The EMA’s safety assessment committee concluded on April 20 that the vaccine’s label should include blood clots as a potential rare side effect and state that the benefits of the vaccine outweigh these risks.Īuthorities are uncertain what causes these cases of blood clotting. Also, the majority of the eight vaccine recipients who experienced these side effects were women. Most of these cases of thrombosis with thrombocytopenia were extremely rare types, including cerebral venous sinus thrombosis (CVST), which occurs in the brain.Īll eight cases occurred within 21 days of vaccination in people under the age of 60. Similar to the AstraZeneca COVID-19 vaccine - Vaxzevria - the Johnson & Johnson vaccine was put on hold after eight cases of a rare blood clotting disorder, in combination with low blood platelet counts, were found in the vaccine recipients. People who have had a severe allergic reaction to any of the vaccine’s ingredients should not receive this particular shot. The CDC advises that anyone with a known allergy to any of the vaccine’s ingredients, including polysorbate 80, seek advice from a healthcare professional before receiving the COVID-19 vaccine. For the Pfizer vaccine, an analysis of one patient who experienced PEG-related anaphylaxis showed that they had a history of allergic reactions to PEG-containing products.Īn evaluation of vaccine allergies with PEG and polysorbate skin testing concluded that the usefulness of skin testing in predicting potential allergic responses remains unclear. While knowledge about the mechanisms of this allergy is limited, PEG and polysorbate allergies are extremely rare. According to the FDA, a severe reaction can be characterized by:Īn ingredient that has raised particular concerns about allergic response is polysorbate 80, a chemical that is structurally related to polyethylene glycol (PEG), found in Pfizer’s and Moderna’s mRNA vaccines, both of which have prompted similar worries. The World Health Organization (WHO) has stated that, while it continues to monitor the safety responses from regulatory agencies, the vaccine is safe and effective against the severe risks of COVID-19.Īs with other COVID-19 vaccines, the Johnson & Johnson vaccine has a low but potential risk of causing an allergic reaction.Ī non-severe allergic reaction may include symptoms such as hives, swelling, rash, and respiratory problems.Ī more severe, anaphylaxis response is much rarer. Moreover, both agencies want women to know that alternative COVID-19 vaccines are available, for which there are currently no reports of rare blood clots. They noted, however, that women under the age of 50 should be aware of the risk of rare blood clots. On April 20, the company announced it would resume distribution of its vaccine in the European Union but with a safety warning, after the EMA concluded that the vaccine’s benefits continue to outweigh its risks.Īfter halting vaccination in the United States a few weeks ago, the FDA and the CDC recently recommended that vaccinations resume. At the same time, Johnson & Johnson delayed the distribution of the vaccine in Europe while the EMA conducted its own review. However, the FDA recommended a pause in the vaccine’s use, as a precautionary measure following a small number of rare blood clot incidents.
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