Tag: Johnson and Johnson

Johnson & Johnson vaccine suspension – a doctor explains what this means for you

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A panel of experts met on April 14, 2021, to review evidence on blood clots that have been reported in seven people after they received the one-dose Johnson & Johnson COVID-19 vaccine. The panel, the Advisory Committee on Immunization Practices, or ACIP, advises the Centers for Disease Control and Prevention on immunization. It delayed voting on a recommendation to the CDC so that members can further evaluate risk and data. The clotting, which resulted in one woman’s death, led the CDC and FDA on April 13, 2021, to pause use of the J&J vaccine. Dr. William Petri, an infectious disease physician and immunologist at the University of Virginia School of Medicine, answers questions to help put this development in context.

What is this potential side effect of the J&J vaccine for COVID-19?

The potential side effect is a blood clot in the veins that drain blood from the brain. This is called central venous sinus thrombosis. In the vaccine-associated cases of this, platelets in blood, which are important for making clots, have been lower than normal. This same side effect has been seen in the AstraZeneca COVID-19 vaccine that also uses an adenovirus to deliver the coronavirus spike glycoprotein. In the case of the AstraZeneca vaccine, the clotting disorder has been linked to antibodies against platelet factor 4 (PF4) that are apparently induced by the adenovirus backbone of the vaccine. This antibody causes the clotting disorder by activating platelets to clot. 

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‘They didn’t like me’: Trump attacks Pfizer in conspiratorial rant after FDA pauses Johnson & Johnson vaccine

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This Tuesday, the Biden administration recommended a “pause” in using the single-dose Johnson & Johnson COVID-19 vaccine after reports of extremely rare blood clots in six people out of approximately 6.8 million doses that have been administered.

Former President Donald Trump took the opportunity to jump on the news, releasing a statement saying the Biden administration “did a terrible disservice to people throughout the world” in calling for the pause, adding that doing so would cause the “reputation” of the vaccine to be “permanently damaged.” 

“The people who have already taken the vaccine will be up in arms, and perhaps all of this was done for politics or perhaps it’s the FDA’s love for Pfizer,” Trump said.  Continue reading.

Drug executives: Big jump in vaccine supply is coming soon

WASHINGTON — COVID-19 vaccine makers told Congress on Tuesday to expect a big jump in the delivery of doses over the coming month, and the companies insist they will be able to provide enough for most Americans to get inoculated by summer.

By the end of March, Pfizer and Moderna expect to have provided the U.S. government with a total of 220 million vaccine doses, up sharply from the roughly 75 million shipped so far.

“We do believe we’re on track,” Moderna President Stephen Hoge said, outlining ways the company has ramped up production. “We think we’re at a very good spot.” Continue reading.

Johnson & Johnson seeks emergency FDA authorization for single-shot coronavirus vaccine

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Pharmaceutical giant Johnson & Johnson submitted its single-shot coronavirus vaccine to U.S. regulators Thursday afternoon for emergency use authorization after the vaccine was shown to be robustly effective against illness in a global trial — and especially at preventing severe disease and death.

The submission is “a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” Paul Stoffels, chief scientific officer of Johnson & Johnson, said in a statement. If the vaccine receives regulatory clearance by the Food and Drug Administration, it would be the third authorized shot in the United States — a much-needed addition to the tools public health officials have to build immunity as virus variants spread.

FDA officials announced that outside experts would discuss the vaccine at a public meeting three weeks from now, on Feb. 26. Continue reading.