Leading COVID Vaccines Linked to Rare Side Effects Medicines & Vaccines 13/07/2021 • Madeleine Hoecklin Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Johnson & Johnson’s single-dose COVID-19 adenovirus vaccine. The single-dose Johnson & Johnson COVID-19 vaccine could lead to an increased risk of a rare neurological condition, warned the US Food and Drug Administration (FDA) on Monday, adding it to the list of possible side effects. This comes along with a series of new reports on the side effects associated with the leading COVID-19 vaccines, which are becoming more evident through mass immunisation campaigns. The neurological disorder, Guillain Barré syndrome (GBS), is one in which the immune system damages nerve cells, causing muscle weakness and occasionally paralysis. Symptoms of the disorder include weakness or tingling sensations in the arms or legs; difficulty walking; difficulty with facial movements; double vision; and difficulty with bladder control. An estimated 3,000 to 6,000 people develop GBS each year in the US, most commonly those over the age of 50. Symptoms were reported in some of the recipients of the jab within 42 days of immunisation. “The chance of having this occur is very low,” said the updated FDA guidelines. There have been 100 preliminary reports of the syndrome in vaccine recipients, 95 of which were deemed serious and required hospitalisation. One case was fatal. With 12.8 million people immunized with the J&J vaccine, there is a rate of approximately one case of GBS per 128,000 people vaccinated. The reports were made to the Vaccine Adverse Events Reporting System, a federal early warning system that monitors the safety of vaccines and possible health problems after vaccination. “Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship,” said the FDA. The agency emphasised that it “continues to find [that] the known and potential benefits [of the vaccine] clearly outweigh the known and potential risks.” The CDC Advisory Committee on Immunization Practices will reportedly discuss the warning at its next meeting, which is scheduled for late October. J&J announced that the adverse event report would be shared with national and regional regulatory agencies that have authorised the vaccine, along with the World Health Organization (WHO). Rare Blood Clotting Associated with J&J Vaccine This is the latest blow to the J&J vaccine, which has been sidelined in the United States. The vaccine was investigated in April by the CDC, FDA, and European Medicines Agency (EMA) for links to cases of blood clotting. Use of the vaccine was temporarily paused in the US, which contributed to public hesitancy about the jab. According to the US Centers for Disease Control and Protection, there is a “plausible causal relationship” between the J&J vaccine and thrombosis with thrombocytopenia syndrome, blood clots combined with low platelet levels. The European Medicines Agency (EMA) also noted the potential connection, but emphasised that it was a “very rare event.” Some 12.8 million doses of J&J’s vaccine have been administered in the US, only 4% of the total number of vaccines administered nationally and far lower than the 185.5 million doses of Pfizer/BioNTech’s vaccine administered or the 135.9 million doses of Moderna’s vaccine. Heart Inflammation Warning for Pfizer and Moderna Vaccines A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US. A warning to patients and healthcare providers was issued by the FDA in late June for the increased risk of heart inflammation associated with the Moderna and Pfizer/BioNTech vaccines. The EMA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have followed suit by launching investigations. Over 1,200 cases of myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the outer lining of the heart, have been reported in the US, the majority in patients under the age of 30. The symptoms often included shortness of breath, a fast-beating, irregular, or pounding heartbeat, and chest pain. Confirmed cases have occurred mostly in men aged 16 or older. Symptoms emerged within several days of the vaccination and more often after the second dose. A total of 321.4 million mRNA vaccines have been administered so far, meaning there have been approximately 12.6 cases per million doses administered. “The risk of myocarditis and pericarditis appears to be very low given the number of vaccine doses that have been administered,” said Janet Woodcock, acting FDA commissioner, in a statement. In Europe, 145 cases of myocarditis have been reported among those who received the Pfizer/BioNTech vaccine and 19 cases among people who received the Moderna vaccine. Some 138 cases of pericarditis were reported in individuals following the administration of Pfizer’s vaccine, compared to 19 cases with Moderna. The cases were fatal for five people, who were either of advanced age or had concomitant diseases. As of mid July, some 284.6 million doses of Pfizer and 36.1 million doses of Moderna have been administered in Europe. The EMA’s safety committee found that the two types of heart inflammation conditions “can occur in very rare cases.” Both the EMA and FDA reaffirmed that the benefits of the vaccines continue to outweigh their risks, particularly given the risk of COVID-19 illness. Shingles as Possible Side Effect of Pfizer Vaccine A study, conducted in Israel and published in Rheumatology journal in April, examined cases of shingles in patients with autoimmune inflammatory rheumatic diseases (AIIRD) after they received the Pfizer/BioNTech vaccine. Singles (herpes zoster) is a painful rash that can be accompanied by a fever, headache, chills, and an upset stomach. It is caused by the varicella zoster virus, the same virus that causes chickenpox. The virus can be reactivated in people who have recovered from chickenpox. The study, which had 491 participants, found that six female patients between the ages of 35 and 65 developed shingles for the first time in their lives after either the first or second dose. The Pfizer/BioNTech vaccine “might provoke reactivation of herpes zoster in patients with AIIRD,” said the authors. The study suggested a “potential causal link between the vaccination and reactivation of zoster infection,” while some researchers argue that there is insufficient evidence to make that claim. “We cannot say the vaccine is the cause at this point,” Dr Victoria Furer, lead researcher on the study, told the Jerusalem Post. “We can say it might be a trigger in some patients.” “So far, the data indicates that shingles and herpes are not occurring at an increased rate in the vaccinated population,” said Dr William Schaffner, Professor in the Division of Infectious Diseases at the Vanderbilt University School of Medicine. Image Credits: Johnson & Johnson, Johnson & Johnson, Flickr – Official US Navy. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.