,000 people in the US, South Africa and Latin American countries. As with other vaccines, the safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU.

The Janssen vaccine joins three other COVID-19 vaccines that have been approved by EMA. Comirnaty, developed by BioNTech and Pfizer, was the first be approved on 21 December 2020. The second was Moderna’s, approved in early January 2021, and the third was AstraZeneca’s, approved in late January 2021.

Additional EMA COVID-19 updates
In addition to the fourth vaccine approval, EMA has also made a number of announcements related to the treatment and control of COVID-19.

The CHMP announced that there was to be an update of the product information of the Comirnaty COVID-19 vaccine. This has now been updated to clarify that the interval between the first and second dose should be three weeks, rather than the previously stated interval of ‘at least 21 days’.

The committee also announced that it had completed its review on the use of the monoclonal antibodies casirivimab and imdevimab (the combination of which is known as REGN-COV2) to treat patients with COVID-19. The products can now be used to treat confirmed COVID-19 in patients that do not require oxygen supplementation but who are at high risk of progressing to severe COVID-19.

EMA has also issued guidance that outlines the requirements for manufacturers planning to modify their COVID-19 vaccines to address novel variants of coronavirus (SARS-CoV-2).

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Brazil sees a COVID vaccine setback but treatment advancement

LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

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Source: EMA

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