EMA Finds Link Between Johnson & Johnson Vaccine and Blood Clots
"In its statement Tuesday, the EMA said that its drug safety group"
Europe’s drug regulator, the European Medicines Agency (EMA) said
Tuesday it found a possible link between the Johnson & Johnson
COVID-19 vaccine and rare forms of blood clots, but that the drug’s
benefits outweigh its risks.
In its statement Tuesday, the EMA said that its drug safety group, the
Pharmacovigilance Risk Assessment Committee (PRAC), after reviewing all
available evidence, concluded that the Johnson & Johnson vaccine’s
product information should include a warning about unusual blood clots
with low blood platelets.
The committee concluded that the events should be listed as very rare side effects of the vaccine.
The EMA gave a similar assessment of the AstraZeneca vaccine which also was found to have a possible link to rare blood clots.
The EMA gave a similar assessment of the AstraZeneca vaccine which also was found to have a possible link to rare blood clots.
The EMA reviewed the Johnson & Johnson vaccine following a small
number of reports from the United States of serious cases of unusual
blood clots associated with low levels of blood platelets among people
who had received the vaccine - one of which had a fatal outcome. As of
April 13, more than 7 million people in the U.S. had received Johnson
and Johnson’s vaccine.
All cases occurred in people under 60 years of age within three weeks of vaccination, the majority in women.
The reports prompted the U.S. Centers for Disease Control (CDC) and the
Food and Drug Administration to recommend a "pause” in the use of the
vaccine in the United States while further evaluations were carried out.
On Monday, top U.S. immunologist and Chief Presidential Medical Advisor
Anthony Fauci told reporters the pause on the use of the vaccine could
be lifted as early as this week.
VOA
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