J&J Vaccine Benefits Outweigh Risks, EU Agency Says, as U.S. Cases Rise -- 2nd Update
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
that the benefits of taking the shot outweigh the risks.
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 Tuesday that it had looked at data from the
The nine U.S. cases 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 Prevention.
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.
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.
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 the unusual clotting with low platelets for every
200,000 shots given. There have been 22 deaths out of 99 cases. The
majority of 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 AstraZeneca vaccine, a similar type to 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 virus.
The AstraZeneca vaccine hasn't yet been authorized for use in
Write to Thomas M. Burton at firstname.lastname@example.org and Eric Sylvers
(END) Dow Jones Newswires
April 20, 2021 12:46 ET (16:46 GMT)
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