FDA Puts Further Restrictions on Use of Janssen/Johnson & Johnson COVID-19 Vaccine

The US Food and Drug Administration (FDA) announced last week that it has limited the authorized use of Janssen/Johnson & Johnson’s COVID-19 vaccine for individuals 18 years of age and older for whom other authorized or approved vaccines are not accessible or clinically appropriate.

According to the FDA’s statement announcing the new limitations, the Janssen/Johnson & Johnson shot would also be available to people 18 years and older who choose to receive it because they are unable to receive any other COVID-19 vaccine.

The FDA’s said the tighter restrictions on the vaccine come after the federal health agency conducted an updated analysis, evaluation and investigation of reported cases, which revealed that the risk of thrombosis with thrombocytopenia syndrome (TTS) “warrants limiting the authorized use of the vaccine.”

TTS involves the occurrence of rare and potentially life-threatening blood clots in combination with low levels of blood platelets. According to the FDA, symptoms appear about one to two weeks following administration of the Janssen COVID-19 vaccine and include shortness of breath, chest pain, swelling in the leg(s), persistent abdominal pain, neurological symptoms like headaches or blurred vision, or petechiae, which are red spots on the skin (outside the vaccinated area).

Overall, the FDA maintains that the benefits of the vaccine continue to outweigh any risks associated with the one-dose shot in individuals 18 years of age and older.

TTS is a very rare side effect of the Janssen vaccine — the incidence has been about three cases for every one million doses of vaccine administered. The highest rate (eight cases in one million) of TTS has been in women 30 to 49 years of age. In a recent update of the vaccine’s fact sheet, the FDA reported that 15 percent of TTS cases have been fatal.

Related: CDC Backs J&J COVID-19 Shot Amid GBS and Delta Variant Concerns

The Centers for Disease Control and Prevention (CDC) maintain that mRNA vaccines, such as those from Pfizer/BioNTech and Moderna, are the preferred shots for COVID-19. The CDC says this means that Janssen’s vaccine is intended for people who have had a severe allergic reaction to an mRNA vaccine or have known allergies against an ingredient(s) in them, people with limited access to mRNA COVID-19 vaccines that would prevent them from getting vaccinated against COVID-19 and those who simply want to get the Janssen vaccine.

Janssen’s COVID-19 vaccine received emergency use authorization (EUA) from the FDA in February 2021.

“We’ve been closely monitoring the Janssen COVID-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the FDA statement.

“We recognize that the Janssen COVID-19 Vaccine still has a role in the current pandemic response in the United States and across the global community. … Today’s action demonstrates the robustness of our safety surveillance systems and our commitment to ensuring that science and data guide our actions.”

Janssen/Johnson & Johnson’s struggles with its COVID-19 shot began early. The FDA put the brakes on the company’s shot just six weeks after it had authorized it due to the TTS concerns. The pause was lifted after ten days, with the FDA saying that the vaccine’s benefits outweigh the risks, but attached a warning on its use.

Janssen’s shot was the third COVID-19 vaccine to have received FDA authorization in the US and was positioned to be an attractive alternative to the mRNA vaccines as an inexpensive, convenient vaccine given its single-dose regimen. However, concerns over blood clots led to the administration of only 18.7 million shots compared to the more than 340 million doses of Pfizer’s vaccine and more than 217 million doses of Moderna’s vaccine that have been dispensed in the country so far.

Last year, sales of Janssen’s vaccine reached $2.4 billion and the company estimated sales to hit between $3 billion and $3.5 billion this year. However, sales have been lackluster so far with the vaccine only bringing in $457 million in the first quarter this year, well below Wall Street’s projection of $785 million.