May 20, 2021

The U.S. FDA has expanded emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include prevention of COVID-19 in individuals 12-15 years of age. The vaccine first received authorization on December 11, 2020, to prevent COVID-19 in individuals who are at least 16 years old.

Expansion of the EUA is based on data from a clinical trial currently underway in the United States. The trial enrolled adolescents 12-15 years of age who received either the Pfizer/BioNTech vaccine or a placebo saline injection. Based on trial results, the FDA has concluded that the potential and known benefits of the vaccine outweigh its potential and known risks. Current data shows that the vaccine was 100% effective in preventing COVID-19 in trial participants. Recommended dosing is two injections given three weeks apart.

Emergency use authorization is not the same as full FDA approval. It allows the FDA to make medical countermeasures such as vaccines available during public health emergencies when there are no adequate FDA-approved alternatives available. When an EUA is granted, it is done based on the totality of currently available clinical and scientific evidence. Pfizer has indicated it is seeking full FDA approval for its COVID-19 vaccine, which was developed in concert with BioNTech.

The FDA has also authorized updated storage guidelines for the Pfizer/BioNTech vaccine. Once thawed, the vaccine can be kept in a refrigerator at 2°C to 8°C (35°F to 46°F) for up to one month before dilution for administration. Previously, the vaccine was authorized to be stored at these temperatures for no more than five days. The decision is based on data from Pfizer demonstrating the vaccine’s stability at refrigerator temperatures for a full month.

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