2023-05-25| COVID-19Special

CDC Calls an End to J&J’s COVID-19 Vaccine in the U.S.

by Reed Slater
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After struggling to keep pace with its mRNA competitors, Johnson & Johnson’s single-dose COVID-19 vaccine’s time has come to an end, according to a recent CDC announcement. With the U.S. market shuttered, J&J will have to start pursuing markets in other countries that may still benefit from the adenovirus vaccine. 

Related Article: J&J’s Single-Shot Vaccine Becomes Third to Bag FDA’s Emergency Use Authorization

The Turbulence of J&J’s COVID-19 Vaccine From Beginning to End

Even before gaining Emergency Use Authorization (EUA), J&J’s COVID-19 jab faced criticism due to its relatively low efficacy rates. Still, the vaccine received a unanimous recommendation from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) just a day before receiving an EUA to prevent COVID-19 in February 2021. 

J&J’s COVID-19 vaccine marked the third authorized COVID-19 vaccine following Pfizer/BioNTech’s and Moderna’s mRNA vaccines. It brought to the table an alternative to the new and intimidating mRNA vaccines with the added benefit of requiring only a single dose, while its competitors called for two shots.

It didn’t take long before the vaccine started a ruckus. In April 2021, just a little over a month after gaining its EUA, the FDA and the CDC jointly called for a pause in administering J&J’s COVID-19 vaccine nationwide. The agencies cited six reports of rare blood clots in individuals who had recently received the vaccine. 

At the time of the pause, nearly 7 million doses of the J&J vaccine reached Americans across the country in the short period it had been authorized. A week later, the FDA and CDC agreed to resume vaccinations, but this time with a warning label about the risk of blood clots. Although vaccinations were permitted to continue, the vaccine had difficulty shedding the stigma, especially with effective competition always one step ahead.

By May 2022, J&J hit another massive roadblock when the FDA decided to limit the use of J&J’s vaccine due to the risk of blood clots. This time, the restriction remained permanent, with few exceptions for those who could receive the J&J jab. Under the new limitations, only people who had adverse reactions to an mRNA vaccine or those who lived in areas with limited availability of mRNA vaccines were eligible to receive the J&J vaccine. 

A Fire That Once Burned Brightly Fizzling Out

After all the hiccups, J&J’s vaccine struggled to keep up with the revolutionary mRNA vaccines brought forth by Pfizer/BioNTech and Moderna. Over the COVID years, the vaccine brought in less and less money for J&J, forcing the company to look to other areas to make up for the lack of activity in the U.S. market. 

The most recent CDC announcement said that the vaccine is no longer available in the U.S. and that all government stock expired on May 7. The agency ordered the disposal of any remaining stock in accordance with local, state, and federal regulations. 

The announcement also noted that anyone over the age of 18 who has received the J&J vaccine in the past should consider receiving at least one dose of a bivalent mRNA vaccine. 

In total, healthcare providers administered just over 19 million doses of J&J’s vaccine in the U.S. during its run out of over 31 million delivered doses. Last year, J&J recorded $2.17 billion in sales from the vaccine, but that number is drastically lower than what the company expected. 

J&J had a good run with its single-dose vaccine, especially during the pandemic’s early days of uncertainty. With the U.S. market closed off to the vaccine, J&J will have to look elsewhere to keep delivering the vaccine to areas in need where mRNA vaccines might not be as readily available. 

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