* EMA says no causal link yet of blood clots to either
vaccine
* Four cases of blood clots in recipients of J&J shots
* J&J says working with regulators to assess data on its
vaccine
* Probe of AstraZeneca vaccine and blood clots already
ongoing
(Recasts, adds details, expert comment)
By Pushkala Aripaka and Julie Steenhuysen
April 9 (Reuters) - Europe's drug regulator said on Friday
that it is reviewing rare blood clots in four people in the
United States who received Johnson & Johnson's COVID-19
vaccine.
The European Medicines Agency's safety committee has also
been looking at how AstraZeneca's COVID-19 vaccine is
associated with very rare cases of unusual blood clots and said
it was now reviewing reports of capillary leak syndrome in
people given AstraZeneca's vaccine.
Johnson & Johnson (J&J) said it was aware of the rare
reports of blood clots in individuals given its COVID-19
vaccine, and was working with regulators to assess the data and
provide relevant information.
"At present, no clear causal relationship has been
established between these rare events and the Janssen COVID-19
vaccine," the company said in an emailed statement.
Of the four serious cases of clotting and low platelets,
three occurred in the United States during the rollout of J&J's
vaccine from its Janssen unit, the European Medicines Agency
(EMA) said. That was in addition to one person who died from a
clotting disorder reported in J&J's clinical trial.
Nearly 5 million people in the United States had received
J&J's vaccine as of Thursday morning, according to the U.S.
Centers for Disease Control and Prevention.
The report from the European Medicines Agency is the first
to mention a probe of blood clots associated with the J&J
vaccine.
The U.S. Food and Drug Administration said it would respond
shortly to a request for comment.
It follows a probe of blood clots in the brain reported in
people given the AstraZeneca vaccine that have caused some
European countries to change their vaccine recommendations.
In its report on Friday, EMA's safety committee said unusual
blood clots linked with low blood platelets should be listed as
very rare side effects of the AstraZeneca vaccine.
It has also started to investigate reports of capillary leak
syndrome - which causes blood vessel swelling and a drop in
blood pressure - in five people who received the AstraZeneca
vaccine. The safety panel said it was not clear whether these
were linked with the vaccine. AstraZeneca did not immediately
respond to a request for comment.
Ian Douglas, a professor of pharmacoepidemiology at London
School of Hygiene & Tropical Medicine, said the reports were
part of a normal process in which the EMA's safety committee
reviews important safety signals as they arise.
"It’s too early to comment on the signal of capillary leak
with the AZ vaccine, or clots with the Janssen vaccine, but from
what we’ve seen in the last few weeks, the EMA’s PRAC
(Pharmacovigilance Risk Assessment Committee) will doubtless
assess all the evidence they have as thoroughly and quickly as
possible," he said.
Some countries in Europe and Asia have restricted the use of
AstraZeneca's vaccine, Vaxzevria, in younger people following an
update by EU and UK regulators this week that found a link
between the events and the shot. Regulators have said the
benefits of the vaccine outweigh the risks.
Dr. Jesse Goodman, an infectious disease expert at
Georgetown University in Washington D.C. and a former chief
scientist for the U.S. Food and Drug Administration, said in a
briefing on Thursday that he was "fairly convinced" the brain
blood clots were linked with the AstraZeneca vaccine, but said
the events are rare and the risk during an active outbreak from
COVID "is much higher."
J&J's single-dose vaccine has been approved for EU use, but
a rollout is yet to begin. It is mainly being used in the United
States currently.
The J&J and AstraZeneca shots are two of the four approved
COVID-19 vaccinations in Europe.
(Reporting by Pushkala Aripaka, Manas Mishra in Bengaluru, Kate
Kelland in London, Julie Steenhuysen in Chicago, Deena Beasley
in Los Angeles; Editing by Shinjini Ganguli, Hugh Lawson and
Susan Fenton)
Astrazeneca (AZN)
