Vaccine back with warning
AMSTERDAM: Johnson & Johnson (J&J) will resume introducing its Covid19 vaccine in Europe after the region’s medical regulator said the benefits of the shot outweighed the risk of very rare, potentially lethal blood clots.
Europe’s health regulator, the European Medicines Agency, yesterday recommended adding a warning about rare blood clots with low blood platelet count to the vaccine’s product label and said the benefits of the onedose shot outweighed its risks.
Use of the J&J vaccine was temporarily halted by US regulators last week after rare brain blood clots combined with a low blood platelet count were reported in six women, prompting the company to delay its rollout in Europe.
Nearly 8 million people in the US have received the shot.
J&J said a new label would include a warning on the risk of the rare side effect and instructions on how to recognise and treat it.
It would restart shipments to the European Union, Norway and Iceland, and was working on restarting clinical trials.
‘‘It’s an extremely rare event. We hope by making people aware as well as putting clear diagnostic and therapeutic guidance in place that we can restore the confidence in our vaccine,’’ J&J chief scientific officer Paul Stoffels said.
The Netherlands said it would use the vaccine starting today.
US authorities are reviewing the rare blood clots reported in people who got the shot. An advisory committee to is due to meet on Saturday and may make a recommendation. — Reuters