FDA extends expiration date on Johnson & Johnson COVID-19 vaccine, saving doses from destruction

The Food and Drug Administration on Thursday extended the expiration date on hundreds of thousands of doses of Johnson & Johnson’s COVID-19 vaccine that otherwise would have expired within the next month, requiring them to be discarded.

The FDA authorization extends the shelf life for the J&J vaccines from three months to four-and-a-half months, the company said in a news release.

The extension is based on ongoing vaccine stability assessment studies that demonstrated the one-shot vaccine remains stable and protective for 18 weeks when refrigerated at 36 to 46 degrees.

The news will be welcome in states faced with the prospect of discarding doses of the J&J vaccine when they reached their expiration date – many on June 24.

Slowing demand and the lingering effects of an 11-day pause on the J&J vaccine meant states were having trouble finding willing arms.

“When we had more demand than the supply could meet, expiration dates weren’t a problem. Vaccine was being used up as fast as it came in the door,” said Dr. Kelly Moore, deputy director of the Immunization Action Coalition.

That changed in the past month.

As of Wednesday in Arkansas, there were 93,271 doses of unadministered J&J vaccine. Of those, 42,971 were set to expire on June 23 and 10,042 on July 4, the Arkansas Department of Health said.

In Iowa, 33,000 doses of the vaccine were on the verge of expiring, the state Department of Public Health said Wednesday.

In Ohio, the governor warned 200,000 J&J doses would have to be tossed June 24 if they don’t get takers.

Fact check: Post misleads on effectiveness of J&J COVID-19 vaccine in older adults

In Arizona, as many as 100,000 doses with the June 23 expiration date hadn’t found people to use them. Other states reported soon-to-expire doses as well.

“You’ve got three choices,” said John Grabenstein, a former Merck executive and former director of a Department of Defense military immunization program. “You increase demand and use the doses up, you extend the expiration date, or you throw them away.”

J&J vaccine demand trails Pfizer-BioNTech and Moderna

Increasing demand has been difficult. Almost 52% of people in the USA have received at least one COVID-19 shot, but vaccination rates are falling to new lows.

Twelve states have seen vaccinations sink to 15 daily shots per 10,000 residents; Alabama had just four people per 10,000 residents get vaccinated last week,

On top of that, confidence in the J&J vaccine plummeted after the Food and Drug Administration and the Centers for Disease Control and Prevention paused the administration of the vaccine April 13, when a small number of cases of a rare blood-clotting disorder were associated with the shot.

FDA extends expiration date on Johnson & Johnson COVID-19 vaccine, saving doses from destruction

The pause was lifted after 11 days when an investigation showed that out of nearly 8 million who received the vaccine, 15 people had developed the condition, and three had died.

Demand for the J&J shot is lower than for the Pfizer/BioNTech or Moderna vaccines, despite being “one and done.”

The vaccine was authorized Feb. 27, and production ramped up in April. That came just as the pause was initiated, leading to increasing supplies even as demand sank.

Vaccine produced in April would have begun to expire in June.

Study:Johnson & Johnson COVID-19 vaccine protects against virus variants

CDC data this week shows about 10 million doses of J&J vaccine have yet to be administered, about half of the doses delivered. When those doses might reach their expiration dates isn’t known.

Extending the shelf life requires extensive testing and FDA approval, a process J&J and FDA have been engaged in since the vaccine was approved.

As they’re manufactured, vials of vaccine are put aside for stability testing to determine how long they stay potent, Grabenstein said.

“Every month, you test five or 10 vials and see how they do,” he said. The numbers are reported to the FDA, which can extend the shelf life if warranted. “A vaccine approved 10 years ago might have started with a 12-month stability at first, and then, over time, testing might extend that two years.”

‘You’re not allowed to guess about expiration dates’

When J&J first presented its data to the FDA’s Vaccines and Related Biological Products Advisory Committee on Feb. 26, the vaccine had a shelf life of three months when refrigerated at 36 to 46 degrees. It remained stable for two years when frozen at minus 4 degrees.

Each vial of vaccine is shipped with a code that can be entered into a website, which will tell when the vial expires. That is being updated.

Even expired, the J&J doses aren’t necessarily ineffective, Moore said, but without the data, they couldn’t be used.

“You’re not allowed to guess about expiration dates,” she said.

When will everyone be vaccinated for COVID-19? Here’s how the vaccine rollout is going

Any vaccine that isn’t used by its expiration date must be disposed of properly, which means a process of “controlled destruction” such as incineration.

“You don’t want this stuff to get diverted so that substandard or counterfeit vaccine could be sold to unsuspecting people,” Grabenstein said.

Some public health officials hoped more creative answers could be found in the two weeks that remained for some of the doses.

William Humble, executive director of the Arizona Public Health Association, hoped Arizona could find a way to get its unused vaccine to people in Mexico across the border, where the J&J vaccine is authorized but little is available.

The Arizona Department of Health Services does have vaccination options near the border that don’t require proof of citizenship, and the state participates in the federal vaccine pool, which is where vaccines to be donated internationally will come from, spokesman Steve Elliott said.

Humble suggested a big push to make sure every last dose gets used before it reaches its expiration date.

“If we even did big mass vaccination clinics in Nogales, Arizona, where people could walk across the border, you could probably give tens of thousands of vaccine doses if you did a several-day event,” he said. “That would be a creative way of not wasting it.”

News Related


Mum reveals $10 reason son can't have 'normal life'

For Lykera Parker, seeing another child walk can trigger a pang of sadness. Because she knows that while her son Kalarny is as bubbly and outgoing as any four-year-old, he ... Read more »

COVID-19: Cases fall in the Netherlands and UK, while Italy and Romania push vaccines

While COVID-19 cases fall in some European countries, others fear a fourth wave of infections is underway. Cases in the Netherlands have fallen by 44% compared to last week, according ... Read more »

Schools implement mask mandates even as some states impose bans; US reports one case every second: Live COVID-19 updates

The U.S. Department of Education Monday released a roadmap for the return to school this fall, encouraging districts to invest in physical and emotional support for students. Among the roadmap’s ... Read more »

Cobblestone stones honor WWII gay and lesbian resistance fighters

Karel Pekelharing stone. Photo: DutchNews.nl Nine Jewish gay and lesbian resistance figurines are to be given their own “Stolperstein” or commemorative street tiles in front of their last known address. ... Read more »

Covid UK news – live: Vaccine to be offered to 16 and 17-year-olds as UK sees highest deaths since mid-March

✕ Close Coronavirus in numbers The coronavirus vaccination programme looks set to be rolled out to more than a million 16- and 17-year-olds. It is expected ministers will on Wednesday ... Read more »

Obese mice lose weight ‘sweating out' fat in an immune system experiment, despite eating more

In search of better treatments for type 2 diabetes and other consequences of obesity, Taku Kambayashi has long wondered if he could harness a bodily function that most think about ... Read more »

NYC will have the first government-issued vaccine mandate in the US. Here's what we know.

NYC Mayor Bill de Blasio just mandated proof of vaccination for indoor restaurants, gyms and performance venues. Here’s how that will work. Read more »

Peak hospital admissions seems to have been reached, 44% fewer new infections

Increase in IC In the past week, 541 new COVID-19 hospitalizations were registered compared to 564 the week before. “In the past week, there were 130 new admissions to the ... Read more »

The Path to Forgiveness When Someone Hurts You: How to Forgive, Let Go, and Protect Yourself

When you’ve been hurt by someone you trust, you might feel angry or resentful, especially if it keeps happening. Forgiving the person who is hurting you can rid you of ... Read more »

How to Boost Your Confidence (13 Steps to Help Your Social Anxiety)

Are you sometimes nervous to speak up and say what’s on your mind? It’s okay to be a little shy every now and then, but it might prevent you from ... Read more »

This South Korean company has figured out how to get the best night's sleep. Does sleep tech work?

A lack of sleep not only makes us grumpy in the mornings but it can also affect our health too. There are a range of gadgets out there with many ... Read more »

NHS must work in “new ways” to deliver care, says new chief executive

Amanda Pritchard during a visit to University College Hospital London, following the announcement of her appointment as the new chief executive of the NHS in England. (PA) The health service ... Read more »

3 ways to show you've gotten the COVID-19 vaccine

Did you misplace your vaccine passport? Here are three other ways you can prove you’ve been vaccinated. Read more »

Covid-19 antibody test: what does your result mean? Why a high score is good but doesn't tell the whole story

Standing in a taxi queue recently I overheard a middle-aged man say to a woman of similar age ahead of him in line, “I got 650”. Whatever he was referring ... Read more »

One-third of all COVID cases reported in Florida and Texas; US reaches 70% of partially vaccinated adults: COVID-19 updates

Florida and Texas had one-third of all COVID cases reported last week, White House COVID-19 Response coordinator Jeff Zients said during a Monday news conference. Florida broke two records — ... Read more »

Rabobank to compensate customers who have paid too much interest

Photo: Rabobank Rabobank is working to settle thousands of customers who have paid large amounts of interest on consumer loans, Cooperative Bank said Tuesday. The decision focuses on the high ... Read more »

Covid UK news - live: PM U-turns on amber watchlist as England could be ‘over the edge' of third wave

✕ Close Boris Johnson hints at U-turn on amber watchlist Plans for an “amber watchlist” have been abandoned as ministers prepare to review the traffic light system which will decide ... Read more »

How to Verify a Physician's License in California

Before you choose a physician for any type of treatment, it’s always a good idea to verify their license. This assures you that their license is in good standing and ... Read more »

Sailing Bronze has won a total of 19 Dutch medals and will win even more.

Annemiek Bekkering and Annette Duetz during the race. Photo: Olaf Kraak ANP In the disappointing medal race of Sailor Annemiek Bekkering and Annette Duetz, she was pushed back to the ... Read more »

From AI to ice vests: How Tokyo 2020 athletes are adapting to the hottest Olympics ever

Tokyo 2020 is likely to go down in history as the hottest modern Olympic and Paralympic Games ever. Daily high temperatures in the Japanese capital have hovered around 31C throughout ... Read more »

How to Use a Monocular

A monocular is like a small telescope. It is smaller and lighter than binoculars while packing the same power. To use a monocular, make sure that you keep a firm ... Read more »

Poorer communities see twice as many smoking related cancers as richer areas, says study

Smoking is linked to poverty and is causing more cancers in poorer communities (Getty Images/iStockphoto) There are nearly twice as many cancers caused by smoking among the poorest people in ... Read more »

Paramedics left in tears from ‘unsustainable demand', warns union

Unison has warned ambulance chiefs that the pressure is taking its toll on their workforce (Getty) Paramedics are being left in tears at the end of stressful shifts, with some ... Read more »

How to Use Apple Health

This wikiHow teaches you how to get started with Apple Health on your iPhone. The Health app makes it easy to access your important health information, including your medical history, ... Read more »

How to Understand Social Distancing

The term “social distancing” is all over the news, but what does it really mean? This term refers to staying a specific distance away from other people to help prevent ... Read more »

How to Treat a Bruised Thigh Muscle

Ouch! A bruised thigh is no joke. The front of your thigh is composed of large muscles called your quadriceps, and anybody who’s ever taken a direct hit there can ... Read more »

How to Treat Tunnel Wounds

A tunnel wound is a secondary wound that occurs alongside a primary wound, and it’s usually caused by an infection or pressure. This kind of wound extends into layers of ... Read more »

How to Treat Overmethylation

Methylation is a fairly complex process, but basically, it’s the natural process where methyl groups (one carbon and three hydrogen atoms) are transferred throughout your body. This happens billions of ... Read more »

How to Treat Numbness in Legs and Feet

Numbness in your legs and feet can cause discomfort and awkwardness, but it’s usually no cause for alarm. If you sit or stand in the same position for an extended ... Read more »

How to Treat Liver Fibrosis

Your liver is an incredible organ—it can grow back from almost nothing. But if it’s damaged too often, it can lead to a condition called fibrosis. The good news is ... Read more »

50 per cent vaxxed is not enough to safely lift restrictions: Doherty Institute

If NSW reaches its target of 6 million Covid-19 vaccinations by the end of the month it will still be “a long way” from being safe from the virus, according ... Read more »

How to Treat Crepitus

Crepitus is a general term for the crackling or popping sound made by a joint. This is typically caused by cartilage or soft tissue rubbing against a joint during movement, ... Read more »

How to Treat Cold Feet

Having cold feet is a pretty common problem, especially during the wintertime. However, if you have persistent cold feet, you could have an underlying condition such as Reynaud’s phenomenon. Fortunately, ... Read more »

How to Treat Buttock Folliculitis

Folliculitis is a common condition causing inflamed hair follicles and a raised rash. While it can occur anywhere on your body, the buttocks are a common area for an outbreak. ... Read more »

'People who do not want to be vaccinated may go elsewhere': Court backs Indiana University mandate

INDIANAPOLIS — Students who don’t like Indiana University’s COVID-19 vaccine requirement can go elsewhere for their education. That was the message delivered by the 7th Circuit Court of Appeals in ... Read more »

How to Take a Mankind Unwanted Kit

A Mankind Unwanted Kit is made up of 1 pill called mifepristone and 4 pills called misoprostol that your OB/GYN can give you. These are taken to terminate an unwanted ... Read more »

How to Take Control of Your Health

No matter what our existing health, financial, mental, economic, or social situation is, there are things we can each do to take (better) control of our own health. No one ... Read more »

How to Take Care of Yourself

Taking care of yourself can feel like a really big task, but it doesn’t have to be overwhelming. Learn to manage your physical, mental, and emotional health so that you ... Read more »

Japanese shadow painting master delivers hope, delight in Seoul

Read more »

How to Store Ascorbic Acid

Ascorbic acid, or ascorbate, is another name for vitamin C. Ascorbic acid helps your body grow and repair itself and is an essential nutrient. Unfortunately, it is also very delicate ... Read more »