J&J COVID-19 vaccine with a warning label about rare clots receives OK from CDC advisory panel

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J&J COVID-19 vaccine with a warning label about rare clots receives OK from CDC advisory panel

Fri, 2021-04-23 17:26 — mike kraft

Johnson & Johnson vaccine use should resume with a warning about risk of rare blood clots, CDC advisers recommend If the United States lifts the pause on the vaccine's use with a warning added to the label, the position would be similar to one taken by Europe’s drug regulator. Lena H. Sun, Carolyn Y. Johnson Washington Post

Breaking: A Centers for Disease Control and Prevention advisory committee recommended Friday that inoculations with the Johnson & Johnson vaccine resume. The vaccine would carry a warning about a rare risk of blood clots in recipients. The director of the CDC has the final call on whether vaccinations should restart.

A federal vaccine advisory committee that reconvened Friday to discuss next steps for Johnson & Johnson’s coronavirus vaccine heard data about 15 confirmed cases of the rare and severe blood clots that prompted federal officials to recommend last week that states pause use of the vaccine.

All the cases were in women, including three who died and seven who remain in the hospital. The 15 cases include the six cases of blood clots previously identified by officials in women between the ages of 18 and 48. The 15 cases were identified among nearly 8 million doses of the vaccine administered as of April 21.

Officials from the Centers for Disease Control and Prevention who presented the data Friday said it was too early to conclude that the incidents affected only women and said a few cases in men were being reviewed.

The independent expert panel, the Advisory Committee on Immunization Practices, is reviewing the data as part of the next steps for the vaccine after the CDC and the Food and Drug Administration recommended a temporary halt April 13 in giving the vaccine following initial reports of blood clots in those six women. ...

Any advisory panel recommendation would need to be approved by CDC director Rochelle Walensky.

If the United States lifts the pause and adds a warning to the vaccine’s label, the position would be similar to one taken by Europe’s drug regulator, the European Medicines Agency, which said this week the Johnson & Johnson vaccine should carry a warning but placed no restrictions on its use. The European agency said the shot’s benefits continue to outweigh the risks. ...

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