FDA Restrictions on J&J Vaccine Haven’t Disrupted Suppliers

The decision by the Food and Drug Administration to restrict the use of Johnson & Johnson’s COVID-19 vaccine will not have a significant impact on health systems.

The FDA has reduced its emergency use authorization for a vaccine developed by J&J and its subsidiary Janssen Pharmaceuticals because it caused a rare bleeding disorder in 60 patients out of 18.7 million doses administered. The agency said the vaccine should only be used in adults who would otherwise be left unvaccinated or who cannot receive the Pfizer and Moderna vaccines.

Most patients have received Pfizer and Moderna mRNA vaccines, several health systems say, with vendors holding minimal amounts of J&J vaccine. The J&J vaccine accounts for only about 3.4% of the 578 million doses of the COVID-19 vaccine administered, according to the Centers for Disease Control and Prevention.

None of Yale New Haven Health’s patients had serious side effects from the J&J vaccine, and most received an mRNA booster, said Dr. Om Deshpande, vice president of Health and Clinical Financial Services at Yale New Haven Health.

“We have not received any significant feedback since the last FDA recognition,” she wrote in an email, adding that the healthcare system is working closely with J&J patients as new data become available. Yale New Haven Health did not have data on whether patients who received the J&J vaccine received more aftercare than those who received the Pfizer or Moderna vaccine.

Both Yale New Haven Health and the University of Utah Health have maintained a minimum amount of the J&J vaccine.

The J&J vaccine has been difficult to obtain, likely limiting its distribution through the healthcare supply chain, said Erin Fox, senior director of pharmacy at the University of Utah Health.

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