U.S. FDA to scrutinize vaccine design behind COVID-19 shots linked to blood clots

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With two COVID-19 vaccines now under scrutiny for possible links to very rare cases of blood clots in the brain, U.S. government scientists are focusing on whether the specific technology behind the shots may be contributing to the risk

FILE PHOTO: Boxes of the Johnson & Johnson COVID-19 vaccine are seen at the McKesson Corporation, in ShepherdsvilleBy Julie Steenhuysen and Kate Kelland

The U.S. Food and Drug Administration on Tuesday recommended temporarily halting use of the Johnson & Johnson vaccine after reports of six cases of CVST in women under age 50 among some 7 million people who received the shot in the United States. The U.S. agency will analyze data from clinical trials of several vaccines using these viral vectors, including J&J's Ebola vaccine, to look for clues.

"It's plainly obvious to us already that what we're seeing with the Janssen vaccine looks very similar to what was being seen with the AstraZeneca vaccine," Marks said. "We can't make some broad statement yet, but obviously, they are from the same general class of viral vectors."In Europe, scientists are exploring a number of hypotheses, including looking more broadly at the way the SARS-CoV-2 virus itself affects blood coagulation.

"It would be interesting to know more about Sputnik V - also a similar adenovirus vaccine," Altmann said. The Russian vaccine developed by the Gamaleya Institute in Moscow uses two different human cold viruses - including the Ad26 virus in the J&J shot. Moore, who took part in an informal White House briefing with other scientists on Tuesday, said the FDA and U.S. Centers for Disease Control and Prevention are working closely with health officials in Europe to determine whether the syndromes linked to the AstraZeneca and J&J vaccines are the same.

 

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