US recommends ‘pause’ for Johnson & Johnson vaccine over clot reports – Times of India

WASHINGTON: The US is recommending a “pause” in administration of the only-dose Johnson & Johnson Covid-19 vaccine to analyze reports of doubtlessly harmful blood clots.
In a joint assertion Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration mentioned they have been investigating clots in six girls that occurred within the days after vaccination.
The clots have been noticed together with diminished platelet counts — making the standard remedy for blood clots, the blood thinner heparin, doubtlessly “dangerous.”
More than 6.8 million doses of the J&J vaccine have been administered within the US, the overwhelming majority with no or delicate negative effects.
US federal distribution channels, together with mass vaccination websites, will pause the use of the J&J shot, and states and different suppliers are anticipated to observe. The different two authorised vaccines, from Moderna and Pfizer, are usually not affected by the pause.
CDC’s Advisory Committee on Immunization Practices will meet Wednesday to debate the circumstances and the FDA has additionally launched an investigation into the trigger of the clots and low platelet counts.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, Principal Deputy Director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research mentioned in a joint assertion.
They are recommending that individuals who got the J&J vaccine who’re experiencing extreme headache, belly ache, leg ache, or shortness of breath inside three weeks after receiving the shot contact their well being care supplier.
Officials say in addition they need to educate vaccine suppliers and well being professionals concerning the “unique treatment” required for this sort of clot.
The J&J vaccine obtained emergency use authorization from the FDA in late February with nice fanfare, with hopes that its single-dose and comparatively easy storage necessities would pace vaccinations throughout the nation.
Yet the shot solely makes up a small fraction of the doses administered within the US as J&J has been tormented by manufacturing delays and manufacturing errors on the Baltimore plant of a contractor.
Last week the drugmaker took over the power to scale up manufacturing in hopes of assembly its dedication to the US authorities of offering about 100 million doses by the top of May.
Until now concern concerning the uncommon blood clots has centered on the vaccine from AstraZeneca, which has not but obtained authorisation within the US Last week, European regulators mentioned they discovered a potential hyperlink between the pictures and a really uncommon sort of blood clot that happens along with low blood platelets, one which appears to happen extra in youthful folks.
The European Medicines Agency confused that the advantages of receiving the vaccine outweigh the dangers for most individuals. But a number of international locations have imposed limits on who can obtain the vaccine; Britain really helpful that folks underneath 30 be provided alternate options.
But the J&J and AstraZeneca vaccines are made with the identical know-how. Leading Covid-19 vaccines prepare the physique to acknowledge the spike protein that coats the outer floor of the coronavirus. But the J&J and AstraZeneca vaccines use a chilly virus, known as an adenovirus, to hold the spike gene into the physique. J&J makes use of a human adenovirus to create its vaccine whereas AstraZeneca makes use of a chimpanzee model.
The announcement hit US inventory markets instantly, with Dow futures falling virtually 200 factors simply over two hours earlier than the opening bell. Shares of Johnson & Johnson dropped virtually 3 per cent.

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