BACK

Can COVID-19 vaccine expiration dates be extended?

Can COVID-19 vaccine expiration dates be extended?

This article was published on
February 13, 2023

This explainer is more than 90 days old. Some of the information might be out of date or no longer relevant. Browse our homepage for up to date content or request information about a specific topic from our team of scientists.

This article has been translated from its original language. Please reach out if you have any feedback on the translation.

Yes. While changing vaccine expiration dates can be confusing for both care providers and the public, vaccine expiration date extensions are normal and can actually be a very good thing. Extensions of vaccine expiration dates have nothing to do with the vaccine itself changing. Instead, the decision to extend a vaccine expiration (including The U.S. Food and Drug Administration’s decision to extend the expiration date for the Pfizer-BioNTech COVID-19 vaccine) is based on studies analyzing the long-term stability of these vaccines.

Yes. While changing vaccine expiration dates can be confusing for both care providers and the public, vaccine expiration date extensions are normal and can actually be a very good thing. Extensions of vaccine expiration dates have nothing to do with the vaccine itself changing. Instead, the decision to extend a vaccine expiration (including The U.S. Food and Drug Administration’s decision to extend the expiration date for the Pfizer-BioNTech COVID-19 vaccine) is based on studies analyzing the long-term stability of these vaccines.

Publication

What our experts say

The U.S. Food and Drug Administration extended the expiration date for the Pfizer-BioNTech COVID-19 vaccine (both the initial vaccine and the booster) from 12 months to 18 months from the manufacturer date. This means that if the manufacturing date was December 1, 2022, the original expiration date was December 1, 2023, and the updated expiration date would be June 1, 2023.

This decision has nothing to do with anything about the vaccine itself changing. The decision was based on studies analyzing the long-term stability of these vaccines. This expiration date extension also applies to both vaccine vials stored at ultra-cold freezer temperatures and those being stored at refrigerated temperatures, even if the vaccine vials were moved to refrigerated temperatures prior to the extension.

Other countries have made similar decisions, such as Australia, Malaysia, and Thailand. Some countries have extended the expiration date to just 15 months from the manufacture date, and others, like the U.S., have extended the expiration date to 18 months from the manufacture date.

In Thailand, the Food and Drug Administration extended the expiration date from nine months from the manufacture date to 15 months from the manufacture date, for vaccines stored between -60 and -90 degrees celsius (-76 to -130 degrees fahrenheit). This means that if the original expiration date was December 1, 2023, the updated expiration date would be June 1, 2023.

This is not the first time Thailand has extended the expiry date of the Pfizer-BioNTech COVID-19 vaccine or any other COVID-19 vaccine. In April 2022, for instance, the expiration date was extended for the first time from six months to nine months after Pfizer re-registered their vaccine for non-emergency use.

Now, based on new data showing that the Pfizer COVID-19 vaccines remain stable, safe, and effective for up to 18 months from the manufacture date, the expiration date has been changed again. There is very specific protocol on how the studies must be rigorously designed to make this sort of change, overseen by pharmaceutical companies and food and drug regulation authorities. The vaccines are safe to use past their expiration date: they are approved for use up to six months after the original expiration date in Thailand, and can be administered accordingly.

While changing vaccine expiration dates can be confusing for both care providers and the public, vaccine expiration date extensions are normal and can actually be a very good thing. Particularly because the Pfizer mRNA COVID-19 can be difficult to store and transport, a longer expiration date means it is less likely to be wasted and even potentially could get to people that may have lower access to vaccines. There have been reports of high amounts of vaccine waste, particularly in wealthier western countries, and extending the expiration date should help with reducing vaccine waste and help to increase vaccine access. 

The U.S. Food and Drug Administration extended the expiration date for the Pfizer-BioNTech COVID-19 vaccine (both the initial vaccine and the booster) from 12 months to 18 months from the manufacturer date. This means that if the manufacturing date was December 1, 2022, the original expiration date was December 1, 2023, and the updated expiration date would be June 1, 2023.

This decision has nothing to do with anything about the vaccine itself changing. The decision was based on studies analyzing the long-term stability of these vaccines. This expiration date extension also applies to both vaccine vials stored at ultra-cold freezer temperatures and those being stored at refrigerated temperatures, even if the vaccine vials were moved to refrigerated temperatures prior to the extension.

Other countries have made similar decisions, such as Australia, Malaysia, and Thailand. Some countries have extended the expiration date to just 15 months from the manufacture date, and others, like the U.S., have extended the expiration date to 18 months from the manufacture date.

In Thailand, the Food and Drug Administration extended the expiration date from nine months from the manufacture date to 15 months from the manufacture date, for vaccines stored between -60 and -90 degrees celsius (-76 to -130 degrees fahrenheit). This means that if the original expiration date was December 1, 2023, the updated expiration date would be June 1, 2023.

This is not the first time Thailand has extended the expiry date of the Pfizer-BioNTech COVID-19 vaccine or any other COVID-19 vaccine. In April 2022, for instance, the expiration date was extended for the first time from six months to nine months after Pfizer re-registered their vaccine for non-emergency use.

Now, based on new data showing that the Pfizer COVID-19 vaccines remain stable, safe, and effective for up to 18 months from the manufacture date, the expiration date has been changed again. There is very specific protocol on how the studies must be rigorously designed to make this sort of change, overseen by pharmaceutical companies and food and drug regulation authorities. The vaccines are safe to use past their expiration date: they are approved for use up to six months after the original expiration date in Thailand, and can be administered accordingly.

While changing vaccine expiration dates can be confusing for both care providers and the public, vaccine expiration date extensions are normal and can actually be a very good thing. Particularly because the Pfizer mRNA COVID-19 can be difficult to store and transport, a longer expiration date means it is less likely to be wasted and even potentially could get to people that may have lower access to vaccines. There have been reports of high amounts of vaccine waste, particularly in wealthier western countries, and extending the expiration date should help with reducing vaccine waste and help to increase vaccine access. 

Context and background

No content available for this section.

No content available for this section.

Resources

  1. Pfizer-BioNTech COVID-19 Vaccine (U.S. Centers for Disease Control and Prevention)
  2. Expiration Dating Extension (U.S. Food and Drug Administration)
  3. FDA defends vaccine shelf-life extensions (The Bangkok Post)
  4. Expiry date of Sinovac, AstraZeneca, Pfizer vaccines to be extended (The Nation Thailand)  
  5. FDA Extends Shelf-Life of Pfizer COVID-19 Vaccine (Association for Professionals in Infection Control and Epidemiology
  6. Pfizer Tris Shelf Life Extension (9-12 months) Approved (Maine Department of Health and Human Services)
  7. EXPIRATION EXTENSION: PFIZER-BIONTECH COVID-19 VACCINE (Michigan Department of Health and Human Services)
  8. NPRA Extends Shelf Life Of Pfizer Covid Vaccines Yet Again (Code Blue)
  1. Pfizer-BioNTech COVID-19 Vaccine (U.S. Centers for Disease Control and Prevention)
  2. Expiration Dating Extension (U.S. Food and Drug Administration)
  3. FDA defends vaccine shelf-life extensions (The Bangkok Post)
  4. Expiry date of Sinovac, AstraZeneca, Pfizer vaccines to be extended (The Nation Thailand)  
  5. FDA Extends Shelf-Life of Pfizer COVID-19 Vaccine (Association for Professionals in Infection Control and Epidemiology
  6. Pfizer Tris Shelf Life Extension (9-12 months) Approved (Maine Department of Health and Human Services)
  7. EXPIRATION EXTENSION: PFIZER-BIONTECH COVID-19 VACCINE (Michigan Department of Health and Human Services)
  8. NPRA Extends Shelf Life Of Pfizer Covid Vaccines Yet Again (Code Blue)

Media briefing

Media Release

Expert Comments: 

No items found.

Q&A

No items found.