Pfizer Inc. said a final analysis of clinical-trial data showed its Covid-19 vaccine was 95% effective, paving the way for the company to apply this week for the first U.S. regulatory authorization for a coronavirus shot.
The U.S. drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that includes almost 44,000 participants.
Pfizer shares were up 2% at 11:25 a.m. in New York, with BioNTech American depositary receipts gaining 5.3%.
The update is the latest in a string of promising developments on the vaccine front in recent days. Moderna Inc.’s rival shot appears equally effective, judging from data published earlier this week, and a third contender, from AstraZeneca Plc and the University of Oxford, is expected to release trial results soon.
Pfizer and its German partner now plan a filing with the U.S. Food and Drug Administration by Friday at the latest, BioNTech Chief Executive Officer Ugur Sahin said in a Bloomberg Television interview. Documents have already been filed with the European Medicines Agency, which is conducting a rolling review, he said.
“There are almost daily phone calls and document exchange” with the European regulator, Sahin said. “I am confident that based on the positive data we have generated today, all authorities -- the FDA, the EMA and other regulatory authorities -- will really push to get this done as quickly as possible.”
Read more:https://www.bloomberg.com/news/articles/2020-11-18/pfizer-biontech-plan-filing-as-vaccine-proves-95-effective?fbclid=IwAR31OrVOwPzsn6uBmPGNL5obbSIazPo-26lT3XdNl5uz4bvIYG3rq7851EQ
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