Federal regulators green light J&J/Janssen vaccine

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Delaware plans to resume Johnson & Johnson/Janssen vaccine doses next week after the Food and Drug Administration and the Centers for Disease Control and Prevention determined the pause should be lifted.

According to a Delaware Division of Public Health dashboard, 28,000 one-dose J&J/Janssen vaccines have been administered out of about 47,000 doses available in the state.

About a quarter of a million Delawareans have been fully vaccinated with the two-dose Moderna and Pfizer vaccines.

News of the pause brought mixed reactions, with some critics claiming it would increase vaccine hesitancy. Others said it would show that federal regulators are focused on safety, even when rare side effects appear.

After reports of six cases from a rare and severe type of blood clot in individuals following administration of the vaccine, the pause was recommended by regulators. One reason for the pause was to alert health care providers on specific treatments needed for rare cases.

During the pause, medical and scientific teams at the FDA and CDC examined available data.

Teams at FDA and CDC also conducted outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS).

The two agencies determined the following:

  • Use of the vaccine should be resumed in the United States.
  • The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.
  • The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

“Above all else, health and safety are at the forefront of our decisions,” said CDC Director Dr. Rochelle P. Walensky. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen Covid-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized Covid-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death.

The agencies confirmed that a total of 15 cases of TTS have been reported, including the original six reported cases, with two deaths reported. These cases occurred in women between the ages of 18 and 59, with a median age of 37 years. Reports indicated symptoms appeared between six and 15 days after vaccination.

About seven million doses of the J&J vaccine have been administered nationwide.

Before the pause, the supply of J&J/Janssen vaccine had been limited in Delaware and elsewhere by production problems at a Maryland contract plant that accidentally mixed does of the J&J/Janssen vaccine with a yet-to-be-approved AstraZeneca vaccine.

Earlier this week, Gov. John Carney said he had his “fingers crossed” regarding a go-ahead for the J&J vaccine. The one-dose vaccine could more rapidly boost the percentage of fully vaccinated Delawareans since it requires only a single dose.

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