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Oct 6, 2020

EU drug regulator starts review of Pfizer-BioNTech COVID vaccine

A health worker injects a person during clinical trials for a Covid-19 vaccine at Research Centers of America in Hollywood, Florida, U.S., on Wednesday, Sept. 9, 2020. Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market.

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Europe’s drugs regulator started an early review of an experimental COVID-19 vaccine from Pfizer Inc. and BioNTech SE, potentially speeding the shot’s assessment and reducing its time to market.

Called a “rolling review,” the process will allow the European Medicines Agency to look at how the vaccine is performing in real time as data emerges from trials, instead of waiting for the drugmakers to submit everything at once. BioNTech shares surged in trading before U.S. markets opened.

Once the regulator has enough information to make a decision, the companies will submit a formal application. The agency has sought to hurry along promising COVID-19 therapies and shots, starting a rolling review last week for a vaccine candidate from AstraZeneca Plc and the University of Oxford. The same tool was used to evaluate Gilead Sciences Inc.’s remdesivir before the antiviral was granted conditional approval in July.

The EMA said it has started looking at data from Pfizer and BioNTech’s laboratory studies -- research that was done before patient trials began. “This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness,” it said in a statement.

Pfizer has said for months that it will seek regulatory approval for its vaccine as early as October. The companies have been granted fast-track review in the U.S.

The partners said they’ve now recruited some 37,000 people into the final stage of studies that will show whether the vaccine works and is safe. More than 28,000 of the participants have received both doses of the vaccine.