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FDA & CDC conference on J&J vaccines starting now - you can follow along here:
FDA Dr. Peter Marks: these events are "extremely rare" but safety is top priority. Fact sheet on the vaccine for providers will be updated.
CDC Anne Schuchat: pause needed to "prepare the health care system" to recognize and treat patients correctly, also to report events if they occur.
Pause will allow CDC expert committee ACIP to "review the situation."
Pause will allow CDC expert committee ACIP to "review the situation."
CDC Dr. Schuchat: "We're going to tell you what we know when we know it," will update public in days ahead.
FDA Dr. Marks: There have been over 180 million doses of Pfe and Mrna vaccines administered, haven't seen any similar reports.
FDA Dr. Woodcock: expect the pause to be a "matter of days"
CDC Dr. Schuchat: ACIP deliberation will review data on cases and possible subsets of the population that may be in a different category.
CDC Dr. Schuchat: ACIP deliberation will review data on cases and possible subsets of the population that may be in a different category.
FDA Dr. Marks: "probable" mechanism is some sort of immune response that happens very, very rarely that leads to activation of platelets.
FDA Dr. Marks: Issue here is not just CVT or thrombocytopenia. It's their occurrence together that makes a pattern. So we have to take the time to make sure we understand the complication.
CDC Dr. Schuchat: decided on the pause so the healthcare community could learn what they needed to learn on how to diagnose, treat and report.
FDA Dr. Marks: the issue is if we give the standard of treatment for blood clots, one can cause tremendous harm.
FDA Dr. Marks: the issue is if we give the standard of treatment for blood clots, one can cause tremendous harm.
CDC Dr. Woodcock: too few cases to say if there are any subpopulations particularly at risk. Aren't ready at this time to single out any subgroups.
FDA Dr. Marks: this is a recommendation and it's not a mandate. It's out of an abundance of caution.
However if an individual health care provider has a convo w/ individual patient & they determine the benefit/risk is appropriate, we're not going to stop HCP from administering.
However if an individual health care provider has a convo w/ individual patient & they determine the benefit/risk is appropriate, we're not going to stop HCP from administering.
FDA Dr. Marks: at this time, not clear there's any association with birth control (oral contraceptive). It's too early to make any speculation on how many cases will come out. It is possible we will learn of more.
