FDA extends shelf life for certain Pfizer vaccine vials, monoclonal antibodies 

Apr 18, 2022 - 02:11 PM
FDA Update 900x400

The Food and Drug Administration last week authorized extending the shelf life to 12 months for two formulations of the Pfizer COVID-19 vaccine when stored at -130ºF to -76ºF. For more information, see the April 13 fact sheets for health care providers.  

The FDA and Health and Human Services Office of the Assistant Secretary for Preparedness and Response also are considering extending the shelf life for the combination monoclonal antibodies bamlanivimab and/or etesevimab, and plan to issue an update in early May. Until then, health care providers may retain all unopened bamlanivimab and etesevimab vials that were stored at 36°F to 46°F as detailed in the authorization letter and fact sheet for providers, HHS said.

Bamlanivimab and etesevimab are not currently authorized in any U.S. region due to the omicron variant’s prevalence, but the agencies recommend retaining the product in case future variants are susceptible to the treatment. 

Related News Articles

Headline
View the AHA's latest United Against the Flu toolkit celebrating fall
AHA's latest social media toolkit for encouraging vaccination against the flu and COVID-19 provides fall-themed social media posts and graphics. Download the…
Headline
CDC recommends two doses of COVID-19 vaccine for older individuals, lowers pneumococcal vaccine age 
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to…
Headline
CDC reminds hospital and health system workers to protect themselves, patients during respiratory virus season
The Centers for Disease Control and Prevention is reminding clinicians and other health care workers to take necessary steps to keep themselves and their…
Chairperson's File
Chair File: The Best Defense Against Flu and COVID-19
Autumn is here, and that means cooler weather and also the start of flu season.We know the best way to prevent influenza is to get a flu vaccine. The Centers…
Headline
Survey: Less than 20% of U.S. adults concerned for themselves or family receiving infection ahead of respiratory virus season
The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a…
Headline
FDA authorizes combination tests for flu, COVID-19
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-…