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Cofepris Says Pfizer Has Not Filed Required Papers for Private Covid-19 Vaccine Sales in Mexico

The regulator reports missing documentation from Pfizer has stalled lot release for pharmacy sales, leaving private outlets without the updated shot.

Overview

  • Cofepris said it has not received the documentation needed to authorize commercial distribution of Pfizer’s updated Covid-19 vaccine to private channels.
  • Pfizer’s LP.8.1 formulation is already being administered free of charge in the public health system as part of the 2025–2026 winter campaign that began in October.
  • The agency noted it granted sanitary registration to Comirnaty in December 2023 and approved the LP.8.1 strain update on August 19, 2025, but private lot release awaits a complete filing.
  • After a November 14 virtual meeting, Pfizer provided only part of the required paperwork and committed to submit the full set on Tuesday, November 18, with Cofepris extending hours to receive it.
  • Moderna opted to supply only the government, which purchased up to 10 million doses with ongoing deliveries, while pharmacies and private clinics remain without authorized stock as Pfizer and Cofepris work on the approval.