Johnson & Johnson (J&J) will resume rolling out its one-shot Covid-19 vaccine after Europe's medical regulator said the benefits of the J&J jab outweigh the risk.
The European Medicines Agency (EMA) on Tuesday recommended adding a safety warning about rare blood clots with low blood platelet count to the vaccine’s product label and ultimately concluded there were far more risks in contracting the virus than there would be taking the J&J vaccine.
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.
J&J said a new package label will include a warning on the risk of the rare side effect and instructions on how to recognize and treat it. The company said it would restart shipments to the European Union, Norway and Iceland, and is 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 during a conference call to discuss the company earnings.
The Pharmacovigilance Risk Assessment Committee (PRAC) – the regulator's safety committee – said that these events should be listed as very rare side effects of the vaccine.
President of the European Commission, Ursula von der Leyen, welcomed the decision and said it was “good news for the roll-out of vaccination campaigns across the EU.”
A consultant Haematologist has said it is likely the National Immunisation Advisory Committee (Niac) will approve the use of the J&J vaccine with the provision of an age limit, similar to the provisions put on the AstraZeneca vaccine, however, it is likely to be several days before Niac will issue advice on the use of J&J jab.
Norway is to begin administering the J&J vaccine on Wednesday.
Over seven million people in the United States have received the one-dose vaccine.
The J&J vaccine can be stored at normal refrigerator temperatures and is expected to be used around the world.