"US FDA Authorizes Use of Leftover Vaccine in Vials After Injection"...Supply Expected to Increase by 40%

Guidelines for Using Residual Vaccine Vials
Concerns Raised Over Possible Vaccine Contamination

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) is reportedly setting guidelines to allow the use of leftover vaccine doses remaining in vaccine vials as a measure to address the shortage of COVID-19 vaccine supply. While this could increase vaccine supply by up to 40%, there are also opposing views citing potential issues such as vaccine contamination.

According to the U.S. political media outlet Politico on the 16th (local time), the FDA plans to revise guidelines late in the afternoon to allow the use of residual amounts remaining in vial-type bottles containing COVID-19 vaccines. Citing an FDA official, Politico reported, "Considering the public health emergency, the guidelines have been revised to allow the use of the entire amount contained in vaccine vials," adding, "This method is expected to increase vaccine supply by up to 40%."

The Pfizer vaccine, which began administration nationwide on the 14th, is supplied in vial bottles with rubber stoppers on the caps, officially containing five doses per vial. However, pharmaceutical companies reportedly inject slightly more than this amount into the vials, and if all residual amounts inside the vial are used, it is known to contain six to seven doses. This is because more than the official volume is generally filled to account for possible spillage or loss during transfer with syringes during the vaccination process.

Originally, FDA guidelines require that leftover vaccine at the bottom of the vial be discarded along with the vial. This is prohibited because the vaccine may be exposed to room temperature and mixing residual amounts from different vials could lead to contamination. Pfizer, the vaccine developer, reportedly received these guidelines late in the afternoon as well, according to Politico. Sharon Castillo, Pfizer’s spokesperson, said, "At this time, it is difficult to comment on the handling of leftover doses," adding, "We are closely consulting with the FDA on this issue."

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