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The Human Medicines Committee (CHMP) at EMA has started a rolling review of a new candidate vaccine for COVID-19, Ad26.COV2.S from Janssen-Cilag International N.V.

Preliminary results from ongoing studies suggest that the vaccine triggers the production of antibodies and immune cells that target the SARS-CoV-2 Coronavirus.

The company is currently conducting trials in humans to assess safety, immunogenicity and effectiveness of the vaccine. EMA will evaluate data from these and other clinical trials as they become available.

Vaccine development for COVID-19 is being fast-tracked globally. However, COVID-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the European pharmaceutical legislation that apply to all medicines in Europe.

Discover more about the development, evaluation, approval and monitoring of COVID-19 vaccines here!

Currently, EMA's CHMP is evaluating the following candidate vaccines:

  • Ad26.COV2.S (Janssen-Cilag International N.V.)
  • BNT162b2 (BioNTech, in collaboration with Pfizer)
  • ChAdOx1-SARS-CoV-2 (AstraZeneca, in collaboration with the University of Oxford)
  • mRNA-1273 (Moderna Biotech Spain, S.L.)

Several clinical trials assessing these vaccines are ongoing in order to collect solid evidence to apply for a marketing authorisation.

As a matter of fact, EMA has received an application for conditional marketing authorisation for mRNA1273 vaccine developed by Moderna Biotech Spain, S.L and BNT162b2 vaccine by BioNTech and Pfizer. The assessment of these vaccines will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within the next weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccines.

Such a short timeframe is only possible because EMA has already reviewed some data on the vaccines during the rolling review.

Once EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID‑19, a conditional marketing authorisation will be recommended. Then the European Commission will evaluate the EMA opinion and will grant the conditional marketing authorisation valid in Europe within days.

As for all medicines, competent authorities will continuously collect and review new information on the vaccines once they are on the market and will take actions when needed.

Visit our COVID-19 page for further information and to keep you up to date on the EMA decisions!

 

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