US CDC, US FDA lift pause on using J&J's coronavirus vaccine, add safety warning

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JUST IN: The US Centers for Disease Control and Prevention and Food and Drug Administration have lifted their pause on the Johnson & Johnson COVID vaccine, following the recommendation of a group of CDC advisers | via CNN

The US Centers for Disease Control and Prevention and US Food and Drug Administration lifted their recommended pause on use of Johnson & Johnson's coronavirus vaccine Friday and said the label will be updated to warn of blood clot risks.

ACIP members worried that taking one of only three vaccines out of the mix available to Americans would slow efforts to immunize the population against a virus that has killed more than half a million people in the United States. Plus, they agreed that having a one-shot vaccine that doesn't need to be stored in freezers was valuable and would be preferred by many people who do not want to come back for a second dose, or who would struggle to make two vaccination appointments.

Some members of the committee were unhappy with the decision and the vote was not unanimous. Four members voted against the recommendation. Dr. Pablo Sanchez, a pediatrician at Ohio State University, also wanted ACIP to include more guidance with its recommendation."I have no problem with the continued availability of this vaccine," he said."But I think that we are just making a blanket recommendation," he added."I think we have to have stronger language."

"We are awaiting and anticipate that the FDA will be putting out a new, a newly approved EUA language," Cohn said. American Medical Association president Dr. Susan Bailey said her organization would help get the word out about risks. Treatment includes using blood thinners, but not heparin, as well as an immune product called IVIG to regulate the antibody response.The US CDC's Dr. Sara Oliver presented the results of several models laying out what might happen if the vaccine is used again, including with restrictions on use in certain groups. The US CDC took into consideration deaths from coronavirus and the likelihood that people would get vaccinated more quickly if the Janssen vaccine was in the mix.

 

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