TTS Concerns Lead to the Removal of the Johnson & Johnson COVID-19 Vaccine
In a recent statement, the Centers for Disease Control and Prevention (CDC) declared that the Johnson & Johnson (J&J) COVID-19 vaccine is no longer available in the United States. The decision comes after the remaining U.S. government stock of the J&J vaccine expired on May 7, 2023. The CDC advised disposing of any remaining doses in accordance with local, state, and federal regulations.
For individuals who have already received the Johnson & Johnson vaccine, the CDC provided recommendations. It stated that individuals aged 18 years and older who have received one or two doses of the J&J vaccine should now receive one bivalent mRNA dose from either Moderna or Pfizer. The recommended interval between the previous J&J dose and the mRNA dose is at least two months.
Previously, the Johnson & Johnson vaccine gained popularity due to its single-dose requirement and its non-mRNA technology, which distinguished it from the Pfizer and Moderna vaccines. However, its use was significantly limited when the U.S. Food and Drug Administration (FDA) released a statement approximately one year ago, expressing serious concerns about a blood clotting disorder associated with the vaccine.
The specific condition mentioned in the FDA’s statement was Thrombosis with Thrombocytopenia Syndrome (TTS), a rare and potentially life-threatening combination of blood clots and low platelet levels. TTS, also known as Vaccine-Induced Prothrombotic Immune Thrombocytopenia (VIPIT) or Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT), typically manifests within four to 42 days after vaccination.
The symptoms of TTS vary depending on the location of the thrombosis. These can include persistent headaches, vision changes, seizures, confusion, coma (cerebral venous thrombosis), abdominal pain (splanchnic vein thrombosis), chest pain, shortness of breath (pulmonary embolism), leg pain, redness, swelling (deep vein thrombosis), symptoms resembling a heart attack (arterial ischemia), and bruising, rashes, and general bleeding (thrombocytopenia).
Research conducted by the CDC indicated that individuals who received the Johnson & Johnson vaccine were far more likely to experience TTS compared to those who received the mRNA vaccines (Pfizer and Moderna). According to the Vaccine Adverse Event Reporting System (VAERS), for every million doses administered, there were 3.55 reported cases of TTS associated with the Johnson & Johnson vaccine, compared to only 0.0057 cases per million for the other vaccines.
Following the FDA’s restrictions last year, the U.S. government halted the purchase of the Johnson & Johnson vaccine. Now, with the expiration of the purchased stock, the CDC confirms the vaccine’s discontinuation in the country. However, it’s important to note that TTS remains a rare occurrence with any vaccine, and swift recognition and treatment are crucial for a positive outcome.
From a financial standpoint, the back-and-forth regarding vaccines will cost the U.S. taxpayer approximately $125 million. The U.S. government had initially agreed to pay $1 billion for 100 million doses of the Johnson & Johnson vaccine, amounting to $10 per dose. However, only 31.5 million doses were purchased. As a result, 12.5 million unused doses will go to waste, representing a loss of approximately $125 million.
The removal of the Johnson & Johnson vaccine leaves three remaining players in the U.S. vaccination efforts: Pfizer, Moderna, and Novavax, which contains a nanoparticle version of the spike protein. The CDC’s guidance underscores the importance of vaccination and provides alternative options for individuals who received the Johnson & Johnson vaccine.
