Two drugmakers with leading COVID-19 vaccines said Tuesday they have asked the European Union to approve their shots.
After submitting an application on Monday to the European Medicines Agency (EMA), Pfizer and BioNTech said the EU regulator accepted the application on Tuesday, per the Wall Street Journal.
Moderna has also submitted its EU application.
The two vaccines were supposed to be assessed December 22 but this has been pushed back by the EU's regulator, according to documents seen by the Financial Times.
The EMA's scientific committee will decide whether data from trials — which suggest the vaccine is 95% effective —show that Pfizer's vaccine is safe and effective enough on or before December 29, it said in a press release.
A decision on that date would mean that distribution of the vaccine is unlikely to kick off by the end of 2020.
EU regulators may not decide on Moderna's jab before January 12, per the FT.
Pfizer and BioNTech said they hoped to begin vaccinating in 2020.
"If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA (conditional marketing authorization) that could potentially enable use of BNT162b2 in Europe before the end of 2020," they said in a joint statement.
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.
Moderna asked the Food and Drug Administration Monday to authorize its coronavirus vaccine for emergency use.
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