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Cofepris Must Inform Authorization for Pfizer COVID-19 Vaccine Use in Children 5 Years Old: Inai Ruling

The Federal Commission for the Protection against Health Risks (Cofepris) must inform the authorization for the use of the Pfizer vaccine contra COVID-19 in minors 5 years old.

The above, for instruction of the National Institute of Transparency, Access to Information and Protection of Personal Data (Inai).

A person requested the resolution by which the use of the vaccine developed by Pfizer against COVID-19 was authorized, for its offer in pharmacies and authorized establishments in Mexico.

However, Cofepris only made available the public version of the response, to which the applicant filed an appeal for review to which the agency responded that the information is non-existent.

The case was brought to the Plenary Session of Inai under the presentation of the Commissioner Julieta del Río Venegaswho determined that not all competent administrative areas were consulted to learn about the resolution.

It was decided to revoke Cofepris’s response and instruct it to carry out a new consistent and exhaustive search for information in all the competent administrative units, among which it cannot omit the Executive Subdirectorate of Drugs and Medications, the Executive Directorate of Pharmacopoeia and Pharmacovigilance, the Executive Directorate of Authorization of Products and Establishments and the Health Authorization Commission.

Cofepris must deliver the public version of the resolution issued to the request submitted by Pfizer SA de CV, for the modification of the conditions of the Temporary Authorization for Emergency Use of the “Pfizer-BioNtech COVID19 Vaccine” vaccine, in the age group of 6 months for children under 5 years old.

With information from López-Dóriga Digital

2023-12-19 16:09:22
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