dft6rtyhfg AstraZeneca Weighs Seeking Full U.S. Approval

[Free21]

AstraZeneca PLC could skip asking the Food and Drug Administration for emergency-use authorization for its Covid-19 vaccine, according to people familiar with the matter—and instead pursue the more time-intensive application for a full-fledged license to sell the shot.

Such a move would further delay any rollout of AstraZeneca shots in the U.S., where the vaccine has already been made and stockpiled. But U.S. government and public-health officials have said they probably don’t need AstraZeneca shots because of ample supplies of three other shots already authorized for use.

The British drugmaker said last week it intended to apply for the emergency go-ahead within weeks. But it has also been considering a different path to getting the drug approved in the U.S., according to these people. That would involve taking what could be several more months to compile and review data necessary for what is known as a biologics license, essentially a more comprehensive, nonemergency seal of approval from the FDA.

The full license is the path most new medicines take on their way to the U.S. market. But Covid-19 vaccine makers including Pfizer Inc., Moderna Inc. and Johnson & Johnson have all sought and received emergency-use authorization as a stopgap, encouraged by the government, with plans eventually to apply for full-blown approval for their respective shots. The emergency-use application allowed all three to win quicker FDA approval in the pandemic.

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