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Vials of Moderna's COVID-19 vaccine are seen in
Bridgeport, Conn., in a file photograph.
(Joseph Prezioso/AFP via Getty Images)

EUROPE


Regulator Reviewing Reports of ‘Rare’ and
Serious Condition Linked to Moderna Vaccine


BY JACK PHILLIPS
November 11, 2021
Updated: November 11, 2021


Europe’s drug regulator on Thursday confirmed it is investigating reports
of a blood condition in recipients of Moderna’s mRNA COVID-19 vaccine.

According to a bulletin posted by the European Medicines Agency (EMA),
it is reviewing six cases capillary leak syndrome, considered a “very rare disorder,”
after they were reported in the EMA’s EudraVigilance database.

“At this stage, it is not yet clear whether there is a causal association between
vaccination and the reports of capillary leak syndrome,” the EMA wrote on
Thursday, adding that “these reports point to a safety signal … information
on new, or changes in, adverse events that may potentially be associated
with a medicine or vaccine and that warrant further investigation.”

The review also will address the risk of capillary leak syndrome in groups
who have a medical history of the disorder.

As a result, EMA researchers will “evaluate all the available data to decide
if a causal relationship is considered likely or not,” the bulletin reads.

It also noted there is “currently insufficient evidence” of a link between
Moderna’s vaccine and cases of multisystem inflammatory syndrome.

Capillary leak syndrome, according to the Mayo Clinic, is a rare disorder involving
repeated leaks of large amounts of plasma from blood vessels into nearby
body cavities and muscles. The condition—known as Clarkson’s disease—can
result in a sharp drop in blood pressure that can lead to organ failure or even death.

“Attacks may be triggered by an upper respiratory infection or intense physical
exertion. The frequency of attacks can range from several a year to a single
instance in a lifetime,” says the clinic.

Symptoms include nausea, fatigue, irritability, muscle aches, more thirst,
or a sudden increase in body weight, the clinic’s website says.

Earlier in the year, the EMA’s safety committee concluded that capillary leak syndrome
should be added to the product information as a side effect of AstraZeneca’s vaccine,
which uses different technology than Moderna’s.

Outside of the European Union, Canada’s health agency earlier this year updated
the label for the Oxford-AstraZeneca and Covishield COVID-19 vaccines to add
capillary leak syndrome as a possible side-effect. The Canadian agency included
a warning for individuals with a history of the ailment to not receive those vaccines.

U.S., European, and Canadian health officials have previously stated that the
Moderna COVID-19 vaccine’s benefits outweigh the potential risks.

“Like all medicines,” the EMA said on Thursday, “this vaccine can cause side effects,
although not everybody will experience them. The most common side effects
known for [Moderna’s vaccine] are usually mild or moderate and get better within
a few days after vaccination.”

Moderna this week confirmed it is seeking to expand the conditional license for
its COVID-19 vaccine in the European Union to include children
between the ages of 6 and 11.

Moderna has not responded to several requests for comment.

COVID-19 is the illness caused by the CCP
(Chinese Communist Party) virus.