Johnson and Johnson on Tuesday, 20 April, said that it will resume roll-out of its single-shot COVID-19 vaccine in Europe after the European Union’s drug regulator announced that blood clots were a very rare side effect of the vaccine and “its benefits outweigh the risk”.
The European Medicines Agency (EMA) has recommended a warning should be added to the vaccine’s product information.
“Healthcare professionals and people who receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” stated the EMA.
The EMA stated that it found a possible link between Johnson and Johnson’s COVID vaccine and rare cases of blood-clotting disorders “very similar” to the those that have occurred with the Oxford-AstraZeneca jab.
The approval from the European Regulators clears a path for J&J in Europe and may also assist the US drug regulators to approach the vaccines side-effects.
In its statement, J&J stated that it will resume its shipment of vaccine to European Union (EU), Norway and Iceland.
“The safety and well-being of the people who use our products is our number one priority. We appreciate the rigorous review of the PRAC and share the goal of raising awareness about the signs and symptoms of this very rare event to ensure the correct diagnosis and appropriate treatment.”Paul Stoffels, MD, Vice-Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.
Both the Johnson & Johnson vaccine and the Oxford-AstraZeneca vaccine, which is manufactured by Serum Institute in India and marketed as Covishield, were under the scanner last week after several European countries and the US reported cases of rare blood-clotting disorders associated with its administration.
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