AstraZeneca, J&J Working to Reduce Clot Risk in Their COVID-19 Vaccines, While EMA Scrutinizes J&J Data on Guillain-Barré Risk
AstraZeneca and Johnson & Johnson are looking at modifying their COVID-19 vaccines to reduce the risk of blood clots, while the European Medicines Agency (EMA), following the lead of the FDA, is analyzing data on rare cases of the nerve disorder Guillain-Barré syndrome (GBS) reported among people who had the J&J vaccine.
AstraZeneca and J&J are reportedly conducting early-stage research with the University of Oxford to determine the cause of the blood clots.
“AstraZeneca is actively working with the regulators and scientific community to understand these extremely rare blood-clotting events, including information to drive early diagnosis and intervention, and appropriate treatment,” an AstraZeneca spokesperson told FDAnews.
“We strongly support awareness of the signs and symptoms of this very rare event to ensure the correct diagnosis, appropriate treatment and expedited reporting by healthcare professionals,” a J&J spokesperson wrote in an email. “We also support continued research and analysis as we work with medical experts and global health authorities.”
Meantime, the EMA is analyzing data on rare cases of the nerve disorder Guillain-Barré syndrome reported among people who were administered J&J’s COVID-19 vaccine. Late Monday, the FDA said it would require J&J to add a warning label about the potential risk of contracting Guillain-Barre for anyone getting the shot.
The European regulator said its safety committee is analyzing data provided by J&J on cases of Guillain-Barré syndrome reported following vaccinations and has requested further detailed data.
Of the 100 preliminary reports of the syndrome, 95 were serious cases that required hospitalization and there was one reported death, the FDA said.
Most people recover from GBS within a few weeks, but some are left with long-term problems with coordination, balance and walking.
Around 12.8 million people have received J&J’s vaccine in the U.S., and about 18.6 million doses have been distributed throughout the European Union.
Last week, the EMA’s safety committee recommended that people who have previously had capillary leak syndrome — a rare condition that causes fluid leakage from small blood vessels — not be vaccinated with J&J’s COVID-19 vaccine. Of the three cases of capillary leak syndrome seen in people who had received the vaccine, two died. — Suz Redfearn