AstraZeneca ready to drop plans for U.S. regulatory approval of COVID-19 shot - FT
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A senior executive at the Anglo-Swedish vaccine maker, AstraZeneca (NASDAQ:AZN), said Thursday that the company would consider not submitting its COVID-19 shot for approval in the U.S. if the regulatory process takes too long, The Financial Times reported.
âWe donât need to push it in places we are not needed or wanted,â Sir Mene Pangalos, AstraZenecaâs (AZN) head of research and development, told the paper on Thursday.
Instead, the company will focus on selling the vaccine in other countries though it will continue the talks with the U.S. Food and Drug Administration (FDA), Pangalos added.
âIf we donât end up submitting it for a BLA [biologics licence application], I donât think it will have an impact around the world,â he added.
So far, the FDA has authorized only three COVID-19 vaccines. In late 2020, it greenlighted messenger RNA-based vaccines from Pfizer (PFE)/ BioNTech (BNTX) and Moderna (MRNA), and in early 2021, the regulator cleared the single-dose vector-based shot from Johnson & Johnson (JNJ).
Developed in partnership with the University of Oxford, AstraZenecaâs (AZN) COVID-19 vaccine, branded as Vaxzevria, generated $3.9 billion in revenue for the company in 2021.