Johnson & Johnson announced Tuesday that it will resume the distribution of its COVID-19 vaccine in Europe after the European Union’s (EU) medical regulator approved of the same but with a safety warning, per Reuters.
The European Medicines Agency (EMA) recommended adding a warning about rare blood clots with low blood platelet count to the vaccine’s product label, citing that the benefits of the one-dose shot outweigh its risks.
J&J Chief Scientific Officer Paul Stoffels said: “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 said it would fulfill its commitments to ship 200 million doses in Europe and 100 million in the United States.
more to come …