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FDA Extends Johnson & Johnson's COVID-19 Vaccine Shelf Life

johnson & johnson boxes on shelf

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Key Takeaways

  • FDA approved the shelf life extension of the Johnson & Johnson COVID-19 vaccine from three months to four and a half months.
  • Vaccine doses are still safe and effective, and extending the shelf life reduces further vaccine wastage.
  • There may have been hundreds of thousands of unused vaccines due to decreased demand following the pause of its use.

The Food and Drug Administration (FDA) recently authorized the extension of the Johnson & Johnson COVID-19 vaccine shelf life by six weeks, preventing millions of doses from going to waste.

Stability assessment studies show that the vaccines remain safe and effective for at least 4.5 months. Despite the FDA authorization, many are concerned about the safety and effectiveness of these nearly-expired doses.

Vaccine Doses Remain Safe and Effective

Although many Johnson & Johnson vaccine doses were due to expire by the end of June, they are still effective, experts say.

“The FDA would not authorize the extension if there were concerns about safety or effectiveness,” William Moss, MD, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, tells Verywell.

“Vaccines should not be used beyond their expiration date,” Moss says, “but the expiration date can be extended if additional stability studies demonstrate that the vaccine remains potent for a longer period under specified storage conditions.”

Some people might prefer to get vaccinated with doses that are far from their initial expiration, but there's no need to make a distinction between older and newer doses.

“There should be no difference between these doses and earlier doses,” Margaret Liu, MD, board chair of the International Society for Vaccines, tells Verywell.

How Is Vaccine Shelf Life Determined?

After a vaccine is introduced to the public, scientists would conduct ongoing stability assessment to evaluate its maximum shelf life.

“Since this vaccine was introduced this year, ongoing studies were needed to ensure shelf life and stability of the vaccine and those data are continuously reviewed,” Leslie Sude, MD, a Yale Medicine pediatrician who vaccinates community members on the Yale School of Medicine Community Health Care Van, tells Verywell.

Existing COVID-19 vaccines were developed under a tight timeline, in which scientists have set up stability tests under certain conditions, but they don’t necessarily have the data for longer time periods. They may perform accelerated stability studies, which try to assess how fast certain vaccine properties change over time by exposing them to higher temperatures, but they cannot accurately predict real-time conditions.

“Many products have stability times that are probably shorter than how long they really would last, because it just takes real time to wait to see how long something is good for,” Liu says. “So a medicine might really be good for five years, but the company might only test for two years or one year because otherwise they'd have to wait five years to know the actual stability.”

Companies would likely state a shorter period of stability to be certain that the vaccine is still safe and effective, rather than overestimating the expiration, Liu adds.

Shelf Life Extension Reduces Vaccine Wastage

“The importance of this [shelf life] extension is that it should reduce vaccine wastage,” Moss says.

As of May 24, about 1.55 million doses of the 353 million vaccines administered in the U.S. reportedly went to waste. However, this is likely a conservative number as waste reporting is generally inconsistent, making it difficult to identify a precise tally.

The extension of the Johnson & Johnson shelf life came just in time to prevent further vaccine wastage. Demands for single-dose vaccine likely dwindled because of the brief pause of its use in April after reports of a rare blood clotting disorder.

“Even after the FDA reinstated authorized use, demand has been diminished,” Moss says. “There remain, however, populations for which a single dose vaccine is advantageous, particularly populations in which it is challenging to administer a second dose.”

Now that the Johnson & Johnson vaccine shelf life has been extended, health officials have more time to reach out to people who have yet to be vaccinated.

“Continued storage and use of these vaccines serve as a critical resource for vaccine providers and the community,” Sude says.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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  1. Johnson & Johnson. Johnson & Johnson statement on FDA approval of shelf life extension for company’s COVID-19 vaccine. Published June 10, 2021.

  2. WHO Expert Committee on Biological Standardization. Fifty-seventh report, annex 3: guidelines on stability evaluation of vaccines. Updated February 3, 2012.

  3. Quartz. Covid-19 vaccine waste is about to go up in the US. Published May 28, 2021.