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FDA Ends Pause on Johnson & Johnson COVID Vaccine

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The Food and Drug Administration and the Centers for Disease Control and Prevention lifted the ten-day pause on Johnson & Johnson’s coronavirus vaccine late Friday over concerns of a potential link to rare blood clots.

Along with ending the pause, the federal administration has edited the emergency use authorization for the vaccine to include a warning about the potential clotting issue and added a warning about the risk of rare blood clots in people with low platelet counts to fact sheets, Politico reported.

“The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19,” the agencies said in a news release.

“At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.”

The CDC is expected to release an analysis of the issue next week in its Morbidity and Mortality Weekly Report, according to Politico.

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“The science supports this news,” CDC Director Rochelle Walensky said during a news briefing Friday evening, according to Politico, adding that the agencies did not take the decision lightly.

The CDC and FDA recommended temporarily pausing the distribution of Johnson & Johnson’s vaccine on April 13 after the rare blood clot — known as thrombosis with thrombocytopenia — was found in six women, ABC News reported.

Fifteen women were diagnosed with the condition, and of those women, seven were hospitalized and three died, according to Fox News.

Before the pause was lifted, a CDC advisory panel voted 10-4 to resume the vaccine for adults 18 and over, Politico reported.

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Walensky added that even though the pause has been lifted, health care providers should explain the potential risks of the vaccine before it is given, especially to younger women.

“This risk trade-off is one that people have to individually measure for themselves,” Walensky said, according to Politico.

“We invite people to talk to their physicians.”

The FDA’s top vaccine regulator, Peter Marks, said the administration is recommending blood thinners for patients who develop severe blood clots after they are vaccinated.

The risk-benefit analysis found that out of a projected 9.8 million doses of the vaccine administered over the next six months, only 26 cases of clotting could occur.

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The CDC also found that all willing adults could be vaccinated 14 days sooner if the jab was given out at the same rate as it did before the pause.

“We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine,” Johnson & Johson’s chief scientific officer, Paul Stoffels, said in a statement Friday.

“We will continue to collaborate with the CDC, FDA and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively.”

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Erin Coates was an editor for The Western Journal for over two years before becoming a news writer. A University of Oregon graduate, Erin has conducted research in data journalism and contributed to various publications as a writer and editor.
Erin Coates was an editor for The Western Journal for over two years before becoming a news writer. She grew up in San Diego, California, proceeding to attend the University of Oregon and graduate with honors holding a degree in journalism. During her time in Oregon, Erin was an associate editor for Ethos Magazine and a freelance writer for Eugene Magazine. She has conducted research in data journalism, which has been published in the book “Data Journalism: Past, Present and Future.” Erin is an avid runner with a heart for encouraging young girls and has served as a coach for the organization Girls on the Run. As a writer and editor, Erin strives to promote social dialogue and tell the story of those around her.
Birthplace
Tucson, Arizona
Nationality
American
Honors/Awards
Graduated with Honors
Education
Bachelor of Arts in Journalism, University of Oregon
Books Written
Contributor for Data Journalism: Past, Present and Future
Location
Prescott, Arizona
Languages Spoken
English, French
Topics of Expertise
Politics, Health, Entertainment, Faith




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