Johnson & Johnson announced on Tuesday that it is pausing the use of its single-dose COVID-19 vaccine in the U.S. and Europe while regulators review cases of blood clots in its recipients. In a joint statement, the FDA and CDC said that six women between the ages of 18 and 48 developed a rare and severe type of blood clot within 6 to 13 days after taking the J&J shot.
J&J’s vaccine, manufactured by its subsidiary pharmaceutical company Janssen, like all COVID-19 vaccines, has not been approved or licensed by the U.S. Food and Drug Administration (FDA) but has been authorized by FDA through an Emergency Use Authorization (EUA) for current immunization against COVID‑19 in individuals 18 years of age and older. Janssen’s website further explains its role in COVID-19 Global Vaccination as follows:
The authorization or approval status of Janssen’s COVID-19 vaccine varies by country. Unless approved or licensed by the relevant health authority, the product is investigational, and its safety and efficacy have not been established.
Today, the FDA and CDC recommended a pause in the use of the Johnson & Johnson vaccine. Here’s what you need to know: pic.twitter.com/QVtrEkqO8F
— President Biden (@POTUS) April 14, 2021
The blood clotting that halted the J&J vaccine, called cerebral venous sinus thrombosis (CVST), appeared in combination with low levels of platelets, which is a condition called thrombocytopenia. According to the National Institute of Health (NIH), thrombocytopenia can be inherited or acquired and occurs when the body’s bone marrow—the sponge-like tissue inside the bones that contains stem cells that develop into red blood cells, white blood cells, and platelets—either doesn’t make enough platelets, it makes enough platelets, but the body destroys them, or the spleen holds onto too many platelets.
The NIH, which boasts Dr. Anthony Fauci as Director of its National Institute of Allergy and Infectious Diseases (NIAID), lists several factors that can negatively influence platelet production in the bone marrow and lead to thrombocytopenia, including viruses; medicines (like heparin, which is a blood thinner typically be given to reduce clotting), toxic chemicals (the J&J vaccine contains the toxic chemical ethanol); autoimmune diseases; and two rare and serious conditions called thrombotic thrombocytopenic purpura (TTP) and disseminated intravascular coagulation (DIC).
In a September 2020 study for the “Public Health Emergency Covid Initiative,” the NIH declared that immune thrombocytopenia (often known as immune thrombocytopenic purpura, or ITP) “has emerged as an important complication of COVID-19.” The study states:
COVID-19 has been associated with a systemic hyperinflammatory state resembling secondary hemophagocytic lymphohistiocytosis. A distinct coagulopathy with a high risk of thrombosis has also been observed, which has mandated clinicians to screen moderate-to-severe COVID-19 patients with sepsis-induced coagulopathy (SIC) score or disseminated intravascular coagulation (DIC) score. Both these conditions can cause thrombocytopenia.
The NIH study indicates that due to the high risk of thrombosis (blood clotting) in patients, heparin is recommended for all adolescents and adults hospitalized with COVID-19. However, the joint statement from the CDC and FDA following the suspension of J&J’s COVID-19 vaccine advises against using heparin, declaring:
Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.
Out of the approximately 7 million Americans who have received the J&J shot, allegedly just six have developed the rare but severe clotting disorder. The CDC and FDA’s statement seems to indicate that the Janssen vaccine is notably more problematic than we are being told, and this could be just the tip of the iceberg.
Physician-scientist Hooman Noorchashm MD, Ph.D. believes that is the case. He says it is extremely likely that the irregular and random administration of these vaccines to individuals who recently either had the natural SARS-CoV-2 virus or were infected with it when vaccinated is the cause of the clotting complications. His hypothesis seems logical considering the NIH study confirmed, as stated above, that immune thrombocytopenia has emerged as a significant complication of COVID-19.
Dr. Noorchashm goes a step further to suggest that both the Moderna and Pfizer vaccines are most likely causing similar clotting problems that the CDC and FDA are downplaying “because of the critical urgency of achieving herd immunity to the virus.” He further states:
“In other words, I am quite confident that the J&J vaccine is NOT intrinsically defective or dangerous—neither are the Pfizer, Moderna, or AstraZeneca versions of these vaccines. Rather, in my opinion, it is highly likely that inappropriate and indiscriminate administration of these vaccines to persons recently or concurrently infected with the natural SARS-CoV-2 virus is the cause of the clotting complications.”
Dr. Anthony Fauci says the rare blood clotting that led to recommended pause of Johnson & Johnson's COVID vaccine "really doesn't mean anything" about the efficacy of the vaccine for people who have received it https://t.co/Nj065CIsxp pic.twitter.com/lNbBba0E2Y
— CBS News (@CBSNews) April 13, 2021
Overwhelming evidence suggests that long before COVID-19 vaccines were available, the NIH and others in the scientific community were well aware of the correlation between SARS-CoV-2 and thrombotic diseases, including thrombocytopenia, which resulted in critical implications for treatment. A study published in Nature last July surrounding thrombotic diseases maintained:
In one review of 1,026 patients with a diagnosis of COVID-19, ~40% had a history of comorbid conditions consistent with a high likelihood of thrombosis. However, even compared with the expected rate of thrombosis in patients in ICUs, reports began to emerge around the world confirming a disproportionate prevalence of abnormal coagulation tests and thrombotic events in patients with COVID-19, even those who were not in ICUs. As case series began to be published from around the world, it became more clear that many of these organ impairments were thrombotic in nature. Furthermore, some of the patients who experienced severe thrombotic events were young people without known risk factors.
According to Dr. Fauci, the J&J vaccine pause won’t last long, but it remains to be seen what answers the confused American public will be given before the campaign resumes. Logic would dictate that, in the middle of an unprecedented mass-vaccination effort, the population deserves transparent and detailed information about this serious situation. On Tuesday, Fauci stated that, according to his understanding of the guidance from the CDC and FDA, the delay should only last “days to weeks,” adding:
“What I heard from the previous press discussion was it’s gonna be more like days to weeks rather than weeks to months.”
Meanwhile, late Wednesday, after meeting to discuss, their policy options and recommendations for Janssen moving forward given the current circumstances, the CDC’s Advisory Committee on Immunization Practices (ACIP) extended the pause of the J&J vaccine although they didn’t elaborate for how long. With several unknowns, including the true background incidence of CVST with low platelet count, specific risk factors, ability to compare thrombotic cases post-vaccination between AstraZeneca and J&J vaccines, and true incidence of cases specific to J&J vaccine recipients, several committee members felt there was insufficient data to make an evidence-based decision.