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EU regulator recommends blood clot warning on labels for J&J vaccine

Agencies/London
Filed on April 20, 2021
Reuters file

The European Medicines Agency says the vaccine’s overall benefits outweigh risks.


Experts at the agency that regulates drugs for the European Union said on Tuesday that a warning about very unusual blood clots should be added to labels for Johnson & Johnson’s Covid-19 vaccine. The European Medicines Agency (EMA) said these rare blood disorders should be considered as “very rare side effects of the vaccine”.

Last week, Johnson & Johnson halted its European roll-out of the vaccine after US officials recommended a pause in the vaccine, when they detected six very rare blood clot cases among nearly 7 million people who had been vaccinated.

European officials said they considered all currently available evidence from the US, including eight reports of serious cases of rare blood clots associated with low blood platelets, including one death.

The EMA found that all instances had occurred in adults under 60 years, mostly women, within three weeks of vaccination, adding that all available evidence, including eight reports of cases in the US, were part of its assessment.

It also said that most clots had occurred in the brain and abdomen, similar to AstraZeneca’s vaccine, and reiterated that the vaccine’s overall benefits outweigh risks.

Johnson & Johnson advised European governments to store their doses until the EU drug regulator issued guidance on their use; widespread use of the shot in Europe has not yet started.

The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems and concerns over unusual blood clots also in a small number of people who received the AstraZeneca Covid-19 vaccine. Experts worry the temporary halt on J&J’s shot could further shake vaccine confidence and complicate worldwide Covid-19 immunisation efforts.

Last week, South Africa suspended its use of the vaccine in the wake of the US pause, and countries including Italy, Romania, the Netherlands, Denmark and Croatia put their J&J doses into storage.

The blood clots linked to the J&J vaccine are occurring in unusual parts of the body, such as veins that drain blood from the brain. Those patients also have abnormally low levels of blood platelets, a condition normally linked to bleeding, not clotting.

With the AstraZeneca vaccine, scientists in Norway and Germany have suggested that some people are experiencing an abnormal immune system response, forming antibodies that attack their own platelets.

The European Union ordered 200 million doses of the Johnson & Johnson for 2021 and EU officials had hoped the one-shot vaccine could be used both to boost the continent’s lagging vaccination rates and to protect hard-to-reach populations, like migrant workers and the homeless.

Last month, the African Union announced it signed a deal to buy up to 400 million doses of the J&J vaccine. Johnson & Johnson also has a deal to supply up to 500 million doses to the UN-backed Covax initiative that helps get vaccines to the world’s poor.





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