EU medicines watchdog finds possible link between J&J vaccine, blood clots

Brussels (Belgium), April21: The European Medicines Agency (EMA) said on Tuesday it had found a "possible link" between the Johnson & Johnson COVID-19 vaccine and cases of blood clots, but insisted that its benefits 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," said Sabine Straus, president of the EMA's safety committee, at a press conference.
On April 13, the medicines watchdog of the European Union (EU) was informed 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 Johnson & Johnson vaccine.
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 Johnson & Johnson jab.
All cases occurred in people under 60 years of age within three weeks after vaccination, the majority in women. The safety committee said that the blood clots occurred mostly at unusual sites such as in veins in the brain and the abdomen and in arteries, together with low levels of blood platelets and sometimes bleeding.
The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, which EMA had also concluded that its benefits outweigh its risks. There have been almost 300 cases of blood clots worldwide linked with the AstraZeneca vaccine.
Johnson & Johnson last week delayed the rollout of its single-shot jab across Europe pending the result of the EMA probe.
EMA executive director Emer Cooke said the recommendation was issued before the vaccine is distributed in the EU and this will "allow the vaccination programs in (EU) member states to take decisions on how to roll out the vaccines based on their national situation."
The EU has given marketing authorization for four COVID-19 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, and more than 27 million people have been fully vaccinated.
Meanwhile, 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, according to information released by the World Health Organization on Tuesday.
Source: Xinhua