FDA Approves Pfizer to Relax COVID-19-IT & Health-cnBeta.COM Vaccine Transportation and Storage Rules

The FDA allows more flexible shipping and storage rules for Pfizer’s COVID-19 vaccine, after the pharmaceutical company announced new evidence that the drug does not necessarily require the initially recommended ultra-low temperature to maintain its activity.Pfizer announced the latest experimental results last week, greatly reducing the difficulty of storage and transportation. At the beginning of the vaccine launch, Pfizer suggested that the vaccine developed by him and BioNTech should be at a temperature between -80ºC and -60ºC (- 112ºF to -76ºF) Next save.

It was under this condition that the United States Food and Drug Administration (FDA) granted emergency use authorization for the vaccine in late 2020. However, the facts have shown that this continues to be a headache for the population. supply chain and medical service providers. Pfizer has developed a special low temperature delivery container for vaccine candidates that can be supplemented with dry ice to maintain a safe temperature range. However, this means that standard refrigeration installations in most places cannot reach sufficient temperatures. But today, the FDA allowed the EUA to be updated based on new research evidence.

The preferred storage method remains the ultra low temperature freezer. However, the FDA will now allow the COVID-19 vaccine to be transported and stored at regular temperatures, usually with the support of regular drug freezing equipment, for up to two weeks. Even at this higher temperature, the vaccine will remain stable.

In fact, the updated guidelines are more flexible. According to the FDA, vaccines that have been frozen at -25 ° C to -15 ° C (-13 ° F to 5 ° F) for less than two weeks can actually be returned to the ultra low temperature freezer if not can used in time. However, the cumulative storage time of the vials at normal freezer temperature should not exceed two weeks.

What has not changed is the rule of thawing the vials, which is in place before using the vaccine. The vial can be stored in the refrigerator for 5 days after thawing, but this is before dilution. It should be used within 6 hours after dilution, but can be stored at refrigerator or room temperature in this state. These changes are expected to have a considerable impact on the management of immunization promotion in the coming months.

“This alternate temperature for transporting and storing undiluted vials is of great importance and allows the vials to be transported and stored under more flexible conditions,” said Peter Marks, MD, director of the FDA’s Center for Biological Evaluation and Research, referring to USA Said during the amendment. “Alternative temperatures for transportation and storage will help ease the burden of purchasing ultra-low temperature storage equipment at vaccination sites and should help deliver vaccines to more vaccination sites.”

Currently, Pfizer expects to provide 300 million doses of the Pfizer-Biotech COVID-19 vaccine to the US government, enough to vaccinate 150 million people.