Regulators Lift Pause on Johnson & Johnson Vaccine

The FDA and CDC have lifted their recommended pause of the Johnson & Johnson vaccine, clearing the way for states to restart the distribution of the vaccine.

The vaccine, a single-dose viral vector vaccine, may have caused blood clots in several extremely rare cases, but regulators say the benefits of the vaccine far outweigh the miniscule risk observed in people who received the vaccine.

Out of more than 6.8 million people who received the Johnson & Johnson vaccine, only 6 had reported blood clots. Several of those people ended up hospitalized and one died.

“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” acting FDA Commissioner Janet Woodcock said. “We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality.”

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