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US recommends pause on J&J Covid-19 vaccine. What we know so far
Six cases of blood clots have been reported among people vaccinated with Johnson and Johnson (J&J) Covid-19 vaccine in the US.
The US Center for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) on Tuesday recommended a “pause” in the use of the Johnson and Johnson (J&J) Covid-19 vaccine “out of an abundance of caution” to probe reports of potentially dangerous blood clots. Six cases of blood clots have been reported among people vaccinated with Johnson and Johnson (J&J) Covid-19 vaccine in the US, reports said.
What we know about the vaccine so far:
FDA and the CDC will review the data of the development of a rare and severe type of blood clot in six individuals after they received the vaccine. The adverse effects cases reported in the US appear to be extremely rare and the treatment of this specific type of blood clot is different from the treatment that might typically be administered, said the FDA.
The six individuals who reported the adverse effects from the vaccine are women aged between 18 to 48 years. The regulators on the treatment of the effects said, reported CNBC, heparin, which is usually used to treat such symptoms will be dangerous in this case.
Johnson and Johnson denied any relation of the symptoms with its vaccine. The company in a statement said, “No clear causal relationship” has been identified between the blood clots and the shot. It is working closely with the regulators to review the data, CNBC quoted J&J as saying.
More than 6.8 million individuals have been administered the vaccine, as of Monday, the FDA informed.
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The regulators have recommended the pause till the process of investigation is not completed. “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases,” it said.
Prior to the reports of blood clots in individuals receiving the J&J vaccine, the AstraZeneca Covid-19 vaccine, which is not in use in the US, reported cases of similar symptoms. The European Medical Agency concluded that unusual blood clots with low platelet count be listed as "very rare side effects" of the AstraZeneca vaccine.
FDA issued emergency use authorization for single-dose Covid-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent the disease in individuals aged 18 and above in February. The administration of the vaccine in a single dose makes it unique from others.
“The J&J vaccine went into Phase III trials as a one-dose vaccine because earlier phase trials had shown strong immune responses after just one dose,” said UC San Francisco infectious disease expert Monica Gandhi in March.
