The European Union’s (EU) drug regulator, the European Medicines Agency (EMA), has discovered a potential link between Johnson & Johnson’s Janssen COVID-19 vaccine and incidents of blood clots in an individual’s deep veins. The issue was highlighted in a Pharmacovigilance Risk Assessment Committee (PRAC) meeting during the last week of September.
In its meeting highlights, published on the EMA website, the agency states that PRAC has “concluded” there is a possible link between rare cases of venous thromboembolism (VTE) and the Janssen vaccine. VTE is a medical condition in which a blood clot forms in a deep vein, potentially traveling to the lungs. This can cause a blockage of blood supply that could threaten a person’s life. The deep vein clot is usually formed in the arms, leg, or groin.
According to the EMA, VTE was included in the risk management plan for Janssen. This was done after it came to light, in a recent study, that a higher proportion of VTE cases occurred among a vaccinated group rather than the placebo group. Taking “all evidence into account,” PRAC concluded that there is a “reasonable possibility” of VTE risk from the vaccine. As such, the committee has recommended J&J to list VTE as a rare side effect of the Janssen vaccine in its product information.
PRAC also identified potential ties between Janssen and immune thrombocytopenia (ITP), a condition in which the blood cells called platelets are mistakenly targeted by the immune system. As with VTE, PRAC also recommended including ITP as a potential adverse reaction in the product information of Janssen.
“If an individual has a history of ITP, healthcare professionals should consider the risk of developing low platelet levels prior to administering the vaccine. In individuals with a history of ITP, it is recommended to monitor platelet levels following vaccination with COVID-19 Vaccine Janssen,” the agency said in its meeting highlights. The risk of VTE should also be taken into consideration when administering the Janssen vaccine to people with high risk factors for blood clots.
The EMA decision comes as one of the EU’s member states, Slovenia, temporarily suspended the use of the J&J vaccine on Sept. 29 following the death of a 20-year-old woman. The victim died of a stroke and had been administered a J&J vaccine two weeks earlier. The suspension will continue until experts are able to ascertain whether there was a link between the woman’s death and her vaccination.
“The patient had blood clots and bleeding in the brain at the same time, intensive care was not successful,” Igor Rigler, a neurologist at the Ljubljana hospital center, told a local news agency.
Around 120,000 people in Slovenia have been administered the Johnson & Johnson vaccine. The government has placed an order for an additional 100,000 doses. Slovenia has seen large protests against the administration’s vaccination measures.
In the United States, the company is seeking Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for using its vaccine as a booster shot among citizens aged 18 and above. J&J claims that booster shots administered after six months of the one-shot vaccine increase antibodies by 12 times in the first month.
“Our clinical program has found that a booster of our COVID-19 vaccine increases levels of protection for those who have received our single-shot vaccine to 94 percent. We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” Mathai Mammen, the Global Head of Janssen Research & Development at Johnson & Johnson, said in a statement.