• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Español
  • English
  • Bloglovin
  • Email
  • Facebook
  • Instagram
  • LinkedIn
  • Twitter
  • YouTube
CDE Almería – Centro de Documentación Europea – Universidad de Almería

CDE Almería - Centro de Documentación Europea - Universidad de Almería

Centro de Documentación Europea de la Universidad de Almería

  • HOME
  • WHAT´S ON
    • EU BULLETINS
    • EU NEWS
    • Activities
    • EU Calls and Awards
    • Radio Program «Europe with You»
  • DOCUMENTATION
    • Bibliographic Collection
      • Almería EDC Digital Collection
      • UNIVERSITY OF ALMERIA LIBRARY
    • Documentation by topic
    • EU Media Collection
      • Web Space
      • MEDIATHEQUE REPOSITORY
  • Europe on the net
    • Institutions
    • EU Representation in Spain
    • European information network of Andalusia
    • EU official journal
  • ABOUT US
    • Presentation
    • People
    • Contact

EMA clears Pfizer’s third dose for the general adult population

Inicio » EU News » Health » Diseases » EMA clears Pfizer’s third dose for the general adult population

06/10/2021

EMA recommendations on extra doses and boosters

EMA’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose.

The recommendation comes after studies showed that an extra dose of these vaccines increased the ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems.

Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. EMA will continue monitoring any data that emerges on its effectiveness.

The product information of both vaccines will be updated to include this recommendation.

Booster doses

It is important to distinguish between the extra dose for people with weakened immune systems and booster doses for people with normal immune systems.

For the latter, the CHMP has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately 6 months after the second dose in people from 18 to 55 years old. On the basis of this data, the Committee concluded that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older.

At national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data. The risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored. As for all medicines, EMA will continue to look at all data on the safety and effectiveness of the vaccine.

More information about the booster recommendations for Comirnaty will be available in the updated product information.

The Committee is currently evaluating data to support a booster dose for Spikevax. EMA will communicate the outcome when the evaluation is complete.

National immunisation campaigns

The implementation of vaccination campaigns in the EU remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State. These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.

EMA will continue working closely with national authorities and the European Centre for Disease Prevention and Control (ECDC) to evaluate available data and provide recommendations to protect the public during the ongoing pandemic.

More information

European Medicine Agency

Comirnaty: EPAR

Spikevax (previously COVID-19 Vaccine Moderna): EPAR

Comirnaty: Paediatric investigation plan

 

Publicaciones relacionadas:

European Commission authorises second safe and effective vaccine against COVID-19 EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca EU urges AstraZeneca to explain vaccine delivery delays Commission concludes exploratory talks with Valneva to secure a new potential vaccine EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

“This is a space for debate. All comments, for or against publication, that are respectful and do not contain expressions that are discriminatory, defamatory or contrary to current legislation will be published”.

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Primary Sidebar

Publicaciones relacionadas

European Commission authorises second safe and effective vaccine against COVID-19 EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca EU urges AstraZeneca to explain vaccine delivery delays Commission concludes exploratory talks with Valneva to secure a new potential vaccine EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen

Footer

Centro de Documentación Europea de Almería
CDE Almería

Edificio Parque Científico-Tecnológico (Pita) Planta: 1ª, Despacho: 29
04120 – Ctra. Sacramento s/n.
Almería (Spain)
Teléfono: (+34) 950 015266

Sing in!

Navigation

  • HOME
  • WHAT´S ON
    • EU BULLETINS
    • EU NEWS
    • Activities
    • EU Calls and Awards
    • Radio Program «Europe with You»
  • DOCUMENTATION
    • Bibliographic Collection
      • Almería EDC Digital Collection
      • UNIVERSITY OF ALMERIA LIBRARY
    • Documentation by topic
    • EU Media Collection
      • Web Space
      • MEDIATHEQUE REPOSITORY
  • Europe on the net
    • Institutions
    • EU Representation in Spain
    • European information network of Andalusia
    • EU official journal
  • ABOUT US
    • Presentation
    • People
    • Contact

Creative Commons LicenseThis work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

Copyright © 2022 CDE Almería · Legal terms · Privacy policy · Cookies policy