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fda lifted johnson and johnson vaccine pause

FDA Lifted Johnson and Johnson Vaccine Pause

The pause on the Johnson & Johnson vaccine has been lifted per the advisement of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA.)

Per a number of outlets – including The New York TimesThe Wall Street Journal and The Washington Post – distribution and administration of the vaccine will start up again this weekend following concerns after the reporting of a handful of rare blood-clotting cases.

CDC committee chair Jose Romero said in a statement, “[The Johnson & Johnson vaccine] can be reinstituted and should be reinstituted. I acknowledge, as does everyone else, that these events are rare, but serious. It is our responsibility as clinicians to make sure that women understand this risk and, when possible, that they have an alternative at the same site that you’re administering the vaccine.”

Moving forward, the FDA and Johnson & Johnson will update the label on the vaccine to include verbiage about the very rare blood clot risk.

Last week, distribution and administration of the J&J vaccine were paused after six recipients of the vaccine experienced a rare blood clotting reaction. All six recipients were women between the ages of 18 and 48. At that time, “6.8 million doses of the Johnson & Johnson vaccine had been administered in the United States.

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2024