EU drug agency backs J&J jab despite clot links finding

BRUSSELS－The European Medicines Agency, or EMA, said on Tuesday it found a "possible link "between the Johnson & Johnson COVID-19 vaccine and cases of blood clots, but insisted the benefits of the jab outweigh the risks.

"A careful review of the cases and other available evidence has led us to affirm that these blood clotting disorders are very rare side effects of the vaccine," Sabine Straus, president of the EMA's safety committee, said at a news conference.

The medicines watchdog of the European Union was informed on April 13 of eight serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. All the cases occurred in the United States, where over seven million people received the J&J vaccine.

The EMA said in a statement that these events "should be listed as very rare side effects of the vaccine". 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 jab.

All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. The safety committee said the blood clots occurred mostly at unusual sites, together with low levels of blood platelets and sometimes bleeding.

Following EU's latest evaluation, Italy gave green light for the shot to regional vaccination centers and recommending it for people aged over 60.

The blood clots reviewed were very similar to cases that occurred with the vaccine developed by AstraZeneca, where the EMA also concluded its benefits outweigh the risks.

J&J last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe.

The EU has given authorization for four vaccines and three of them have been rolled out widely in the bloc. With a target of inoculating 70 percent of its adult citizens, the EU has administered over 100 million doses.

A total of 275 candidate vaccines are still being developed worldwide－91 of them in clinical trials in countries including Germany, China, Russia, Britain and the United States, said information released by the World Health Organization on Tuesday.

Shocking figures

Globally, the coronavirus had infected nearly 143,000,000 people and killed 3,044,475 as of Wednesday, a tally kept by Johns Hopkins University said.

India reported on Tuesday a new daily record of 295,041 coronavirus cases, as the death toll crossed 2,000 per day for the first time.

Even with hospitals struggling, Prime Minister Narendra Modi advised state governments against imposing a harsh lockdown in favor of micro-containment zones as he sought to avoid another economic slump.

The surge in India has exacerbated the slowdown in global vaccination campaigns. India is a major vaccine producer but was forced to delay deliveries of shots to focus on its domestic demand. So far, India has administered over 130 million doses of vaccines in a nation of nearly 1.4 billion since mid-January.

Overall, India has reported more than 15.6 million confirmed cases, the second highest in the world behind the United States.

Agencies - Xinhua