J&J Shot’s Shelf Life Extended by FDA After Fear of SpoilingBy
Move comes as demand for shots eases and doses languish
Drug giant still awaiting clearance of contract manufacturer
Johnson & Johnson’s Covid-19 vaccine can be kept in a refrigerator for four and a half months, extending the shot’s shelf life by 50% as doses languish amid a slowing immunization campaign.
The company said in a statement that the Food and Drug Administration adopted the extension based on study data showing the vaccine is stable when refrigerated at 36 to 46 degrees Fahrenheit (2.2 to 7.8 degrees Celsius) for four and a half months. The FDA confirmed the adoption in an email.
As the U.S. vaccination effort slows, concern has been growing that some shots could spoil before they are used. About 1.1 million doses a day are being administered in the U.S., according to Bloomberg’s Vaccine Tracker, well below the daily peak of more than 3 million seen in April.
Organizations involved in the rollout, from CVS Health Corp. to Sanford Health to the Michigan Health & Hospital Association, said they have more J&J supply than they’ve been able to deploy as demand wanes. The groups had been exploring how to avoid waste as some J&J doses neared expiration at the end of June and in early July.
The FDA-adopted extension now comes as welcome news to many providers who are continuing -- slowly but surely -- to roll out the shot.
In Utah, Salt Lake County had roughly 8,000 J&J doses set to expire on June 23, said Rich Lakin, the state’s immunization manager, in an interview.
With the ticking clock pushing back another month-and-a-half, Utah will be well suited to hit President Joe Biden’s goal of having 70% of American adults vaccinated by the Fourth of July. “In Utah, some communities find the J&J option appealing,” he said.
Extending the shot’s shelf life will buy J&J some time to boost supply. The company has struggled to meet production targets after one of its most important contract manufacturers, Emergent BioSolutions Inc., was asked by U.S. regulators to stop making the vaccine’s underlying substance.
On April 16, the FDA demanded Emergent stop making any new materials and it quarantined the bulk drug substance already made. Earlier in the year, staff at an Emergent facility in Baltimore mixed up ingredients for the J&J shot and another developed by AstraZeneca Plc., prompting the companies to launch an internal investigation and the FDA to inspect the plant.
Though the inspection and Emergent’s subsequent remediation activities have since concluded, the U.S. health agency still hasn’t decided whether to allow Emergent to release ready-made doses of the J&J vaccine.
Until that clearance, J&J’s production capacity remains strained. The New Brunswick, New Jersey-based company had promised the U.S. 100 million doses by the end of June. The Biden administration wanted them by the end of May.
Louisiana Department of Health spokesman Kevin Litten and Utah’s Latkin said the states haven’t been getting new allocations of the J&J vaccine for weeks. Utah has turned to a federal pool of excess shots being shared by other states. Last week, the state ordered a small tranche of 2,500 doses.
It’s unclear how many new J&J vaccine doses will be needed for the U.S. to reach its immunization targets. Roughly 10 million J&J doses already delivered in the U.S. have yet to be administered, according to Centers for Disease Control and Prevention.
Some health-care providers continue to see interest in the J&J vaccine at the community level.
“We know there will be a role for the J&J vaccine moving forward,” said Nate Leedahl, manager of health system pharmacy at Sioux Falls, South Dakota-based Sanford Health, the largest provider of rural health care in the country. “When it comes to emergency departments, hospital discharges, we see a clear utility for the one-and-done option.
Not all providers are seeking shots beyond what they already have. Alabama is focusing on its existing stock, and has paused requests for more J&J vaccine, said state health officer Karen Landers.
In Georgia, the Gwinnett, Newton and Rockdale County Health Departments aren’t planning to order additional J&J doses due to lack of demand following a U.S.-mandated pause on administering the shot over a safety concern, said Chad Wasdin, the departments’ communications director.
The extended expiration date may allow the U.S. to keep its existing supply and donate future doses to low- and middle-income countries. The Biden administration has come under rising pressure to share the government’s stockpile with many nations still lacking vaccines.
The White House intends to buy 500 million doses of the Pfizer Inc.-BioNTech SE coronavirus vaccine to share internationally, Bloomberg reported on Wednesday, as the U.S. turns its attention to combating the pandemic globally.
— With assistance by Angelica LaVito, and Fiona Rutherford