The advice came from advisers to the US Centers for Disease
Control and Prevention (CDC).
The vaccine was paused by the CDC and US Food and Drug
Administration (FDA) last week after eight "serious" cases of rare
blood clots associated with low blood platelets. One person died.
Johnson & Johnson's vaccine, which is given as a single
jab as opposed to two doses, has been given to almost eight million people in
the US.
The American government is now likely to quickly resume use
of the jab - also known as the Janssen vaccine.
The advisory panel voted 10-4 to reaffirm the vaccine's use
in adults. One member abstained.
Panellists who voted against said they were concerned women
might not be fully informed of the risks, or might not be told they could opt
for a different vaccine.
All eight US cases of blood clots were in people under 60,
with the majority women. They developed the condition within three weeks of
vaccination.
The FDA will update information about the risk and how to
identify and treat the condition, Johnson & Johnson executives told the
panel.
The EU medicines regulator, the EMA, said this week that the
clots should be listed as "very rare" side effects but stressed
overall benefits outweighed the risks.
They were "very similar to the cases that occurred with
the coronavirus vaccine developed by AstraZeneca", it added.
Johnson & Johnson decided to delay its rollout in Europe
out of an "abundance of caution" while US authorities investigated
the clots.
The vaccine has not yet been approved for use in the UK, but
30 million doses have been ordered.
A member of the US panel that recommended resuming use of
the jab said its benefits "clearly outweigh the risk from a population and
individual perspective".
"It's a new risk. It's admittedly an extremely small
risk and smaller than many other risks that we choose to take every day,"
said Dr Beth Bell from the University of Washington.
Johnson & Johnson's chief scientific officer, Paul
Stoffels, said the panel's advice was an "essential step toward continuing
urgently needed vaccinations in a safe way for millions of people in the
US".
He said the company would work with the CDC, FDA and
European authorities "to ensure this very rare event can be identified
early and treated effectively".
Earlier this month, the EMA resumed the rollout of the
AstraZeneca vaccine following similar reports of rare blood clots.
That vaccine has yet to be approved in the US.
0 comments:
Post a Comment