Federal health agencies requested an abrupt pause in the use of Johnson & Johnson’s single-dose coronavirus vaccine after six U.S. recipients developed a rare disorder involving blood clots within nearly two weeks of vaccination, officials said on Tuesday.
The Food and Drug Administration, along with the Centers for Disease Control and Prevention, announced the news on Twitter and will reportedly stop distributing the vaccine at federal sites and encourage states to do so while an investigation is underway for safety issues.
— U.S. FDA (@US_FDA) April 13, 2021
“Today FDA and @CDCgov issued a statement regarding the Johnson & Johnson #COVID19 vaccine. We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA announced at 7 a.m.
The six recipients who suffered from the blood clots were women between the ages of 18 and 48, officials said. One woman died, and a second woman in Nebraska has been hospitalized in critical condition.
The FDA said the pause for Johnson & Johnson rollouts would last a “matter of days,” according to the Washington Post.
Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, though the pharmaceutical company said no link to its vaccine had been established.
Around 6.8 million people in the country have received the single-dose vaccine so far, and roughly 9 million more doses have been shipped out to states, according to data from the CDC.
“This announcement will not have a significant impact on our vaccination plan,” Jeffrey Zients, White House coronavirus response coordinator, said in a Tuesday statement.
“Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date. Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans,” he added.
Following the announcement, Ohio Gov. Mike DeWine tweeted that state health officials are advising vaccine providers in the state to pause using the Johnson & Johnson vaccine.
In New York, the Johnson & Johnson vaccine will be replaced by Pfizer to avoid risking any slowing down of the vaccine rollout, according to a statement from Health Commissioner Howard Zucker.
Washington, D.C., canceled appointments for the Johnson & Johnson vaccine on Tuesday, and DC Health said it would reach out people to reschedule their appointments, a local NBC affiliate reported.
Out of 34 million recipients who took the Johnson & Johnson vaccine in Britain, the European Union, and three other countries, 222 people reported blood clots that were linked with a low level of platelets, 0.00000086% of the entire group.
Concerns about the atypical blood clots were raised last week about the AstraZeneca vaccine by European regulators. The shot does not yet have authorization in the U.S.
Regulators said they found a possible connection between the AstraZeneca shots and a rare type of blood clot that occurs with low blood platelets and is seemingly more likely to occur in younger people, the Associated Press reported.
Despite concerns surrounding AstraZeneca, the European Medicines Agency emphasized that the benefits of receiving a vaccine far outweigh the risks for most people. Some countries, such as the United Kingdom, have begun recommending people under 30 take alternatives to the AstraZeneca vaccine.
Author : Kaelan Deese
Source : Washington Examiner : Federal health agencies call to pause Johnson & Johnson vaccine after clotting cases