Download.pdf

19736_S0335-M1_smsr-01apr2021-29apr2021.pdf
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🔗 Source: icandecide.org
📊 Size: 58.83 MB
📄 Pages: 5983 pages
⬇️ Downloads: 111

Summary

PF-07302048 (BNT162b2) Summary Monthly Safety Report 5 covers the period from 01 April 2021 to 29 April 2021. Approximately 415,922,715 doses were shipped worldwide, with 172,777,410 doses shipped during the reporting interval. The vaccine is indicated for active immunization to prevent COVID-19 in individuals 16 years and older, administered intramuscularly in two doses. No authorisation withdrawals for safety reasons occurred during the reporting interval, and no actions were taken for safety reasons by Health Authorities or the MAH. The report evaluated signals including asthenia, lethargy, decreased appetite, hyperhidrosis, night sweats, herpes zoster, seizure, myocarditis, and pericarditis, with some determined to be risks and added to the RSI and local product labels.

Description

PF-07302048 (BNT162b2) Summary Monthly Safety Report 5 covers the period from 01 April 2021 to 29 April 2021.

Technical Information

  • File Format: PDF
  • File Size: 58.83 MB
  • Pages: 5983
  • Language: EN
  • Total Downloads: 111
  • Last Updated: 2 months ago

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