FDA Update & Statement on Johnson & Johnson COVID-19 Vaccine Pause Recommendation
On Tuesday, the FDA and Centers for Disease Control and
Prevention (CDC) issued a Statement
regarding the Janssen (Johnson & Johnson) COVID-19 Vaccine. Out of an
abundance of caution, the FDA and CDC recommended a pause in the use of this
vaccine while we review the data from six reported cases in the U.S. of a rare
and severe type of blood clot in people who received the vaccine. This pause
was recommended, in part, to ensure that the health care provider community is
aware of the potential for these adverse events and can plan for proper
recognition and management due to the unique treatment required with this type
of blood clot.
The FDA added three questions about the recommended pause in
the use of this vaccine to the Janssen
COVID-19 Frequently Asked Questions webpage and provided additional
information and answered questions, Tuesday during an online media briefing. A
recording of the call can be found on YouTube by clicking here.
American Medical Association President, Susan R. Bailey, MD,
hosted a conversation with Peter Marks, MD, PhD, Director of the Center for
Biologics Evaluation and Research at the Food and Drug Administration (FDA) as
part of its ongoing webinar series for physicians on COVID-19 vaccines. The
most recent webinar focused on the Johnson & Johnson (Janssen)
vaccine. You can view the webinar at this link.
An Emergency ACIP
meeting will be held to discuss the Johnson & Johnson COVID-19 vaccine next
Friday, April 23, 2021, 11:00 a.m. to 5:00 p.m. ET. The webcast link of the
meeting can be found here.
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