Things get pretty unfortunate for the much-awaited J&J vaccine as the European Medicines Agency (EMA), the European Union’s primal drug regulator on Friday found a potential link between Johnson & Johnson’s SARS COVID-19 vaccine and the involvement of rare cases of blood clotting in deep veins to those injected.
J and J Vaccine
J&J, an American Multinational corporation on February 27th announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine. It is solely developed by the Janssen Pharmaceutical Companies of Johnson & Johnson to prevent the transmission of COVID-19 in individuals 18 years of age and above.
This decision was established entirely based on constructive scientific evidence, including data from the PHASE 3 ENSEMBLE study that thoroughly demonstrated the above vaccine was 85 percent effective and far from average potent in thwarting severe disease across all regions.
It was under constant observation and manifested decent protection against COVID-19 related hospitalization and death rates during the initial 28 days post-vaccination.
Diagnosis of the clotting
This recent development was raised during a Pharmacovigilance Risk Assessment Committee assembly, the agency stated it found a possible link between Venous thromboembolism (VTE) and the J&J vaccine. Venous thromboembolism (VTE) is a medical diagnostic term referring to blood clots in the veins, an underdiagnosed and severe yet preventable medical condition that can cause disability and death.
The most highlighting complexity of DVT ensues when a part of the clot goes through a fracture and advances through the bloodstream to the lungs. As a result, causing a blockage called pulmonary embolism (PE). Fortunately, if the clot is at a minimum radius and with appropriate treatment, people can recover from PE. However, there could be corresponding damage to the lungs.
If the clot is large, it can substantially stop blood from reaching towards the lungs, leading to bronchopulmonary segment blockage, which is a fatal situation anyone gets into.
The severity of this side effect
Records suggest that 1/3rd to 1/5th of the population who are diagnosed with DVT will have long-term complications caused by the damage the clot does to the valves in the vein called post-thrombotic syndrome (PTS).
People with PTS have symptoms such as swelling, pain, discoloration, and scaling or ulcers in the affected part of the body in almost severe cases. In some instances, the symptoms can get critical that a person may find a way towards disability.
Regardless of being injected by the vaccine, VTE is most probably caused by injury or devoid of movement in bedridden patients. Birth control pills and several chronic conditions are also considered risk factors.
J&J – AstraZeneca likely to be out of the race?
The EMA also recommends that immune thrombocytopenia (ITP) should not overrule this situation as a mild ” error” and be listed as a side effect of the J&J vaccine and AstraZeneca’s vaccine.
ITP is a bleeding disorder in which “the immune system erroneously targets blood cells called platelets that are much needed for regulating the normal blood clotting.” While the J&J stated that such conditions are rare and contradictory, it will update the product information and work closely with EMA and other government agencies.
The J&J and AstraZeneca vaccines have previously been associated with an aberrant combination of blood clotting and low platelet counts known as thrombosis with thrombocytopenia syndrome (TTS). These products are based on harmless vector viruses that command the human cells to construct a protein that primes the immune system against future coronavirus infections.