EU adds another rare blood condition as side effect of AstraZeneca shot

Cites another rare blood condition as side effect

Europe’s drug regulator on Friday identified another rare blood condition as a potential side effect of AstraZeneca's Covid-19 vaccine and said it was looking into cases of heart inflammation after inoculation with all coronavirus shots.
 
The European Medicines Agency’s (EMA) safety committee said that capillary leak syndrome must be added as a new side effect to labelling on AstraZeneca's vaccine, known as Vaxzevria.
 
People who had previously sustained the condition, where fluids leak from the smallest blood vessels causing swelling and a drop in blood pressure, should not receive the shot, the EMA added.
 

The regulator first began looking into these cases in April and the recommendation adds to AstraZeneca’s woes after its vaccine was associated with very rare and potentially lethal cases of blood clotting that come with a low platelet count.

 
Last month, the EMA had advised against using the second AstraZeneca shot for people with that clotting condition, known as thrombosis with thrombocytopenia syndrome (TTS).
 

FDA orders J&J to discard 60 mn doses
 
Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation. The FDA plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices. NYT