US Advises Pause for J&J COVID-19 Vaccine After Reports of Blood Clots
BY ZACHARY STIEBER April 13, 2021 Updated: April 13, 2021
U.S. health officials are recommending Johnson & Johnsons COVID-19
vaccine not be used until an investigation into cases of
post-vaccination blood clots is finished.
The six cases, all among women, involve a rare and severe type of clot
called cerebral venous sinus thrombosis in combination with low levels
of blood platelets, officials told reporters in a call on April 13.
One of the patients died while a second is in critical condition at a
The patients are between the ages of 18 and 48, who experienced the
symptoms between six and 13 days after getting the COVID-19 vaccine.
Right now, these adverse events appear to be extremely rare, Dr. Peter
Marks, director of the Food and Drug Administrations (FDA) Center for
Biologics Evaluation and Research, said on the call.
More than 6.8 million doses of Johnson & Johnsons shot have been
administered in the United States as of April 12.
In response to the cases, the Centers for Disease Control and
Prevention (CDC) is convening a meeting of its vaccination advisory
committee on April 14 to review and assess their potential
significance. The Food and Drug Administration, along with an
investigation into the cases themselves, will review that analysis.
Until the probe is complete, health officials and drug regulators are recommending a pause in the use of the vaccine out of an abundance of
While these events are very rare, were recommending a pause in the use
of the J&J COVID-19 vaccine in order to prepare the health care
system, to recognize and treat patients appropriately, and to report
severe events they may be seeing in people whove received the J&J
vaccine, said Dr. Anne Schuchat, principal deputy director of the CDC.
Treatment of the specific type of blood clot is different from
treatments that might be typically administered. Usually, clots are
treated with heparin, an anticoagulant drug, but using the drug to
treat cerebral venous sinus thrombosis may be dangerous.
While the definitive cause of the clots hasnt been identified, Marks
speculated that the incidents stem from an immune response to the vaccine.
The person being vaccinated makes an immune response potentially, that
actually involves their own platelets or other parts of the
coagulation system, and can cause this problem. And thats the sort of
leading theory or hypothesis about whats going on here, said Janet
Woodcock, another FDA official.
CVS, Walgreens, and a number of states, including Massachusetts and
New York, said they would stop giving Johnson & Johnsons vaccine in
light of the federally recommended pause. The Pentagon also is halting
the use of the J&J shot.
The pause is appropriate, and its obviously being done to be very
careful, to be very prudent, to carefully examine these cases for a
possible association with the vaccine, Dr. Mark Rupp, chief of the
University of Nebraska Medical Centers Division of Infectious
Diseases, told reporters in a Zoom call. Its a demonstration that the
Vaccine Adverse Event Reporting System really is working.
One of the six cases happened at the medical center.
Johnson & Johnson told The Epoch Times in a recent statement that the
company was aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines.
Our close tracking of side effects has revealed a small number of very
rare events following vaccination. At present, no clear causal
relationship has been established between these rare events and the
Janssen COVID-19 vaccine. Janssen is a J&J unit.
In an update on April 13, the company said that in light of the
federal recommendation, the company is delaying the rollout of its
vaccine in Europe.
We have been working closely with medical experts and health
authorities, and we strongly support the open communication of this
information to healthcare professionals and the public, Johnson &
Johnson & Johnsons vaccine hasnt yet been administered in Europe. The
United States was one of the first countries in the world to authorize
While health officials are raising concerns about blood clots, drug
regulators havent revoked the emergency use authorization (EUA),
former Food and Drug Administration Commissioner Scott Gottlieb said
on CNBCs Squawk Box.
They didnt revoke the EUA, they didnt order this off the market. This
was a requested pause which is an awkward regulatory step but it
reflects a level of caution not to appear too forcefully here, he
White House officials said the pause wouldnt affect the governments
At least four mass vaccination sites have suspended administering
vaccines in recent days because of sets of adverse reactions following
shots from the New Jersey-based company, including Cumming Fairgrounds
in Georgia and PNC Arena in North Carolina. Other smaller sites have
also suspended injections because of similar reactions.
Adverse reactions included dizziness, lightheadedness, and sweating
symptoms, among others, a CDC spokesperson told The Epoch Times via email.
In an April 12 statement, the agency said it analyzed the vaccine lots
that were used at the sites and has not found any reason for concern.
At the time, the CDC said it and Food and Drug Administration
officials werent recommending a pause in the administration of J&J
The European Medicines Agency announced last week it was probing cases
of blood clots forming in people who had received the shots in the