The New Molecules Committee of the Federal Commission for Protection against Health Risks (Cofepris) recommended authorizing the use of Pfizer’s COVID-19 vaccine in populations aged 12 and over.
The undersecretary of Health, Hugo Lopez Gatell, informed, through a tweet, that in case the vaccine is authorized to people from this age, the Secretariat will prepare to include them in the National Vaccination Plan.
Read more: Pfizer will ask cofepris for endorsement to apply COVID vaccine to children aged 12 to 15
This is not yet the authorization for emergency use that is being granted to vaccines in many countries of the world and through various health agencies, it is a preliminary step, but a fundamental step.
New Molecules Committee ? issues favorable opinion to expand emergency use of Pfizer-BioNTech vaccine from the age of 12.
Know the results ? https://t.co/o8XM5dSjQ9
Get to know the optimization process ?https://t.co/gxqqRaZmn3 pic.twitter.com/IVzpitRdDn
— COFEPRIS (@COFEPRIS) June 11, 2021
Two auxiliary bodies for consultation and opinion to requests related to medicines and other health inputs – the Committee on New Molecules (CMN) and the Subcommittee on the Evaluation of Biotechnological Products (SEPB) – met on June 11 to issue a technical opinion on the expansion of the age group from the age of 12, for the application of the BNT162b2 vaccine (Pfizer-BioNTech COVID19 vaccine). The opinion was unanimously favourable.
This decision is part of the approval process necessary for compliance with the requirements of quality, safety and efficacy, indispensable when considering a product.
CMN and SEPB do not authorize or reject molecules; they issue a favorable or non-favorable technical opinion based on the scientific and medical evidence presented, which the laboratories integrate into their files submitted to the Health Authorization Commission.
The instance is now pending the request for expansion of the age group of the BNT162b2 (Pfizer- BioNTech COVID19 vaccine) vaccine.
The vaccine from Pfizer and BioNTech already has emergency use authorization for children up to 12 years of age in Europe, the United States, Canada, Brazil and Chile.
In fact, since May, the U.S. Food and Drug Administration (FDA) authorized the use of this vaccine, in the United States, in children from 12 to 15 years old.
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