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The EU medicines watchdog recommended that the possible side effects of tinnitus, dizziness and blood platelet hypoplasia be added to the product information of Johnson & Johnson’s Covid vaccine, after reviewing the data on the vaccine.
In an update on Covid vaccine safety concerns released on Friday, the European Medicines Agency (EMA) said tinnitus, more commonly known as ringing in the ears, as well as dizziness, should be included in the list possible side effects of the injection vaccine alone, after finding out that the conditions were related to jab.
EMA said update product information is needed “To alert healthcare professionals and people who get vaccinated to these potential side effects.”
According to the regulator’s statement, 1,183 cases of dizziness have been reported among anxiety-related responses after vaccination with the J&J jab. However, reports of tinnitus were significantly lower, with six cases reported in clinical trials and Johnson & Johnson recording 108 incidences. “During the follow-up of spontaneous reports”, the EMA said.
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The agency also recommended that immune thrombocytopenia – a disorder in which the immune system mistakenly attacks and kills blood cells in platelets – be reclassified as “A significant identified risk”. The EMA had previously listed the condition as only one “potential” risk of single injection vaccine.
Despite the low risk of rare side effects, the EU medical regulator said “The benefit-risk ratio of the vaccine remains unchanged. “
In July, the EMA advised people who have suffered from capillary leak syndrome in the past not to opt for the vaccine and that the side effect should also be added to the list of possible side effects.
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The effectiveness of the Johnson & Johnson jab was found to be lower than that of other Covid inoculations, including the two-dose mRNA vaccines produced by Pfizer / BioNTech (95%) and Moderna (94.5%). In phase three clinical trials, J&J jab was found to be 66% effective. Meanwhile, the efficacy of the Oxford / AstraZeneca vaccine has been shown to be 79% protective against symptomatic Covid, and Russia’s Sputnik V has been shown to be 91.6% effective, according to data published in The Lancet. .
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