EMA: Benefits of Johnson & Johnson Vaccine Far Outweigh The Risks

The European Medicines Agency (EMA) has identified a possible link between Johnson & Johnson’s Covid-19 vaccine and very rare cases of blood clots. However, cases with these side effects are in single figures among millions vaccinated, meaning that the benefits of the vaccine outweigh the potential risks. Photo Credit: Freepik / Illustrative Photo.

Czech Rep., Apr 22 (BD) – EU countries are expected to receive 55 million doses of the Johnson & Johnson vaccine during the second quarter of the year, and according to the government’s vaccination strategy, 2.2 million doses are intended for the Czech Republic by the end of the year.

However, last week, the American company Johnson & Johnson temporarily paused deliveries of its vaccine to Europe for precautionary reasons, due to several instances in the United States of health problems after vaccination.

Of the seven million vaccinated with the Johnson & Johnson vaccine so far, there have been eight cases of thromboembolic complications, including one death, appearing in people under the age of 60, mostly women, three weeks after vaccination.

At a meeting on April 20th, the EMA stated that the benefits of the vaccine far outweigh its risks, and that a warning about unusual blood clots for those with low blood platelets should be added to the vaccine’s product information. One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to the one sometimes observed in patients with heparin-induced thrombocytopenia (HIT). By recognizing the signs of blood clots and low blood platelets and treating them early, healthcare professionals can assist those who are affected and avoid complications.

The assessment of safety signals, carried out by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC), seeks to establish whether a causal relationship between the medicine and the adverse event is at least a reasonable possibility. It also underpins the safe and effective use of COVID-19 vaccines. The EMA’s recommendations are the foundation upon which individual EU Member States will design and implement their national vaccination campaigns. These may differ from country to country depending on their national needs and circumstances, such as infection rates, priority populations, vaccine availability, and hospitalization rates.

As for all vaccines, the EMA will continue to monitor the vaccine’s safety and effectiveness and provide the public with the latest information.

The risk of experiencing this side effect is very low, but anyone receiving this vaccine should still be aware of symptoms so they can seek prompt medical treatment to help recovery and avoid complications. Individuals must seek urgent medical attention if they have any of the following symptoms in the three weeks after being vaccinated with the Johnson & Johnson Covid-19 vaccine:

  • shortness of breath
  • chest pain
  • leg swelling
  • persistent abdominal (belly) pain
  • neurological symptoms, such as severe and persistent headaches or blurred vision
  • tiny blood spots under the skin beyond the site of the injection.

Speak to your healthcare professional or contact your relevant national health authorities if you have any questions about your vaccination.

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