US health authorities have recommended a pause in the administration of the single dose Johnson & Johnson vaccine to investigate reports of rare and severe blood clots cases.
In a joint statement, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) noted that it is investigating blood clots in six women in the days after vaccination, in combination with reduced platelet counts.
“People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”
Because US states control their own health response, the health agencies framed their statement as a recommendation. Federal sites will, however, immediately pause administration of the vaccine.
All six women affected were between the ages of 18 and 48. Reports indicate that one woman has died, and another in Nebraska is hospitalized in critical care.
The FDA indicated in the joint statement that it has launched an investigation.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution.”
The blood clot concerns mirror those of drugs agencies in Europe and Australia over the AstraZeneca vaccine. AstraZeneca is not authorized in the US, and there have been no significant safety concerns;raised;about the two other vaccines that makeup the majority of US supply, from Pfizer-BioNTech and Moderna.
More than 6.8m J&J doses have been administered in the US. The vaccine is also under scrutiny by the European Medicines Agency, which is investigating four cases of clotting.
Blow to American immunization campaign
Officials say the pause in administration of the Johnson & Johnson vaccine is certain to be a blow to the American immunization campaign. The campaign was relying on the easy to administer doses, to rollout hundreds of thousands of jabs nationally.
Unlike vaccines developed;by;Pfizer and Moderna, Johnson & Johnson’s vaccine requires only one dose;to provoke immunity, and can be stored in a common refrigerator. Both Pfizer and Moderna’s vaccine require ultra-cold storage and a two-dose regiment.
Health agencies said the blood clotting concern is “extremely rare”. That rarity, they say, may in fact be part of the concern, as it may make it more difficult to recognize and treat.
The authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin. moreover
“In this setting, administration of heparin may be dangerous and alternative treatments need to be given.”
CDC’s Advisory Committee on Immunization Practices announced it will meet on April 13, to discuss the cases.
The pause also comes;as Johnson & Johnson, was recently;forced;to throw away between 13m and 15m doses of vaccine after a federal contractor;botched doses.
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