Stock Track | BioNTech SE Plummets 5.02% Intraday Amid FDA Stricter Vaccine Approval Rules

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BioNTech SE (BNTX) shares dropped sharply by 5.02% during Monday's intraday trading session, reflecting broader declines in vaccine stocks following the FDA's announcement of stricter approval requirements for vaccines.

The sell-off was triggered by an internal FDA memo linking COVID-19 vaccines to rare heart conditions in children and proposing tighter regulations for vaccine approvals. Dr. Vinay Prasad, the FDA's top vaccine regulator, cited safety concerns, which could increase scrutiny and delay future vaccine approvals for companies like BioNTech.

Analysts noted that the regulatory uncertainty and potential additional testing requirements could weigh on BioNTech's revenue from its COVID-19 vaccine, Comirnaty, developed in partnership with Pfizer.

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