EU agency: Clot ‘very rare’ J&J vaccine side effect
THE HAGUE: Europe’s medicines regulator said Tuesday that blood clots should be listed as a “very rare” side effect of Johnson & Johnson’s coronavirus vaccine, but that the benefits of the shot still outweighed the risks.
The United States is expected to announce its decision on the single-shot J&J vaccine by Friday, as nations around the world urgently try to accelerate inoculation campaigns and revive their pandemic-ravaged economies.
The European Medicines Agency (EMA) assessment came as an EU official promised to have enough doses available to vaccinate 70 percent of European adults by the summer -- a boon for the continent’s sluggish rollout.
Europe’s Johnson & Johnson campaign was delayed after US health regulators said the shot should be paused over blood clot fears.
After reviewing isolated cases of clotting among people who received the vaccine, EMA’s safety committee said it found a “possible link” to the jab.
The regulator said its safety committee “concluded that a warning about unusual blood clots with low blood platelets should be added to the product information” for the J&J shot.
“This is a very rare effect,” EMA chief Emer Cooke told reporters. “But it also makes it very important for doctors and patients to be aware of the signs so that they can spot any concerns.”
Italy’s health authorities said that in light of the EMA ruling, the vaccine should be considered “definitively safe” but the country would prioritise its use for people aged over 60.
Only two countries had started administering the J&J shot before it was paused – the United States and South Africa – with more than seven million doses given out so far, according to an AFP tally.
The vaccine was praised as easier to administer and transport than some of its rivals, because it requires just one dose and can be stored at warmer temperatures.
The EU approved the J&J shot on March 3 and started taking deliveries on April 19, but has not yet started administering it to people.
A top Johnson & Johnson executive said Tuesday he hoped for a speedy resolution to the current pause.
“We remain very confident and very hopeful that the benefitrisk profile will play out,” chief financial officer Joseph Wolk told CNBC.
The J&J concerns follow similar reports of blood clots in a very small number of people who received the AstraZeneca shot.
The EMA also described those clots as a “very rare” side effect, stressing that the AstraZeneca jab’s benefits outweigh the risks.
Europe’s leaders are keen to accelerate vaccinations and expand availability after facing intense criticism over a slow rollout and with the public desperate for a return to some degree of normality. — AFP