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Flashback: Pfizer Withdraws COVID Vaccine Application in India After Regulators Demand Local Safety and Immunogenicity Study

Pfizer pulled its application for emergency-use authorization of its COVID-19 vaccine in India after the country’s pharmaceutical regulator’s demand for a local safety and immunogenicity study, Reuters reported.

Flashback: Pfizer Withdraws COVID Vaccine Application in India After Regulators Demand Local Safety and Immunogenicity Study
Flashback: Pfizer Withdraws COVID Vaccine Application in India After Regulators Demand Local Safety and Immunogenicity Study

 

Last year, India’s COVID-19 Subject Expert Committee (SEC) reviewed the data presented by Pfizer during a meeting. The committee did not recommend the Pfizer vaccine due to serious adverse events reported abroad and the companies’ lack of safety and immunogenicity studies in the Indian population.

The local trial is a standard procedure imposed in India when a new vaccine is available to determine its safety and generate an immune response in its citizens.

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The decision would affect Pfizer COVID-19 vaccine distribution as it will not be available for purchase in India and China, two of the most populous countries in the world.

 

Last year, India’s COVID-19 Subject Expert Committee (SEC) reviewed the data presented by Pfizer during a meeting. The committee did not recommend the Pfizer vaccine due to serious adverse events reported abroad and the companies’ lack of safety and immunogenicity studies in the Indian population.

The local trial is a standard procedure imposed in India when a new vaccine is available to determine its safety and generate an immune response in its citizens.

TRENDING: CDC Casually Admits Covid Nose Swabs Ended Up in a Lab for Genomic Sequencing Analysis

The decision would affect Pfizer COVID-19 vaccine distribution as it will not be available for purchase in India and China, two of the most populous countries in the world.

More from Reuters:

Corbevax vaccine

  • Covaxin vaccine
  • Covishield vaccine
  • Johnson & Johnson
  • Moderna vaccine
  • Novavax vaccine
  • Sputnik Light vaccine
  • Sputnik V vaccine
  • Zydus Cadila vaccine

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