Pfizer Shares Gain As European Officials Start Coronavirus Vaccine Review; BioNTech Jumps

The European Medicines Agency launched a preliminary 'rolling review' of Pfizer's experimental coronavirus vaccine Tuesday, which the drugmaker is developing with Germany-based BioNTech.

Pfizer Inc.  (PFE) - Get Pfizer Inc. Report shares jumped higher Tuesday after European health authorities launched a 'rolling review' of the experimental coronavirus vaccine the drugmaker is developing with Germany-based BioNTech  (BNTX) - Get BioNTech SE Sponsored ADR Report.

The human medicines committee of the European Medicines Agency said Tuesday has started evaluating the first batch of data from non-clinical studies of BNT162b2, the pair's mRNA-based coronavirus vaccine. 

Pfizer received 'fast track' designation by the U.S. Food and Drug Administration in July based on preliminary data from Phase 1 and Phase 2 studies.

A rolling review, the European Medicines Agency said, typically precedes any formal application for market authorization in the world's biggest economic block and is largely based on preliminary results.

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"Large-scale clinical trials involving several thousands of people are ongoing, and results will become available over the coming weeks and months," the Agency said. "These results will provide information on how effective the vaccine is in protecting people against COVID-19 and will be assessed once they are available. All the available data on the safety of the vaccine as well as on its quality (such as its ingredients and the way it is produced) will also be reviewed."

Pfizer shares were marked 0.2% higher in early trading following news of the EMA review to change hands at $36.80 each. BioNTech's U.S.-listed shares, meanwhile, rose 5.25% to $84.94 each in early trading on the Nasdaq.

Last month, the pair reached an agreement with the European Union to supply as many as 300 million doses of the vaccine -- and said it could have as many as 1.3 billion doses ready by the end of 2021 -- if and when it is ultimately approved by health officials.