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The US health regulators on Friday, 23 April, said that the Johnson & Johnson COVID-19 vaccines can be put to use again, reported AFP. The rollout of the vaccine was paused due to concerns over cases of blood clotting.
The resumption of the vaccine came shortly after an expert panel recommended lifting the pause as the vaccine benefits exceeded its dangers.
Janet Woodcock, head of Food and Drug Administration in a joint statement with the Centers for Disease Control and Prevention (CDC) said, "We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older.”
CDC head Rochelle Walensky, in a statement said that ‘exceptionally rare events’ of clotting were found. He also said that the regulators will continue to observe the rollout of the J&J vaccines, reported AFP.
13 out of those 15 women were under 50 years of age. There were no reported cases among men.
On Tuesday, Johnson and Johnson said that it will resume roll-out of its 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) recommended a warning should be added to the vaccine’s product information but said blood clotting was ‘rare’. 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.
In its statement, J&J stated that it will resume its shipment of vaccine to European Union (EU), Norway and Iceland.
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 after several European countries and the US reported cases of rare blood-clotting disorders associated with its administration.
(With inputs from AFP)
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