European Union’s drug regulator said it has found a possible blood clot link with the Johnson & Johnson vaccine but stressed the benefits of the shot outweigh the risk, coming about a week after U.S. health regulators recommended a pause.
The European Medicines Agency (EMA) said its “safety committee concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen,” according to a statement published Tuesday.
“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination,” the statement added.
The agency said it researched at least eight reports, including a death, from the United States about cases involving unusual blood clots occurring after the COVID-19 vaccine was administered. It noted that more than 7 million people in the United States have been given the single-shot vaccine so far.
“All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. Based on the currently available evidence, specific risk factors have not been confirmed,” EMA added.
Earlier this month, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) declared that J&J’s vaccine shot should be suspended “out of an abundance of caution” due to the reports of blood clots.
And J&J, as a result, confirmed that it will now delay the rollout of the shot in Europe.
Last week, South Africa suspended its use of the vaccine in the wake of the U.S. pause, and countries including Italy, Romania, the Netherlands, Denmark, and Croatia put their J&J doses into storage.
The delay was a further blow to vaccination efforts in the European Union, which have been plagued by supply shortages, logistical problems, and concerns over unusual blood clots also in a small number of people who received the AstraZeneca COVID-19 vaccine. Experts worry the temporary halt on J&J’s shot could further shake vaccine confidence and complicate worldwide COVID-19 immunization efforts.
Following the FDA and CDC statements, some Republicans, including former President Donald Trump, said the pause in using the J&J vaccine is was poorly conceived.
Trump, in an interview with Fox News’s Sean Hannity on Monday night, noted that “what the FDA did with Johnson & Johnson is so stupid,” referring to last week’s decision by the agency.
“That’s the worst thing you could have done from a public relations standpoint. And it probably even affects the other vaccines a little bit,” the former president commented.
The Epoch Times has contacted J&J for comment.
COVID-19 is the illness caused by the CCP (Chinese Communist Party) virus.
The Associated Press contributed to this report.