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Johnson & Johnson vaccine once again available

Anyone considering getting the J&J vaccine will be informed of potential risks.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) recommended restarting use of the Johnson & Johnson vaccine on April 23, 2021, after a temporary pause. The pause followed reports of a rare adverse event called thrombosis with thrombocytopenia syndrome (TTS), or vaccine-induced thrombotic thrombocytopenia (VITT), which causes blood clots with low platelets among a small number of people, mostly women younger than 50 years old. There have also been a small number of reported cases among men, although confirmation of these diagnoses is pending by the CDC. Pausing the J&J COVID-19 vaccine allowed experts to evaluate the reports and better understand TTS.

After carefully reviewing the data, the CDC and FDA determined that the benefits of getting the J&J vaccine far outweigh potential risks. They estimated that every 10 million doses will prevent 600-1,400 deaths and 4,000-10,000 hospitalizations from COVID-19. The FDA and CDC will continue to closely monitor the safety and efficacy of all COVID-19 vaccines.

“As the CDC and FDA balanced the decision to go back to using the J&J vaccine, they balanced the risk of getting COVID-19, getting hospitalized by COVID-19, and even getting severely sick or dying because of the virus,” says Richard Orlandi, M.D., associate chief medical officer of ambulatory health at University of Utah Health.

As of April 23, 2021, more than 8 million doses of the J&J COVID-19 vaccine have been safely administered in the United States. The CDC found that serious adverse events following the use of the J&J vaccine are extremely rare, occurring at a rate of seven per one million vaccinations.

To put that in perspective, Andy Pavia, MD, chief of the Division of Pediatric Infectious Diseases at U of U Health, explains that patients are 40 times more likely to experience a severe blood clot in the brain during pregnancy and 30-40 times more likely to experience a blood clot while taking oral contraceptives. A person also has a significantly higher risk of developing a blood clot if infected with COVID-19—between a 10-30% risk if the patient is severely ill.

The vaccine is a safe option for patients 18 years and older and has specific advantages because it requires just one dose. “This is a great option for patients who can’t take time away from work or home,” Orlandi says. “Patients don’t need to worry about scheduling a second appointment for full immunity.” The vaccine is also convenient for health systems because it is easier to transport and handle, which is ideal for rural areas.

The pause had another important purpose: it gave the CDC time to identify common symptoms of TTS, or VITT, along with the best treatment. Officials have provided this information to health care providers nationwide, which ultimately led to the diagnosis and successful treatment of at least one patient with suspected TTS/VITT.

Anyone considering getting the J&J vaccine will be informed of the rare but increased risk for developing TTS/VITT and the availability of the other COVID-19 vaccines (Pfizer/BioNTech and Moderna), which do not have the same risk.