A healthcare worker injects a patient with the Pfizer and BioNTech vaccine in a phase 3 trial in Turkey, October 2020.
  • Pfizer and partner BioNTech said Tuesday they have asked the EU to approve their coronavirus vaccine.
  • Regulator the European Medicines Agency said in a press release that it might not decide whether the Covid-19 vaccine is safe and effective enough until December 29.
  • Approval on December 29 would make an EU vaccine rollout this year almost impossible.
  • The drugmaker's application to the EMA follows authorization applications in the US on November 20 and the UK on November 23.
  • Visit Business Insider's homepage for more stories.

Pfizer and its German partner BioNTech said Tuesday they have asked the European Union to approve their Covid-19 vaccine, but that distribution is unlikely to start until January.

After submitting an application on Monday to the European Medicines Agency (EMA), the drugmakers said the EU regulator accepted the application on Tuesday, per the Wall Street Journal.

The EMA's scientific committee will decide whether data from trials — which suggest the vaccine is 95% effective —show that the vaccine is safe and effective enough on or before December 29, it said in a press release.

This means that distribution of the vaccine is unlikely to kick off by the end of 2020.

Pfizer didn't immediately respond to a request for comment.

The drugmakers submitted an application for conditional marketing authorization (CMA), which is a fast-track for approval. For this to be granted, data from the companies' trials must show that the benefits of the vaccine outweigh any potential risks.

If the EMA grants the vaccine a CMA, the drugmakers still have to provide more data from ongoing or new studies within a certain timeframe.

Pfizer and BioNTech's application to the EMA comes after the companies applied for authorization in the US on November 20 and the UK on November 23.

Pfizer's coronavirus vaccine candidate was 95% effective at protecting people against Covid-19 in its late-stage trial, the pharmaceutical giant announced November 18.

The biotech company Moderna said two days before that its vaccine appeared to be 94.5% effective against Covid-19, based on a preliminary analysis of its late-stage trial.

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