The US CDC and FDA have lifted their recommended pause on use of Johnson & Johnson’s coronavirus vaccine with a condition that it will now include a safety label warning that its vaccine comes with blood clot risks.
J&J vaccination shots were paused last week after nine rare side effects were reported. Seven of the reactions were seen in women.
Five medical experts voted in a committee meeting on whether to lift pause on J&J covid-19 vaccine.
Two U.S. officials suggested that vaccine should come with warning about rare side effects.
Officials said the CDC is unlikely to recommend an age restriction on who can receive J&J vaccination, but some members wanted a warning for young women.
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Dr Sarah Long, a Drexel University professor of pediatrics and one of committee members said, ‘I think almost surely this is going to turn out to be related to the vaccine because of the clustering and because of the extraordinary, unusual presentation and findings of the patients who have it,’
The panel debated various possibilities, including recommending restricted use of the vaccine, but finally voted simply on the option to recommend use of the vaccine as it had been before — in all adults over the age of 18.
The FDA updated fact sheets (read below) accompanying the vaccine, indicating that women under the age of 50 should be aware of the risk of a rare blood clotting syndrome associated with the vaccine.
Here is what the FDA updates Fact Sheet on J&J COVID-19 vaccine say:
Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of thrombosis involving the cerebral venous sinuses and other sites (including but not limited to the large blood vessels of the abdomen and the veins of the lower extremities) combined with thrombocytopenia and with onset of symptoms approximately one to two weeks after vaccination.
Most cases of thrombosis with thrombocytopenia reported following the Janssen COVID-19 Vaccine have occurred in females ages 18 through 49 years; some have been fatal.
The clinical course of these events shares features with autoimmune heparin-induced thrombocytopenia.
In individuals with suspected thrombosis
with thrombocytopenia following the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed.
As reported by GreatGameIndia, German scientists have recently found the exact 2 step process how the AstraZeneca COVID-19 vaccine causes blood clots in recipients.
Scientists believes the mechanism linking the vaccine with the rare clotting reactions is likely to apply to other vaccines that also use adenoviruses to ferry instructions for making the virus’s spike protein into cells.
They describe a series of events that has to happen in the body before the vaccines create these large clots.
“This is, in my opinion, rock-solid evidence,” said Andreas Greinacher, MD, head of the Institute of Immunology and Transfusion Medicine, University Hospital Greifswald, Germany, who was among the first scientists in the world to link the rare clots to antibodies against a key protein in platelets.
Meanwhile, for reporting extensively on the blood clots controversy, GreatGameIndia is being targeted and being accused of spreading misinformation for the flimsy reason that our tweets were shared widely after the controversy.