Federal agencies today said they will stop using the single-shot Johnson & Johnson (J&J) COVID vaccine at mass vaccination sites while they investigate the vaccine’s possible link to potentially dangerous blood clots. States and other providers also are expected to pause vaccinations.
In a joint statement from the Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA), the agencies said they are investigating six cases of blood clots in the U.S. All six occurred in women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
One woman died and a second woman in Nebraska was hospitalized and is in critical condition, The New York Times reported.
The agencies said that until “that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.”
In addition to advising healthcare workers to report any adverse reactions to the Vaccine Adverse Event Reporting System, the agencies recommended people who have received the J&J vaccine and develop severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their healthcare provider.
Blood clots have also been linked to AstraZeneca’s COVID vaccine, which has not yet been approved in the U.S.
EU regulators on April 7 said they identified a “possible link” between AstraZeneca’s vaccine and blood clots, but said the benefits of the vaccine outweighed the risks. At the time, the European Medicines Agency said it was also investigating several reports of blood clots in recipients of the J&J vaccine.
On Monday, the FDA confirmed it is investigating blood clots in people who received the J&J vaccine.
A Mississippi family is demanding answers after 43-year-old Brad Malagerie suffered a mysterious stroke just hours after receiving the Johnson & Johnson COVID-19 vaccine.
Malagerie received the vaccine last week after leaving work from his office in D’Iberville around Noon. He went back to work after getting the shot where he was found a few hours later unresponsive, and colleagues had to rush him to the hospital.
“They called me and said he had that vaccine and something is wrong, we think it’s a stroke,” said Celeste Foster O’Keefe, Malagarie’s aunt.
The hospital found that Malagerie suffered a stroke likely due to a blood clot in his left middle cerebral artery. O’Keefe, who is also Malagerie’s boss, thinks it is a complication from receiving the vaccine as does the rest of his family.
“He’s a young, healthy 43-year-old, and I immediately thought it, and I said be sure to tell the doctors he took that J & J vaccine and that, to me, is what caused his stroke,” she said.
There are negative health effects from the stroke that may be permanent for Malagerie, and the entire family is devastated as a result of this tragedy.
“He can’t talk now and he can’t walk. He’s paralyzed on the right side. He knows who we are and he will just cry when he sees us,” O’Keefe said.
“At least we want him to be able to communicate, to be able to walk and talk again, even if it’s not perfect,” she added.
Big League Politics reported on how federal regulators have suggested a temporary pause on the Johnson & Johnson vaccine due to similar reports of blood clots developing in people who were recently injected with the shot:
“The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have called for the Johnson & Johnson vaccine to be temporarily halted after multiple reported cases of blood clots.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint press release. “Right now, these adverse events appear to be extremely rare.”
One woman has died after developing a rare disorder two weeks following the vaccination while another remains in critical condition. Johnson & Johnson’s vaccine production division, Janssen, is denying any culpability for the public health disaster.
“We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine,” Johnson & Johnson stated.
More than six million doses of the Johnson & Johnson vaccine have been administered so far.
No comments:
Post a Comment