Last month, when Johnson & Johnson said it would not include COVID-19 vaccine sales in its revenue forecast for the year, it seemed an obituary was being written for the ill-fated jab.
Now, the FDA has stepped in, restricting the use of the J&J shot because of the threat of rare but serious blood clots.
On Thursday, in an oddly worded statement, the U.S. regulator limited use of the J&J vaccine to those 18 and older who cannot access other vaccines. Also excluded from the restrictions are those who “elect to receive the Janssen COVID-19 Vaccine because they would otherwise not receive a COVID-19 vaccine.”
The ruling brings the vaccine back to where it started just over a year ago. Six weeks after the shot launched, the FDA paused its use because of the threat of thrombosis or thrombocytopenia syndrome (TTS). But 10 days later, on April 23, the regulator lifted the pause saying the benefit of the shot outweighed the risk and attaching a warning to its use.
Thrombotic events associated with use of the J&J shot have appeared one to two weeks after administration. While making the ruling, the FDA still maintains that the benefit of the shot still outweighs the risk.
In December, the CDC recommended the use of other vaccines because of the blood clot threat. Now, additional analysis has convinced the FDA to adjust its emergency use authorization further.
Once hailed as convenient and inexpensive option to the double-dose vaccines produced by Pfizer, Moderna and AstraZeneca, the single-shot J&J vaccine struggled to find its niche.
While more than 340 million doses of the Pfizer shot and more than 217 million doses of the Moderna jab have been administered in the U.S., only 18.7 million J&J shots have been used.
Sales of the J&J vaccine reached $2.4 billion last year. In February, the company predicted sales this year to fall between $3 billion and $3.5 billion.
But last month, when J&J reported disappointing sales of $457 million for the vaccine for the first quarter—far short of Wall Street’s estimate of $785 million—the company said it would not include revenue from the shot in its guidance for the year.
“Market demand for all COVID-19 vaccines is currently challenged by global supply surplus and vaccine hesitancy in developing markets,” J&J chief financial officer Joseph Wolk, said then in a conference call.