By Thomas M. Burton and Eric Sylvers
Europe's health agency said a warning should be added to the
product information of the Johnson & Johnson Covid-19 vaccine
that unusual blood clots are a very rare possible side effect, but
said the benefits of taking the shot outweigh the risks, even as
the number of clotting cases rose slightly.
In the U.S., the number of cases of blood-clot disorders linked
to the vaccine has increased to nine, up from the six initially
reported, according to a senior U.S. health official. The European
Medicines Agency said on Tuesday that it had looked at data from
the U.S. in making its assessment.
The nine U.S. cases, including one death, are being
investigated, the official said. Use of the J&J vaccine has
been temporarily suspended on the recommendation of the Food and
Drug Administration and Centers for Disease Control and
The instances of clots overall is still very small given that
about seven million doses of the vaccine have been administered in
Last week, U.S. health authorities recommended pausing the
rollout out of the J&J vaccine. They had considered only
issuing a warning, but decided a pause would help make doctors
aware of how to treat the rare condition. J&J then followed
with the decision to pre-emptively pause the rollout in Europe,
which had just begun.
An advisory committee to the CDC is scheduled to meet Friday to
advise the U.S. about the next course of action. Federal
authorities have been considering a possible age restriction -- the
U.S. cases were all in people 48 years old or younger -- or adding
cautionary language to doctors who use the vaccine.
Dr. Anthony Fauci, President Biden's chief medical adviser, on
Sunday predicted the pause would end as soon as Friday, perhaps
with additional restrictions or warnings.
The cases in the U.S. were similar to those that have occurred
with the AstraZeneca PLC vaccine in Europe, something that the EMA
said it took into consideration in making its recommendation. The
two vaccines use similar technology.
"We have already done a very detailed review of the risks and
cases with the AstraZeneca vaccine, which gave us the experience to
come to a conclusion in the context of the [J&J] vaccine," EMA
Executive Director Emer Cooke said at a briefing on Tuesday.
The EMA worked closely with the FDA while carrying out the
review and has commissioned more research to look into the blood
clotting issue, Ms. Cooke said.
Europe's slowly accelerating vaccine campaign should get a boost
from the conclusion of the J&J review. Before the company
halted deliveries, the EU expected to receive 55 million doses of
the vaccine in the quarter through June, accounting for roughly 13%
of 410 million expected doses in the period. But since the J&J
vaccine requires only one shot -- not two, like all other available
Covid-19 vaccines -- the deliveries could account for almost 25% of
In the U.K., where 20.6 million people had received at least one
dose of the AstraZeneca vaccine by April 5, there has been about
one case of unusual clotting with low platelets for every 200,000
shots given. There have been 22 deaths out of 99 cases. Overall in
Europe, there have been 287 cases up to April 13, the EMA said. The
agency didn't say how many of those resulted in deaths.
Most cases and deaths have been in women under 60 years old,
prompting many countries to restrict the use of the vaccine to
The U.S. official noted that more cases could still arise. The
cases so far involved blood clots in a major vein draining the
brain, while the patients had sharp drops in their blood platelets
and, in some cases, bleeding.
Because some of the patients got the wrong treatment -- the
blood-thinner heparin -- U. S. authorities issued a pause on the
use of the J&J vaccine.
The EMA warned healthcare providers and people who have received
the AstraZeneca or J&J vaccines to be on the lookout for
symptoms like shortness of breath, chest pain, leg swelling,
persistent abdominal pain and skin bruising beyond the area of the
injection. There can also be neurological symptoms such as severe
and persistent headaches and blurred vision.
"Early intervention by a specialist can change the outcome," Ms.
The AstraZeneca vaccine, like the J&J one, is known as an
adenovirus-vector vaccine, in which a virus causing the common cold
is altered to cause human cells to grow spikes similar to those of
the spike protein on coronavirus cells. The changes in a vaccine
recipient's cells cause an immune response to the coronavirus cells
that protects a large percentage of recipients against the
The AstraZeneca vaccine hasn't been authorized for use in the
The EMA's finding leaves in the hands of EU governments
decisions on whether to use the J&J vaccine and about any
restrictions. It remains unclear when J&J would resume European
Despite the controversy around the vaccine, J&J said the
product contributed $100 million to the company's sales growth in
the latest quarter, though the outlook for future sales is
uncertain. It is unclear whether publicity around the blood-clot
risk will hurt demand for the vaccine.
"We're cautiously hopeful that there is a very viable path
forward," Chief Financial Officer Joseph Wolk said on a conference
call with analysts. J&J said it remains committed to supply 100
million vaccine doses for U.S. use under a contract with the
Write to Thomas M. Burton at email@example.com and Eric Sylvers
(END) Dow Jones Newswires
April 20, 2021 14:32 ET (18:32 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.